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Trial record 1 of 1 for:    AL203
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Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

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ClinicalTrials.gov Identifier: NCT00343889
Recruitment Status : Completed
First Posted : June 23, 2006
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Infections
Interventions Biological: DTaP-HB-PRP~T vaccine + OPV
Biological: Tritanrix-HepB/Hib™ + OPV vaccine
Biological: Oral Polio Vaccine
Enrollment 379
Recruitment Details Participants were enrolled and treated from 07 July 2006 to 26 September 2006 in 2 clinical centers in the Philippines.
Pre-assignment Details A total of 379 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Period Title: Overall Study
Started 190 189
Completed 187 188
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             2             0
Withdrawal by Subject             0             1
Protocol Violation             1             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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. Total of all reporting groups
Overall Number of Baseline Participants 190 189 379
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 189 participants 379 participants
<=18 years
190
 100.0%
189
 100.0%
379
 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:  Weeks
Number Analyzed 190 participants 189 participants 379 participants
6.31  (0.308) 6.31  (0.304) 6.31  (0.306)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 189 participants 379 participants
Female
101
  53.2%
92
  48.7%
193
  50.9%
Male
89
  46.8%
97
  51.3%
186
  49.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 190 participants 189 participants 379 participants
190 189 379
1.Primary Outcome
Title Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination 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 hepatitis B (HBs) antibodies.

Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.

Time Frame 1 month post third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to hepatitis H Antigen was 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 184 186
Measure Type: Number
Unit of Measure: Participants
146 167
2.Secondary Outcome
Title Number of Participants With Anti-Hepatitis B Responses After Vaccination 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 hepatitis B (HBs) antibodies.

Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination.

Time Frame 1 month post third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-Hepatitis B Responses was 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 184 186
Measure Type: Number
Unit of Measure: Participants
54 97
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies After 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 1 month after the third vaccination (Day 150).
Time Frame 1 month post third 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 260 271
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hepatitis B (N = 184, 186)
39.1
(31.0 to 49.2)
86.2
(68.0 to 109)
Anti-PRP (N = 178, 185)
2.35
(1.83 to 3.01)
7.82
(6.45 to 9.48)
Anti-Diphtheria (N = 184, 186)
0.018
(0.015 to 0.022)
0.018
(0.014 to 0.021)
Anti-Tetanus (N = 184, 186)
1.30
(1.16 to 1.46)
1.76
(1.58 to 1.97)
Anti-Pertussis (N = 183, 184)
5.16
(4.36 to 6.11)
5.84
(4.81 to 7.09)
Anti-Filamentous Hemagglutinin (N = 184, 186)
5.50
(4.68 to 6.48)
5.71
(4.85 to 6.71)
4.Secondary Outcome
Title Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination 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 Diphtheria and Tetanus antibodies.

Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination.

Time Frame 1 month post third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-Hepatitis B Responses was 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 184 186
Measure Type: Number
Unit of Measure: Participants
Anti-Diphtheria ≥ 0.01 IU/mL 137 134
Anti-Diphtheria ≥ 0.1 IU/mL 13 11
Anti-Tetanus ≥ 0.01 IU/mL 184 186
Anti-Tetanus ≥ 0.1 IU/mL 184 186
5.Secondary Outcome
Title Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description

Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).

Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.

