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Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

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ClinicalTrials.gov Identifier: NCT00654901
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : June 26, 2013
Last Update Posted : May 13, 2016
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 Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type B Infection
Interventions Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
Biological: Infanrix Hexa™
Enrollment 881
Recruitment Details Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico.
Pre-assignment Details A total of 881 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTaP-IPV-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
Period Title: Overall Study
Started 254 262 252 113
Completed 250 262 250 113
Not Completed 4 0 2 0
Reason Not Completed
Lost to Follow-up             1             0             1             0
Withdrawal by Subject             3             0             1             0
Arm/Group Title DTaP-IPV-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™ Total
Hide Arm/Group Description Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. Total of all reporting groups
Overall Number of Baseline Participants 254 262 252 113 881
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 262 participants 252 participants 113 participants 881 participants
<=18 years
254
 100.0%
262
 100.0%
252
 100.0%
113
 100.0%
881
 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 254 participants 262 participants 252 participants 113 participants 881 participants
17.3  (1.51) 17.2  (1.47) 17.4  (1.42) 17.1  (1.51) 17.3  (1.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 262 participants 252 participants 113 participants 881 participants
Female
125
  49.2%
125
  47.7%
130
  51.6%
58
  51.3%
438
  49.7%
Male
129
  50.8%
137
  52.3%
122
  48.4%
55
  48.7%
443
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 254 participants 262 participants 252 participants 113 participants 881 participants
254 262 252 113 881
1.Primary Outcome
Title Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
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 by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). 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 ELISA.
Time Frame Day 0 (pre-booster) and Day 30 (one month post-booster)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in a subset of 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-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
Overall Number of Participants Analyzed 58 61 58 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti Hep B Pre-booster (N = 58, 60, 58, 65)
91.1
(56.8 to 146)
127
(83.9 to 193)
69.2
(42.3 to 113)
127
(86.2 to 186)
Anti Hep B Post-booster (N = 58, 61, 58, 65)
2167
(1314 to 3573)
3998
(2510 to 6368)
1877
(1152 to 3058)
4757
(3124 to 7243)
Anti PRP Pre-booster (N = 58, 60, 57, 65)
1.09
(0.644 to 1.86)
1.32
(0.937 to 1.87)
0.880
(0.510 to 1.52)
1.33
(0.839 to 2.10)
Anti PRP Post-booster (N = 58, 61, 58, 65)
64.0
(47.4 to 86.6)
94.8
(71.6 to 125)
49.7
(30.6 to 80.6)
102
(72.8 to 144)
Anti Diphtheria Pre-booster (N = 58, 60, 57, 64)
0.116
(0.072 to 0.187)
0.190
(0.126 to 0.287)
0.101
(0.062 to 0.164)
0.081
(0.055 to 0.119)
Anti Diphtheria Post-booster (N = 58, 61, 58, 65)
7.78
(4.88 to 12.4)
15.2
(10.1 to 23.1)
9.31
(5.80 to 14.9)
6.01
(3.99 to 9.06)
Anti Tetanus Pre-booster (N = 58, 60, 57, 65)
0.330
(0.236 to 0.462)
0.331
(0.256 to 0.427)
0.231
(0.167 to 0.318)
0.297
(0.229 to 0.385)
Anti Tetanus Post-booster (N = 58, 61, 58, 65)
5.26
(3.97 to 6.96)
8.49
(6.50 to 11.1)
5.55
(4.20 to 7.33)
6.98
(5.26 to 9.26)
Anti Polio 1 Pre-booster (N = 57, 59, 57, 65)
614
(382 to 988)
663
(458 to 959)
551
(356 to 853)
887
(571 to 1378)
Anti Polio 1 Post-booster (N = 57, 61, 58, 64)
7037
(4977 to 9949)
9938
(7418 to 13313)
8907
(6474 to 12254)
10173
(7909 to 13086)
Anti Polio 2 Pre-booster (N = 58, 59, 56, 65)
936
(584 to 1501)
839
(530 to 1326)
531
(309 to 913)
1267
(747 to 2152)
Anti Polio 2 Post-booster (N = 56, 61, 58, 64)
10756
(7636 to 15151)
10224
(7476 to 13981)
9232
(6549 to 13014)
13482
(10245 to 17742)
Anti Polio 3 Pre-booster (N = 58, 59, 56, 65)
428
(255 to 719)
373
(224 to 619)
241
(130 to 446)
896
(508 to 1580)
Anti Polio 3 Post-booster (N = 56, 60, 58, 64)
6597
(4281 to 10164)
9575
(6859 to 13365)
5296
(3503 to 8007)
13337
(9619 to 18491)
Anti PT Pre-booster (N = 57, 59, 55, 64)
15.6
(11.6 to 20.9)
14.7
(11.8 to 18.4)
14.5
(11.3 to 18.6)
15.3
(11.6 to 20.2)
Anti PT Post-booster (N = 58, 61, 58, 64)
186
(151 to 230)
200
(166 to 241)
171
(137 to 212)
162
(131 to 200)
Anti FHA Pre-booster (N = 58, 60, 56, 64)
42.1
(30.6 to 57.9)
33.7
(26.0 to 43.8)
28.3
(21.5 to 37.3)
25.9
(19.6 to 34.2)
Anti FHA Post-booster (N = 58, 60, 58, 65)
410
(336 to 499)
455
(387 to 536)
346
(284 to 421)
291
(242 to 349)
2.Primary Outcome
Title Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Hide Description

