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Trial record 3 of 3 for:    A3L24

A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

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ClinicalTrials.gov Identifier: NCT01177722
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : May 5, 2014
Last Update Posted : May 5, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Interventions Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Biological: DTaP-Hep B-IPV vaccine
Enrollment 1375
Recruitment Details Participants were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica.
Pre-assignment Details A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Hide Arm/Group Description Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Period Title: Overall Study
Started 344 [1] 344 [2] 342 345
Completed 331 334 333 338
Not Completed 13 10 9 7
Reason Not Completed
Serious Adverse Event             0             0             1             0
Protocol Violation             0             0             1             0
Lost to Follow-up             3             4             3             1
Withdrawal by Subject             10             6             4             6
[1]
A Batch B participant got Batch A vaccine data analyses was according to actual vaccine administered
[2]
A randomized participant got Batch A vaccine, analyses was according to actual vaccine administered.
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa Total
Hide Arm/Group Description Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Total of all reporting groups
Overall Number of Baseline Participants 344 344 342 345 1375
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 344 participants 342 participants 345 participants 1375 participants
<=18 years
344
 100.0%
344
 100.0%
342
 100.0%
345
 100.0%
1375
 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:  Days
Number Analyzed 344 participants 344 participants 342 participants 345 participants 1375 participants
58.8  (3.49) 58.7  (3.25) 58.5  (3.16) 58.7  (3.31) 58.7  (3.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 344 participants 342 participants 345 participants 1375 participants
Female
161
  46.8%
165
  48.0%
152
  44.4%
156
  45.2%
634
  46.1%
Male
183
  53.2%
179
  52.0%
190
  55.6%
189
  54.8%
741
  53.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 344 participants 342 participants 345 participants 1375 participants
Colombia 233 234 233 233 933
Costa Rica 111 110 109 112 442
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™
Hide Description Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Time Frame Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Hide Arm/Group Description:
Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Number of Participants Analyzed 312 310 313 316
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hep B Pre-dose 1
4.02
(3.50 to 4.61)
4.07
(3.58 to 4.62)
4.93
(4.20 to 5.79)
4.30
(3.68 to 5.03)
Anti-Hep B Post-dose 3
3048
(2672 to 3476)
2801
(2467 to 3181)
3202
(2794 to 3668)
2766
(2466 to 3102)
2.Primary Outcome
Title Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Hide Description Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
Time Frame 30 Days post-dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Hide Arm/Group Description:
Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Number of Participants Analyzed 312 310 313 316
Measure Type: Number
Unit of Measure: Participants
Anti-Diphtheria (N = 310, 310, 312, 315) 310 310 312 315
Anti-Tetanus (N = 311, 310, 311, 314) 311 310 311 314
Anti-PT (N = 308, 309, 308, 312) 304 299 299 307
Anti-FHA (N = 306, 306, 304, 311) 306 305 303 309
Anti-Polio 1 (N = 310, 309, 308, 311) 310 309 308 311
Anti-Polio 2 (N = 309, 309, 307, 312) 309 309 307 312
Anti-Polio 3 (N = 310, 309, 307, 312) 310 309 307 311
Anti-Hep B (N = 312, 310, 312, 316) 311 310 310 316
Anti-PRP (N = 312, 310, 312, 316) 299 298 287 303
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Hide Description Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
Time Frame Day 0 (pre-vaccination) and 30 days post-dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa™
Hide Arm/Group Description:
Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Number of Participants Analyzed 312 310 313 316
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)
0.599
(0.513 to 0.699)
0.596
(0.505 to 0.703)
0.641
(0.547 to 0.752)
0.630
(0.530 to 0.749)
Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)
0.252
(0.224 to 0.285)
0.279
(0.247 to 0.316)
0.228
(0.201 to 0.260)
0.240
(0.214 to 0.269)
Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)
1.66
(1.54 to 1.78)
1.55
(1.43 to 1.68)
1.45
(1.33 to 1.59)
1.80
(1.69 to 1.93)
Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)
3.02
(2.65 to 3.45)
3.50
(3.03 to 4.04)
3.54
(3.10 to 4.05)
3.11
(2.70 to 3.59)
Anti-PT Post-dose 3 (N = 312, 310, 311, 314)
102
(96.1 to 108)
103
(95.9 to 110)
102
(95.0 to 110)
98.9
(92.3 to 106)
Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)
5.36
(4.77 to 6.02)
5.66
(5.01 to 6.39)
5.76
(5.12 to 6.49)
5.13
(4.61 to 5.70)
Anti-FHA Post-dose 3 (N=311, 309, 310, 315)
186
(174 to 199)
175
(163 to 188)
183
(171 to 197)
118
(110 to 127)
Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)
755
(674 to 847)
655
(580 to 739)
636
(561 to 722)
1298
(1151 to 1464)
Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)
1190
(1054 to 1344)
1232
(1101 to 1379)
1120
(994 to 1261)
1981
(1756 to 2234)
Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)
1102
(972 to 1250)
1119
(975 to 1284)
1097
(963 to 1250)
1944
(1680 to 2249)
Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)
3.37
(2.80 to 4.05)
4.02
(3.35 to 4.82)
3.33
(2.72 to 4.07)
2.24
(1.90 to 2.64)
4.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Hide Description Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
Time Frame Day 0 up to 7 after each dose
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Hide Arm/Group Description:
Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Number of Participants Analyzed 345 343 342 345
Measure Type: Number
Unit of Measure: Participants
Pain Post-dose 1 (N = 338, 341, 340, 344) 199 194 216 185
Pain Post-dose 2 (N = 333, 337, 335, 340) 180 196 203 188
Pain Post-dose 3 (N = 331, 331, 334, 337) 168 163 162 147
Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344) 21 22 22 7
Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338) 10 9 8 8
Erythema Post-dose 1 (N = 338, 341, 340, 344 72 63 82 52
Erythema Post-dose 2 (N = 333, 337, 335, 340 87 78 80 67
Erythema Post-dose 3 (N = 331, 331, 334, 337) 85 79 96 68
Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344) 2 3 2 0
Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337) 0 0 1 0
Swelling Post dose 1 (N = 338, 341, 340, 344) 47 30 47 33
Swelling Post dose 2 (N = 333, 337, 335, 340) 44 35 45 44
Swelling Post dose 3 (N = 331, 331, 334, 337) 43 34 48 42
Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344) 2 3 2 0
Grade 3 Swelling post-dose 3(N=331, 331, 340, 338) 0 0 0 0
Pyrexia Post dose 1 (N = 338, 341, 340, 344) 46 42 68 46
Pyrexia Post dose 2 (N = 333, 337, 335, 340) 70 68 68 70
Pyrexia Post dose 3 (N = 331, 331, 333, 337) 67 63 72 65
Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344) 2 0 0 0
Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337) 4 1 1 2
Vomiting Post dose 1 (N = 338, 341, 340, 344) 85 90 86 94
Vomiting Post dose 2 (N = 333, 337, 335, 340) 58 80 64 62
Vomiting Post dose 3 (N = 331, 331, 334, 337) 32 58 46 39
Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344) 4 5 6 5
Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337) 3 1 2 2
Crying Post dose 1 (N = 338, 341, 340, 344) 198 186 189 161
Crying Post dose 2 (N = 333, 337, 335, 340) 163 179 169 161
Crying Post dose 3 (N = 331, 331, 334, 337) 141 145 142 120
Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344) 15 10 23 9
Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337) 8 6 10 6
Somnolence Post dose 1 (N = 338, 341, 341, 344) 159 146 160 147
Somnolence Post dose 2 (N = 333, 337, 335, 340) 109 108 110 111
