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Trial record 2 of 2 for:    A3L11
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Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00404651
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Interventions Biological: DTaP-IPV-HB-PRP~T vaccine
Biological: DTaP-HBV-IPV vaccine
Enrollment 1189
Recruitment Details Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.
Pre-assignment Details A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
Period Title: Overall Study
Started 340 343 339 167
Completed 301 315 294 146
Not Completed 39 28 45 21
Reason Not Completed
Serious Adverse Event             0             0             2             0
Protocol Violation             10             5             14             5
Lost to Follow-up             15             11             13             10
Withdrawal by Subject             14             12             16             6
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™ Total
Hide Arm/Group Description Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. Total of all reporting groups
Overall Number of Baseline Participants 340 343 339 167 1189
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 343 participants 339 participants 167 participants 1189 participants
<=18 years
340
 100.0%
343
 100.0%
339
 100.0%
167
 100.0%
1189
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 340 participants 343 participants 339 participants 167 participants 1189 participants
2.00  (0.200) 2.00  (0.197) 2.01  (0.193) 1.98  (0.189) 2.00  (0.195)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 343 participants 339 participants 167 participants 1189 participants
Female
160
  47.1%
163
  47.5%
167
  49.3%
82
  49.1%
572
  48.1%
Male
180
  52.9%
180
  52.5%
172
  50.7%
85
  50.9%
617
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 340 participants 343 participants 339 participants 167 participants 1189 participants
340 343 339 167 1189
1.Primary Outcome
Title Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Hide Description Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Time Frame Day 150 (one month post-dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 231 236 228 119
Measure Type: Number
Unit of Measure: Participants
Anti-Hep B (N = 230, 234, 236, 119) 226 231 221 119
Anti-PRP (N = 231, 236, 228, 119) 229 232 226 118
Anti-Diphtheria (N = 231, 236, 228, 119) 220 228 222 118
Anti-Tetanus (N = 231, 236, 227, 119) 231 236 227 119
2.Primary Outcome
Title Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
Hide Description Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
Time Frame Day 150 (one month post-dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 231 236 228 119
Measure Type: Number
Unit of Measure: Participants
Anti-Pertussis (N= 228, 234, 223, 118) 223 226 218 113
Anti-FHA (N= 227, 233, 221, 115) 225 229 216 111
3.Primary Outcome
Title Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Hide Description Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Time Frame Day 150 (one month post-dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 231 236 228 119
Measure Type: Number
Unit of Measure: Participants
Anti-Polio 1 (N = 231, 236, 225, 119) 230 236 225 119
Anti-Polio 2 (N = 230, 236, 226, 118) 230 236 226 118
Anti-Polio 3 (N = 230, 236, 226, 119) 229 235 226 117
4.Secondary Outcome
