To demonstrate that DTPa-HBV-IPV/Hib-MenC-TT co-administered with 10Pn, is non-inferior to DTPa-HBV-IPV/Hib coadministered

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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.: (DTPA-HBV-IPV=HIB-MENC-TT-002) Title: Immunogenicity and safety study of GlaxoSmithKline Biologicals GSK A vaccine in healthy infants at 2, 3 and 4 months of age. GSK A (DTPa-HBV-IPV/Hib-MenC-TT): GlaxoSmithKline (GSK) Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, Haemophilus influenzae type b (Hib), meningococcal serogroup C (MenC) and tetanus toxoid conjugate vaccine Rationale: The purpose of this study was to evaluate the safety and immunogenicity of a combined DTPa-HBV-IPV/Hib- MenC-TT vaccine, when co-administered with Synflorix in healthy infants at 2, 3 and 4 months of age. This study also aimed at demonstrating non-inferiority of combined DTPa-HBV-IPV/Hib-MenC-TT vaccine, co-administered with Synflorix to Infanrix hexa co-administered with Menjugate or Synflorix. In accordance with the local recommended immunisation schedule, all subjects received 2 doses of Rotarix at 2 and 3 months of age. Infanrix hexa (DTPa-HBV-IPV/Hib): GSK Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine. Synflorix (10Pn): GSK Biologicals 10-valent pneumococcal-protein D, diphtheria and tetanus toxoid conjugate vaccine Menjugate (MenC-CRM): Novartis meningococcal serogroup C Cross Reacting Material 197 (CRM197) conjugated vaccine. Rotarix (HRV): GSK Biologicals live attenuated human rotavirus vaccine. Phase: II Study Period: 13 August 2009 to 27 January Study Design: Open, randomised (1:1:1), multicentre study with 3 parallel groups. Centres: 9 centres in Poland. Indication: Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, Neisseria meningitidis serogroup C. Treatment: The 3 groups in the study were as follows: Hepta + 10Pn Group: Subjects received 3 doses of DTPa-HBV-IPV/Hib-MenC-TT and 10Pn at 2, 3 and 4 months of age and 2 doses of HRV at 2 and 3 months of age. Hexa + MenC Group: Subjects received 3 doses of DTPa-HBV-IPV/Hib at 2, 3 and 4 months of age, 2 doses of MenC- CRM at 3 and 4 months of age and 2 doses of HRV at 2 and 3 months of age. Hexa + 10Pn Group: Subjects in this group received 3 doses of DTPa-HBV-IPV/Hib and 10Pn at 2, 3 and 4 months of age and 2 doses of HRV at 2 and 3 months of age. DTPa-HBV-IPV/Hib-MenC-TT and DTPa-HBV-IPV/Hib were administered intramuscularly in right thigh, 10Pn and MenC-CRM were administered intramuscularly in left thigh and HRV was administered orally. Objectives: To demonstrate that DTPa-HBV-IPV/Hib-MenC-TT co-administered with 10Pn, is non-inferior to DTPa-HBV-IPV/Hib coadministered with MenC-CRM, in terms of seroprotection to MenC one month after the third dose of primary vaccination. Non-inferiority for MenC was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference (Hexa + MenC Group minus Hepta + 10Pn Group) in the percentage of seroprotected subjects was 10%. To demonstrate that DTPa-HBV-IPV/Hib-MenC-TT co-administered with 10Pn, is non-inferior to DTPa-HBV-IPV/Hib coadministered with 10 Pn, in terms of seroprotection to Hib one month after the third dose of primary vaccination. Non-inferiority for Hib was demonstrated if the upper limit of the 95% CI on the group difference (Hexa + 10Pn Group minus Hepta + 10Pn Group) in percentage of seroprotected subjects was 10%. Primary Outcome/Efficacy Variable: Immunogenicity one month after the third dose of primary vaccination: Anti-Polyribosyl-Ribitol-Phosphate (Anti-PRP) seroprotection status. Serum bactericidal assay against Neisseria meningitidis serogroup C using baby rabbit complement (rsba-menc) seroprotection status. Secondary Outcome/Efficacy Variable(s): Immunogenicity one month after the third dose of primary vaccination: Anti-PRP, rsba-menc, anti-polysaccharide Neisseria meningitides serogroup C (anti-psc), anti-tetanus, anti-diphtheria, anti-pertussis toxoid (anti-pt), anti-filamentous haemagglutinin (anti-fha), anti-pertactin (anti-prn), anti-hepatitis B surface antigen (anti-hbs), anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-pneumococcal

