- Infanrix hexa (DTPa-HBV-IPV/Hib): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis

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1 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.: (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 (10PN-PD-DIT-011) and booster vaccination during study (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)

2 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 (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 (10PN-PD-DIT-011) and in the booster study (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.

3 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 (10PN-PD-DIT-011) and (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 (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 (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 Enrolled, N (Total Enrolled cohort Month 36) 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) 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) PII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PII(M4) PII(M5) Pre-Booster PB(M1) PB(36M age) Pn- HibC PII(M4) PIII(M5) Pre-Booster PB(M1) PB(36M age)* Pr-HibC PII(M4) PIII(M5) Pre-Booster

4 PB(M1) PB(36M age)* 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) PIII(M5) Pre-Booster PB(M1) PB(36M age) PII(M4) PIII(M5) Pre-Booster PB(M1) PB(36M age) PII(M4) PIII(M5) Pre-Booster PB(M1) PB(36M age) PII(M4) PIII(M5) Pre-Booster PB(M1) PB(36M age) 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

5 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) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-4 Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-5 Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-6B Pn-Men PIII(M5) Pre-Booster

6 PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-7F Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-9V Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-14 Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age)

7 Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-18C Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-19F Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Anti-23F Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster

8 PB(M1) PB(36M age) 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) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-4 Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-5 Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age)

9 Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-6B Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-7F Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-9V Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster

10 PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-14 Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-18C Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Opsono-19F Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age)

11 Opsono-23F Pn-Men PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) 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) Pre-Booster PB(M1) PB(36M age) Pn-Neis PIII(M5) Pre-Booster PB(M1) PB(36M age) Pn-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) Pr-HibC PIII(M5) Pre-Booster PB(M1) PB(36M age) 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)

12 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) PB(36M age) Pn-Neis PIII(M5) PB(36M age) Pn- PIII(M5) HibC PB(36M age) Pr-HibC PIII(M5) PB(36M age) 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 = (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