Trial Outcomes & Findings for Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™ (NCT NCT00680914)

NCT ID: NCT00680914

Last Updated: 2018-06-08

Results Overview

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 503 participants
• Primary outcome timeframe: One month after administration of 3rd dose of the pneumococcal conjugate vaccine
• Results posted on: 2018-06-08

Participant Flow

Participant milestones

Measure	Synflorix Group Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Overall Study STARTED	374	129
Overall Study COMPLETED	364	125
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Measure	Synflorix Group Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Overall Study Consent withdrawal	6	3
Overall Study Lost to Follow-up	4	0
Overall Study serious adverse event (SAE)	0	1

Baseline Characteristics

Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

Baseline characteristics by cohort

Measure	Synflorix Group n=374 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Total n=503 Participants Total of all reporting groups
Age, Continuous	9.5 years STANDARD_DEVIATION 1.49 • n=5 Participants	9.5 years STANDARD_DEVIATION 1.43 • n=7 Participants	9.5 years STANDARD_DEVIATION 1.47 • n=5 Participants
Sex: Female, Male Female	189 Participants n=5 Participants	71 Participants n=7 Participants	260 Participants n=5 Participants
Sex: Female, Male Male	185 Participants n=5 Participants	58 Participants n=7 Participants	243 Participants n=5 Participants
Region of Enrollment East Asia	373 participants n=5 Participants	129 participants n=7 Participants	502 participants 0 • n=5 Participants
Region of Enrollment Southeast Asia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants 0 • n=5 Participants

PRIMARY outcome

Timeframe: One month after administration of 3rd dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Outcome measures

Measure	Synflorix Group n=344 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=123 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-6B	318 subjects	121 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-7F	344 subjects	4 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-9V	343 subjects	122 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-14	342 subjects	123 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-23F	331 subjects	121 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-1	344 subjects	7 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-4	343 subjects	123 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-5	344 subjects	18 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-18C	343 subjects	123 subjects
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value Anti-19F	340 subjects	123 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.

Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL.

Outcome measures

Measure	Synflorix Group n=344 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=123 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-PD	343 subjects	123 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-1	344 subjects	44 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-18C	344 subjects	123 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-4	344 subjects	123 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-5	344 subjects	85 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-6B	337 subjects	122 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-7F	344 subjects	22 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-9V	343 subjects	123 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-14	344 subjects	123 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-19F	344 subjects	123 subjects
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes Anti-23F	340 subjects	122 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8.

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Outcome measures

Measure	Synflorix Group n=165 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=63 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-1 (N=162; 62)	150 subjects	8 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-4 (N=161; 63)	158 subjects	63 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-5 (N=165; 62)	161 subjects	6 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-6B (N=162; 63)	152 subjects	63 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-7F (N=164; 59)	164 subjects	40 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-9V (N= 165; 63)	164 subjects	62 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-14 (N= 165; 63)	163 subjects	62 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-18C (N= 159; 63)	142 subjects	61 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-19F (N=164; 61)	159 subjects	55 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value Opsono-23F (N= 164; 63)	160 subjects	62 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).

Pneumococcal cross-reactive serotypes were 6A and 19A.

Outcome measures

Measure	Synflorix Group n=344 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=123 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value Anti-6A	232 subjects	85 subjects
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value Anti-19A	203 subjects	33 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Outcome measures

Measure	Synflorix Group n=344 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=123 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-9V	3.39 ug/mL Interval 3.09 to 3.71	5.09 ug/mL Interval 4.34 to 5.96
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-14	5.54 ug/mL Interval 5.02 to 6.12	8.51 ug/mL Interval 7.27 to 9.95
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-1	3.41 ug/mL Interval 3.14 to 3.71	0.04 ug/mL Interval 0.04 to 0.05
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-4	4.00 ug/mL Interval 3.67 to 4.35	5.35 ug/mL Interval 4.66 to 6.15
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-5	4.52 ug/mL Interval 4.24 to 4.83	0.07 ug/mL Interval 0.06 to 0.08
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-6B	1.40 ug/mL Interval 1.24 to 1.58	2.07 ug/mL Interval 1.75 to 2.44
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-7F	4.08 ug/mL Interval 3.77 to 4.41	0.03 ug/mL Interval 0.03 to 0.04
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-18C	5.80 ug/mL Interval 5.17 to 6.52	5.13 ug/mL Interval 4.31 to 6.11
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-19F	7.41 ug/mL Interval 6.67 to 8.23	2.77 ug/mL Interval 2.45 to 3.13
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine Anti-23F	1.96 ug/mL Interval 1.75 to 2.19	3.94 ug/mL Interval 3.26 to 4.77

SECONDARY outcome

Timeframe: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.

Outcome measures

Measure	Synflorix Group n=344 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=123 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Anti-PD Antibody Concentration	1622.4 EL.U/mL Interval 1500.8 to 1754.0	88.2 EL.U/mL Interval 74.7 to 104.0

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.