2 serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and protein D (PD) antibody concentrations or titres, and seroprotection or seropositivity status. Vaccine response to PT, FHA and PRN. Immunogenicity before the first vaccine dose of primary vaccination: Anti-PRP, rsba-menc, anti-psc, PT, FHA and PRN antibody concentrations or titres. Safety: Occurrence of solicited local and general symptoms during the 8-day (Day 0-Day 7) follow-up period after each vaccination. Occurrence of unsolicited symptoms during the 31-day (Day 0-Day 30) follow-up period after each vaccination. Occurrence of serious adverse events (SAEs) from Dose 1 up to study end. Statistical Methods: The analyses were performed on the Total Vaccinated Cohort and the According-to-Protocol (ATP) cohort for immunogenicity. The Total Vaccinated Cohort included all vaccinated subjects for whom data were available. The ATP cohort for immunogenicity included all evaluable subjects (who met all eligibility criteria in this study, complied with the procedures and intervals defined in the protocol) for whom immunogenicity data were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point. Analysis of Immunogenicity: The analyses were performed on the ATP cohort for immunogenicity. Inferential analysis: The 95% CIs in terms of seroprotection for rsba-men C and anti-prp antibodies titres were computed. The objective of noninferiority of DTPa-HBV-IPV/Hib-MenC-TT co-administered with 10Pn was reached if the upper limit of the 95% confidence interval (CI) on the group difference (Hexa + MenC Group minus Hepta + 10Pn Group) in the percentage of seroprotected subjects was 10%. Descriptive analyses: For each group, at each time point and for each antigen for which a serological result was available, serpositivity/seroprotection/vaccine response rates with exact 95% CIs and geometric mean antibody concentrations (GMCs) or geometric mean antibody titres (GMTs) with 95% CIs were tabulated. Seroprotection status: Anti-PRP antibody concentrations 0.15 µg/ml. rsba-menc antibody titres 1:8. Anti-diphtheria antibody concentrations 0.1 IU/mL. Anti-tetanus antibody concentrations 0.1 IU/mL. Anti-HBs antibody concentrations 10* miu/ml. Anti-poliovirus types 1, 2 and 3 antibody titres 1:8. Seropositivity status: Anti-PT, anti-fha and anti-prn antibody concentrations 5 EL.U/mL. Anti-HBs antibody concentrations 3.3 miu/ml. Anti-PSC antibody concentrations 0.3 µg/ml. serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations 0.05 µg/ml. Anti-PD antibody concentrations 100 EL.U/mL. The following other cut-offs were also used: Anti-PSC antibody concentrations 2 µg/ml. Anti-PRP antibody concentrations 1 µg/ml. rsba-menc antibody titres 1:128. serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations 0.2 µg/ml. Vaccine response to PT, FHA and PRN, was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations cut-off value), taking into consideration the decreasing maternal antibodies. A decrease in the specificity of the anti-hb ELISA assay had been observed in some studies for low levels of antibody ( miu/ml). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.

