Trial Outcomes & Findings for Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines (NCT NCT00148941)
NCT ID: NCT00148941
Last Updated: 2020-02-05
Results Overview
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4209 participants
Primary outcome timeframe
At Month 1 (i.e. one month after vaccination)
Results posted on
2020-02-05
Participant Flow
This study was conducted at 24 centers in the United States.
All 4209 subjects enrolled in the study, received the study vaccination and were included in the Total vaccination cohort (TVC).
Participant milestones
| Measure |
SB213503 Lot 1 + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1053
|
1051
|
1052
|
1053
|
|
Overall Study
COMPLETED
|
1035
|
1027
|
1032
|
1029
|
|
Overall Study
NOT COMPLETED
|
18
|
24
|
20
|
24
|
Reasons for withdrawal
| Measure |
SB213503 Lot 1 + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
24
|
18
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines
Baseline characteristics by cohort
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1051 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1052 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Total
n=4209 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
4.2 Years
STANDARD_DEVIATION 0.38 • n=99 Participants
|
4.2 Years
STANDARD_DEVIATION 0.37 • n=107 Participants
|
4.2 Years
STANDARD_DEVIATION 0.37 • n=206 Participants
|
4.2 Years
STANDARD_DEVIATION 0.38 • n=7 Participants
|
4.2 Years
STANDARD_DEVIATION 0.37 • n=31 Participants
|
|
Sex: Female, Male
Female
|
526 Participants
n=99 Participants
|
515 Participants
n=107 Participants
|
533 Participants
n=206 Participants
|
513 Participants
n=7 Participants
|
2087 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
527 Participants
n=99 Participants
|
536 Participants
n=107 Participants
|
519 Participants
n=206 Participants
|
540 Participants
n=7 Participants
|
2122 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
65 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
293 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
489 Participants
n=99 Participants
|
488 Participants
n=107 Participants
|
486 Participants
n=206 Participants
|
457 Participants
n=7 Participants
|
1920 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Arabic/North African
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · East/South East Asian
|
83 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
356 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · South Asian
|
45 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
201 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · American Hispanic
|
208 Participants
n=99 Participants
|
201 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
194 Participants
n=7 Participants
|
791 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Japanese
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Not specified
|
151 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
158 Participants
n=7 Participants
|
603 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=283 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects
Anti-D
|
16.704 IU/mL
Interval 15.198 to 18.36
|
18.658 IU/mL
Interval 17.045 to 20.424
|
18.437 IU/mL
Interval 16.771 to 20.269
|
18.112 IU/mL
Interval 16.443 to 19.949
|
|
Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects
Anti-T
|
9.693 IU/mL
Interval 8.843 to 10.624
|
9.974 IU/mL
Interval 9.12 to 10.908
|
11.300 IU/mL
Interval 10.264 to 12.441
|
11.235 IU/mL
Interval 10.275 to 12.284
|
PRIMARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=285 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=281 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=285 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects
Anti-PT
|
66.9 EL.U/mL
Interval 61.1 to 73.3
|
74.1 EL.U/mL
Interval 66.6 to 82.4
|
71.4 EL.U/mL
Interval 64.7 to 78.6
|
80.4 EL.U/mL
Interval 72.4 to 89.1
|
|
Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects
Anti-FHA
|
809.1 EL.U/mL
Interval 740.5 to 884.2
|
918.8 EL.U/mL
Interval 840.0 to 1005.0
|
869.2 EL.U/mL
Interval 795.2 to 950.2
|
939.7 EL.U/mL
Interval 858.3 to 1028.8
|
|
Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects
Anti-PRN
|
617.4 EL.U/mL
Interval 549.2 to 694.0
|
584.7 EL.U/mL
Interval 519.7 to 657.9
|
594.2 EL.U/mL
Interval 526.6 to 670.4
|
593.8 EL.U/mL
Interval 525.7 to 670.7
|
PRIMARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
GMTs were measured by Neutralization assay and expressed in titers.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=276 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=274 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=276 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=252 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects
Anti-poliovirus 1
|
2095.0 Titers
Interval 1852.1 to 2369.8
|
2103.1 Titers
Interval 1863.4 to 2373.5
|
2129.2 Titers
Interval 1889.2 to 2399.7
|
1683.1 Titers
Interval 1444.7 to 1960.9
|
|
Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects
Anti-poliovirus 2
|
2345.4 Titers
Interval 2104.8 to 2613.5
|
2132.9 Titers
Interval 1888.0 to 2409.5
|
2326.6 Titers
Interval 2074.5 to 2609.3
|
1802.0 Titers
Interval 1566.3 to 2073.2
|
|
Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects
Anti-poliovirus 3
|
3683.5 Titers
Interval 3283.4 to 4132.3
|
3400.7 Titers
Interval 3023.2 to 3825.4
|
3603.8 Titers
Interval 3185.1 to 4077.5
|
3367.8 Titers
Interval 2923.3 to 3879.8
|
PRIMARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 0.1 international units per milliliter (IU/mL)\] with an increase of at least four times the cut-off one month after vaccination \[post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL\]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=280 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=283 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=282 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects
Anti-D, Total