Title Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Hide Description Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
Time Frame Day 150 (one month post-dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 231 236 228 119
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hep B (N = 230, 234, 226, 119)
935
(755 to 1158)
1566
(1288 to 1905)
1009
(814 to 1252)
1576
(1283 to 1934)
Anti-PRP (N = 231, 236, 228, 119)
11.9
(9.77 to 14.5)
13.1
(10.7 to 16.0)
11.5
(9.26 to 14.3)
6.68
(5.10 to 8.74)
Anti-Diphtheria (N = 231, 236, 228, 119)
0.176
(0.143 to 0.217)
0.246
(0.194 to 0.311)
0.173
(0.139 to 0.214)
0.173
(0.132 to 0.226)
Anti-Tetanus (N = 231, 236, 227, 119)
1.90
(1.67 to 2.15)
1.86
(1.64 to 2.10)
1.77
(1.57 to 2.01)
2.20
(1.93 to 2.52)
Anti-Polio 1 (N = 231, 236, 225, 119)
860
(725 to 1021)
945
(809 to 1102)
843
(712 to 999)
1370
(1082 to 1736)
Anti-Polio 2 (N = 230, 236, 226, 118)
1689
(1429 to 1996)
1665
(1416 to 1957)
1612
(1374 to 1892)
2337
(1878 to 2909)
Anti-Polio 3 (N = 230, 235, 226, 117)
1198
(1015 to 1413)
1170
(995 to 1377)
962
(809 to 1143)
2186
(1752 to 2727)
Anti-Pertusiss toxoid (N = 230, 235, 226, 119)
242
(226 to 260)
238
(220 to 258)
241
(222 to 262)
228
(205 to 254)
Anti-FHA (N = 230, 234, 226, 118)
243
(228 to 259)
256
(237 to 277)
220
(202 to 239)
182
(165 to 200)
5.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Hide Description Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
Time Frame Day 0 (pre-each vaccination) up to 7 days post-each dose
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 337 345 340 167
Measure Type: Number
Unit of Measure: Participants
Pain Post-dose 1 (N = 323, 336, 329, 155) 220 237 225 95
Pain Post-dose 2 (N = 310, 319, 316, 153) 191 220 199 88
Pain Pos-dose 3 (N = 302, 317, 306, 149) 188 209 198 87
Erythema-Post dose 1 (N = 323, 336, 329, 156) 92 97 97 41
Erythema Post-dose 2 (N = 310, 319, 315, 153) 94 101 96 33
Erythema Post-dose 3 (N = 302, 317, 306, 149) 95 94 101 43
Swelling Post-dose 1 (N = 323, 336, 329, 156) 67 86 80 35
Swelling Post-dose 2 (N = 310, 319, 315, 153) 74 70 60 26
Swelling Post-dose 3 (N = 302, 317, 306, 149) 66 65 72 22
Pyrexia Post-dose 1 (N = 323, 336, 329, 156) 63 77 82 17
Pyrexia Post-dose 2 (N = 310, 318, 315, 153) 75 84 85 32
Pyrexia Post-dose 3 (N = 302, 317, 306, 149) 69 85 70 28
Vomiting Post-dose 1 (N = 323, 336, 329, 156) 68 63 56 27
Vomiting Post-dose 2 (N = 310, 319, 316, 153) 37 46 34 18
Vomiting Post-dose 3 (N = 302, 317, 306, 149) 51 46 47 20
Crying Post-dose 1 (N = 323, 336, 329, 156) 160 156 148 62
Crying Post-dose 2 (N=310, 319, 316, 153) 133 145 134 59
Crying Post-dose 3 (N=302, 317, 306, 149) 110 118 122 40
Somnolence Post-dose 1 (N = 323, 336, 329, 156) 93 110 102 45
Somnolence Post-dse 2 (N = 310, 319, 316, 153) 69 78 65 24
Somnolence Post-dose 3 (N = 302, 317, 306, 149) 56 57 54 20
Anorexia Post-dose 1 (N = 323, 336, 329, 156) 62 75 70 27
Anorexia Post-dose 2 (N = 310, 319, 315, 153) 56 64 65 25
Anorexia Post-dose 3 (N = 302, 317, 306, 149) 61 58 65 29
Irritability Post-dose 1 (N = 323, 336, 329, 156) 188 198 193 83
Irritability Post-dose 2 (N = 310, 319, 316, 153) 158 192 174 72
Irritability Post-dse 3 (N = 302, 317, 306, 149) 158 167 165 69
Time Frame Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Adverse Event Reporting Description Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
 
Arm/Group Title DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
All-Cause Mortality
DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/337 (1.48%)      5/345 (1.45%)      12/340 (3.53%)      6/167 (3.59%)    
Congenital, familial and genetic disorders         
Heart Disease Congenital * 1  0/337 (0.00%)  0 1/345 (0.29%)  1 0/340 (0.00%)  0 0/167 (0.00%)  0
Gastrointestinal disorders         
Intussusception * 1  0/337 (0.00%)  0 0/345 (0.00%)  0 1/340 (0.29%)  1 0/167 (0.00%)  0
Infections and infestations         
Bronchiolitis * 1  1/337 (0.30%)  1 0/345 (0.00%)  0 0/340 (0.00%)  0 2/167 (1.20%)  2
Bronchopneumonia * 1  0/337 (0.00%)  0 0/345 (0.00%)  0 1/340 (0.29%)  1 0/167 (0.00%)  0
Ear Infection * 1  0/337 (0.00%)  0 0/345 (0.00%)  0 1/340 (0.29%)  1 0/167 (0.00%)  0
Gastroenteritis * 1  2/337 (0.59%)  2 2/345 (0.58%)  2 5/340 (1.47%)  5 2/167 (1.20%)  2
Pneumonia * 1  1/337 (0.30%)  1 0/345 (0.00%)  0 1/340 (0.29%)  1 0/167 (0.00%)  0
Injury, poisoning and procedural complications         
Head Injury * 1  0/337 (0.00%)  0 1/345 (0.29%)  1 0/340 (0.00%)  0 0/167 (0.00%)  0
Multiple Fractures * 1  0/337 (0.00%)  0 1/345 (0.29%)  1 0/340 (0.00%)  0 0/167 (0.00%)  0
Metabolism and nutrition disorders         
Food Intolerance * 1  1/337 (0.30%)  1 0/345 (0.00%)  0 0/340 (0.00%)  0 0/167 (0.00%)  0
Nervous system disorders         
Febrile Convulsion * 1  1/337 (0.30%)  1 0/345 (0.00%)  0 1/340 (0.29%)  2 1/167 (0.60%)  1
Infantile Spasms * 1  0/337 (0.00%)  0 0/345 (0.00%)  0 1/340 (0.29%)  1 0/167 (0.00%)  0
Partial Seizures * 1  0/337 (0.00%)  0 0/345 (0.00%)  0 0/340 (0.00%)  0 1/167 (0.60%)  1
Respiratory, thoracic and mediastinal disorders         
Asphyxia * 1  0/337 (0.00%)  0 0/345 (0.00%)  0 1/340 (0.29%)  1 0/167 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
DTaP-IPV-HB-PRP~T Batch 1 DTaP-IPV-HB-PRP~T Batch 2 DTaP-IPV-HB-PRP~T Batch 3 Infanrix Hexa™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   220/337 (65.28%)      237/345 (68.70%)      225/340 (66.18%)      95/167 (56.89%)    
Gastrointestinal disorders         
Vomiting † 1  68/323 (21.05%)  68 63/336 (18.75%)  63 56/329 (17.02%)  56 27/156 (17.31%)  27
General disorders         
Injection Site Pain † 1  220/323 (68.11%)  220 237/336 (70.54%)  237 225/329 (68.39%)  225 95/155 (61.29%)  95
Injection Site Erythema † 1  95/302 (31.46%)  95 101/319 (31.66%)  101 101/306 (33.01%)  101 43/149 (28.86%)  43
Injection Site Swelling † 1  74/310 (23.87%)  74 86/336 (25.60%)  86 80/329 (24.32%)  80 35/156 (22.44%)  35
Irritability † 1  188/323 (58.20%)  188 198/336 (58.93%)  198 193/329 (58.66%)  193 83/156 (53.21%)  83
Pyrexia † 1  75/310 (24.19%)  75 85/317 (26.81%)  85 85/315 (26.98%)  85 32/153 (20.92%)  32
Metabolism and nutrition disorders         
Anorexia † 1  62/323 (19.20%)  62 75/336 (22.32%)  75 70/329 (21.28%)  70 29/149 (19.46%)  29
Nervous system disorders         
Somnolence † 1  93/323 (28.79%)  93 110/336 (32.74%)  110 102/329 (31.00%)  102 45/156 (28.85%)  45
Psychiatric disorders         
Crying † 1  160/323 (49.54%)  160 156/336 (46.43%)  156 148/329 (44.98%)  148 62/156 (39.74%)  62
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
[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
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00404651    
Other Study ID Numbers: A3L11
First Submitted: November 28, 2006
First Posted: November 29, 2006
Results First Submitted: February 14, 2014
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014