3 Analysis of Safety: The analysis was performed on the Total vaccinated Cohort. The incidence of solicited local and general symptom occurring during the 8-day (Day 0-Day 7) follow-up period after each vaccination was tabulated with exact 95% CI for each treatment group. The same tabulations were performed for Grade 3 symptoms and for solicited general symptoms assessed by the investigators as related to vaccination. The percentage of subjects with at least one report of an unsolicited adverse event (AE) classified by to Medical Dictionary for Regulatory Activities (MedDRA) preferred term and reported during the 31-day (Day 0-Day 30) follow-up period after each vaccination was tabulated. SAEs were collected and summarised during the entire study period according to MedDRA preferred term. Study Population: Healthy male and female infants aged between, and including 8 and 12 weeks at the time of the first vaccination and had received one dose of hepatitis B (HBV) vaccination at birth as per local recommendations were enrolled in the study. Written informed consent was obtained from the parents/legally Acceptable Representative (LAR) of the subjects. Number of subjects Hepta + 10Pn Group Hexa + MenC Group Hexa + 10Pn Group Planned, N Randomised, N (Total Vaccinated Cohort) Completed, n (%) 138 (97.9) 136 (97.8) 139 (98.6) Total Number Subjects Withdrawn, n (%) 3 (2.1) 3 (2.2) 2 (1.4) Withdrawn due to Adverse Events, n (%) 1 (0.7) 0 (0.0) 0 (0.0) Withdrawn due to Lack of Efficacy, n (%) Not applicable Not applicable Not applicable Withdrawn for other reasons, n (%) 2 (1.4) 3 (2.2) 2 (1.4) Demographics Hepta + 10Pn Group Hexa + MenC Group Hexa + 10Pn Group N (Total Vaccinated Cohort) Females:Males 74:67 86:53 68:73 Mean Age, weeks (SD) 8.5 (0.98) 8.7 (1.02) 8.7 (1.13) White-Caucasian/European Heritage, n (%) 141 (100) 139 (100) 141 (100) Primary Efficacy Results: Difference between groups Hexa + MenC and Hepta + 10Pn, in percentage of subjects with rsba-menc titres 1:8 one month after the third dose of vaccination (ATP cohort for immunogenicity) Difference in percentage (Hexa + MenC minus Hepta + 10Pn) Hexa + MenC Hepta + 10Pn 95% CI Antibody Cut-off N n % N n % % LL UL rsba-menc 1: * n (%) = number (percentage) of subjects with titre within the specified range 95% CI = Standardized asymptotic 95% confidence interval; LL = lower limit, UL = upper limit * Criterion for non inferiority = Upper limit of the 95% CI 10% Primary Efficacy Results: Difference between groups Hexa + 10Pn and Hepta + 10Pn, in percentage of subjects with anti- PRP concentrations 0.15 µg/ml one month after the third dose of vaccination (ATP cohort for immunogenicity) Difference in percentage (Hexa + 10Pn minus Hepta + 10Pn) Hexa + 10Pn Hepta + 10Pn 95% CI Antibody Cut-off N n % N n % % LL UL Anti-PRP * n (%) = number (percentage) of subjects with titre within the specified range 95% CI = Standardized asymptotic 95% confidence interval; LL = lower limit, UL = upper limit * Criterion for non inferiority = Upper limit of the 95% CI 10% Primary Efficacy Results: Percentage of subjects with anti-prp antibody concentrations 0.15 µg/ml, 1.0 µg/ml and GMCs before and one month after primary vaccination (ATP cohort for immunogenicity) 0.15 µg/ml* 1.0 µg/ml GMC (µg/ml) Antibody Group Timing N n % LL UL n % LL UL value LL UL Anti-PRP Hepta + 10Pn Pre Post* Hexa + MenC Pre

4 Post* Hexa + 10Pn Pre Post* Pre = Pre-primary blood sample time-point. * Primary efficacy result Primary Efficacy Results: Percentage of subjects with rsba-menc antibody titres 1:8, 1:128 and GMTs before and one month after primary vaccination (ATP cohort for immunogenicity) 1:8* 1:128 GMT Antibody Group Timing N n % LL UL n % LL UL value LL UL rsba- Hepta + 10Pn Pre MenC Post* Hexa + MenC Pre Post* Hexa + 10Pn Pre Post GMT = geometric mean antibody titre calculated on all subjects n (%) = number (percentage) of subjects with titre within the specified range Pre = Pre-primary blood sample time-point. * Primary efficacy result Secondary Outcome Variable(s): Percentage of subjects with anti-psc antibody concentrations 0.3 µg/ml, 2.0 µg/ml and GMCs before and one month after primary vaccination (ATP cohort for immunogenicity) 0.3 µg/ml 2.0 µg/ml GMC (µg/ml) Antibody Group Timing N n % LL UL n % LL UL value LL UL Anti-PSC Hepta + 10Pn Pre Post Hexa + MenC Pre Post Hexa + 10Pn Pre Post Pre = Pre-primary blood sample time-point. Secondary Outcome Variable(s): Seroprotection rates and GMCs for anti-tetanus and anti-diphtheria antibodies one month after primary vaccination (ATP cohort for immunogenicity) 0.1 IU/mL GMC (IU/mL ) 95% CI 95% CI Antibody Group Timing N n % LL UL value LL UL Anti-tetanus Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Anti-diphtheria Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post