Somnolence Post dose 3 (N = 331, 331, 334, 337) 85 99 96 81
Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344 3 14 19 9
Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337 5 2 4 4
Anorexia Post dose 1 (N = 338, 341, 341, 344) 78 97 96 75
Anorexia Post dose 2 (N = 333, 337, 335, 340) 75 93 86 74
Anorexia Post dose 3 (N = 331, 331, 334, 337) 63 64 60 54
Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344) 3 4 8 3
Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337) 4 7 4 3
Irritability Post dose 1 (N = 338, 341, 341, 344) 208 206 208 180
Irritability Post dose 2 (N = 333, 337, 335, 340) 193 199 191 193
Irritability Post dose 3 (N = 331, 332, 334, 337) 155 161 154 144
Grd 3 Irritability Post-dose 1N=338, 341, 341, 344 15 17 20 8
Grd 3 Irritability Post-dose 3N=331, 332, 334, 337 11 13 12 5
5.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Hide Description Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
Time Frame Day 0 up to 7 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Hide Arm/Group Description:
Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
Overall Number of Participants Analyzed 345 341 342 345
Measure Type: Number
Unit of Measure: Participants
Pain Post-dose 1 (N = 338, 341, 340, 344) 171 173 184 169
Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344) 15 15 16 8
Pain Post-dose 2 (N = 333, 337, 335, 340) 160 183 180 174
Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340) 14 17 16 13
Pain Post-dose 3 (N =331, 331, 334, 337) 146 105 146 125
Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337) 8 9 10 7
Erythema Post-dose 1 (N = 338, 341, 340, 344) 47 48 55 42
Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344 0 1 2 0
Erythema Post-dose 2 (N = 333, 337, 335, 340) 65 55 62 53
Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340 1 0 0 0
Erythema Post-dose 3 (N = 331, 331, 334, 337) 63 57 69 49
Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337 1 1 0 0
Swelling Post-dose 1 (N = 338, 341, 340, 344) 34 21 33 31
Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344 0 0 2 1
Swelling Post-dose 2 (N = 333, 337, 335, 340) 32 28 36 32
Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340 0 0 1 0
Swelling Post-dose 3 (N = 331, 331, 334, 337) 27 29 36 29
Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337 0 0 0 0
Time Frame Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose.
Adverse Event Reporting Description A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
 
Arm/Group Title DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Hide Arm/Group Description Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
All-Cause Mortality
DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/345 (2.90%)      14/343 (4.08%)      16/342 (4.68%)      10/345 (2.90%)    
Cardiac disorders         
Cardiac Failure * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Congenital, familial and genetic disorders         
Cerebral Atrophy Congenital * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Gastrointestinal disorders         
Abdominal strangulated hernia * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 0/342 (0.00%)  0 1/345 (0.29%)  1
Diarrhoea * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 0/342 (0.00%)  0 1/345 (0.29%)  1
Enteritis * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 1/345 (0.29%)  1
Intussusception * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 1/345 (0.29%)  1
Stomatitis * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Vomiting * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
General disorders         
Pyrexia * 1  1/345 (0.29%)  1 1/343 (0.29%)  1 0/342 (0.00%)  0 0/345 (0.00%)  0
Sudden Infant Death Syndrome * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Infections and infestations         
Bronchiolitis * 1  5/345 (1.45%)  5 6/343 (1.75%)  6 9/342 (2.63%)  10 8/345 (2.32%)  8
Bronchopneumonia * 1  1/345 (0.29%)  1 0/343 (0.00%)  0 0/342 (0.00%)  0 0/345 (0.00%)  0
Dengue Fever * 1  1/345 (0.29%)  1 0/343 (0.00%)  0 0/342 (0.00%)  0 1/345 (0.29%)  1
