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Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

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ClinicalTrials.gov Identifier: NCT00619502
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : April 3, 2014
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Polio
Pertussis
Hepatitis B
Intervention Biological: DTaP-IPV-HB-PRP~T vaccine
Enrollment 254
Recruitment Details Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.
Pre-assignment Details A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™
Hide Arm/Group Description All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
Period Title: Overall Study
Started 130 124
Completed 122 114
Not Completed 8 10
Reason Not Completed
Lost to Follow-up             8             10
Arm/Group Title DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™ Total
Hide Arm/Group Description All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. Total of all reporting groups
Overall Number of Baseline Participants 130 124 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 124 participants 254 participants
<=18 years
130
 100.0%
124
 100.0%
254
 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:  Months
Number Analyzed 130 participants 124 participants 254 participants
17.6  (0.198) 17.6  (0.279) 17.6  (0.241)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 124 participants 254 participants
Female
56
  43.1%
54
  43.5%
110
  43.3%
Male
74
  56.9%
70
  56.5%
144
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 130 participants 124 participants 254 participants
130 124 254
1.Primary Outcome
Title Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™
Hide Description Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.
Time Frame Day 0 before and Day 30 Post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.
Arm/Group Title DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™
Hide Arm/Group Description:
All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
Overall Number of Participants Analyzed 114 103
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Hep B Pre-booster (N = 109, 103) 81 99
Anti-Hep B Post-booster (N = 111, 103) 97 100
Anti-PRP Pre-booster (N = 113,102) 85 83
Anti-PRP Post-booster (N = 114, 103) 100 100
Anti-Diphtheria Pre-booster (N = 104, 94) 90 88
Anti-Diphtheria Post-booster (N = 112, 98) 100 100
Anti-Tetanus Pre-booster (N = 97, 90) 100 100
Anti-Tetanus Post-booster (N = 109, 96) 100 100
Anti-Polio 1 Pre-booster (N = 88, 86) 99 99
Anti-Polio 1 Post-booster (N = 105, 87) 100 100
Anti-Polio 2 Pre-booster (N = 84, 87) 100 98
Anti-Polio 2 Post-booster (N = 101, 83) 100 100
Anti-Polio 3 Pre-booster (N = 88,86) 85 97
Anti-Polio 3 Post-booster (N = 102, 84) 100 100
Anti-PT Post-booster (N = 86, 79) 97 96
Anti-FHA Post-booster (N = 73,77) 92 97
2.Primary Outcome
Title Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Hide Description Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).
Time Frame Day 0 before and Day 30 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).
Arm/Group Title DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™
Hide Arm/Group Description:
All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
Overall Number of Participants Analyzed 114 103
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hep B Pre-booster (N = 109, 103)
44.2
(32.3 to 60.7)
223
(176 to 282)
Anti-Hep B Post-booster (N = 111, 103)
1379
(916 to 2078)
26189
(19133 to 35846)
Anti-PRP Pre-booster (N = 113, 102)
0.724
(0.541 to 0.968)
0.612
(0.443 to 0.844)
Anti-PRP Post-booster (N = 114, 103)
72.5
(55.8 to 94.3)
86.9
(69.8 to 108)
Anti-Diphtheria Pre-booster (N = 104, 94)
0.028
(0.022 to 0.035)
0.032
(0.024 to 0.041)
Anti-Diphtheria Post-booster (N = 112, 98)
5.09
(3.89 to 6.66)
10.2
(7.59 to 13.8)
Anti-Tetanus Pre-booster (N = 97, 90)
0.244
(0.204 to 0.292)
0.194
(0.158 to 0.238)
Anti-Tetanus Post-booster (N = 109, 96)
8.98
(7.52 to 10.7)
13.1
(10.8 to 15.8)
Anti-Polio 1 Pre-booster (N= 88, 86)
110
(81.6 to 148)
114
(82.4 to 157)
Anti-Polio 1 Post-booster (N = 105, 87)
5477
(4401 to 6814)
9050
(7134 to 11480)
Anti-Polio 2 Pre-booster (N = 84, 87)
114
(84.9 to 153)
131
(95.3 to 179)
Anti-Polio 2 Post-booster (N = 101, 83)
6099
(4916 to 7566)
9170
(7170 to 11727)
Anti-Polio 3 Pre-booster (N = 88, 86)
47.1
(33.1 to 67.1)
101
(73.0 to 141)
Anti-Polio 3 Post-booster (N = 102, 84)
5542
(4156 to 7392)
10152
(7806 to 13205)
Anti-PT Pre-booster (N = 86, 87)
6.08
(4.74 to 7.79)
7.49
(5.97 to 9.41)
Anti-PT Post-booster (N = 113, 95)
160
(137 to 187)
237
(202 to 278)
Anti-FHA Pre-booster (N = 74, 81)
12.5
(9.59 to 16.4)
8.18
(6.49 to 10.3)
Anti-FHA Post-booster (N = 111, 97)
222
(194 to 254)
234
(201 to 272)
3.Primary Outcome
Title Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Hide Description