5 Secondary Outcome Variable(s): Seropositivity rates and GMCs for anti-pt, anti-fha, anti-prn antibodies before and one month after primary vaccination (ATP cohort for immunogenicity) 5 EL.U/mL GMC (EL.U/mL) 95% CI 95% CI Antibody Group Timing N n % LL UL value LL UL Anti-PT Hepta + 10Pn Pre Post Hexa + MenC Pre Post Hexa + 10Pn Pre Post Anti-FHA Hepta + 10Pn Pre Post Hexa + MenC Pre Post Hexa + 10Pn Pre Post Anti-PRN Hepta + 10Pn Pre Post Hexa + MenC Pre Post Hexa + 10Pn Pre Post Pre = Pre-primary blood sample time-point. Secondary Outcome Variable(s): Vaccine response to PT, FHA and PRN antigens one month after primary vaccination (ATP cohort for immunogenicity) Vaccine response 95% CI Antibody Group Pre-vaccination status N n % LL UL Anti-PT Hepta + 10Pn S S Total Hexa + MenC S S Total Hexa + 10Pn S S Total Anti-FHA Hepta + 10Pn S S Total Hexa + MenC S S Total Hexa + 10Pn S

6 S Total Anti-PRN Hepta + 10Pn S S Total Hexa + MenC S S Total Hexa + 10Pn S S Total Vaccine response defined as : For initially seronegative subjects, antibody concentration 5 EL.U/mL one month after primary vaccination For initially seropositive subjects : antibody concentration one month after primary vaccination 1 fold the pre- vaccination antibody concentration N = number of subjects with both pre- and post-vaccination results available n (%) = number (percentage) of responders 95% CI = exact 95% confidence interval, LL = Lower Limit, UL = Upper Limit S- = seronegative subjects (antibody concentration < 5 EL.U/mL for Anti-PT, Anti-FHA, Anti-PRN) prior to vaccination S+ = seropositive subjects (antibody concentration 5 EL.U/mL for Anti-PT, Anti-FHA, Anti-PRN) prior to vaccination Total = subjects either seropositive or seronegative at pre-vaccination Secondary Outcome Variable(s): Percentage of subjects with anti-hbs antibody concentrations 3.3 miu/ml, 10 miu/ml, 100 miu/ml and GMCs one month after primary vaccination (ATP cohort for immunogenicity) 3.3 miu/ml 10 miu/ml 100 miu/ml GMC (miu/ml) 95% CI Antibody Group Timing N n % LL UL n % LL UL n % LL UL value LL UL Anti-HBs Hepta + Post Pn Hexa + Post MenC Hexa + 10Pn Post A decrease in the specificity of the anti-hb ELISA assay had been observed in some studies for low levels of antibody ( miu/ml). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA. Secondary Outcome Variable(s): Seroprotection rates and GMTs for anti-poliovirus type 1, anti-poliovirus type 2 and antipoliovirus type 3 antibodies one month after primary vaccination (ATP cohort for immunogenicity) 1:8 GMT 95% CI 95% CI Antibody Group Timing N n % LL UL value LL UL Anti-poliovirus type 1 Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Anti-poliovirus type 2 Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Anti-poliovirus type 3 Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post

