Trial Outcomes & Findings for Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age (NCT NCT00808444)
NCT ID: NCT00808444
Last Updated: 2018-08-17
Results Overview
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
466 participants
Primary outcome timeframe
One month after primary immunization (month 4)
Results posted on
2018-08-17
Participant Flow
Participant milestones
| Measure |
Synflorix Clinical Lot & Infanrix Group
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
233
|
|
Overall Study
COMPLETED
|
232
|
232
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Synflorix Clinical Lot & Infanrix Group
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Baseline characteristics by cohort
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.3 Weeks
STANDARD_DEVIATION 1.35 • n=93 Participants
|
7.2 Weeks
STANDARD_DEVIATION 1.30 • n=4 Participants
|
7.3 Weeks
STANDARD_DEVIATION 1.32 • n=27 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
217 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=93 Participants
|
129 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=219 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=218 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-1
|
2.67 μg/mL
Interval 2.46 to 2.91
|
2.46 μg/mL
Interval 2.25 to 2.69
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-4
|
3.95 μg/mL
Interval 3.59 to 4.36
|
3.14 μg/mL
Interval 2.84 to 3.47
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-5
|
4.34 μg/mL
Interval 3.95 to 4.76
|
3.59 μg/mL
Interval 3.29 to 3.92
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-6B
|
1.31 μg/mL
Interval 1.16 to 1.48
|
1.23 μg/mL
Interval 1.07 to 1.41
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-7
|
3.10 μg/mL
Interval 2.83 to 3.39
|
3.20 μg/mL
Interval 2.92 to 3.51
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-9V
|
3.34 μg/mL
Interval 3.03 to 3.69
|
3.14 μg/mL
Interval 2.83 to 3.49
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-14
|
5.13 μg/mL
Interval 4.54 to 5.79
|
4.74 μg/mL
Interval 4.23 to 5.32
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-18C
|
5.00 μg/mL
Interval 4.4 to 5.69
|
5.15 μg/mL
Interval 4.43 to 5.97
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-19F
|
6.69 μg/mL
Interval 6.04 to 7.41
|
6.96 μg/mL
Interval 6.26 to 7.73
|
|
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Anti-23F
|
1.98 μg/mL
Interval 1.76 to 2.23
|
1.68 μg/mL
Interval 1.49 to 1.9
|
PRIMARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=219 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=218 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentration of Antibody Against Protein D (PD)
|
2543.6 EL.U/mL
Interval 2319.4 to 2789.4
|
1869.8 EL.U/mL
Interval 1671.2 to 2091.9
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=219 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=218 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-1
|
219 Participants
|
218 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-4
|
219 Participants
|
218 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-5
|
218 Participants
|
218 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-6B
|
211 Participants
|
204 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-7F
|
218 Participants
|
217 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-9V
|
219 Participants
|
218 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-14
|
218 Participants
|
218 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-18C
|
219 Participants
|
217 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-19F
|
218 Participants
|
217 Participants
|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Anti-23F
|
215 Participants
|
212 Participants
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Anti-pneumococcal cross-reactive serotypes were 6A and 19A.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=219 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=218 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
Anti-6A
|
152 Participants
|
132 Participants
|
|
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
Anti-19A
|
135 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=209 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=210 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-9V
|
207 Participants
|
208 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-14
|
208 Participants
|
207 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-23F
|
207 Participants
|
206 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-18C
|
202 Participants
|
199 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-19F
|
202 Participants
|
200 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-1
|
185 Participants
|
189 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-4
|
207 Participants
|
203 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-5
|
204 Participants
|
203 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-6B
|
196 Participants
|
191 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Opsono-7F
|
206 Participants
|
208 Participants
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Cross-reactive pneumococcal serotypes were 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=197 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=200 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Opsono-6A
|
173 Participants
|
171 Participants
|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Opsono-19A
|
83 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Opsonophagocytic titers were expressed as GMTs. Cross-reactive pneumococcal serotypes included 6A and 19A.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=197 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=200 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
Opsono-6A
|
230.8 titer
Interval 180.3 to 295.4
|
173.7 titer
Interval 133.9 to 225.3
|
|
Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
Opsono-19A
|
18.1 titer
Interval 13.7 to 23.8
|
15.1 titer
Interval 11.5 to 19.8
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Titers were given as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=99 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=93 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Poliovirus Types 1, 2 and 3 Titers
Anti-Polio 1
|
313.8 titer
Interval 250.4 to 393.3
|
328.7 titer
Interval 253.1 to 427.0
|
|
Poliovirus Types 1, 2 and 3 Titers
Anti-Polio 2
|
278.7 titer
Interval 225.4 to 344.7
|
229.1 titer
Interval 176.9 to 296.6
|
|
Poliovirus Types 1, 2 and 3 Titers
Anti-Polio 3
|
408.8 titer
Interval 330.1 to 506.4
|
449.4 titer
Interval 351.9 to 573.8
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentrations were defined as GMCs in international units per milliter (IU/mL)
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=109 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=107 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)
Anti-DT
|
3.317 IU/mL
Interval 2.895 to 3.8
|
3.353 IU/mL
Interval 2.991 to 3.759
|
|
Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)
Anti-TT
|
4.879 IU/mL
Interval 4.358 to 5.502
|
4.476 IU/mL
Interval 4.013 to 4.992
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete reanalysis.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=87 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=97 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).
|
1521.2 mIU/mL
Interval 1129.7 to 2048.4
|
2114.1 mIU/mL
Interval 1658.5 to 2694.9
|
SECONDARY outcome
Timeframe: 3 months after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentration was expressed as GMC in units per milliliter (U/mL).
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=105 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=106 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)
|
141.1 U/mL
Interval 103.0 to 193.4
|
114.8 U/mL
Interval 85.0 to 155.1
|
SECONDARY outcome
Timeframe: Following vaccination and throughout the entire study period (Month 0 to Month 4)Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
SAEs assessed include medical occurrences that result in death, is 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 Clinical Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Occurrence of Serious Adverse Events
|
18 subjects
|
7 subjects
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Titers are presented as Geometric Mean Titers (GMTs). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=209 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=210 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-1
|
128.9 titer
Interval 102.7 to 161.7
|
122.1 titer
Interval 98.3 to 151.7
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-4
|
698.3 titer
Interval 619.6 to 786.9
|
609.3 titer
Interval 519.6 to 714.3
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-5
|
127.9 titer
Interval 109.0 to 149.9
|
98.6 titer
Interval 83.0 to 117.1
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-6B
|
870.7 titer
Interval 710.2 to 1067.6
|
619.2 titer
Interval 483.4 to 793.2
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-7F
|
3905.8 titer
Interval 3420.2 to 4460.4
|
3585.7 titer
Interval 3119.8 to 4121.2
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-9V
|
1800.0 titer
Interval 1596.6 to 2029.3
|
1851.3 titer
Interval 1612.3 to 2125.8
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-14
|
1521.0 titer
Interval 1313.3 to 1761.6
|
1485.8 titer
Interval 1280.5 to 1724.0
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-18C
|
533.5 titer
Interval 461.8 to 616.4
|
383.9 titer
Interval 319.3 to 461.5
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-19F
|
689.6 titer
Interval 581.1 to 818.2
|
573.5 titer
Interval 477.2 to 689.3
|
|
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Opsono-23F
|
2716.7 titer
Interval 2316.3 to 3186.3
|
2379.5 titer
Interval 2043.4 to 2770.7
|
SECONDARY outcome
Timeframe: Within 4 days (day 0-3) after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which inlcuded all vaccinated subjects.
Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Number of Subjects With Solicited Local and General Symptoms.
Diarrhoea
|
53 Participants
|
54 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Pain
|
162 Participants
|
157 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Redness
|
149 Participants
|
142 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Swelling
|
133 Participants
|
124 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Drowsiness
|
151 Participants
|
136 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Fever
|
193 Participants
|
175 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Irritability
|
168 Participants
|
171 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Loss of appetite
|
127 Participants
|
121 Participants
|
|
Number of Subjects With Solicited Local and General Symptoms.
Vomiting
|
44 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentrations are expressed as GMCs in EL.U/mL.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=109 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=107 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Anti-PT
|
46.5 EL.U/mL
Interval 41.1 to 52.6
|
45.4 EL.U/mL
Interval 39.8 to 51.7
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Anti-FHA
|
179.2 EL.U/mL
Interval 157.5 to 203.9
|
186.2 EL.U/mL
Interval 165.5 to 209.5
|
|
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Anti-PRN
|
142.1 EL.U/mL
Interval 123.2 to 164.0
|
128.3 EL.U/mL
Interval 110.9 to 148.5
|
SECONDARY outcome
Timeframe: One month after primary immunization (month 4)Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Concentrain was expressed as GMC in µg/mL.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=112 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=108 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
|
9.745 µg/mL
Interval 7.807 to 12.164
|
6.387 µg/mL
Interval 5.051 to 8.078
|
SECONDARY outcome
Timeframe: Within 31 days (day 0-30) after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=233 Participants
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Occurrence of Unsolicited Adverse Events
|
88 Participants
|
96 Participants
|
Adverse Events
Synflorix Clinical Lot & Infanrix Group
Serious events: 18 serious events
Other events: 230 other events
Deaths: 0 deaths
Synflorix Commercial Lot & Infanrix Group
Serious events: 7 serious events
Other events: 228 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=233 participants at risk
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=233 participants at risk
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
5/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.3%
3/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Gastroenteritis
|
1.7%
4/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Bronchiolitis
|
0.86%
2/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.86%
2/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Vascular disorders
Kawasaki's disease
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Urinary tract infection
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Bacteraemia
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Bronchopneumonia
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Gastrointestinal disorders
Gastritis
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Influenza
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Meningitis tuberculous
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Meningitis viral
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Pharyngitis
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Congenital, familial and genetic disorders
Spinal muscular atrophy
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Nervous system disorders
Vith nerve parlysis
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
0.43%
1/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
Other adverse events
| Measure |
Synflorix Clinical Lot & Infanrix Group
n=233 participants at risk
Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
Synflorix Commercial Lot & Infanrix Group
n=233 participants at risk
Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
|
|---|---|---|
|
General disorders
Pain
|
69.5%
162/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
67.4%
157/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Redness
|
63.9%
149/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
60.9%
142/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Swelling
|
57.1%
133/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
53.2%
124/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Drowsiness
|
64.8%
151/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
58.4%
136/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Fever
|
82.8%
193/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
75.1%
175/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Irritability
|
72.1%
168/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
73.4%
171/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Diarrhoea
|
22.7%
53/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
23.2%
54/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Vomiting
|
18.9%
44/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
19.7%
46/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
28/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
17.2%
40/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
|
General disorders
Loss of appetite
|
54.5%
127/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
51.9%
121/233 • Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).
|
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