Antibody persistence and immunogenicity response:

Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.

Time Frame Day 0 (pre-booster) and Day 30 (one month post-booster)
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody persistence and immunogenicity response 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-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
Overall Number of Participants Analyzed 58 61 58 65
Measure Type: Number
Unit of Measure: Participants
Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65) 51 56 51 62
Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65) 29 39 25 38
Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65) 58 61 57 65
Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65) 52 58 55 63
Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65) 51 54 47 60
Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65) 27 36 25 32
Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65) 58 61 58 65
Anti-PRP Level 2 Post booster (N=58, 61, 58, 65) 58 61 55 64
Anti-D Level 1 Pre-booster (N=58, 60, 57, 64) 51 59 51 62
Anti-D Level 2 Pre-booster (N=58, 60, 57, 64) 31 39 29 32
Anti-D Level 1 Post-booster (N=58, 61, 58, 65) 58 60 58 64
Anti-D Level 2 Post-booster (N=58, 61, 58, 65) 56 60 56 63
Anti-D Level 3 Post-booster (N=58, 61, 58, 65) 53 59 53 60
Anti-T Level 1 Pre-booster (N=58, 60, 57, 65) 58 60 57 65
Anti-T Level 2 Pre-booster (N=58, 60, 57, 65) 48 52 41 54
Anti-T Level 1 Post-booster (N=58, 61, 58, 65) 58 61 58 65
Anti-T Level 2 Post-booster (N=58, 61, 58, 65) 58 61 58 64
Anti-T Level 3 Post-booster (N=58, 61, 58, 65) 52 58 55 62
Anti-Polio 1 Pre-booster (N=57, 59, 57, 65) 57 59 57 65
Anti-Polio 1 Post-booster (N=57, 61, 58, 64) 57 61 58 64
Anti-Polio 2 Pre-booster (N=58, 59, 56, 65) 58 59 56 65
Anti-Polio 2 Post-booster (N=56, 61, 58, 64) 56 61 58 64
Anti-Polio 3 Pre-booster (N=58, 59, 56, 65) 57 57 53 64
Anti-Polio 3 Post-booster (N=56, 60, 58, 64) 56 60 58 64
Anti-PT Post-booster (N=57, 59, 55, 63) 48 57 52 51
Anti-FHA Post-booster (N=58, 59, 56, 64) 48 50 52 57
3.Primary Outcome
Title Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Hide Description

Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.

Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.