7 GMT = geometric mean antibody titre calculated on all subjects n (%) = number (percentage) of subjects with titre within the specified range Secondary Outcome Variable(s): Percentage of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations 0.05 µg/ml, 0.2 µg/ml and GMCs one month after primary vaccination (ATP cohort for immunogenicity) 0.05 µg/ml 0.2 µg/ml GMC (µg/ml ) Antibody Group Timing N n % LL UL n % LL UL value LL UL serotype 1 serotype 4 serotype 5 serotype 6B serotype 7F serotype 9V Anti- pneumococcal serotype 14 serotype 18C serotype 19F Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post Hepta + 10Pn Post serotype 23F Hexa + MenC Post Hexa + 10Pn Post Secondary Outcome Variable(s): Percentage of subjects with anti-pd concentrations 100 EL.U/mL and GMCs one month after primary vaccination (ATP cohort for immunogenicity) 100 EL.U/mL GMC (EL.U/mL) 95% CI 95% CI Antibody Group Timing N n % LL UL value LL UL Anti-PD Hepta + 10Pn Post Hexa + MenC Post Hexa + 10Pn Post

8 Secondary Outcome Variable(s): Number (percentage) of subjects with solicited local symptom during the 8-day (Days 0 to Day 7) post-vaccination period following each dose and across doses (Total Vaccinated Cohort) Hepta + 10Pn Group Hexa + MenC Group Hexa + 10Pn Group Symptom Intensity N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any Grade Redness Any >20 mm Swelling Any >20 mm Dose 2 Pain Any Grade Redness Any >20 mm Swelling Any >20 mm Dose 3 Pain Any Grade Redness Any >20 mm Swelling Any >20 mm Across Doses Pain Any Grade Redness Any >20 mm Swelling Any >20 mm N= number of subjects with at least one documented dose n (%) = number (percentage) of subjects reporting a specified symptom 95%CI, LL and UL = Exact 95% confidence interval, lower and upper limit Any = Incidence of a local symptom irrespective of intensity grade Grade 3 pain = cried when limb was moved/spontaneously painful Secondary Outcome Variable(s): Number (percentage) of subjects with solicited general symptoms during the 8-day (Days 0-7) following each dose and across doses (Total Vaccinated Cohort) Hepta + 10Pn Group Hexa + MenC Group Hexa + 10Pn Group Symptom Intensity/ Relationship N n % LL UL N n % LL UL N n % LL UL Dose 1 Drowsiness Any Grade Related Irritability Any Grade Related Loss of appetite Any Grade

9 Temperature (Axillary) Related C >39.0 C Related Dose 2 Drowsiness Any Grade Related Irritability Any Grade Related Loss of appetite Temperature (Axillary) Any Grade Related C >39.0 C Related Dose 3 Drowsiness Any Grade Related Irritability Any Grade Related Loss of appetite Temperature (Axillary) Any Grade Related C >39.0 C Related Across Doses Drowsiness Any Grade Related Irritability Any Grade Related Loss of appetite Any Grade Related Temperature 37.5 C (Axillary) >39.0 C Related N= number of subjects with at least one documented dose n (%)= number (percentage) of subjects reporting at least once the symptom 95%CI= Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of a general symptom irrespective of intensity grade and relationship to vaccination Grade 3 drowsiness = drowsiness that prevented normal activity Grade 3 irritability = crying that could not be comforted/prevented normal activity Grade 3 loss of appetite = did not eat at all Related = symptoms assessed by the investigator as causally related to vaccination Safety results: Number (%) of subjects with unsolicited adverse events within the 31-day (Days 0-30) post-vaccination period (Total Vaccinated Cohort) Most frequent adverse events - On-Therapy (occurring within Day 0 to Day 30 following vaccination) Hepta + 10Pn Group Hexa + MenC Group N = 139 Hexa + 10Pn Group

