The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: 112830 (Hib-MenC-TT-035 EXT: 10PN-PD-DIT-017) Title: Persistence of antibodies after full vaccination course with GSK Biologicals Menitorix or MenC conjugate vaccine, coadministered with DTPa or DTPa/Hib containing vaccine and pneumococcal conjugate vaccine, in children up to 6 years of age Menitorix : (Hib-MenC): GlaxoSmithKline (GSK) Biologicals Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine MenC conjugate vaccine: - Meningitec (MenC-CRM197): Pfizer s (formerly Wyeth) meningococcal serogroup C CRM197 conjugate vaccine - NeisVac-C (MenC-TT): Baxter s meningococcal serogroup C tetanus toxoid conjugate vaccine DTPa containing vaccine: - Infanrix penta (DTPa-HBV-IPV): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine - Infanrix IPV (DTPa-IPV): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, inactivated polio vaccine DTPa/Hib containing vaccine: - Infanrix hexa (DTPa-HBV-IPV/Hib): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio and Haemophilus influenzae type b vaccine - Infanrix IPV/Hib (DTPa-IPV/Hib): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b vaccine Pneumococcal conjugate vaccine: - Prevenar (7Pn): Pfizer s (formerly Wyeth) 7-valent pneumococcal conjugate vaccine - Synflorix (10Pn): GSK Biologicals 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate vaccine Rationale: The aim of the study was to assess the long-term antibody persistence at 3, 4 and 6 years of age in children who previously received a full vaccination course (primary and booster vaccination) with Hib-MenC or MenC conjugate vaccines (MenC-CRM197 or MenC-TT vaccine) co-administered with DTPa - or DTPa/Hib - containing vaccine and pneumococcal conjugate vaccine (10Pn or 7Pn vaccine) in the primary vaccination study 10PN-PD-DIT-011 (107005) and booster vaccination study 10PN-PD-DIT-017 BST: 011 (109507). This summary presents data up to Month 36 of age (i.e. approximately 2 years post booster vaccination). This summary will be updated when additional data become available. For data on the booster study please refer to the CTRS of study 10PN-PD-DIT-017 (109507) and for the primary vaccination phase refer to the CTRS of study 10-PN-PD-DIT-011 (107005). Phase: III Study Period: 14 May 2009 to 24 June 2010 (data lock point at Month 36) Study Design: Open, controlled, multi-centre study with 4 parallel groups Centres: 28 centres (23 in Germany, 3 in Poland and 2 in Spain) Indication: Immunisation against Streptococcus pneumoniae, Neisseria meningitidis serogroup C, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B and polio of healthy male or female children. Treatment: No study vaccines were administered during this study. The subjects received primary vaccination during study 107005 (10PN-PD-DIT-011) and booster vaccination during study 109507 (10PN-PD-DIT-017 BST: 011). The study groups were the same as in the primary and the booster studies: Pn-Men Group: subjects received 10Pn, MenC-CRM and DTPa-HBV-IPV/Hib vaccines during primary vaccination (all subjects) and a booster vaccination of 10Pn, MenC-CRM, DTPa-HBV-IPV/Hib (Germany and Poland) or DTPa-IPV/Hib (Spain) vaccines Pn-Neis Group: subjects received 10Pn, MenC-TT and DTPa-HBV-IPV/Hib vaccines during primary vaccination (all subjects) and a booster vaccination of 10Pn, MenC-TT and DTPa-HBV-IPV/Hib (Germany and Poland) or DTPa- IPV/Hib (Spain) vaccines Pn-HibC Group: subjects received 10Pn, Hib-MenC and DTPa-HBV-IPV vaccines during primary vaccination (all subjects) and a booster vaccination of 10Pn, Hib-MenC and DTPa-HBV-IPV (Germany and Poland) or DTPa-IPV (Spain) vaccines Pr-HibC Group: subjects received 7Pn, Hib-MenC and DTPa-HBV-IPV vaccines during primary vaccination (all subjects) and a booster vaccination of 7Pn, Hib-MenC and DTPa-HBV-IPV (Germany and Poland) or DTPa-IPV (Spain)
vaccines Pneumococcal vaccines, DTPa- or DTPa/Hib containing vaccines and Hib-MenC vaccine were administered at 2, 4, 6 and the booster dose at 11 to 18 months of age. The primary doses of MenC-CRM and MenC-TT were administered at 2 and 4 months of age and the booster dose at 11 to 18 months of age. To comply with the national vaccination schedule, the Polish subjects of groups Pn-Men and Pn-Neis received a third primary dose of MenC-CRM or MenC-TT after the last blood sample of the primary phase was taken at 7 months of age. Objectives: To evaluate the antibody persistence with respect to the meningococcal serogroup C (MenC) component of the Hib- MenC vaccine in terms of percentage of subjects with meningococcal serogroup C serum bactericidal titres using rabbit complement (rsba-menc) 1:8. Primary Outcome/Efficacy Variable: Persistence of immunogenicity with respect to components of the Hib-MenC conjugate vaccine at 3, 4* and 6* years of age - rsba-menc titres 1:8 * This summary presents data up to Month 36 months of age (Year 2 post-booster) only. It will be updated when additional data become available. Secondary Outcome/Efficacy Variable(s): Immunogenicity Persistence of immunogenicity with respect to components of the Hib-MenC conjugate vaccine, at 3, 4* and 6* years of age: - rsba-menc titres 1:128 and titres. - Anti-polyribosyl-ribitol phosphate (PRP) antibody concentrations 0.15µg/mL, 1.0 µg/ml and concentrations. Persistence of immunogenicity with respect to components of the 10Pn vaccine, at 3, 4* and 6* years of age. - Antibody concentrations against vaccine pneumococcal serotypes - Opsonophagocytic activity against vaccine pneumococcal serotypes - Concentrations of antibodies against protein D Persistence of immunogenicity of anti-hepatitis B antibodies, at 3, 4* and 6* years of age. - Anti-hepatitis B surface antigen (HBs) antibody concentrations 10 miu/ml, 100 miu/ml and concentrations. Safety Serious Adverse Events (SAEs) occurring from the last study contact of the booster study 109507 (10PN-PD-DIT-017 BST: 011) to the end of this persistence study. Note: at each visit of this long-term persistence study (i.e. at 3, 4* and 6* years of age), the subject s parents/guardians were asked if any SAE had occurred since the last visit. Only those SAEs that were determined by the investigator to have a causal relationship to the vaccination, as well as the SAEs related to study procedures were recorded and described individually, along with the nature of the SAEs and the outcome. Any event related to lack of vaccine efficacy (i.e. lack of efficacy related to the Hib-MenC, 10Pn-PD-DiT conjugate vaccines and hepatitis B vaccine during the longterm persistence phase) or related to study participation was described in details. * This summary presents data up to Month 36 of age (Year 2 post-booster) only. This summary will be updated when additional data become available. Statistical Methods: The analysis was performed on the Total Enrolled cohort Month 36 and the According-To-Protocol (ATP) cohort for antibody persistence at 36 months of age. The Total Enrolled cohort Month 36 included all subjects vaccinated in the booster study (10PN-PD-DIT-017 BST: 011) and part of the blood sample subset. ATP cohort for antibody persistence at 36 months of age included all evaluable subjects who received the full vaccination course corresponding to their group in the primary study 107005 (10PN-PD-DIT-011) and in the booster study 109507 (10PN-PD-DIT-017 BST: 011), who had available assay results at Month 36, who had not received a meningococcal serogroup C vaccine, Hib vaccine, pneumococcal vaccine, hepatitis B vaccine or a product forbidden by the protocol before Month 36, who did not have a history of meningococcal serogroup C, pneumococcal disease, Hib or hepatitis B disease before Month 36, who complied with the age defined in the protocol for Month 36, who did not have an immunocompromising medical condition and who had not received any immunosuppressant(s) or other immune modifying drug(s), immunoglobulins, any blood products, investigational drugs, and/or investigational vaccines.
