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Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

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ClinicalTrials.gov Identifier: NCT01346293
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : May 29, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Tetanus
Diphtheria
Pertussis
Measles
Polio
Interventions Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Enrollment 3372
Recruitment Details The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico.
Pre-assignment Details A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description 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 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®
Period Title: Overall Study
Started 2743 629
Completed 2676 608
Not Completed 67 21
Reason Not Completed
Protocol Violation             30             9
Lost to Follow-up             21             8
Withdrawal by Subject             15             4
Other             1             0
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL® Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 2743 629 3372
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2743 participants 629 participants 3372 participants
<=18 years
2743
 100.0%
629
 100.0%
3372
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2743 participants 629 participants 3372 participants
4.4  (0.5) 4.4  (0.5) 4.4  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2743 participants 629 participants 3372 participants
Female
1330
  48.5%
306
  48.6%
1636
  48.5%
Male
1413
  51.5%
323
  51.4%
1736
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2743 participants 629 participants 3372 participants
2743 629 3372
1.Primary Outcome
Title Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Measure Type: Number
Unit of Measure: Participants
Anti-Pertussis toxoid (N=252, 247) 240 222
Anti-Filamentous hemagglutinin (N=255, 248) 242 217
Anti-Pertactin (N=254, 248) 246 231
Anti-Fimbriae types 2 and 3 (N=250, 249) 243 230
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were > -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
0.7 to 10.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were > -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.4
Confidence Interval (2-Sided) 95%
2.5 to 21.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were > -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.7
Confidence Interval (2-Sided) 3.7%
-0.2 to 7.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were > -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
0.9 to 9.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-PT pre-vaccination (N=254, 248)
5.16
(4.48 to 5.94)
4.74
(4.18 to 5.39)
Anti-PT post-vaccination (N=261, 252)
121
(108 to 134)
61.3
(54.5 to 68.9)
Anti-FHA pre-vaccination (N=255, 248)
7.93
(6.63 to 9.47)
9.42
(7.85 to 11.3)
Anti-FHA post-vaccination (N=263, 253)
123
(108 to 141)
79.0
(69.3 to 90.0)
Anti-PRN pre-vaccination (N=255, 249)
18.6
(16.2 to 21.3)
16.7
(14.6 to 19.1)
Anti-PRN post-vaccination (N=262, 252)
283
(252 to 317)
187
(164 to 214)
Anti-FIM pre-vaccination (N=253, 249)
31.9
(27.0 to 37.6)
33.3
(28.3 to 39.2)
Anti-FIM post-vaccination (N=260, 253)
506
(448 to 571)
379
(331 to 433)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were > 2/3.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.97
Confidence Interval (2-Sided) 95%
1.68 to 2.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were > 2/3.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
1.30 to 1.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were > 2/3.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.27 to 1.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTaP-IPV, DAPTACEL®+IPOL®
Comments Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were > 2/3.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
1.12 to 1.60
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Measure Type: Number
Unit of Measure: Participants
Anti-Tetanus (N=253, 248) 213 209
Anti-Diphtheria (N=256, 249) 249 247
4.Primary Outcome