|
279 Participants
|
280 Participants
|
281 Participants
|
260 Participants
|
|
Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects
Anti-T, Total
|
266 Participants
|
273 Participants
|
277 Participants
|
245 Participants
|
PRIMARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 5 EL.U/mL\] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=281 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=281 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Anti-PT, Total
|
251 Participants
|
250 Participants
|
257 Participants
|
237 Participants
|
|
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Anti-FHA, Total
|
265 Participants
|
272 Participants
|
268 Participants
|
251 Participants
|
|
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Anti-PRN, Total
|
270 Participants
|
277 Participants
|
279 Participants
|
253 Participants
|
PRIMARY outcome
Timeframe: Within 4 days (Day 0-3) after vaccinationPopulation: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Swelling (at the SB213503 \& Infanrix injection sites) was categorized as an increase of \> or ≤ 30 mm in mid upper arm circumference compared to baseline measurement or with an increase in mid upper arm missing; extent of swelling \> or ≤ 50 % of upper arm length, or diameter of injection site missing.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1051 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1052 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Circumference increase>30mm;swelling>50% of length
|
5 Participants
|
10 Participants
|
5 Participants
|
11 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Circumference increase>30mm;swelling≤50% of length
|
10 Participants
|
20 Participants
|
23 Participants
|
22 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Circumference increase>30mm;diameter missing
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Circumference increase≤30mm;swelling>50% of length
|
9 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Circumference increase≤30mm;swelling≤50% of length
|
62 Participants
|
42 Participants
|
52 Participants
|
54 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Circumference increase≤30mm;diameter missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Increase in mid upper arm;swelling>50% of length
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Increase in mid upper arm;swelling≤50% of length
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Circumferential Swelling at the Injection Site
Increase in mid upper arm;diameter missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=283 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects
Anti-D
|
284 Participants
|
282 Participants
|
284 Participants
|
260 Participants
|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects
Anti-T
|
284 Participants
|
283 Participants
|
284 Participants
|
261 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody titers greater than or equal to 1:8.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=276 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=274 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=276 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=252 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Anti-poliovirus type 1
|
275 Participants
|
274 Participants
|
275 Participants
|
249 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Anti-poliovirus type 2
|
276 Participants
|
273 Participants
|
269 Participants
|
252 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Anti-poliovirus type 3
|
271 Participants
|
259 Participants
|
268 Participants
|
239 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=285 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=281 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=285 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Anti-PT
|
285 Participants
|
279 Participants
|
283 Participants
|
261 Participants
|
|
Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Anti-FHA
|
285 Participants
|
280 Participants
|
285 Participants
|
261 Participants
|
|
Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects
Anti-PRN
|
285 Participants
|
281 Participants
|
285 Participants
|
261 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
The number of subjects with anti-D and anti-T antibody concentrations greater than or equal to (≥) 1 IU/mL is reported.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=283 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=284 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=261 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL
Anti-D
|
284 Participants
|
282 Participants
|
284 Participants
|
260 Participants
|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL
Anti-T
|
281 Participants
|
282 Participants
|
281 Participants
|
261 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.
Vaccine response defined as: For initially seronegative subjects (pre-booster antibody titer below cut-off of 1:8), an antibody titer ≥ 1:32 at one month after vaccination. For initially seropositive subjects (pre-booster antibody titer ≥1:8), an increase at least four times the pre-booster antibody titer at one month after vaccination.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=274 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=268 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=273 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=252 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Anti-poliovirus type 1, Total
|
264 Participants
|
257 Participants
|
264 Participants
|
231 Participants
|
|
Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Anti-poliovirus type 2, Total
|
271 Participants
|
252 Participants
|
258 Participants
|
234 Participants
|
|
Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects
Anti-poliovirus type 3, Total
|
259 Participants
|
245 Participants
|
256 Participants
|
220 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.