Outcome measures

Measure	Synflorix Group n=344 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=123 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes Anti-6A	0.38 ug/mL Interval 0.33 to 0.44	0.48 ug/mL Interval 0.36 to 0.63
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes Anti-19A	0.29 ug/mL Interval 0.25 to 0.33	0.12 ug/mL Interval 0.1 to 0.14

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.

Outcome measures

Measure	Synflorix Group n=162 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=60 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes Opsono-6A (N=158; 60)	134 subjects	54 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes Opsono-19A (N= 162; 60)	53 subjects	7 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Concentration of anti-PRP antibody given as GMC in ug/mL.

Outcome measures

Measure	Synflorix Group n=175 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=60 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	20.131 ug/mL Interval 16.775 to 24.158	11.844 ug/mL Interval 8.542 to 16.424

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL

Outcome measures

Measure	Synflorix Group n=175 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=60 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Seroprotection Status Against PRP Above 0.15	175 subjects	60 subjects
Number of Subjects With Seroprotection Status Against PRP Above 1.0	173 subjects	58 subjects

SECONDARY outcome

Timeframe: Within 4 days after each vaccination

Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Solicited local symptoms assessed include pain, redness and swelling.

Outcome measures

Measure	Synflorix Group n=371 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects Reporting Solicited Local Symptoms Pain	210 subjects	72 subjects
Number of Subjects Reporting Solicited Local Symptoms Redness	252 subjects	84 subjects
Number of Subjects Reporting Solicited Local Symptoms Swelling	182 subjects	69 subjects

SECONDARY outcome

Timeframe: Within 4 days after each vaccination

Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.

Fever was defined as axillary temperature >= 37.5 degrees Celsius.

Outcome measures

Measure	Synflorix Group n=371 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Solicited General Symptoms Drowsiness	212 subjects	65 subjects
Number of Subjects With Solicited General Symptoms Fever	113 subjects	33 subjects
Number of Subjects With Solicited General Symptoms Irritability	293 subjects	99 subjects
Number of Subjects With Solicited General Symptoms Loss of Appetite	177 subjects	66 subjects

SECONDARY outcome

Timeframe: Within 31 days after each vaccination

Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Outcome measures

Measure	Synflorix Group n=374 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects Reporting Unsolicited Adverse Events	213 subjects	62 subjects

SECONDARY outcome

Timeframe: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5

Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

An SAE is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Measure	Synflorix Group n=374 Participants Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 Participants Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Number of Subjects With Serious Adverse Events (SAE)	56 subjects	9 subjects

Adverse Events

Synflorix Group

Serious events: 56 serious events

Other events: 357 other events

Deaths: 0 deaths

Prevenar Group

Serious events: 9 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix Group n=374 participants at risk Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 participants at risk Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Infections and infestations Bronchiolitis	5.9% 22/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Gastroenteritis	2.1% 8/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	2.3% 3/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Urinary tract infection	2.4% 9/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Pneumonia	1.1% 4/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Croup infections	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Gastrointestinal disorders Intussusception	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Meningitis aseptic	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Pharyngitis	0.80% 3/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Bronchopneumonia	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Gastrointestinal disorders enteritis	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Gastroenteritis rotavirus	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Renal and urinary disorders Hydronephrosis	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Influenza	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Otitis media acute	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Pyrexia	0.53% 2/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Metabolism and nutrition disorders Anorexia	0.00% 0/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Cystitis	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Exanthema subitum	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Nervous system disorders Febrile convulsion	0.00% 0/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Hepatobiliary disorders Hepatitis	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Herpangina	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Injection site abscess	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Laryngitis	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Meningitis	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Nasopharyngitis	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Otitis media	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Pyelonephritis acute	0.27% 1/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.00% 0/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations rhinitis	0.00% 0/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Upper respiratory tract infection	0.00% 0/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	0.78% 1/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Other adverse events

Measure	Synflorix Group n=374 participants at risk Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4	Prevenar Group n=129 participants at risk Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
General disorders Pain	56.1% 210/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	55.8% 72/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Redness	67.4% 252/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	65.1% 84/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Swelling	48.7% 182/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	53.5% 69/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Drowsiness	56.7% 212/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	50.4% 65/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Fever	30.2% 113/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	25.6% 33/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Irritability	78.3% 293/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	76.7% 99/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
General disorders Loss of appetite	47.3% 177/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	51.2% 66/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Upper respiratory tract infection	11.8% 44/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	12.4% 16/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Nasopharyngitis	11.2% 42/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	12.4% 16/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations bronchiolitis	5.3% 20/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	3.1% 4/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Pharyngitis	6.1% 23/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	4.7% 6/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Infections and infestations Bronchitis	3.7% 14/374 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.	5.4% 7/129 • Up to study Month 5 Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER