Trial Outcomes & Findings for Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age (NCT NCT00489554)

NCT ID: NCT00489554

Last Updated: 2020-01-13

Results Overview

Concentrations were expressed as geometric mean concentration (GMC). 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: 230 participants
• Primary outcome timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
• Results posted on: 2020-01-13

Participant Flow

Participant milestones

Measure	Synflorix Vaccine Group Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Overall Study STARTED	230
Overall Study COMPLETED	226
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Synflorix Vaccine Group Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age

Baseline characteristics by cohort

Measure	Synflorix Vaccine Group n=230 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Age, Continuous	8.2 weeks STANDARD_DEVIATION 1.63 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-1 antibody (N=219)	2.13 microgram per milliliter Interval 1.94 to 2.34
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-4 antibody (N=218)	3.04 microgram per milliliter Interval 2.77 to 3.34
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-5 antibody (N=218)	3.24 microgram per milliliter Interval 2.97 to 3.53
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-18C antibody (N=219)	6.05 microgram per milliliter Interval 5.3 to 6.89
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-19F antibody (N=219)	5.49 microgram per milliliter Interval 4.88 to 6.17
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-23F antibody (N=218)	2.00 microgram per milliliter Interval 1.7 to 2.35
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-6B antibody (N=218)	1.32 microgram per milliliter Interval 1.14 to 1.54
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-7F antibody (N=218)	3.72 microgram per milliliter Interval 3.4 to 4.07
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-9V antibody (N=218)	3.71 microgram per milliliter Interval 3.37 to 4.09
Antibody Concentrations Against Pneumococcal Vaccine Serotypes Anti-14 antibody (N=218)	5.27 microgram per milliliter Interval 4.66 to 5.96

PRIMARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Antibody Concentrations Against Protein D	2923.2 ELISA units per milliliter Interval 2588.6 to 3301.1

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Outcome measures

Measure	Synflorix Vaccine Group n=97 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-1 titer (N=97)	94.1 titer Interval 68.2 to 130.0
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-4 titer (N=97)	670.8 titer Interval 516.1 to 871.7
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-5 titer (N=94)	148.8 titer Interval 120.6 to 183.6
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-6B titer (N=96)	345.4 titer Interval 205.5 to 580.4
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-7F titer (N=96)	4435.4 titer Interval 3635.9 to 5410.7
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-9V titer (N=96)	1186.1 titer Interval 955.9 to 1471.7
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-14 titer (N=94)	1168.3 titer Interval 907.4 to 1504.2
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-18C titer (N=94)	222.9 titer Interval 157.9 to 314.9
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-19F titer (N=92)	589.2 titer Interval 441.9 to 785.5
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes Opsono-23F titer (N=95)	1876.3 titer Interval 1325.4 to 2656.0

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

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

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-1 antibody (N=219)	219 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-4 antibody (N=218)	218 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-5 antibody (N=218)	218 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-6B antibody (N=218)	203 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-7F antibody (N=218)	218 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-9V antibody (N=218)	218 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-14 antibody (N=218)	216 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-18C antibody (N=219)	218 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-23F antibody (N=218)	207 subjects
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter Anti-19F antibody (N=219)	217 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes Anti-6A antibody	0.28 microgram per milliliter Interval 0.24 to 0.34
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes Anti-19A antibody	0.26 microgram per milliliter Interval 0.22 to 0.31

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

Outcome measures

Measure	Synflorix Vaccine Group n=91 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes Opsono-6A titer (N=91)	159.2 titer Interval 98.8 to 256.4
Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes Opsono-19A titer (N=81)	11.6 titer Interval 7.3 to 18.4

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-1 antibody (N=219)	219 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-4 antibody (N=218)	218 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-5 antibody (N=218)	218 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-6B antibody (N=218)	212 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-7F antibody (N=218)	218 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-9V antibody (N=218)	218 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-14 antibody (N=218)	218 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-18C antibody (N=219)	218 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-19F antibody (N=219)	219 subjects
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes Anti-23F antibody (N=218)	212 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Outcome measures

Measure	Synflorix Vaccine Group n=97 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-1 titer (N=97)	83 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-4 titer (N=97)	93 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-5 titer (N=94)	93 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-6B titer (N=96)	76 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-7F titer (N=96)	96 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-9V titer (N=96)	96 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-14 titer (N=94)	93 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-18C titer (N=94)	91 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-19F titer (N=92)	90 subjects
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes Opsono-23F titer (N=95)	90 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes Anti-19A antibody	198 subjects
Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes Anti-6A antibody	203 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.

Outcome measures

Measure	Synflorix Vaccine Group n=91 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes Opsono-6A titer (N=91)	69 subjects
Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes Opsono-19A titer (N=81)	19 subjects

SECONDARY outcome

Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.

Outcome measures

Measure	Synflorix Vaccine Group n=219 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Seropositive for Anti-Protein D Antibodies	219 subjects

SECONDARY outcome

Timeframe: Within 4 days following any vaccine dose

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.

Outcome measures

Measure	Synflorix Vaccine Group n=230 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any pain	196 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 pain	80 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any redness	91 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 redness	0 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any swelling	178 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 swelling	10 subjects

SECONDARY outcome

Timeframe: Within 4 days following any vaccine dose

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature > 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.

Outcome measures

Measure	Synflorix Vaccine Group n=230 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related drowsiness	153 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fever	147 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fever	0 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fever	147 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any irritability	198 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 irritability	21 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related irritability	196 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any loss of appetite	113 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 loss of appetite	1 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related loss of appetite	111 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 vomiting	7 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related vomiting	56 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any diarrhea	55 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 diarrhea	5 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related diarrhea	55 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any drowsiness	156 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 drowsiness	7 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any vomiting	56 subjects

SECONDARY outcome

Timeframe: Within 31 days after any vaccine dose

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Measure	Synflorix Vaccine Group n=230 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Reporting Any Unsolicited AEs	174 subjects

SECONDARY outcome

Timeframe: Up to Month 5

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Synflorix Vaccine Group n=230 Participants Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	15 subjects

Adverse Events

Synflorix Vaccine Group

Serious events: 15 serious events

Other events: 229 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix Vaccine Group n=230 participants at risk Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
Infections and infestations Bronchopneumonia	2.6% 6/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Bronchiolitis	1.7% 4/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Metabolism and nutrition disorders Dehydration	0.87% 2/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Gastroenteritis	0.87% 2/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Nasopharyngitis	0.87% 2/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Nervous system disorders Cerebral infarction	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Eye disorders Conjunctivitis	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Nervous system disorders Convulsion	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Herpangina	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Laryngitis	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Pharyngitis	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Infections and infestations Pneumonia viral	0.43% 1/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.

Other adverse events

Measure	Synflorix Vaccine Group n=230 participants at risk Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
General disorders Pain	85.2% 196/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Redness	39.6% 91/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Swelling	77.4% 178/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Diarrhea	6.1% 14/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Drowsiness	67.8% 156/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Fever	63.9% 147/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Irritability	86.1% 198/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Loss of appetite	49.1% 113/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Vomiting	24.3% 56/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Nasopharyngitis	53.5% 123/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Pharyngitis	16.1% 37/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Conjunctivitis	9.1% 21/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Cough	7.4% 17/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Gastroenteritis	7.0% 16/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
General disorders Laryngitis	5.7% 13/230 • Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.

Additional Information

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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