Analysis of immunogenicity The analysis of immunogenicity was performed on the ATP cohort for antibody persistence at 36 months of age. For each treatment group and for each antigen, percentages of subjects with titres or concentrations above proposed cut-offs with 95% confidence intervals (CIs) were tabulated along with the geometric mean antibody titres or concentrations (GMTs or GMCs) with 95% CIs. Antibody concentrations or titres below the assay cut-off were given an arbitrary value of half the cut-off for the purpose of GMT or GMC calculation. Analysis of safety The analysis of safety was performed on the Total Enrolled cohort Month 36. The occurrence of SAEs assessed by the investigator as causally related to vaccination or to study procedures was tabulated per group classified by the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. Study population: Male or female subjects between and including 36 to 40 months of age at the time of Visit 1 (Year 2). Subjects who previously participated in study 107005 (10PN-PD-DIT-011) and 109507 (10PN-PD-DIT-017 BST: 011) who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part of the blood sampling subset of study 109507 (10PN-PD-DIT-017 BST: 011), who were free of obvious health problems and who had not had any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine or history of meningococcal serogroup C, Haemophilus influenzae tybe b, hepatitis B and invasive pneumococcal diseases since the end of study 109507 (10PN-PD-DIT-017 BST: 011). Written informed consent was obtained from the parents/guardians of the subject. Number of subjects Pn-Men Group Pn-Neis Group Pn-HibC Group Pr-HibC Group Planned, N 165 172 170 162 Enrolled, N (Total Enrolled cohort Month 36) 144 147 149 141 Completed, n (%) 144 (100) 147 (100) 149 (100) 141 (100) Total Number Subjects Withdrawn, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Withdrawn due to Adverse Events, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Withdrawn due to Lack of Efficacy, n (%) NA NA NA NA Withdrawn for other reasons, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Demographics Pn-Men Group Pn-Neis Group Pn-HibC Group Pr-HibC Group N (Total Enrolled cohort at Month 36) 144 147 149 141 Females:Males 71:73 65:82 86:63 71:70 Mean Age, months (SD) 37.1 (1.17) 37.2 (1.20) 37.3 (1.18) 37.3 (1.28) White - Caucasian / European heritage, n (%) 138 (95.8) 145 (98.6) 142 (95.3) 141 (100) NA = Not applicable Primary Efficacy Results: Percentage of subjects with titres 1:8 or 1:128 and GMTs for rsba-menc antibodies (ATP cohort for antibody persistence at 36 months of age). 1:8* 1:128 GMT 95% CI 95% CI 95% CI Antibody Group Timing N n % LL UL n % LL UL value LL UL rsba- MenC Pn-Men PII(M4) 136 135 99.3 96.0 100 132 97.1 92.6 99.2 1315.4 1089.9 1587.5 PII(M5) 105 103 98.1 93.3 99.8 99 94.3 88.0 97.9 672.7 529.6 854.5 Pre-Booster 60 51 85.0 73.4 92.9 22 36.7 24.6 50.1 63.3 42.7 93.9 PB(M1) 82 82 100 95.6 100 81 98.8 93.4 100 2743.0 2138.8 3518.0 PB(36M age) 139 120 86.3 79.5 91.6 69 49.6 41.1 58.2 100.5 75.6 133.8 Pn-Neis PII(M4) 145 145 100 97.5 100 141 97.2 93.1 99.2 1437.9 1217.1 1698.7 PII(M5) 110 110 100 96.7 100 107 97.3 92.2 99.4 1105.8 903.2 1353.9 Pre-Booster 60 57 95.0 86.1 99.0 44 73.3 60.3 83.9 219.8 148.5 325.2 PB(M1) 76 76 100 95.3 100 76 100 95.3 100 4694.4 3753.1 5871.7 PB(36M age) 146 144 98.6 95.1 99.8 109 74.7 66.8 81.5 235.3 189.1 292.7 Pn- HibC PII(M4) 139 136 97.8 93.8 99.6 124 89.2 82.8 93.8 499.4 400.9 622.1 PIII(M5) 115 115 100 96.8 100 112 97.4 92.6 99.5 1575.5 1268.3 1957.2 Pre-Booster 59 55 93.2 83.5 98.1 39 66.1 52.6 77.9 163.5 114.1 234.3 PB(M1) 68 68 100 94.7 100 68 100 94.7 100 5650.8 4339.0 7359.2 PB(36M age)* 143 127 88.8 82.5 93.5 98 68.5 60.2 76.0 167.5 126.0 222.7 Pr-HibC PII(M4) 130 127 97.7 93.4 99.5 111 85.4 78.1 91.0 443.1 353.7 555.0 PIII(M5) 98 97 99.0 94.4 100 93 94.9 88.5 98.3 1127.5 876.8 1449.8 Pre-Booster 70 61 87.1 77.0 93.9 43 61.4 49.0 72.8 132.5 91.0 192.9
PB(M1) 66 66 100 94.6 100 64 97.0 89.5 99.6 2978.1 2202.5 4026.9 PB(36M age)* 137 113 82.5 75.1 88.4 68 49.6 41.0 58.3 84.0 61.6 114.6 GMT = Geometric Mean Titre N = number of subjects with results available n/% = number/percentage of subjects with titre within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PII (M4) = two months after dose 2 (primary phase) PII (M5) = three months after dose 2 (at study month 5) of MenC-CRM or MenC-TT vaccine (primary phase) PIII (M5) = one month after dose 3 (at study month 5) of Hib-MenC vaccine (primary phase) Pre-Booster = pre-booster vaccination blood sample (booster phase) PB(M1) = one month post-booster vaccination blood sample (booster phase) PB (36M age) = persistence blood sample at 36 months of age (i.e. approximately 24 months post-booster) * Primary