GMTs were measured by hemagglutination inhibition assay and expressed in titers.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=4 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=2 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=2 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
Anti-H1N1, Day 0
|
5.0 Titers
The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable) because number of subjects with concentrations within the specified range = 0.
|
20.0 Titers
Interval 0.1 to 7789.1
|
20.0 Titers
Interval 0.0 to 893160000.0
|
56.6 Titers
Interval 0.0 to
NA=1.38\*10\^15 in this case
|
|
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
Anti-H1N1, Month 1
|
57.0 Titers
The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable) because number of subjects with concentrations within the specified range = 0.
|
134.5 Titers
Interval 25.7 to 703.7
|
20.0 Titers
Interval 0.0 to 133653.0
|
226.3 Titers
Interval 0.0 to 826100000000.0
|
|
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
Anti-H3N2, Day 0
|
1280.0 Titers
The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable) because number of subjects with concentrations within the specified range = 0.
|
80.0 Titers
Interval 0.2 to 31156.2
|
80.0 Titers
Interval 0.0 to
NA=1.595\*10\^17 in this case
|
134.5 Titers
Interval 14.8 to 1225.1
|
|
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
Anti-H3N2, Month 1
|
1280.0 Titers
The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable) because number of subjects with concentrations within the specified range = 0.
|
493.6 Titers
Interval 61.6 to 3958.1
|
113.1 Titers
Interval 0.0 to
NA=2.76\*10\^15 in this case
|
538.1 Titers
Interval 0.7 to 397480.8
|
|
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
Anti-B, Day 0
|
160.0 Titers
The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable) because number of subjects with concentrations within the specified range = 0.
|
10.0 Titers
Interval 0.5 to 197.3
|
7.1 Titers
Interval 0.1 to 578.0
|
10.0 Titers
Interval 0.0 to 66826.5
|
|
Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects
Anti-B, Month 1
|
1810.0 Titers
The lower limit (LL) and upper limit (UL) of the 95% confidence interval could not be determined in this group (not applicable) because number of subjects with concentrations within the specified range = 0.
|
95.1 Titers
Interval 9.8 to 924.4
|
28.3 Titers
Interval 0.3 to 2312.2
|
226.3 Titers
Interval 0.0 to 826100000000.0
|
SECONDARY outcome
Timeframe: At Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.
Seroconversion was defined as a post-vaccination haemagglutination-inhibition (HI) titer of ≥ 1:40 in an initially HI antibody seronegative subject (pre-vaccination HI titer \< 1:10), or a ≥ 4 fold rise in HI titer in an initially HI antibody seropositive subject (pre-vaccination HI titer ≥ 1:10) The 3 flu strains assessed were H1N1, H3N2, and B.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=3 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=2 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=2 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-H1N1
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-H3N2
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-B
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)Population: The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.
A seroprotected subject is defined as a vaccinated subject with anti-H1N1, anti-H3N2, and anti-B antibody titers greater than or equal to (≥) 1:40.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=4 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=2 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=2 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-H1N1, Day 0
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-H1N1, Month 1
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-H3N2, Day 0
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-H3N2, Month 1
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-B, Day 0
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects
Anti-B, Month 1
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodPopulation: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
Assessed solicited local symptoms were pain, redness, and swelling (at the SB213503 \& Infanrix vaccination sites). Any = any symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading up to or beyond 50 mm diameter.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1046 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1039 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1043 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1043 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any
|
620 Participants
|
582 Participants
|
642 Participants
|
601 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3
|
19 Participants
|
17 Participants
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Any
|
391 Participants
|
399 Participants
|
412 Participants
|
423 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, Grade 3
|
187 Participants
|
186 Participants
|
194 Participants
|
213 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any
|
295 Participants
|
266 Participants
|
291 Participants
|
296 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Grade 3
|
111 Participants
|
95 Participants
|
118 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodPopulation: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
Assessed specific symptom was increase in mid upper arm circumference (at the SB213503 \& Infanrix injection sites). Any = any symptom regardless of intensity grade. Grade 3 increase in mid upper arm circumference = mid upper arm circumference greater than 30 mm.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1046 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1039 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1043 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1043 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site
Increase in mid-upper arm circumference, Any
|
368 Participants
|
374 Participants
|
393 Participants
|
397 Participants
|
|
Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site
Increase in mid-upper arm circumference, Grade 3
|
16 Participants
|
29 Participants
|
29 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodPopulation: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
Assessed solicited general symptoms were drowsiness, fever (orally) \[≥ 37.5 degrees Celsius (°C)\] and loss of appetite. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever \>39°C.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1044 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1037 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1040 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1036 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Drowsiness, Any
|
194 Participants
|
216 Participants
|
185 Participants
|
181 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Drowsiness, Grade 3
|
9 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Drowsiness, Related
|
153 Participants
|
166 Participants
|
148 Participants
|
141 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), ≥ 37.5 °C
|
167 Participants
|
154 Participants
|
166 Participants
|
147 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), > 39.0 °C
|
9 Participants
|
8 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Fever (orally), Related
|
154 Participants
|
136 Participants
|
143 Participants
|
128 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Loss of appetite, Any
|
162 Participants
|
160 Participants
|
162 Participants
|
166 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Loss of appetite, Grade 3
|
11 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Loss of appetite, Related
|
127 Participants
|
117 Participants
|
130 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: During the 15-day (Day 0-14) post-vaccination periodPopulation: The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.
Solicited general symptoms specific to M-M-R II vaccination were fever \[≥ 37.5 degrees Celsius (°C)\], rash/exanthem, parotid/salivary gland swelling, and suspected signs of meningism including febrile convulsions . Any = any symptom regardless of intensity grade. Grade 3 = symptom that prevented normal everyday activity. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever \>39°C.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1044 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1037 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1040 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1036 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Rash site, Any
|
34 Participants
|
44 Participants
|
21 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Non-administration site rash, Measles/Rubella-like
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Non-administration site rash, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Non-administration site rash, Related
|
5 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Parotitis, Any
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Suspected signs of meningism, Any
|
7 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Fever (orally), ≥ 37.5°C
|
213 Participants
|
215 Participants
|
218 Participants
|
208 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Fever (orally), > 39.0°C
|
22 Participants
|
25 Participants
|
36 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination
Fever (orally), Related
|
169 Participants
|
155 Participants
|
159 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: Within 31 days (Days 0-30) post-vaccination periodPopulation: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1051 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1052 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
321 Participants
|
317 Participants
|
326 Participants
|
307 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination])Population: The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) that were assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1051 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1052 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1053 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
4 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the extended safety follow-up phase (i.e. 5 months following the active phase [from Day 31 up to minimum 182 days post-vaccination])Population: The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all vaccinated subjects who had a follow-up contact during the ESFU period/who reported an unsolicited AE as specified in the protocol/onset of a chronic illness/SAE beyond Day 30, after the last vaccination.
Among assessed chronic illness(es) were: autoimmune disorders, asthma, type I diabetes, and allergies. AEs leading to emergency room (ER) visits or to physician office visits that were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis, and gastroenteritis.
Outcome measures
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1028 Participants
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1019 Participants
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1024 Participants
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1022 Participants
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits
Chronic illness
|
6 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits
Emergency room visit
|
7 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits
Physician's office visit
|
20 Participants
|
22 Participants
|
22 Participants
|
19 Participants
|
Adverse Events
SB213503 Lot 1 + M-M-R Group
Serious events: 4 serious events
Other events: 797 other events
Deaths: 0 deaths
SB213503 Lot 2 + M-M-R Group
Serious events: 7 serious events
Other events: 783 other events
Deaths: 0 deaths
SB213503 Lot 3 + M-M-R Group
Serious events: 1 serious events
Other events: 814 other events
Deaths: 0 deaths
Infanrix + IPOL + M-M-R Group
Serious events: 4 serious events
Other events: 804 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1053 participants at risk
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1051 participants at risk
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1052 participants at risk
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1053 participants at risk
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.19%
2/1051 • Number of events 2 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1052 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Viral infection
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1052 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Eye disorders
Optic atrophy
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Pneumonia necrotizing
|
0.09%
1/1053 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1051 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.10%
1/1051 • Number of events 1 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1052 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
0.00%
0/1053 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
Other adverse events
| Measure |
SB213503 Lot 1 + M-M-R Group
n=1053 participants at risk
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 2 + M-M-R Group
n=1051 participants at risk
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
SB213503 Lot 3 + M-M-R Group
n=1052 participants at risk
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
Infanrix + IPOL + M-M-R Group
n=1053 participants at risk
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
162/1053 • Number of events 162 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
15.2%
160/1051 • Number of events 160 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
15.4%
162/1052 • Number of events 162 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
15.8%
166/1053 • Number of events 166 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
37.1%
391/1053 • Number of events 392 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
38.1%
400/1051 • Number of events 400 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
39.2%
412/1052 • Number of events 412 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
40.3%
424/1053 • Number of events 424 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
General disorders
Pain
|
58.9%
620/1053 • Number of events 622 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
55.5%
583/1051 • Number of events 584 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
61.0%
642/1052 • Number of events 642 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
57.1%
601/1053 • Number of events 604 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
General disorders
Pyrexia
|
21.6%
227/1053 • Number of events 229 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
21.7%
228/1051 • Number of events 232 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
22.2%
234/1052 • Number of events 241 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
22.1%
233/1053 • Number of events 236 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Nervous system disorders
Somnolence
|
18.4%
194/1053 • Number of events 194 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
20.6%
217/1051 • Number of events 217 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
17.6%
185/1052 • Number of events 185 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
17.2%
181/1053 • Number of events 181 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
General disorders
Swelling
|
28.0%
295/1053 • Number of events 295 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
25.3%
266/1051 • Number of events 266 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
27.8%
292/1052 • Number of events 292 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
28.3%
298/1053 • Number of events 298 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
54/1053 • Number of events 56 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
5.4%
57/1051 • Number of events 59 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
6.7%
71/1052 • Number of events 71 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
|
5.7%
60/1053 • Number of events 63 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period; MMR II specific solicited symptoms: during the 15-day (Days 0-14) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination]).
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Additional Information
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