Trial record 1 of 1 for:
AL203
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00343889 |
Recruitment Status :
Completed
First Posted : June 23, 2006
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 190 participants | 189 participants | 379 participants | |
<=18 years |
190 100.0%
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189 100.0%
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379 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Weeks |
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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 |
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Number Analyzed | 190 participants | 189 participants | 379 participants | |
Female |
101 53.2%
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92 48.7%
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193 50.9%
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Male |
89 46.8%
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97 51.3%
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186 49.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Philippines | Number Analyzed | 190 participants | 189 participants | 379 participants |
190 | 189 | 379 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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. |
EMail: | RegistryContactUs@sanofipasteur.com |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00343889 |
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 |