Time Frame Days 0 up to 7 after any injection
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).
Arm/Group Title DTaP-IPV-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description:
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
Overall Number of Participants Analyzed 254 262 252 113
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 174 193 177 80
Grade 3 injection site Pain 8 11 14 6
Injection site Erythema 135 127 135 63
Grade 3 injection site Erythema 3 4 5 1
Injection site Swelling 51 69 58 35
Grade 3 injection site Swelling 2 3 3 1
Extensive Swelling of Vaccinated Limb 0 1 0 0
Grade 3 Extensive Swelling of Vaccinated Limb 0 1 0 0
Pyrexia 25 35 28 22
Grade 3 Pyrexia 2 0 2 1
Vomiting 44 49 36 19
Grade 3 Vomiting 0 1 0 1
Crying 91 91 87 42
Grade 3 Crying 1 2 2 2
Somnolence 55 66 54 33
Grade 3 Somnolence 5 2 0 0
Anorexia 95 101 87 42
Grade 3 Anorexia 6 5 3 3
Irritability 145 166 166 75
Grade 3 Irritability 8 3 3 2
Time Frame Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DTaP-IPV-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Hide Arm/Group Description Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
All-Cause Mortality
DTaP-IPV-Hep B-PRP~T Batch 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 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 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/254 (0.39%)      1/262 (0.38%)      1/252 (0.40%)      0/113 (0.00%)    
Infections and infestations         
Bronchiolitis * 1  1/254 (0.39%)  1 0/262 (0.00%)  0 0/252 (0.00%)  0 0/113 (0.00%)  0
Pharyngitis * 1  0/254 (0.00%)  0 0/262 (0.00%)  0 1/252 (0.40%)  1 0/113 (0.00%)  0
Pneumonia * 1  0/254 (0.00%)  0 1/262 (0.38%)  1 0/252 (0.00%)  0 0/113 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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 1 DTaP-IPV-Hep B-PRP~T Batch 2 DTaP-IPV-Hep B-PRP~T Batch 3 Infanrix Hexa™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   188/254 (74.02%)      207/262 (79.01%)      197/252 (78.17%)      92/113 (81.42%)    
Gastrointestinal disorders         
Vomiting  1  44/254 (17.32%)  44 49/262 (18.70%)  49 36/252 (14.29%)  36 19/113 (16.81%)  19
General disorders         
Solicited Injection Site Erythema  1  135/254 (53.15%)  135 127/262 (48.47%)  127 135/252 (53.57%)  135 63/113 (55.75%)  63
Solicited Injection Site Pain  1  174/254 (68.50%)  174 193/262 (73.66%)  193 177/252 (70.24%)  177 80/113 (70.80%)  80
Solicited Injection Site Swelling  1  51/254 (20.08%)  51 69/262 (26.34%)  69 58/252 (23.02%)  58 35/113 (30.97%)  35
Pyrexia  1  25/254 (9.84%)  25 35/262 (13.36%)  35 28/252 (11.11%)  28 22/113 (19.47%)  22
Infections and infestations         
Nasopharyngitis * 1  13/254 (5.12%)  14 19/262 (7.25%)  19 14/252 (5.56%)  14 4/113 (3.54%)  4
Metabolism and nutrition disorders         
Anorexia  1  95/254 (37.40%)  95 101/262 (38.55%)  101 87/252 (34.52%)  87 42/113 (37.17%)  42
Nervous system disorders         
Somnolence  1  55/254 (21.65%)  55 66/262 (25.19%)  66 54/252 (21.43%)  54 33/113 (29.20%)  33
Psychiatric disorders         
Irritability  1  145/254 (57.09%)  145 166/262 (63.36%)  166 166/252 (65.87%)  166 75/113 (66.37%)  75
Crying  1  91/254 (35.83%)  91 91/262 (34.73%)  91 87/252 (34.52%)  87 42/113 (37.17%)  42
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: NCT00654901     History of Changes
Other Study ID Numbers: A3L21
First Submitted: April 3, 2008
First Posted: April 9, 2008
Results First Submitted: May 6, 2013
Results First Posted: June 26, 2013
Last Update Posted: May 13, 2016