Title Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Tetanus pre-vaccination (N=254, 248)
0.644
(0.548 to 0.758)
0.608
(0.518 to 0.715)
Anti-Tetanus post-vaccination (N=262, 253)
6.42
(5.74 to 7.18)
5.48
(4.88 to 6.15)
Anti-Diphtheria pre-vaccination (N=257, 249)
0.510
(0.437 to 0.596)
0.426
(0.362 to 0.501)
Anti-Diphtheria post-vaccination (N=262, 253)
18.6
(16.6 to 20.8)
15.5
(13.7 to 17.6)
5.Primary Outcome
Title Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Measure Type: Number
Unit of Measure: Participants
Anti-Polio 1 (N=249, 248) 214 204
Anti-Polio 2 (N=249, 248) 195 196
Anti-Polio 3 (N=247, 248) 210 210
6.Primary Outcome
Title Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1 pre-vaccination (N=254, 248)
135
(114 to 160)
129
(110 to 151)
Anti-Polio 1 post-vaccination (N=258, 253)
3477
(3088 to 3915)
2731
(2384 to 3128)
Anti-Polio 2 pre-vaccination (N=254, 248)
214
(183 to 249)
188
(160 to 221)
Anti-Polio 2 post-vaccination (N=258, 253)
3491
(3111 to 3917)
3894
(3393 to 4468)
Anti-Polio 3 pre-vaccination (N=252, 248)
102
(85.1 to 123)
90.9
(74.5 to 111)
Anti-Polio 3 post-vaccination (N=258, 252)
4591
(4011 to 5256)
3419
(2946 to 3969)
7.Other Pre-specified Outcome
Title Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Measure Type: Number
Unit of Measure: Participants
Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248) 233 221
Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248) 93 89
Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253) 262 251
Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253) 259 245
Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249) 233 207
Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249) 78 72
Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253) 262 252
Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253) 261 252
8.Other Pre-specified Outcome
Title Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 253
Measure Type: Number
Unit of Measure: Participants
Anti-Polio 1 pre-vaccination (N=254, 248) 250 245
Anti-Polio 1 post-vaccinatin (N=258, 253) 258 252
Anti-Polio 2 pre-vaccination (N=254, 248) 253 247
Anti-Polio 2 post-vaccination (N=258, 253) 258 253
Anti-Polio 3 pre-vaccination (N=252, 248) 244 231
Anti-Polio 3 post-vaccination (N=258, 252) 258 252
9.Other Pre-specified Outcome
Title Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Hide Description 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.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 262 252
Measure Type: Number
Unit of Measure: Participants
Anti-Polio 1 4th dose (N=238, 235) 205 199
Anti-Polio 1 5th dose (N=10, 12) 8 4
Anti-Polio 2 4th dose (N=238, 235) 188 190
Anti-Polio 2 5th dose (N=10, 12) 7 5
Anti-Polio 3 4th dose (N=236, 235) 203 202
Anti-Polio 3 5th dose (N=10, 12) 6 7
10.Other Pre-specified Outcome
Title Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Hide Description Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
Time Frame Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 263 252
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1 pre-4th dose (N=243, 235)
134
(112 to 159)
123
(105 to 144)
Anti-Polio 1 post-4th dose (N=247, 240)
3471
(3072 to 3921)
2774
(2420 to 3179)
Anti-Polio 1 pre-5th dose (N=10, 12)
194
(70.6 to 533)
342
(131 to 890)
Anti-Polio 1 post-5th dose (N=10, 12)
3327
(1769 to 6256)
1773
(692 to 4543)
Anti-Polio 2 pre-4th dose (N=243, 235)
210
(179 to 246)
181
(153 to 213)
Anti-Polio 2 post-4th dose (N=247, 240)
3495
(3117 to 3920)
3991
(3470 to 4590)
Anti-Polio 2 pre-5th dose (N=10, 12)
274
(135 to 558)
431
(166 to 1119)
Anti-Polio 2 post-5th dose (N=10, 12)
3566
(1205 to 10554)
2048
(1002 to 4187)
Anti-Polio 3 pre-4th dose (N=241, 235)
99.5
(82.1 to 121)
86.3
(70.6 to 106)
Anti-Polio 3 post-4th dose (N=247, 239)
4773
(4168 to 5466)
3500
(3007 to 4075)
Anti-Polio 3 pre-5th dose (N=10, 12)
239
(137 to 417)
323
(139 to 748)
Anti-Polio 3 post-5th dose (N=10, 12)
1663
(687 to 4026)
2436
(1033 to 5744)
11.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Hide Description 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.
Time Frame Day 0 up to Day 28 post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 2733 621
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain (N=2689, 603) 2081 461
Grade 3 Injection-site Pain (N=2689, 603) 53 18
Injection-site Erythema (N=2687, 603) 1587 322
Grade 3 Injection-site Erythema (N=2687, 603) 484 72
Injection-site Swelling (N=2678, 602) 1076 219
Grade 3 Injection-site Swelling (N=2678, 602) 229 43
Extensive limb swelling (N=2666, 598) 39 8
Grade 3 Extensive limb swelling (N=2666, 598) 39 8
Change in limb circumference (N=2500, 464) 1703 302
Grade 3 Change in limb circumference (N=2500, 464) 4 0
Fever (N=2668, 598) 161 41
Grade 3 Fever (N=2668, 598) 35 12
Headache (N=2688, 603) 419 100
Grade 3 Headache (N=2688, 603) 15 4
Malaise (N=2687, 603) 940 200
Grade 3 Malaise (N=2687, 603) 71 20
Myalgia (N=2688, 603) 1445 317
Grade 3 Myalgia (N=2688, 603) 52 17
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
Adverse Event Reporting Description 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.
 
Arm/Group Title DTaP-IPV DAPTACEL®+IPOL®
Hide Arm/Group Description 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 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®
All-Cause Mortality
DTaP-IPV DAPTACEL®+IPOL®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
DTaP-IPV DAPTACEL®+IPOL®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/2733 (0.77%)      3/621 (0.48%)    
Gastrointestinal disorders     
Intestinal obstruction * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Intestinal perforation * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Rectal prolapse * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Vomiting * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Immune system disorders     
Immunodeficiency common variable * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Infections and infestations     
Clostridial infection * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Croup infectious * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Gastroenteritis * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Gastroenteritis viral * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Lobar pneumonia * 1  2/2733 (0.07%)  2 0/621 (0.00%)  0
Sinusitis * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Urinary tract infection * 1  0/2733 (0.00%)  0 1/621 (0.16%)  1
Injury, poisoning and procedural complications     
Skull fracture * 1  0/2733 (0.00%)  0 1/621 (0.16%)  1
Metabolism and nutrition disorders     
Dehydration * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Type 1 diabetes mellitus * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Synovitis * 1  0/2733 (0.00%)  0 1/621 (0.16%)  1
Nervous system disorders     
Autism * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Petit mal epilepsy * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  6/2733 (0.22%)  6 0/621 (0.00%)  0
Vascular disorders     
Kawasaki's disease * 1  1/2733 (0.04%)  1 0/621 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
DTaP-IPV DAPTACEL®+IPOL®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2081/2733 (76.14%)      461/621 (74.24%)    
General disorders     
Injection site induration * 1  139/2733 (5.09%)  142 20/621 (3.22%)  20
Injection site Pain † 1  2081/2689 (77.39%)  2081 461/603 (76.45%)  461
Injection site Erythema † 1  1587/2687 (59.06%)  1587 322/603 (53.40%)  322
Injection site Swelling † 1  1076/2678 (40.18%)  1076 219/602 (36.38%)  219
Change in limb circumference † 1  1703/2500 (68.12%)  1703 302/464 (65.09%)  302
Fever † 1  161/2668 (6.03%)  161 41/598 (6.86%)  41
Malaise † 1  940/2687 (34.98%)  940 200/603 (33.17%)  200
Musculoskeletal and connective tissue disorders     
Myalgia † 1  1445/2688 (53.76%)  1445 317/621 (51.05%)  317
Nervous system disorders     
Headache † 1  419/2688 (15.59%)  419 100/603 (16.58%)  100
Respiratory, thoracic and mediastinal disorders     
Cough * 1  142/2733 (5.20%)  147 26/621 (4.19%)  26
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01346293    
Other Study ID Numbers: M5I02
U1111-1116-4842 ( Other Identifier: WHO )
First Submitted: April 29, 2011
First Posted: May 2, 2011
Results First Submitted: April 23, 2015
Results First Posted: May 29, 2015
Last Update Posted: June 3, 2015