Trial Outcomes & Findings for Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age (NCT NCT01346293)
NCT ID: NCT01346293
Last Updated: 2015-06-03
Results Overview
Booster responses to pertussis antigens \[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3372 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 28 post-vaccination
Results posted on
2015-06-03
Participant Flow
The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico.
A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Participant milestones
| Measure |
DTaP-IPV
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Overall Study
STARTED
|
2743
|
629
|
|
Overall Study
COMPLETED
|
2676
|
608
|
|
Overall Study
NOT COMPLETED
|
67
|
21
|
Reasons for withdrawal
| Measure |
DTaP-IPV
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Overall Study
Protocol Violation
|
30
|
9
|
|
Overall Study
Lost to Follow-up
|
21
|
8
|
|
Overall Study
Withdrawal by Subject
|
15
|
4
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Baseline characteristics by cohort
| Measure |
DTaP-IPV
n=2743 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=629 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
Total
n=3372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2743 Participants
n=5 Participants
|
629 Participants
n=7 Participants
|
3372 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.4 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.4 Years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
4.4 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1330 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
1636 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1413 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
1736 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2743 Participants
n=5 Participants
|
629 Participants
n=7 Participants
|
3372 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.
Booster responses to pertussis antigens \[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Pertussis toxoid (N=252, 247)
|
240 Participants
|
222 Participants
|
|
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Filamentous hemagglutinin (N=255, 248)
|
242 Participants
|
217 Participants
|
|
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Pertactin (N=254, 248)
|
246 Participants
|
231 Participants
|
|
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Fimbriae types 2 and 3 (N=250, 249)
|
243 Participants
|
230 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.
Geometric mean concentrations to pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], and fimbriae types 2 and 3 \[FIM\]) were measured by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-PRN post-vaccination (N=262, 252)
|
283 Titers
Interval 252.0 to 317.0
|
187 Titers
Interval 164.0 to 214.0
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-PT pre-vaccination (N=254, 248)
|
5.16 Titers
Interval 4.48 to 5.94
|
4.74 Titers
Interval 4.18 to 5.39
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-PT post-vaccination (N=261, 252)
|
121 Titers
Interval 108.0 to 134.0
|
61.3 Titers
Interval 54.5 to 68.9
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-FHA pre-vaccination (N=255, 248)
|
7.93 Titers
Interval 6.63 to 9.47
|
9.42 Titers
Interval 7.85 to 11.3
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-FHA post-vaccination (N=263, 253)
|
123 Titers
Interval 108.0 to 141.0
|
79.0 Titers
Interval 69.3 to 90.0
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-PRN pre-vaccination (N=255, 249)
|
18.6 Titers
Interval 16.2 to 21.3
|
16.7 Titers
Interval 14.6 to 19.1
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-FIM pre-vaccination (N=253, 249)
|
31.9 Titers
Interval 27.0 to 37.6
|
33.3 Titers
Interval 28.3 to 39.2
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-FIM post-vaccination (N=260, 253)
|
506 Titers
Interval 448.0 to 571.0
|
379 Titers
Interval 331.0 to 433.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.
Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration \<0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but \<2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus (N=253, 248)
|
213 Participants
|
209 Participants
|
|
Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria (N=256, 249)
|
249 Participants
|
247 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.
Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus pre-vaccination (N=254, 248)
|
0.644 Titers
Interval 0.548 to 0.758
|
0.608 Titers
Interval 0.518 to 0.715
|
|
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus post-vaccination (N=262, 253)
|
6.42 Titers
Interval 5.74 to 7.18
|
5.48 Titers
Interval 4.88 to 6.15
|
|
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria pre-vaccination (N=257, 249)
|
0.510 Titers
Interval 0.437 to 0.596
|
0.426 Titers
Interval 0.362 to 0.501
|
|
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria post-vaccination (N=262, 253)
|
18.6 Titers
Interval 16.6 to 20.8
|
15.5 Titers
Interval 13.7 to 17.6
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.
Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration \<1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 1 (N=249, 248)
|
214 Participants
|
204 Participants
|
|
Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 2 (N=249, 248)
|
195 Participants
|
196 Participants
|
|
Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 3 (N=247, 248)
|
210 Participants
|
210 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.
Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 1 pre-vaccination (N=254, 248)
|
135 Titers
Interval 114.0 to 160.0
|
129 Titers
Interval 110.0 to 151.0
|
|
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 1 post-vaccination (N=258, 253)
|
3477 Titers
Interval 3088.0 to 3915.0
|
2731 Titers
Interval 2384.0 to 3128.0
|
|
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 2 pre-vaccination (N=254, 248)
|
214 Titers
Interval 183.0 to 249.0
|
188 Titers
Interval 160.0 to 221.0
|
|
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 2 post-vaccination (N=258, 253)
|
3491 Titers
Interval 3111.0 to 3917.0
|
3894 Titers
Interval 3393.0 to 4468.0
|
|
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 3 pre-vaccination (N=252, 248)
|
102 Titers
Interval 85.1 to 123.0
|
90.9 Titers
Interval 74.5 to 111.0
|
|
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 3 post-vaccination (N=258, 252)
|
4591 Titers
Interval 4011.0 to 5256.0
|
3419 Titers
Interval 2946.0 to 3969.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.
Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248)
|
233 Participants
|
221 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248)
|
93 Participants
|
89 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253)
|
262 Participants
|
251 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253)
|
259 Participants
|
245 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249)
|
233 Participants
|
207 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249)
|
78 Participants
|
72 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253)
|
262 Participants
|
252 Participants
|
|
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253)
|
261 Participants
|
252 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=253 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 1 pre-vaccination (N=254, 248)
|
250 Participants
|
245 Participants
|
|
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 1 post-vaccinatin (N=258, 253)
|
258 Participants
|
252 Participants
|
|
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 2 pre-vaccination (N=254, 248)
|
253 Participants
|
247 Participants
|
|
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 2 post-vaccination (N=258, 253)
|
258 Participants
|
253 Participants
|
|
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 3 pre-vaccination (N=252, 248)
|
244 Participants
|
231 Participants
|
|
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Polio 3 post-vaccination (N=258, 252)
|
258 Participants
|
252 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.
Outcome measures
| Measure |
DTaP-IPV
n=262 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=252 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Polio 1 4th dose (N=238, 235)
|
205 Participants
|
199 Participants
|
|
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Polio 1 5th dose (N=10, 12)
|
8 Participants
|
4 Participants
|
|
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Polio 2 4th dose (N=238, 235)
|
188 Participants
|
190 Participants
|
|
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Polio 2 5th dose (N=10, 12)
|
7 Participants
|
5 Participants
|
|
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Polio 3 4th dose (N=236, 235)
|
203 Participants
|
202 Participants
|
|
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Anti-Polio 3 5th dose (N=10, 12)
|
6 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccinationPopulation: Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
Outcome measures
| Measure |
DTaP-IPV
n=263 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=252 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 1 pre-4th dose (N=243, 235)
|
134 Titers
Interval 112.0 to 159.0
|
123 Titers
Interval 105.0 to 144.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 1 post-4th dose (N=247, 240)
|
3471 Titers
Interval 3072.0 to 3921.0
|
2774 Titers
Interval 2420.0 to 3179.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 1 pre-5th dose (N=10, 12)
|
194 Titers
Interval 70.6 to 533.0
|
342 Titers
Interval 131.0 to 890.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 1 post-5th dose (N=10, 12)
|
3327 Titers
Interval 1769.0 to 6256.0
|
1773 Titers
Interval 692.0 to 4543.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 2 pre-4th dose (N=243, 235)
|
210 Titers
Interval 179.0 to 246.0
|
181 Titers
Interval 153.0 to 213.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 2 post-4th dose (N=247, 240)
|
3495 Titers
Interval 3117.0 to 3920.0
|
3991 Titers
Interval 3470.0 to 4590.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 2 pre-5th dose (N=10, 12)
|
274 Titers
Interval 135.0 to 558.0
|
431 Titers
Interval 166.0 to 1119.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 2 post-5th dose (N=10, 12)
|
3566 Titers
Interval 1205.0 to 10554.0
|
2048 Titers
Interval 1002.0 to 4187.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 3 pre-4th dose (N=241, 235)
|
99.5 Titers
Interval 82.1 to 121.0
|
86.3 Titers
Interval 70.6 to 106.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 3 post-4th dose (N=247, 239)
|
4773 Titers
Interval 4168.0 to 5466.0
|
3500 Titers
Interval 3007.0 to 4075.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 3 pre-5th dose (N=10, 12)
|
239 Titers
Interval 137.0 to 417.0
|
323 Titers
Interval 139.0 to 748.0
|
|
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Anti-Polio 3 post-5th dose (N=10, 12)
|
1663 Titers
Interval 687.0 to 4026.0
|
2436 Titers
Interval 1033.0 to 5744.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 28 post-final vaccinationPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference \>50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.
Outcome measures
| Measure |
DTaP-IPV
n=2733 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=621 Participants
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Injection-site Pain (N=2689, 603)
|
2081 Participants
|
461 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Injection-site Pain (N=2689, 603)
|
53 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Injection-site Erythema (N=2687, 603)
|
1587 Participants
|
322 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Injection-site Erythema (N=2687, 603)
|
484 Participants
|
72 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Injection-site Swelling (N=2678, 602)
|
1076 Participants
|
219 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Injection-site Swelling (N=2678, 602)
|
229 Participants
|
43 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Extensive limb swelling (N=2666, 598)
|
39 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Extensive limb swelling (N=2666, 598)
|
39 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Change in limb circumference (N=2500, 464)
|
1703 Participants
|
302 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Change in limb circumference (N=2500, 464)
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Fever (N=2668, 598)
|
161 Participants
|
41 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Fever (N=2668, 598)
|
35 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Headache (N=2688, 603)
|
419 Participants
|
100 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Headache (N=2688, 603)
|
15 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Malaise (N=2687, 603)
|
940 Participants
|
200 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Malaise (N=2687, 603)
|
71 Participants
|
20 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Myalgia (N=2688, 603)
|
1445 Participants
|
317 Participants
|
|
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Grade 3 Myalgia (N=2688, 603)
|
52 Participants
|
17 Participants
|
Adverse Events
DTaP-IPV
Serious events: 21 serious events
Other events: 2081 other events
Deaths: 0 deaths
DAPTACEL®+IPOL®
Serious events: 3 serious events
Other events: 461 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTaP-IPV
n=2733 participants at risk
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=621 participants at risk
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Immune system disorders
Immunodeficiency common variable
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Clostridial infection
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Croup infectious
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Gastroenteritis
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Lobar pneumonia
|
0.07%
2/2733 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2733 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.16%
1/621 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/2733 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.16%
1/621 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/2733 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.16%
1/621 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Nervous system disorders
Autism
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
6/2733 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Vascular disorders
Kawasaki's disease
|
0.04%
1/2733 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
0.00%
0/621 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
Other adverse events
| Measure |
DTaP-IPV
n=2733 participants at risk
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
|
DAPTACEL®+IPOL®
n=621 participants at risk
Children ≥4 to \<7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
|
|---|---|---|
|
General disorders
Injection site induration
|
5.1%
139/2733 • Number of events 142 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
3.2%
20/621 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
142/2733 • Number of events 147 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
4.2%
26/621 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
General disorders
Injection site Pain
|
77.4%
2081/2689 • Number of events 2081 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
76.5%
461/603 • Number of events 461 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
General disorders
Injection site Erythema
|
59.1%
1587/2687 • Number of events 1587 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
53.4%
322/603 • Number of events 322 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
General disorders
Injection site Swelling
|
40.2%
1076/2678 • Number of events 1076 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
36.4%
219/602 • Number of events 219 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
General disorders
Change in limb circumference
|
68.1%
1703/2500 • Number of events 1703 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
65.1%
302/464 • Number of events 302 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
General disorders
Fever
|
6.0%
161/2668 • Number of events 161 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
6.9%
41/598 • Number of events 41 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Nervous system disorders
Headache
|
15.6%
419/2688 • Number of events 419 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
16.6%
100/603 • Number of events 100 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
General disorders
Malaise
|
35.0%
940/2687 • Number of events 940 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
33.2%
200/603 • Number of events 200 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.8%
1445/2688 • Number of events 1445 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
51.0%
317/621 • Number of events 317 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER