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Trial record 1 of 1 for:    AL204
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Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

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ClinicalTrials.gov Identifier: NCT00514709
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : November 14, 2013
Last Update Posted : August 2, 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
Influenza
Interventions Biological: DTaP-HB PRP~T Combined Vaccine
Biological: DTaP-HB-PRP~T vaccine
Biological: Oral Polio Vaccine
Enrollment 1843
Recruitment Details Participants were randomized and enrolled from 06 August 2007 to 29 July 2008 in 2 clinic centers in the Philippines.
Pre-assignment Details A total of 1843 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881). Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
Period Title: Overall Study
Started 1230 613
Completed 1230 613
Not Completed 0 0
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV Total
Hide Arm/Group Description Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201. Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201. Total of all reporting groups
Overall Number of Baseline Participants 1230 613 1843
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1230 participants 613 participants 1843 participants
<=18 years
1230
 100.0%
613
 100.0%
1843
 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 1230 participants 613 participants 1843 participants
15.1  (1.96) 15.1  (1.95) 15.1  (1.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1230 participants 613 participants 1843 participants
Female
629
  51.1%
302
  49.3%
931
  50.5%
Male
601
  48.9%
311
  50.7%
912
  49.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 1230 participants 613 participants 1843 participants
1230 613 1843
1.Primary Outcome
Title Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Hide Description

Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.

Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.

Time Frame Day 0 (pre-vaccination) and Day 28 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
Overall Number of Participants Analyzed 93 105
Measure Type: Number
Unit of Measure: Participants
Anti-Hep B Pre-booster (N = 93, 103) 81 80
Anti-Hep B Post-booster (N = 93, 105) 91 103
Anti-PRP Pre-booster (N = 93, 105) 78 105
Anti-PRP Post-booster (N = 93, 105) 93 105
Anti-Diphtheria Pre-booster (N = 93, 105) 72 68
Anti-Diphtheria Post-booster (N = 93, 105) 93 103
Anti-Tetanus Pre-booster (N = 93, 105) 93 105
Anti-Tetanus Post-booster (N = 93, 105) 93 105
Anti-Pertussis 4-Fold increase (N = 89, 101) 85 100
Anti-Pertussis booster response (N = 89, 101) 87 101
Anti-FHA 4-Fold increase (N = 91, 103) 80 102
Anti-FHA booster response (N = 91, 103) 89 102
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Hide Description Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population.
Arm/Group Title Group 1: DTaP-Hep B-PRP-T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP-T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
Overall Number of Participants Analyzed 93 105
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hep B Pre-booster (N = 93, 103)
71.6
(51.1 to 100)
42.2
(30.5 to 58.5)
Anti-Hep Bs Post-booster (N = 93, 105)
4224
(2760 to 6464)
3673
(2441 to 5527)
Anti-PRP Pre-booster (N = 93, 105)
0.889
(0.602 to 1.31)
5.32
(4.13 to 6.84)
Anti-PRP Post-booster (N = 93, 105)
58.1
(40.4 to 83.4)
242
(195 to 299)
Anti-Diphtheria Pre-booster (N = 93, 105)
0.016
(0.013 to 0.021)
0.014
(0.011 to 0.018)
Anti-Diphtheria Post-booster (N = 93, 105)
1.36
(1.05 to 1.77)
1.43
(1.06 to 1.93)
Anti-Tetanus pre-booster (N = 93, 105)
0.364
(0.308 to 0.431)
0.504
(0.438 to 0.581)
Anti-Tetanus post-booster (N = 93, 105)
11.6
(9.71 to 13.9)
24.7
(21.9 to 27.7)
Anti-Pertusiss pre-booster (N = 89, 101)
7.34
(6.22 to 8.64)
6.82
(5.30 to 8.76)
Anti-Pertusiss post-booster (N = 93, 105)
128
(107 to 153)
185
(149 to 229)
Anti-FHA Pre-booster (N = 91,103)
14.0
(11.3 to 17.3)
2.21
(1.83 to 2.67)
Anti-FHA Post-booster (N = 91,103)
204
(179 to 233)
158
(135 to 185)
3.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Hide Description

Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.

Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.

Time Frame Day 0 up to Day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was assessed on the safety analysis (intent-to-treat) population.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
Overall Number of Participants Analyzed 1230 613
Measure Type: Number
Unit of Measure: Participants
Injection site Pain post-vaccination 411 216
Grade 3 Injection site Pain post-vaccination 10 1
Injection site Erythema post-vaccination 272 136
Grade 3 Injection site Erythema post-vaccination 7 3
Injection site Swelling post-vaccination 211 120
Grade 3 Injection site Swelling post-vaccination 7 4
Extensive swelling of vaccinated limb 0 0
Pyrexia post-vaccination 137 70
Grade 3 Pyrexia post-vaccination 0 3
Vomiting post-vaccination 53 33
Grade 3 Vomiting post-vaccination 3 0
Crying post-vaccination 98 58
Grade 3 Crying post-vaccination 0 0
Somnolence post-vaccination 114 73
Grade 3 Somnolence post-vaccination 0 0
Anorexia post-vaccination 97 53
Grade 3 Anorexia post-vaccination 2 3
Irritability post-vaccination 224 114
Grade 3 Irritability post-vaccination 1 0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201. Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
All-Cause Mortality
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/1230 (0.24%)      0/613 (0.00%)    
Infections and infestations     
Gastroenteritis * 1  2/1230 (0.16%)  2 0/613 (0.00%)  0
Meningitis tuberculous * 1  1/1230 (0.08%)  1 0/613 (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%
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   411/1230 (33.41%)      216/613 (35.24%)    
Gastrointestinal disorders     
Vomiting * 1  53/1230 (4.31%)  33/613 (5.38%) 
General disorders     
Solicited injection site Pain  1  411/1230 (33.41%)  216/613 (35.24%) 
Solicited injection site Erythema  1  272/1230 (22.11%)  136/613 (22.19%) 
Solicited injection site Swelling  1  211/1230 (17.15%)  120/613 (19.58%) 
Pyrexia  1  137/1230 (11.14%)  70/613 (11.42%) 
Infections and infestations     
Upper respiratory tract infection * 1  69/1230 (5.61%)  38/613 (6.20%) 
Metabolism and nutrition disorders     
Anorexia  1  97/1230 (7.89%)  53/613 (8.65%) 
Nervous system disorders     
Somnolence  1  114/1230 (9.27%)  73/613 (11.91%) 
Psychiatric disorders     
Crying  1  98/1230 (7.97%)  58/613 (9.46%) 
Irritability  1  224/1230 (18.21%)  114/613 (18.60%) 
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: NCT00514709     History of Changes
Other Study ID Numbers: AL204
First Submitted: August 9, 2007
First Posted: August 10, 2007
Results First Submitted: September 9, 2013
Results First Posted: November 14, 2013
Last Update Posted: August 2, 2016