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Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

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ClinicalTrials.gov Identifier: NCT00534833
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : November 21, 2013
Last Update Posted : November 21, 2013
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
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type b
Interventions Biological: DTaP-HB-PRP~T vaccine
Biological: Tritanrix-HepB/Hib™
Biological: Oral Polio Vaccine
Enrollment 362
Recruitment Details Participants were randomized and enrolled from 21 September 2007 to 03 December 2007 in 2 clinical centers in the Philippines.
Pre-assignment Details A total of 362 participants who met the inclusion but not 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 DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
Period Title: Overall Study
Started 182 180
Completed 182 180
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 DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. Total of all reporting groups
Overall Number of Baseline Participants 182 180 362
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 180 participants 362 participants
<=18 years
182
 100.0%
180
 100.0%
362
 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 182 participants 180 participants 362 participants
15.9  (0.946) 15.9  (0.942) 15.9  (0.945)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 180 participants 362 participants
Female
97
  53.3%
88
  48.9%
185
  51.1%
Male
85
  46.7%
92
  51.1%
177
  48.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 182 participants 180 participants 362 participants
182 180 362
1.Primary Outcome
Title Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description

Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization 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 at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
Time Frame 28 Days post-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 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 AL203.
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 AL203
Overall Number of Participants Analyzed 98 98
Measure Type: Number
Unit of Measure: Participants
Anti-Hep B, Pre-booster (N = 98, 98) 36 58
Anti-Hep B, Post-booster (N = 98, 98) 81 94
Anti-PRP, Pre-booster (N = 98, 98) 82 97
Anti-PRP, Post-booster (N = 98, 98) 97 98
Anti-Diphtheria, Pre-booster (N = 98, 98) 67 59
Anti-Diphtheria, Post-booster (N = 98, 98) 97 97
Anti-Tetanus, Pre-booster (N = 98, 97) 98 97
Anti-Tetanus, Post-booster (N = 98, 98) 98 98
Anti-Pertussis, 4-Fold Increase (N = 96, 92) 94 83
Anti-Pertussis, Booster response (N = 96, 92) 95 85
Anti-FHA, 4-Fold Increase (N = 94, 93) 89 92
Anti-FHA, Booster response (N = 94, 93) 93 93
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in 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 DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
Overall Number of Participants Analyzed 98 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hepatitis B Pre-booster (N = 98, 98)
6.75
(5.17 to 8.81)
17.5
(12.7 to 24.0)
Anti-Hepatitis B Post-booster (N = 98, 98)
119
(75.3 to 188)
1352
(883 to 2071)
Anti-PRP Pre-booster (N = 98, 98)
0.908
(0.631 to 1.31)
3.76
(2.76 to 5.13)
Anti-PRP Post-booster (N = 98, 98)
64.4
(47.1 to 88.2)
103
(82.8 to 129)
Anti-Diphtheria Pre-booster (N = 98, 98)
0.016
(0.012 to 0.021)
0.013
(0.010 to 0.018)
Anti-Diphtheria Post-booster (N = 98, 98)
2.81
(2.01 to 3.92)
1.15
(0.779 to 1.70)
Anti-Tetanus Pre-booster (N = 98, 98)
0.382
(0.320 to 0.455)
0.500
(0.429 to 0.584)
Anti-Tetanus Post-booster (N = 98, 98)
15.8
(13.2 to 18.9)
14.7
(13.1 to 16.4)
Anti-Pertussis Pre-booster (N = 96, 92)
9.11
(7.77 to 10.7)
6.94
(5.20 to 9.25)
Anti-Pertussis Post-booster (N = 98, 98)
199
(174 to 228)
105
(76.9 to 144)
Anti-FHA Pre-booster (N = 95, 93)
15.0
(12.4 to 18.2)
2.10
(1.76 to 2.51)
Anti-FHA Post-booster (N = 97, 98)
233
(206 to 263)
117
(101 to 135)
3.Secondary Outcome
Title Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description

Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.

Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - 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 post-vaccination
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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 DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
Overall Number of Participants Analyzed 182 180
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 65 124
Grade 3 Injection site Pain 1 9
Injection site Erythema 71 90
Grade 3 Injection site Erythema 2 1
Injection site Swelling 21 47
Grade 3 Injection site Swelling 1 2
Extensive swelling of vaccinated limb 0 0
Pyrexia 39 46
Grade 3 Pyrexia 0 2
Vomiting 16 15
Grade 3 Vomiting 1 0
Crying 23 42
Grade 3 Crying post-vaccination 0 0
Somnolence post-vaccination 22 41
Grade 3 Somnolence 1 0
Anorexia 24 39
Grade 3 Anorexia 1 0
Irritability 38 71
Grade 3 Irritability 0 1
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 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 DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
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   --/--      --/--    
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   14/182 (7.69%)      7/180 (3.89%)    
Immune system disorders     
Hypersensitivity * 1  1/182 (0.55%)  1 0/180 (0.00%)  0
Infections and infestations     
Gastroenteritis * 1  6/182 (3.30%)  6 3/180 (1.67%)  3
Pneumonia * 1  0/182 (0.00%)  0 2/180 (1.11%)  2
Typhoid fever * 1  0/182 (0.00%)  0 1/180 (0.56%)  1
Urinary tract infections * 1  1/182 (0.55%)  1 0/180 (0.00%)  0
Nervous system disorders     
Convulsion * 1  1/182 (0.55%)  1 0/180 (0.00%)  0
Febrile convulsion * 1  3/182 (1.65%)  4 0/180 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  2/182 (1.10%)  2 0/180 (0.00%)  0
Pneumonia aspiration * 1  0/182 (0.00%)  0 1/180 (0.56%)  1
*
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%
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   101/182 (55.49%)      142/180 (78.89%)    
Gastrointestinal disorders     
Vomiting † 1  16/182 (8.79%)  15/180 (8.33%) 
General disorders     
Injection site pain † 1  65/182 (35.71%)  124/180 (68.89%) 
Injection site erythemia † 1  71/182 (39.01%)  90/180 (50.00%) 
Injection site swelling † 1  21/182 (11.54%)  47/180 (26.11%) 
Pyrexia † 1  39/182 (21.43%)  46/180 (25.56%) 
Infections and infestations     
Upper respiratory tract infection * 1  43/182 (23.63%)  43/180 (23.89%) 
Metabolism and nutrition disorders     
Anorexia † 1  24/182 (13.19%)  39/180 (21.67%) 
Rhinitis * 1  16/182 (8.79%)  16/180 (8.89%) 
Nervous system disorders     
Somnolence † 1  22/182 (12.09%)  41/180 (22.78%) 
Psychiatric disorders     
Crying † 1  23/182 (12.64%)  42/180 (23.33%) 
Irritability † 1  38/182 (20.88%)  71/180 (39.44%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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: NCT00534833    
Other Study ID Numbers: AL205
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: September 19, 2013
Results First Posted: November 21, 2013
Last Update Posted: November 21, 2013