outcome variables Note: The results for the primary and booster study time points are also presented for clarity. Please note that results may differ slightly from other CTRS postings because they were generated on the ATP cohort for persistence, and not the Primary ATP cohort or the Booster ATP cohort. Secondary Outcome Variable(s): Percentage of subjects with concentrations 0.15 µg/ml or 1.0 µg/ml and GMCs for anti-prp antibodies (ATP cohort for antibody persistence at 36 months of age) 0.15 µg/ml 1 µg/ml GMC(µg/mL) 95% CI 95% CI 95% CI Antibody Group Timing N n % LL UL n % LL UL value LL UL Anti-PRP Pn- Men Pn- Neis Pn- HibC Pr- HibC PII(M4) 141 130 92.2 86.5 96.0 80 56.7 48.1 65.0 1.405 1.076 1.835 PIII(M5) 140 138 98.6 94.9 99.8 121 86.4 79.6 91.6 4.200 3.377 5.224 Pre-Booster 133 113 85.0 77.7 90.6 45 33.8 25.9 42.5 0.563 0.445 0.713 PB(M1) 140 140 100 97.4 100 139 99.3 96.1 100 32.570 26.640 39.820 PB(36M age) 132 132 100 97.2 100 101 76.5 68.4 83.5 2.293 1.870 2.812 PII(M4) 145 141 97.2 93.1 99.2 110 75.9 68.1 82.6 2.618 2.086 3.286 PIII(M5) 142 142 100 97.4 100 135 95.1 90.1 98.0 6.485 5.486 7.668 Pre-Booster 132 117 88.6 82.0 93.5 42 31.8 24.0 40.5 0.615 0.494 0.765 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 35.840 29.994 42.826 PB(36M age) 139 139 100 97.4 100 105 75.5 67.5 82.4 2.222 1.794 2.752 PII(M4) 143 134 93.7 88.4 97.1 96 67.1 58.8 74.8 1.944 1.508 2.506 PIII(M5) 141 139 98.6 95.0 99.8 138 97.9 93.9 99.6 13.916 11.395 16.994 Pre-Booster 136 131 96.3 91.6 98.8 80 58.8 50.1 67.2 1.338 1.067 1.679 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 84.676 71.314 100.541 PB(36M age) 137 137 100 97.3 100 127 92.7 87.0 96.4 4.177 3.427 5.092 PII(M4) 136 126 92.6 86.9 96.4 82 60.3 51.6 68.6 1.600 1.206 2.122 PIII(M5) 137 137 100 97.3 100 132 96.4 91.7 98.8 10.519 8.713 12.700 Pre-Booster 132 127 96.2 91.4 98.8 63 47.7 39.0 56.6 0.871 0.712 1.065 PB(M1) 137 137 100 97.3 100 137 100 97.3 100 61.845 49.989 76.514 PB(36M age) 138 138 100 97.4 100 115 83.3 76.0 89.1 3.636 2.957 4.471 GMC = Geometric Mean Concentration N = number of subjects with results available n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PII (M4) = two months after dose 2 (primary phase) PIII (M5) = one month after dose 3 (primary phase) Pre-Booster = pre-booster vaccination blood sample (booster phase) PB(M1) = one month post-booster vaccination blood sample (booster phase) PB(36M age) = persistence blood sample at 36 months of age (i.e. approximately 24 months post-booster) Note: The results for the primary and booster study time points are also presented for clarity. Please note that results may differ slightly from other CTRS postings because they were generated on the ATP cohort for persistence, and not the Primary ATP cohort or the Booster ATP cohort. Secondary Outcome Variable(s): Percentage of subjects with concentrations 0.05 µg/ml or 0.2 µg/ml and GMCs for vaccine pneumococcal serotypes anti-1, anti-4, anti-5, anti-6b, anti-7f, anti-9v, anti-14, anti-18c, anti-19f and anti-23f
antibodies (ATP cohort for antibody persistence at 36 months of age) 0.05 µg/ml 0.2 µg/ml GMC (µg/ml) 95% CI 95% CI 95% CI Antibody Group Timing N n % LL UL n % LL UL value LL UL Anti-1 Pn-Men PIII(M5) 141 141 100 97.4 100 137 97.2 92.9 99.2 1.16 1.02 1.33 Pre-Booster 133 130 97.7 93.5 99.5 75 56.4 47.5 65.0 0.22 0.19 0.26 PB(M1) 141 141 100 97.4 100 141 100 97.4 100 2.33 2.00 2.72 PB(36M age) 139 138 99.3 96.1 100 88 63.3 54.7 71.3 0.26 0.22 0.30 Pn-Neis PIII(M5) 142 142 100 97.4 100 139 97.9 94.0 99.6 1.10 0.96 1.27 Pre-Booster 136 132 97.1 92.6 99.2 78 57.4 48.6 65.8 0.22 0.19 0.25 PB(M1) 143 143 100 97.5 100 142 99.3 96.2 100 2.07 1.77 2.41 PB(36M age) 146 143 97.9 94.1 99.6 77 52.7 44.3 61.1 0.23 0.19 0.26 Pn-HibC PIII(M5) 142 141 99.3 96.1 100 132 93.0 87.4 96.6 1.02 0.87 1.19 Pre-Booster 135 126 93.3 87.7 96.9 74 54.8 46.0 63.4 0.21 0.18 0.26 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 2.11 1.83 2.43 PB(36M age) 142 135 95.1 90.1 98.0 72 50.7 42.2 59.2 0.21 0.18 0.25 Pr-HibC PIII(M5) 137 10 7.3 3.6 13.0 1 0.7 0.0 4.0 0.03 0.03 0.03 Pre-Booster 134 18 13.4 8.2 20.4 3 2.2 0.5 6.4 0.03 0.03 0.03 PB(M1) 136 25 18.4 12.3 25.9 4 2.9 0.8 7.4 0.03 0.03 0.04 PB(36M age) 139 83 59.7 51.1 67.9 24 17.3 11.4 24.6 0.07 0.06 0.09 Anti-4 Pn-Men PIII(M5) 141 141 100 97.4 100 141 100 97.4 100 1.78 1.60 1.98 Pre-Booster 135 134 99.3 95.9 100 106 78.5 70.6 85.1 0.43 0.37 0.50 PB(M1) 141 141 100 97.4 100 141 100 97.4 100 4.01 3.48 4.62 PB(36M age) 141 138 97.9 93.9 99.6 84 59.6 51.0 67.7 0.27 0.23 0.32 Pn-Neis PIII(M5) 142 142 100 97.4 100 141 99.3 96.1 100 2.00 1.77 2.25 Pre-Booster 141 141 100 97.4 100 114 80.9 73.4 87.0 0.45 0.39 0.53 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 4.06 3.55 4.65 PB(36M age) 146 141 96.6 