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

Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; 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 feeds or most feeds; Irritability, inconsolable.
Time Frame Day 0 up to Day 7 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP~T according to the primary series received (Safety Analysis Population).
Arm/Group Title DTaP-IPV-HepB-PRP-T Pentaxim™ + Engerix B™
Hide Arm/Group Description:
All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
Overall Number of Participants Analyzed 121 111
Measure Type: Number
Unit of Measure: Participants
Pain 56 67
Grade 3 Pain 4 2
Erythema 35 50
Grade 3 Erythema 3 4
Swelling 26 36
Grade 3 Swelling 2 3
Extensive Swelling of Vaccinated Limb 0 0
Pyrexia 29 36
Grade 3 Pyrexia 1 0
Vomiting 13 11
Grade 3 Vomiting 2 2
Crying 29 35
Grade 3 Crying 3 4
Somnolence 24 25
Grade 3 Somnolence 2 3
Anorexia 40 43
Grade 3 Anorexia 9 8
Irritability 51 61
Grade 3 Irritability 5 7
Time Frame Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™
Hide Arm/Group Description All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
All-Cause Mortality
DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
DTaP-IPV-HepB-PRP~T Pentaxim™ + Engerix B™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/130 (3.08%)      2/124 (1.61%)    
Gastrointestinal disorders     
Gastroesophageal reflux disease * 1  1/130 (0.77%)  1 0/124 (0.00%)  0
Infections and infestations     
Bronchitis * 1  1/130 (0.77%)  1 0/124 (0.00%)  0
Gastroenteritis * 1  1/130 (0.77%)  1 1/124 (0.81%)  1
Gastroenteritis rotavirus * 1  0/130 (0.00%)  0 1/124 (0.81%)  1
Injury, poisoning and procedural complications     
Poisoning * 1  1/130 (0.77%)  1 0/124 (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-HepB-PRP~T Pentaxim™ + Engerix B™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/130 (43.08%)      67/124 (54.03%)    
Gastrointestinal disorders     
Vomiting † 1  13/130 (10.00%)  13 11/124 (8.87%)  11
General disorders     
Injection site erythema † 1  35/130 (26.92%)  35 50/124 (40.32%)  50
Injection site pain † 1  56/130 (43.08%)  56 67/124 (54.03%)  67
Injection site swelling † 1  26/130 (20.00%)  26 36/124 (29.03%)  36
Irritability † 1  51/130 (39.23%)  51 61/124 (49.19%)  61
Pyrexia † 1  29/130 (22.31%)  29 36/124 (29.03%)  36
Metabolism and nutrition disorders     
Anorexia † 1  40/130 (30.77%)  40 43/124 (34.68%)  43
Nervous system disorders     
Somnolence † 1  24/130 (18.46%)  24 25/124 (20.16%)  25
Psychiatric disorders     
Crying † 1  29/130 (22.31%)  29 35/124 (28.23%)  35
†
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: NCT00619502    
Other Study ID Numbers: A3L22
First Submitted: February 11, 2008
First Posted: February 21, 2008
Results First Submitted: February 22, 2014
Results First Posted: April 3, 2014
Last Update Posted: May 13, 2016