10 Subjects with any AE(s), n (%) 61 (43.3) 52 (37.4) 61 (43.3) Rhinitis 11 (7.8) 18 (12.9) 17 (12.1) Upper respiratory tract infection 10 (7.1) 7 (5.0) 10 (7.1) Bronchitis 3 (2.1) 6 (4.3) 7 (5.0) Nasopharyngitis 9 (6.4) 4 (2.9) - Viral infection 4 (2.8) 3 (2.2) 4 (2.8) Dermatitis allergic 3 (2.1) 2 (1.4) 4 (2.8) Urinary tract infection 4 (2.8) - 4 (2.8) Diarrhoea (4.3) Pharyngitis 4 (2.8) 2 (1.4) - Weight gain poor 3 (2.1) - 3 (2.1) Conjunctivitis - 5 (3.6) - Otitis media - 2 (1.4) 3 (2.1) Dermatitis atopic 3 (2.1) - - Hypochromic anaemia (2.1) Milk allergy 3 (2.1) - - Rash 3 (2.1) - - Candidiasis - 2 (1.4) - Cough - 2 (1.4) - Counting rule applied: As there were more than 30 subjects per treatment group and 3 groups, only the 10 most frequent events in each treatment group are to be listed. -: Implies that adverse event was not reported in the particular group or that the adverse event was reported in the particular group but did not fall within the pre-defined counting rule of 10 most frequent events for that group. Safety results: Number (%) of subjects with serious adverse events during the entire study period (Total Vaccinated Cohort) Serious adverse event, n (%) [n considered by the investigator to be related to study medication] All SAEs Hepta + 10Pn Group Hexa + MenC Group N = 139 Hexa + 10Pn Group Subjects with any SAE(s), n (%) [n assessed by 5 (3.5) [1] 6 (4.3) [0] 3 (2.1) [0] the investigator as related] Bronchopneumonia 2 (1.4) [0] 1 (0.7) [0] 0 (0.0) [0] Bronchitis 1 (0.7) [0] 1 (0.7) [0] 0 (0.0) [0] Urinary tract infection 1 (0.7) [0] 1 (0.7) [0] 0 (0.0) [0] Abdominal pain 0 (0.0) [0] 1 (0.7) [0] 0 (0.0) [0] Aspiration 1 (0.7) [0] 0 (0.0) [0] 0 (0.0) [0] Bronchiolitis 0 (0.0) [0] 1 (0.7) [0] 0 (0.0) [0] Diarrhoea 0 (0.0) [0] 0 (0.0) [0] 1 (0.7) [0] Gastroenteritis 0 (0.0) [0] 0 (0.0) [0] 1 (0.7) [0] Otitis media 0 (0.0) [0] 1 (0.7) [0] 0 (0.0) [0] Pharyngitis 0 (0.0) [0] 1 (0.7) [0] 0 (0.0) [0] Pyelonephritis 0 (0.0) [0] 0 (0.0) [0] 1 (0.7) [0] Thrombocytopenia 1 (0.7) [1] 0 (0.0) [0] 0 (0.0) [0] Fatal SAEs Hepta + 10Pn Group Hexa + MenC Group Hexa + 10Pn Group Subjects with fatal SAE(s), n (%) [n assessed by the investigator as related] N = (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] Conclusion: One month after primary vaccination, 100% of subjects in Hepta + 10Pn Group, 93.2% of subjects in Hexa + MenC Group and 99.2% of subjects in Hexa + 10Pn Group had anti-prp antibody concentrations 0.15 µg/ml. At the same time point, 98.4% of the subjects in the Hepta + 10Pn Group and 97.7% of the subjects in the Hexa + MenC Group had rsba-menc antibody titres 1:8. Within the 31-day (Days 0-30) post-vaccination period, at least one unsolicited AE was reported for 61 (43.3%) subjects in the Hepta + 10Pn Group, 52 (37.4%) subjects in the Hexa + MenC Group and 61 (43.3%) subjects in the Hexa + 10Pn Group. During the entire study period, SAEs were reported for 5 subjects in the Hepta + 10Pn Group, 6 subjects in the Hexa + MenC Group and 3 subjects in the Hexa + 10Pn Group. One SAE reported in the Hexa + 10Pn Group was assessed by the investigators as causally related to vaccination. No fatal SAEs were reported during the study period. Date updated: 05-February-2014

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