92.2 98.9 83 56.8 48.4 65.0 0.23 0.20 0.27 Pn-HibC PIII(M5) 142 142 100 97.4 100 140 98.6 95.0 99.8 1.78 1.58 2.00 Pre-Booster 135 132 97.8 93.6 99.5 108 80.0 72.3 86.4 0.40 0.34 0.48 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 3.68 3.27 4.13 PB(36M age) 144 140 97.2 93.0 99.2 79 54.9 46.4 63.2 0.23 0.20 0.27 Pr-HibC PIII(M5) 137 137 100 97.3 100 137 100 97.3 100 2.60 2.27 2.97 Pre-Booster 137 134 97.8 93.7 99.5 109 79.6 71.8 86.0 0.45 0.38 0.54 PB(M1) 137 137 100 97.3 100 137 100 97.3 100 5.11 4.35 6.00 PB(36M age) 139 133 95.7 90.8 98.4 101 72.7 64.5 79.9 0.35 0.29 0.42 Anti-5 Pn-Men PIII(M5) 141 141 100 97.4 100 141 100 97.4 100 2.00 1.80 2.22 Pre-Booster 132 132 100 97.2 100 109 82.6 75.0 88.6 0.52 0.44 0.61 PB(M1) 140 140 100 97.4 100 140 100 97.4 100 2.89 2.47 3.37 PB(36M age) 140 140 100 97.4 100 115 82.1 74.8 88.1 0.46 0.39 0.54 Pn-Neis PIII(M5) 142 142 100 97.4 100 142 100 97.4 100 1.92 1.71 2.14 Pre-Booster 132 132 100 97.2 100 100 75.8 67.5 82.8 0.45 0.38 0.54 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 2.59 2.21 3.03 PB(36M age) 145 144 99.3 96.2 100 106 73.1 65.1 80.1 0.39 0.33 0.46 Pn-HibC PIII(M5) 142 141 99.3 96.1 100 141 99.3 96.1 100 1.75 1.53 2.01 Pre-Booster 132 130 98.5 94.6 99.8 103 78.0 70.0 84.8 0.43 0.35 0.52 PB(M1) 143 143 100 97.5 100 142 99.3 96.2 100 2.58 2.21 3.01 PB(36M age) 144 142 98.6 95.1 99.8 110 76.4 68.6 83.1 0.41 0.35 0.50 Pr-HibC PIII(M5) 135 28 20.7 14.2 28.6 2 1.5 0.2 5.2 0.03 0.03 0.03 Pre-Booster 133 34 25.6 18.4 33.8 5 3.8 1.2 8.6 0.04 0.03 0.04 PB(M1) 135 61 45.2 36.6 54.0 9 6.7 3.1 12.3 0.05 0.04 0.05 PB(36M age) 140 101 72.1 63.9 79.4 27 19.3 13.1 26.8 0.09 0.07 0.10 Anti-6B Pn-Men PIII(M5) 141 138 97.9 93.9 99.6 130 92.2 86.5 96.0 0.91 0.76 1.08 Pre-Booster 134 133 99.3 95.9 100 110 82.1 74.5 88.2 0.51 0.43 0.61
PB(M1) 141 140 99.3 96.1 100 138 97.9 93.9 99.6 2.51 2.12 2.97 PB(36M age) 139 137 98.6 94.9 99.8 100 71.9 63.7 79.2 0.59 0.45 0.76 Pn-Neis PIII(M5) 143 141 98.6 95.0 99.8 130 90.9 85.0 95.1 0.90 0.75 1.08 Pre-Booster 138 136 98.6 94.9 99.8 107 77.5 69.7 84.2 0.45 0.37 0.54 PB(M1) 143 141 98.6 95.0 99.8 139 97.2 93.0 99.2 2.19 1.85 2.59 PB(36M age) 146 143 97.9 94.1 99.6 115 78.8 71.2 85.1 0.56 0.45 0.71 Pn-HibC PIII(M5) 142 135 95.1 90.1 98.0 128 90.1 84.0 94.5 0.75 0.61 0.92 Pre-Booster 136 130 95.6 90.6 98.4 108 79.4 71.6 85.9 0.46 0.37 0.58 PB(M1) 143 141 98.6 95.0 99.8 139 97.2 93.0 99.2 2.11 1.79 2.50 PB(36M age) 144 139 96.5 92.1 98.9 103 71.5 63.4 78.7 0.63 0.47 0.84 Pr-HibC PIII(M5) 136 136 100 97.3 100 124 91.2 85.1 95.4 1.13 0.93 1.37 Pre-Booster 135 121 89.6 83.2 94.2 77 57.0 48.2 65.5 0.29 0.22 0.37 PB(M1) 138 138 100 97.4 100 137 99.3 96.0 100 4.65 3.94 5.49 PB(36M age) 138 137 99.3 96.0 100 126 91.3 85.3 95.4 0.95 0.77 1.18 Anti-7F Pn-Men PIII(M5) 141 141 100 97.4 100 141 100 97.4 100 2.71 2.43 3.03 Pre-Booster 134 134 100 97.3 100 130 97.0 92.5 99.2 0.83 0.73 0.95 PB(M1) 141 141 100 97.4 100 141 100 97.4 100 4.81 4.25 5.44 PB(36M age) 141 141 100 97.4 100 130 92.2 86.5 96.0 0.58 0.50 0.67 Pn-Neis PIII(M5) 143 143 100 97.5 100 142 99.3 96.2 100 2.57 2.30 2.87 Pre-Booster 138 138 100 97.4 100 130 94.2 88.9 97.5 0.81 0.70 0.94 PB(M1) 142 142 100 97.4 100 142 100 97.4 100 4.71 4.13 5.36 PB(36M age) 146 146 100 97.5 100 129 88.4 82.0 93.1 0.51 0.43 0.59 Pn-HibC PIII(M5) 142 141 99.3 96.1 100 140 98.6 95.0 99.8 2.31 2.01 2.65 Pre-Booster 134 133 99.3 95.9 100 125 93.3 87.6 96.9 0.79 0.67 0.93 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 4.26 3.79 4.79 PB(36M age) 144 141 97.9 94.0 99.6 123 85.4 78.6 90.7 0.54 0.45 0.66 Pr-HibC PIII(M5) 136 33 24.3 17.3 32.4 3 2.2 0.5 6.3 0.04 0.03 0.04 Pre-Booster 135 14 10.4 5.8 16.8 3 2.2 0.5 6.4 0.03 0.03 0.03 PB(M1) 136 23 16.9 11.0 24.3 2 1.5 0.2 5.2 0.03 0.03 0.04 PB(36M age) 140 68 48.6 40.0 57.2 26 18.6 12.5 26.0 0.07 0.05 0.09 Anti-9V Pn-Men PIII(M5) 141 141 100 97.4 100 140 99.3 96.1 100 1.75 1.55 1.98 Pre-Booster 132 132 100 97.2 100 126 95.5 90.4 98.3 0.83 0.72 0.95 PB(M1) 141 141 100 97.4 100 141 100 97.4 100 4.97 4.35 5.69 PB(36M age) 141 138 97.9 93.9 99.6 124 87.9 81.4 92.8 0.60 0.49 0.73 Pn-Neis PIII(M5) 143 143 100 97.5 100 141 98.6 95.0 99.8 1.78 1.56 2.03 Pre-Booster 140 140 100 97.4 100 135 96.4 91.9 98.8 0.84 0.73 0.96 PB(M1) 143 143 100 97.5 100 142 99.3 96.2 100 4.44 3.88 5.09 PB(36M age) 146 144 98.6 95.1 99.8 120 82.2 75.0 88.0 0.54 0.44 0.66 Pn-HibC PIII(M5) 142 142 100 97.4 100 140 98.6 95.0 99.8 1.66 1.46 1.88 Pre-Booster 135 135 100 97.3 100 121 89.6 83.2 94.2 0.78 0.65 0.94 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 4.25 3.74 4.82 PB(36M age) 144 141 97.9 94.0 99.6 116 80.6 73.1 86.7 0.47 0.39 0.57 Pr-HibC PIII(M5) 136 136 100 97.3 100 134 98.5 94.8 99.8 2.98 2.54 3.50 Pre-Booster 136 136 100 97.3 100 128 94.1 88.7 97.4 0.89 0.74 1.07 PB(M1) 138 138 100 97.4 100 138 100 97.4 100 8.05 6.94 9.34 PB(36M age) 140 139 99.3 96.1 100 124 88.6 82.1 93.3 0.70 0.57 0.85 Anti-14 Pn-Men PIII(M5) 141 141 100 97.4 100 141 100 97.4 100 3.65 3.14 4.23 Pre-Booster 137 135 98.5 94.8 99.8 126 92.0 86.1 95.9 1.00 0.81 1.22 PB(M1) 141 141 100 97.4 100 140 99.3 96.1 100 5.96 5.10 6.97 PB(36M age) 141 141 100 97.4 100 129 91.5 85.6 95.5 1.33 1.04 1.70 Pn-Neis PIII(M5) 143 143 100 97.5 100 143 100 97.5 100 3.98 3.52 4.50 Pre-Booster 143 142 99.3 96.2 100 135 94.4 89.3 97.6 1.15 0.95 1.39 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 5.81 5.01 6.74 PB(36M age) 146 146 100 97.5 100 140 95.9 91.3 98.5 1.09 0.88 1.35