Time Frame 1 month post third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 184 186
Measure Type: Number
Unit of Measure: Participants
Anti-Pertussis Toxoid (N =184, 180) 183 168
Anti-Filamentous Hemagglutinin (N = 178, 131) 178 116
6.Secondary Outcome
Title Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each 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 defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; 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 each 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 190 189
Measure Type: Number
Unit of Measure: Participants
Injection site Pain post any vaccination 123 152
Grade 3 Injection site Pain post any vaccination 7 24
Injection site Pain post-vaccination 1 100 142
Injection site Pain post-vaccination 2 86 109
Injection site Pain post-vaccination 3 62 88
Injection site Erythema post any vaccination 121 148
Grade 3 Injec. site Erythema post any vaccination 2 3
Injection site Erythema post-vaccination 1 70 89
Injection site Erythema post-vaccination 2 70 105
Injection site Erythema post-vaccination 3 76 104
Injection site Swelling post any vaccination 60 107
Grade 3 Injec. site Swelling post any vaccination 4 7
Injection site Swelling post-vaccination 1 41 89
Injection site Swelling post-vaccination 2 28 57
Injection site Swelling post-vaccination 3 24 49
Pyrexia post any vaccination 85 129
Grade 3 Pyrexia post any vaccination 1 4
Pyrexia post-vaccination 1 59 106
Pyrexia post-vaccination 2 40 54
Pyrexia post-vaccination 3 22 51
Vomiting post any vaccination 43 61
Grade 3 Vomiting post any vaccination 0 0
Vomiting post-vaccination 1 37 40
Vomiting post-vaccination 2 16 24
Vomiting post-vaccination 3 9 13
Crying post any vaccination 56 97
Grade 3 Crying post any vaccination 0 0
Crying post-vaccination 1 41 71
Crying post-vaccination 2 29 42
Crying post-vaccination 3 16 34
Somnolence post any vaccination 52 63
Grade 3 Somnolence post any vaccination 2 2
Somnolence post-vaccination 1 43 49
Somnolence post-vaccination 2 24 26
Somnolence post-vaccination 3 10 18
Anorexia post any vaccination 48 67
Grade 3 Anorexia post any vaccination 1 1
Anorexia post-vaccination 1 32 50
Anorexia post-vaccination 2 20 25
Anorexia post-vaccination 3 16 27
Irritability post any vaccination 102 128
Grade 3 Irritability post any vaccination 4 7
Irritability post-vaccination 1 90 116
Irritability post-vaccination 2 48 71
Irritability post-vaccination 3 32 56
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
Adverse Event Reporting Description The total number (N) for each adverse event indicated those with available data for the event.
 
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
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   17/190 (8.95%)      10/189 (5.29%)    
Gastrointestinal disorders     
Intussusception * 1  0/190 (0.00%)  0 1/189 (0.53%)  1
Infections and infestations     
Bronchopneumonia * 1  1/190 (0.53%)  1 0/189 (0.00%)  0
Bronchitis * 1  1/190 (0.53%)  1 0/189 (0.00%)  0
Bullus impetigo * 1  1/190 (0.53%)  1 0/189 (0.00%)  0
Diarrhoea infectious * 1  1/190 (0.53%)  1 0/189 (0.00%)  0
Exanthema subitum * 1  1/190 (0.53%)  1 0/189 (0.00%)  0
Gastroenteritis * 1  8/190 (4.21%)  8 4/189 (2.12%)  4
Pneumonia * 1  3/190 (1.58%)  3 5/189 (2.65%)  5
Sepsis * 1  1/190 (0.53%)  1 0/189 (0.00%)  0
Urinary tract infection * 1  0/190 (0.00%)  0 1/189 (0.53%)  1
*
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   123/190 (64.74%)      152/189 (80.42%)    
Gastrointestinal disorders     
Vomiting  1  43/189 (22.75%)  61/189 (32.28%) 
Injection site pain  1  123/189 (65.08%)  152/189 (80.42%) 
General disorders     
Injection site erythemia  1  121/189 (64.02%)  148/189 (78.31%) 
Injection site swelling  1  60/189 (31.75%)  107/189 (56.61%) 
Pyrexia  1  85/189 (44.97%)  129/189 (68.25%) 
Pyrexia * 1  7/190 (3.68%)  17/189 (8.99%) 
Infections and infestations     
Upper respiratory tract infection * 1  89/190 (46.84%)  113/189 (59.79%) 
Metabolism and nutrition disorders     
Anorexia  1  48/189 (25.40%)  67/189 (35.45%) 
Rhinitis * 1  14/190 (7.37%)  16/189 (8.47%) 
Nervous system disorders     
Somnolence  1  52/189 (27.51%)  63/189 (33.33%) 
Psychiatric disorders     
Crying  1  56/189 (29.63%)  97/189 (51.32%) 
Irritability  1  102/189 (53.97%)  128/189 (67.72%) 
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: NCT00343889     History of Changes
Other Study ID Numbers: AL203
First Submitted: June 21, 2006
First Posted: June 23, 2006
Results First Submitted: September 9, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013