Exanthema Subitum * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Gastroenteritis * 1  1/345 (0.29%)  1 0/343 (0.00%)  0 0/342 (0.00%)  0 0/345 (0.00%)  0
Gastroenteritis bacterial * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 0/342 (0.00%)  0 1/345 (0.29%)  1
Kawasaki's Disease * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Otitis Media Acute * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 0/345 (0.00%)  0
Periorbital Cellulitis * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 0/342 (0.00%)  0 1/345 (0.29%)  1
Pneumonia * 1  4/345 (1.16%)  4 5/343 (1.46%)  6 11/342 (3.22%)  11 5/345 (1.45%)  7
Pneumonia Primary Atypical * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 1/345 (0.29%)  1
Pneumonia Viral * 1  1/345 (0.29%)  1 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Pyelonephritis Acute * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Urinary Tract Infection * 1  3/345 (0.87%)  3 2/343 (0.58%)  3 2/342 (0.58%)  2 3/345 (0.87%)  3
Viral Diarrhoea * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Viral Infection * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 1/342 (0.29%)  1 0/345 (0.00%)  0
Injury, poisoning and procedural complications         
Thermal Burn * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 0/345 (0.00%)  0
Nervous system disorders         
Convulsion * 1  0/345 (0.00%)  0 2/343 (0.58%)  2 1/342 (0.29%)  1 0/345 (0.00%)  0
Epilepsy * 1  1/345 (0.29%)  1 0/343 (0.00%)  0 0/342 (0.00%)  0 0/345 (0.00%)  0
Febrile Convulsion * 1  2/345 (0.58%)  3 1/343 (0.29%)  1 0/342 (0.00%)  0 1/345 (0.29%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 1/342 (0.29%)  1 0/345 (0.00%)  0
Asthmatic Crisis * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 0/345 (0.00%)  0
Diaphragmatic Hernia * 1  1/345 (0.29%)  1 0/343 (0.00%)  0 0/342 (0.00%)  0 0/345 (0.00%)  0
Foreign Body Aspiration * 1  0/345 (0.00%)  0 0/343 (0.00%)  0 0/342 (0.00%)  0 1/345 (0.29%)  1
Urticaria * 1  0/345 (0.00%)  0 1/343 (0.29%)  1 0/342 (0.00%)  0 0/345 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
DTap-IPV-Hep B-PRP~T Batch A DTaP-IPV-Hep B-PRP~T Batch B DTaP-IPV-Hep B-PRP~T Batch C Infanrix Hexa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   208/345 (60.29%)      206/343 (60.06%)      216/342 (63.16%)      193/345 (55.94%)    
Gastrointestinal disorders         
Vomiting  1  85/338 (25.15%)  85 90/341 (26.39%)  90 86/340 (25.29%)  86 94/344 (27.33%)  94
General disorders         
Injection Site Erythema  1  87/338 (25.74%)  87 79/341 (23.17%)  79 96/340 (28.24%)  96 68/344 (19.77%)  68
Injection Site Pain  1  199/338 (58.88%)  199 196/341 (57.48%)  196 216/340 (63.53%)  216 188/344 (54.65%)  188
Injection Site Swelling  1  47/338 (13.91%)  47 35/341 (10.26%)  35 48/340 (14.12%)  48 44/344 (12.79%)  44
Irritability  1  208/338 (61.54%)  208 206/341 (60.41%)  206 208/341 (61.00%)  208 193/344 (56.10%)  193
Pyrexia  1  70/338 (20.71%)  70 68/341 (19.94%)  68 72/340 (21.18%)  72 70/344 (20.35%)  70
Infections and infestations         
Nasopharyngitis * 1  99/345 (28.70%)  125 96/343 (27.99%)  132 90/342 (26.32%)  116 87/345 (25.22%)  105
Metabolism and nutrition disorders         
Anorexia  1  75/338 (22.19%)  75 97/341 (28.45%)  97 96/341 (28.15%)  96 75/344 (21.80%)  75
Nervous system disorders         
Somnolence  1  159/338 (47.04%)  159 146/341 (42.82%)  146 160/341 (46.92%)  160 147/344 (42.73%)  147
Psychiatric disorders         
Crying  1  198/338 (58.58%)  198 186/341 (54.55%)  186 189/340 (55.59%)  189 161/344 (46.80%)  161
Respiratory, thoracic and mediastinal disorders         
Cough  1  21/345 (6.09%)  24 17/343 (4.96%)  17 23/342 (6.73%)  25 17/345 (4.93%)  18
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01177722     History of Changes
Other Study ID Numbers: A3L24
UTN: U1111-1111-5801 ( Other Identifier: WHO )
First Submitted: August 6, 2010
First Posted: August 9, 2010
Results First Submitted: February 22, 2014
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014