Pn-HibC PIII(M5) 142 142 100 97.4 100 142 100 97.4 100 3.42 2.94 3.98 Pre-Booster 138 138 100 97.4 100 125 90.6 84.4 94.9 0.84 0.68 1.02 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 6.02 5.19 6.99 PB(36M age) 144 144 100 97.5 100 132 91.7 85.9 95.6 1.00 0.80 1.25 Pr-HibC PIII(M5) 136 136 100 97.3 100 136 100 97.3 100 5.72 4.73 6.91 Pre-Booster 137 135 98.5 94.8 99.8 132 96.4 91.7 98.8 1.81 1.51 2.18 PB(M1) 138 138 100 97.4 100 138 100 97.4 100 10.91 9.22 12.91 PB(36M age) 140 140 100 97.4 100 138 98.6 94.9 99.8 1.48 1.23 1.78 Anti-18C Pn-Men PIII(M5) 141 141 100 97.4 100 140 99.3 96.1 100 2.36 2.01 2.78 Pre-Booster 133 133 100 97.3 100 117 88.0 81.2 93.0 0.63 0.53 0.74 PB(M1) 140 140 100 97.4 100 140 100 97.4 100 7.13 6.33 8.03 PB(36M age) 141 141 100 97.4 100 119 84.4 77.3 90.0 0.60 0.50 0.71 Pn-Neis PIII(M5) 143 143 100 97.5 100 141 98.6 95.0 99.8 3.86 3.29 4.52 Pre-Booster 138 136 98.6 94.9 99.8 130 94.2 88.9 97.5 0.94 0.78 1.13 PB(M1) 142 142 100 97.4 100 142 100 97.4 100 10.02 8.66 11.60 PB(36M age) 146 146 100 97.5 100 141 96.6 92.2 98.9 0.84 0.73 0.97 Pn-HibC PIII(M5) 142 142 100 97.4 100 142 100 97.4 100 2.43 2.07 2.85 Pre-Booster 130 130 100 97.2 100 108 83.1 75.5 89.1 0.60 0.50 0.72 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 7.42 6.52 8.44 PB(36M age) 143 140 97.9 94.0 99.6 121 84.6 77.6 90.1 0.59 0.48 0.71 Pr-HibC PIII(M5) 136 136 100 97.3 100 134 98.5 94.8 99.8 2.81 2.43 3.25 Pre-Booster 135 135 100 97.3 100 112 83.0 75.5 88.9 0.56 0.48 0.66 PB(M1) 137 137 100 97.3 100 137 100 97.3 100 7.29 6.33 8.39 PB(36M age) 139 139 100 97.4 100 120 86.3 79.5 91.6 0.59 0.50 0.70 Anti-19F Pn-Men PIII(M5) 141 141 100 97.4 100 139 98.6 95.0 99.8 4.75 4.11 5.49 Pre-Booster 129 129 100 97.2 100 123 95.3 90.2 98.3 0.97 0.81 1.16 PB(M1) 141 141 100 97.4 100 140 99.3 96.1 100 7.74 6.57 9.12 PB(36M age) 141 141 100 97.4 100 139 98.6 95.0 99.8 2.06 1.58 2.69 Pn-Neis PIII(M5) 143 143 100 97.5 100 142 99.3 96.2 100 4.80 4.13 5.58 Pre-Booster 131 131 100 97.2 100 124 94.7 89.3 97.8 1.25 1.02 1.53 PB(M1) 141 141 100 97.4 100 140 99.3 96.1 100 7.49 6.27 8.96 PB(36M age) 146 146 100 97.5 100 139 95.2 90.4 98.1 1.63 1.27 2.09 Pn-HibC PIII(M5) 142 142 100 97.4 100 141 99.3 96.1 100 4.03 3.48 4.65 Pre-Booster 127 127 100 97.1 100 113 89.0 82.2 93.8 0.92 0.76 1.12 PB(M1) 143 143 100 97.5 100 143 100 97.5 100 6.76 5.93 7.70 PB(36M age) 144 144 100 97.5 100 134 93.1 87.6 96.6 1.35 1.05 1.72 Pr-HibC PIII(M5) 137 137 100 97.3 100 137 100 97.3 100 2.43 2.16 2.74 Pre-Booster 134 127 94.8 89.5 97.9 59 44.0 35.5 52.9 0.25 0.19 0.33 PB(M1) 137 137 100 97.3 100 135 98.5 94.8 99.8 3.69 3.17 4.30 PB(36M age) 139 137 98.6 94.9 99.8 115 82.7 75.4 88.6 1.48 1.07 2.05 Anti-23F Pn-Men PIII(M5) 141 138 97.9 93.9 99.6 133 94.3 89.1 97.5 1.23 1.05 1.44 Pre-Booster 135 132 97.8 93.6 99.5 115 85.2 78.1 90.7 0.54 0.44 0.66 PB(M1) 141 141 100 97.4 100 139 98.6 95.0 99.8 3.50 2.97 4.13 PB(36M age) 140 140 100 97.4 100 111 79.3 71.6 85.7 0.73 0.58 0.92 Pn-Neis PIII(M5) 143 140 97.9 94.0 99.6 139 97.2 93.0 99.2 1.22 1.03 1.45 Pre-Booster 141 138 97.9 93.9 99.6 114 80.9 73.4 87.0 0.46 0.39 0.55 PB(M1) 143 142 99.3 96.2 100 141 98.6 95.0 99.8 3.13 2.64 3.71 PB(36M age) 146 145 99.3 96.2 100 118 80.8 73.5 86.9 0.69 0.55 0.88 Pn-HibC PIII(M5) 142 142 100 97.4 100 133 93.7 88.3 97.1 1.06 0.90 1.25 Pre-Booster 136 130 95.6 90.6 98.4 102 75.0 66.9 82.0 0.37 0.31 0.45 PB(M1) 143 142 99.3 96.2 100 142 99.3 96.2 100 2.75 2.36 3.20 PB(36M age) 144 140 97.2 93.0 99.2 109 75.7 67.9 82.4 0.62 0.46 0.82 Pr-HibC PIII(M5) 136 135 99.3 96.0 100 126 92.6 86.9 96.4 1.98 1.59 2.45 Pre-Booster 137 125 91.2 85.2 95.4 102 74.5 66.3 81.5 0.38 0.30 0.48
PB(M1) 138 138 100 97.4 100 137 99.3 96.0 100 8.76 7.21 10.66 PB(36M age) 140 139 99.3 96.1 100 128 91.4 85.5 95.5 1.36 1.07 1.73 GMC = Geometric Mean Concentration N = number of subjects with results available n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PIII (M5) = one month after dose 3 (primary phase) Pre-Booster = pre-booster vaccination blood sample (booster phase) PB(M1) = one month post-booster vaccination blood sample (booster phase) PB(36M age) = persistence blood sample at 36 months of age (i.e. approximately 24 months post-booster) Note: The results for the primary and booster study time points are also presented for clarity. Please note that results may differ slightly from other CTRS postings because they were generated on the ATP cohort for persistence, and not the Primary ATP cohort or the Booster ATP cohort. Secondary Outcome Variable(s): Percentage of subjects with titres 1:8 and GMTs for opsonophagocytic activity for vaccine pneumococcal serotypes: Opsono-1, Opsono-4, Opsono-5, Opsono-6B, Opsono-7F, Opsono-9V, Opsono-14, Opsono-18C, Opsono-19F and Opsono-23F antibodies (ATP cohort for antibody persistence at 36 months of age) 1:8 GMT 95% CI 95% CI Antibody Group Timing N n % LL UL value LL UL Opsono-1 Pn-Men PIII(M5) 134 76 56.7 47.9 65.2 24.5 17.9 33.4 Pre-Booster 130 41 31.5 23.7 40.3 9.4 7.3 12.0 PB(M1) 128 121 94.5 89.1 97.8 233.9 176.4 310.2 PB(36M age) 131 30 22.9 16.0 31.1 7.7 6.1 9.8 Pn-Neis PIII(M5) 138 71 51.4 42.8 60.0 19.1 14.2 25.8 Pre-Booster 130 36 27.7 20.2 36.2 8.9 6.9 11.5 PB(M1) 131 126 96.2 91.3 98.7 202.7 156.8 262.0 PB(36M age) 131 32 24.4 17.3 32.7 8.0 6.3 10.1 Pn-HibC PIII(M5) 135 70 51.9 43.1 60.5 19.8 14.6 26.8 Pre-Booster 127 38 29.9 22.1 38.7 8.6 6.9 10.7 PB(M1) 127 116 91.3 85.0 95.6 161.6 120.5 216.6 PB(36M age) 131 29 22.1 15.4 30.2 7.5 6.0 9.3 Pr-HibC PIII(M5) 128 2 1.6 0.2 5.5 4.2 3.9 4.6 Pre-Booster 130 8 6.2 2.7 11.8 4.7 4.2 5.2 PB(M1) 124 13 10.5 5.7 17.3 5.2 4.5 6.1 PB(36M age) 131 14 10.7 6.0 17.3 5.8 4.7 7.1 Opsono-4 Pn-Men PIII(M5) 127 127 100 97.1 100 666.7 588.2 755.6 Pre-Booster 96 53 55.2 44.7 65.4 25.6 16.7 39.4 PB(M1) 125 125 100 97.1 100 2021.4 1737.1 2352.2 PB(36M age) 126 54 42.9 34.1 52.0 24.5 16.2 37.2 Pn-Neis PIII(M5) 132 132 100 97.2 100 793.8 688.5 915.2 Pre-Booster 112 62 55.4 45.7 64.8 26.9 18.4 39.2 PB(M1) 127 127 100 97.1 100 1942.9 1625.1 2322.7 PB(36M age) 127 48 37.8 29.3 46.8 19.6 13.0 29.6 Pn-HibC PIII(M5) 134 130 97.0 92.5 99.2 635.1 513.1 786.1 Pre-Booster 100 51 51.0 40.8 61.1 21.6 14.8 31.6 PB(M1) 125 125 100 97.1 100 1507.0 1246.3 1822.3 PB(36M age) 129 43 33.3 25.3 42.2 19.5 12.7 29.9 Pr-HibC PIII(M5) 128 128 100 97.2 100 891.5 740.2 1073.6 Pre-Booster 98 64 65.3 55.0 74.6 34.8 23.2 52.4 PB(M1) 123 123 100 97.0 100 3209.8 2672.0 3856.0 PB(36M age) 128 77 60.2 51.1 68.7 76.8 47.8 123.5 Opsono-5 Pn-Men PIII(M5) 126 118 93.7 87.9 97.2 94.8 74.3 121.0 Pre-Booster 107 74 69.2 59.5 77.7 21.8 16.7 28.5 PB(M1) 114 113 99.1 95.2 100 203.2 158.9 259.9 PB(36M age) 130 73 56.2 47.2 64.8 11.9 9.6 14.8
Pn-Neis PIII(M5) 133 116 87.2 80.3 92.4 74.9 57.5 97.6 Pre-Booster 106 63 59.4 49.5 68.9 19.6 14.4 26.6 PB(M1) 120 117 97.5 92.9 99.5 167.9 133.0 212.1 PB(36M age) 130 47 36.2 27.9 45.0 8.4 6.8 10.3 Pn-HibC PIII(M5) 132 117 88.6 82.0 93.5 80.0 61.7 103.8 Pre-Booster 102 61 59.8 49.6 69.4 15.0 11.5 19.4 PB(M1) 122 118 96.7 91.8 99.1 157.2 122.3 202.0 PB(36M age) 129 55 42.6 34.0 51.6 9.0 7.4 11.0 Pr-HibC PIII(M5) 126 3 2.4 0.5 6.8 4.3 3.9 4.7 Pre-Booster 111 3 2.7 0.6 7.7 4.2 4.0 4.3 PB(M1) 117 4 3.4 0.9 8.5 4.3 4.0 4.7 PB(36M age) 132 5 3.8 1.2 8.6 4.4 4.0 4.8 Opsono-6B Pn-Men PIII(M5) 124 107 86.3 79.0 91.8 394.8 276.3 563.9 Pre-Booster 121 68 56.2 46.9 65.2 31.7 20.6 48.6 PB(M1) 129 122 94.6 89.1 97.8 711.7 519.5 975.0 PB(36M age) 128 84 65.6 56.7 73.8 93.4 57.7 151.1 Pn-Neis PIII(M5) 124 105 84.7 77.1 90.5 397.2 273.3 577.3 Pre-Booster 121 54 44.6 35.6 53.9 27.3 17.5 42.5 PB(M1) 127 120 94.5 89.0 97.8 692.2 512.2 935.4 PB(36M age) 127 81 63.8 54.8 72.1 66.3 41.9 104.7 Pn-HibC PIII(M5) 125 101 80.8 72.8 87.3 309.1 205.6 464.7 Pre-Booster 120 66 55.0 45.7 64.1 30.8 20.4 46.6 PB(M1) 128 122 95.3 90.1 98.3 613.1 459.1 818.8 PB(36M age) 124 78 62.9 53.8 71.4 96.1 57.6 160.3 Pr-HibC PIII(M5) 124 120 96.8 91.9 99.1 1370.1 1040.0 1805.2 Pre-Booster 124 57 46.0 37.0 55.1 33.6 20.9 53.9 PB(M1) 127 125 98.4 94.4 99.8 4341.6 3421.9 5508.6 PB(36M age) 131 115 87.8 80.9 92.9 390.0 259.8 585.7 Opsono-7F Pn-Men PIII(M5) 124 124 100 97.1 100 2422.7 1981.5 2962.1 Pre-Booster 101 100 99.0 94.6 100 1025.0 809.1 1298.6 PB(M1) 127 127 100 97.1 100 4661.5 4042.0 5376.1 PB(36M age) 131 128 97.7 93.5 99.5 1212.9 976.2 1507.0 Pn-Neis PIII(M5) 137 135 98.5 94.8 99.8 2732.4 2175.0 3432.5 Pre-Booster 111 108 97.3 92.3 99.4 1117.0 865.5 1441.6 PB(M1) 129 129 100 97.2 100 5292.6 4495.2 6231.4 PB(36M age) 130 130 100 97.2 100 1377.2 1149.7 1649.8 Pn-HibC PIII(M5) 133 128 96.2 91.4 98.8 2276.4 1727.1 3000.3 Pre-Booster 102 97 95.1 88.9 98.4 1119.0 802.5 1560.3 PB(M1) 124 124 100 97.1 100 4852.2 4032.5 5838.4 PB(36M age) 131 131 100 97.2 100 1547.4 1317.7 1817.0 Pr-HibC PIII(M5) 116 18 15.5 9.5 23.4 8.8 6.2 12.4 Pre-Booster 92 39 42.4 32.1 53.1 44.8 24.3 82.4 PB(M1) 101 49 48.5 38.4 58.7 65.1 36.3 117.0 PB(36M age) 130 126 96.9 92.3 99.2 954.0 743.0 1225.1 Opsono-9V Pn-Men PIII(M5) 128 128 100 97.2 100 1029.7 837.3 1266.2 Pre-Booster 121 120 99.2 95.5 100 318.7 255.3 397.8 PB(M1) 129 129 100 97.2 100 2520.9 2111.3 3010.0 PB(36M age) 131 127 96.9 92.4 99.2 441.3 347.1 561.0 Pn-Neis PIII(M5) 125 124 99.2 95.6 100 1233.1 992.6 1531.9 Pre-Booster 120 117 97.5 92.9 99.5 316.8 250.0 401.4 PB(M1) 131 131 100 97.2 100 2619.9 2221.1 3090.4 PB(36M age) 131 131 100 97.2 100 495.1 406.7 602.8 Pn-HibC PIII(M5) 131 131 100 97.2 100 1074.1 888.0 1299.3 Pre-Booster 118 108 91.5 85.0 95.9 249.1 183.1 338.8
PB(M1) 129 129 100 97.2 100 2179.5 1789.2 2654.9 PB(36M age) 129 127 98.4 94.5 99.8 437.1 353.0 541.3 Pr-HibC PIII(M5) 124 123 99.2 95.6 100 1265.1 983.8 1626.9 Pre-Booster 117 113 96.6 91.5 99.1 253.8 194.2 331.7 PB(M1) 125 125 100 97.1 100 4602.9 3830.9 5530.4 PB(36M age) 132 124 93.9 88.4 97.3 516.1 389.6 683.6 Opsono-14 Pn-Men PIII(M5) 129 126 97.7 93.4 99.5 763.7 614.4 949.3 Pre-Booster 111 107 96.4 91.0 99.0 319.6 248.5 411.1 PB(M1) 126 126 100 97.1 100 1815.8 1491.4 2210.7 PB(36M age) 129 110 85.3 78.0 90.9 281.8 191.1 415.5 Pn-Neis PIII(M5) 137 135 98.5 94.8 99.8 981.4 796.8 1208.7 Pre-Booster 112 104 92.9 86.4 96.9 233.3 176.5 308.5 PB(M1) 129 129 100 97.2 100 1738.5 1450.1 2084.3 PB(36M age) 128 118 92.2 86.1 96.2 349.4 259.3 470.8 Pn-HibC PIII(M5) 134 128 95.5 90.5 98.3 789.6 615.4 1013.2 Pre-Booster 101 94 93.1 86.2 97.2 229.1 173.3 302.8 PB(M1) 124 124 100 97.1 100 1629.3 1331.7 1993.4 PB(36M age) 128 106 82.8 75.1 88.9 207.4 142.5 301.9 Pr-HibC PIII(M5) 126 123 97.6 93.2 99.5 1461.5 1128.8 1892.2 Pre-Booster 112 111 99.1 95.1 100 425.8 342.7 529.1 PB(M1) 121 121 100 97.0 100 2831.3 2338.7 3427.6 PB(36M age) 131 112 85.5 78.3 91.0 298.3 209.4 424.9 Opsono-18C Pn-Men PIII(M5) 129 125 96.9 92.3 99.1 161.8 131.1 199.6 Pre-Booster 114 37 32.5 24.0 41.9 8.1 6.5 10.1 PB(M1) 110 110 100 96.7 100 854.5 656.6 1112.1 PB(36M age) 126 51 40.5 31.8 49.6 19.7 13.3 29.2 Pn-Neis PIII(M5) 135 133 98.5 94.8 99.8 274.8 226.6 333.2 Pre-Booster 109 54 49.5 39.8 59.3 16.9 12.0 23.9 PB(M1) 122 119 97.5 93.0 99.5 990.9 772.3 1271.4 PB(36M age) 121 68 56.2 46.9 65.2 31.7 21.0 47.6 Pn-HibC PIII(M5) 132 120 90.9 84.7 95.2 138.8 107.9 178.6 Pre-Booster 111 29 26.1 18.2 35.3 7.7 6.1 9.8 PB(M1) 108 108 100 96.6 100 772.0 593.7 1003.9 PB(36M age) 123 44 35.8 27.3 44.9 17.1 11.6 25.3 Pr-HibC PIII(M5) 122 122 100 97.0 100 205.5 165.4 255.3 Pre-Booster 111 27 24.3 16.7 33.4 7.7 5.9 10.1 PB(M1) 103 99 96.1 90.4 98.9 744.8 518.9 1069.1 PB(36M age) 122 48 39.3 30.6 48.6 25.3 16.2 39.7 Opsono-19F Pn-Men PIII(M5) 132 130 98.5 94.6 99.8 424.7 334.3 539.5 Pre-Booster 116 91 78.4 69.9 85.5 24.7 19.3 31.5 PB(M1) 126 122 96.8 92.1 99.1 908.6 704.8 1171.3 PB(36M age) 130 105 80.8 72.9 87.2 61.2 42.6 87.8 Pn-Neis PIII(M5) 137 130 94.9 89.8 97.9 329.3 251.0 432.1 Pre-Booster 123 103 83.7 76.0 89.8 36.1 27.3 47.8 PB(M1) 129 123 95.3 90.2 98.3 648.5 477.2 881.4 PB(36M age) 130 108 83.1 75.5 89.1 49.5 35.9 68.3 Pn-HibC PIII(M5) 132 126 95.5 90.4 98.3 265.9 200.4 352.7 Pre-Booster 120 85 70.8 61.8 78.8 21.9 17.1 28.0 PB(M1) 124 124 100 97.1 100 550.6 433.8 698.7 PB(36M age) 131 89 67.9 59.2 75.8 32.2 22.7 45.5 Pr-HibC PIII(M5) 122 110 90.2 83.4 94.8 47.6 36.7 61.8 Pre-Booster 121 26 21.5 14.5 29.9 7.6 5.8 9.9 PB(M1) 121 119 98.3 94.2 99.8 307.1 237.2 397.6 PB(36M age) 132 91 68.9 60.3 76.7 48.2 32.9 70.5
Opsono-23F Pn-Men PIII(M5) 122 115 94.3 88.5 97.7 959.5 700.1 1314.9 Pre-Booster 119 110 92.4 86.1 96.5 823.8 569.9 1190.7 PB(M1) 131 131 100 97.2 100 3271.2 2760.6 3876.2 PB(36M age) 125 106 84.8 77.3 90.6 667.2 432.2 1030.0 Pn-Neis PIII(M5) 128 122 95.3 90.1 98.3 1300.2 970.4 1742.2 Pre-Booster 125 110 88.0 81.0 93.1 670.7 445.6 1009.6 PB(M1) 134 134 100 97.3 100 3181.8 2679.1 3778.7 PB(36M age) 124 112 90.3 83.7 94.9 965.1 656.9 1418.1 Pn-HibC PIII(M5) 123 111 90.2 83.6 94.9 848.5 589.7 1220.9 Pre-Booster 116 96 82.8 74.6 89.1 429.3 269.4 683.9 PB(M1) 132 132 100 97.2 100 3025.1 2566.6 3565.5 PB(36M age) 125 113 90.4 83.8 94.9 960.7 656.6 1405.6 Pr-HibC PIII(M5) 121 120 99.2 95.5 100 5033.8 3940.6 6430.3 Pre-Booster 124 111 89.5 82.7 94.3 1031.3 681.7 1560.3 PB(M1) 130 130 100 97.2 100 24310.6 19368.7 30513.5 PB(36M age) 132 129 97.7 93.5 99.5 3609.7 2700.4 4825.3 GMT = Geometric Mean Titre N = number of subjects with available results n/% = number/percentage of subjects with titre within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PIII (M5) = one month after dose 3 (primary phase) Pre-Booster = pre-booster vaccination blood sample (booster phase) PB(M1) = one month post-booster vaccination blood sample (booster phase) PB(36M age) = persistence blood sample at 36 months of age (i.e. approximately 24 months post-booster) Note: The results for the primary and booster study time points are also presented for clarity. Please note that results may differ slightly from other CTRS postings because they were generated on the ATP cohort for persistence, and not the Primary ATP cohort or the Booster ATP cohort. Secondary Outcome Variable(s): Percentage of subjects with concentrations 100 EL.U per ml and GMCs for anti-protein D (PD) antibodies (ATP cohort for antibody persistence at 36 months of age) 100 EL.U/mL GMC(EL.U/mL 95% CI 95% CI Antibody Group Timing N n % LL UL value LL UL Anti-PD Pn-Men PIII(M5) 140 140 100 97.4 100 2162.3 1870.8 2499.2 Pre-Booster 130 127 97.7 93.4 99.5 772.8 654.1 913.1 PB(M1) 141 141 100 97.4 100 3182.4 2732.9 3705.8 PB(36M age) 140 132 94.3 89.1 97.5 494.6 414.0 591.0 Pn-Neis PIII(M5) 142 142 100 97.4 100 1740.8 1493.1 2029.5 Pre-Booster 138 134 97.1 92.7 99.2 709.1 597.2 841.9 PB(M1) 142 142 100 97.4 100 2565.1 2185.6 3010.4 PB(36M age) 145 137 94.5 89.4 97.6 444.8 373.2 530.1 Pn-HibC PIII(M5) 142 141 99.3 96.1 100 1808.2 1534.0 2131.4 Pre-Booster 132 126 95.5 90.4 98.3 654.1 542.4 788.8 PB(M1) 143 143 100 97.5 100 2775.9 2387.7 3227.3 PB(36M age) 144 136 94.4 89.3 97.6 439.8 366.4 527.9 Pr-HibC PIII(M5) 132 29 22.0 15.2 30.0 71.4 62.8 81.2 Pre-Booster 131 51 38.9 30.5 47.8 92.5 79.4 107.8 PB(M1) 133 58 43.6 35.0 52.5 94.1 81.6 108.5 PB(36M age) 139 69 49.6 41.1 58.2 100.3 87.6 114.9 GMC = Geometric Mean Concentration N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PIII (M5) = one month after dose 3 (primary phase) Pre-Booster = pre-booster vaccination blood sample (booster phase) PB(M1) = one month post-booster vaccination blood sample (booster phase)
PB(36M age) = persistence blood sample at 36 months of age (i.e. approximately 24 months post-booster) Note: The results for the primary and booster study time points are also presented for clarity. Please note that results may differ slightly from other CTRS postings because they were generated on the ATP cohort for persistence, and not the Primary ATP cohort or the Booster ATP cohort. Secondary Outcome Variable(s): Percentage of subjects with concentrations 10 miu per ml or 100 miu/ml and GMCs for anti-hbs antibodies (ATP cohort for antibody persistence at 36 months of age) 10 miu/ml 100 miu/ml GMC(mIU/mL) 95% CI 95% CI 95% CI Antibody Group Timing N n % LL UL n % LL UL value LL UL Anti-HBs Pn-Men PIII(M5) 52 52 100 93.2 100 51 98.1 89.7 100 924.2 725.0 1178.1 PB(36M age) 107 105 98.1 93.4 99.8 77 72.0 62.5 80.2 367.5 256.8 525.9 Pn-Neis PIII(M5) 65 62 95.4 87.1 99.0 62 95.4 87.1 99.0 822.9 599.9 1128.6 PB(36M age) 102 96 94.1 87.6 97.8 81 79.4 70.3 86.8 325.7 228.3 464.7 Pn- PIII(M5) 74 74 100 95.1 100 74 100 95.1 100 997.6 808.8 1230.5 HibC PB(36M age) 105 102 97.1 91.9 99.4 74 70.5 60.8 79.0 288.1 198.7 417.9 Pr-HibC PIII(M5) 56 56 100 93.6 100 56 100 93.6 100 760.4 615.4 939.4 PB(36M age) 102 99 97.1 91.6 99.4 74 72.5 62.8 80.9 371.4 254.1 542.8 GMC = Geometric Mean Concentration N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PIII (M5) = one month after dose 3 (primary phase) PB (36M) = persistence blood sample at 36 months of age (i.e. approximately 24 months post-booster) Note: The results for the primary and booster study time points are also presented for clarity. Please note that results may differ slightly from other CTRS postings because they were generated on the ATP cohort for persistence, and not the Primary ATP cohort or the Booster ATP cohort. Safety results: No information regarding unsolicited adverse events was collected during this persistence study. Safety results: Number (%) of subjects with serious adverse events related to vaccination or related to study procedures since the last study contact of the booster study (Total Enrolled cohort Month 36) Serious adverse event, n (%) [n considered by the investigator to be related to study medication] All SAEs Pn-Men Group N = 144 Pn-Neis Group N = 147 Pn-HibC Group N = 149 Pr-HibC Group N = 141 Subjects with any SAE(s), n (%) [n assessed by 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] the investigator as related] Fatal SAE(s) Pn-Men Group Pn-Neis Group Pn-HibC Group Pr-HibC Group Subjects with fatal SAE(s), n (%) [n assessed by the investigator as related] N = 144 N = 147 N = 149 N = 141 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] Conclusion: At 3 years (36 months) of age, 86.3% of the subjects in the Pn-Men Group, 98.6% of the subjects in the Pn-Neis Group, 88.8% of the subjects in the Pn-HibC Group and 82.5% of the subjects in the Pr-HibC Group had rsba-menc titre 1:8. No SAE assessed by the investigators as possibly related to vaccination or to study procedures was reported from the last contact of the booster study until 3 years of age. Publications: None. Date updated: 19-Nov-2010