Trial record 1 of 1 for:
AL201
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
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ClinicalTrials.gov Identifier: NCT00348881 |
Recruitment Status :
Completed
First Posted : July 6, 2006
Results First Posted : October 22, 2013
Last Update Posted : October 22, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Hepatitis B Influenza |
Interventions |
Biological: DTaP-HB-PRP~T combined vaccine Biological: Tritanrix-HepB/Hib™ vaccine Biological: Oral poliomyelitis vaccine (OPV) |
Enrollment | 2133 |
Participant Flow
Recruitment Details | Participants were enrolled and treated from 17 May 2006 to 26 September 2006 in 1 clinic center in the Philippines. |
Pre-assignment Details | A total of 2133 participants who met the inclusion and 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 poliomyelitis 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 poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age. |
Period Title: Overall Study | ||
Started | 1424 | 709 |
Completed | 1407 | 697 |
Not Completed | 17 | 12 |
Reason Not Completed | ||
Lost to Follow-up | 12 | 6 |
Withdrawal by Subject | 3 | 4 |
Adverse Event | 2 | 0 |
Serious Adverse Event | 0 | 2 |
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 poliomyelitis 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 poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age. | Total of all reporting groups | |
Overall Number of Baseline Participants | 1424 | 709 | 2133 | |
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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 | 1424 participants | 709 participants | 2133 participants | |
<=18 years |
1424 100.0%
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709 100.0%
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2133 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 | 1424 participants | 709 participants | 2133 participants | |
6.27 (0.280) | 6.30 (0.310) | 6.28 (0.291) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1424 participants | 709 participants | 2133 participants | |
Female |
718 50.4%
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356 50.2%
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1074 50.4%
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Male |
706 49.6%
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353 49.8%
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1059 49.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Philippines | Number Analyzed | 1424 participants | 709 participants | 2133 participants |
1424 | 709 | 2133 |
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: | NCT00348881 |
Other Study ID Numbers: |
AL201 |
First Submitted: | July 5, 2006 |
First Posted: | July 6, 2006 |
Results First Submitted: | June 10, 2013 |
Results First Posted: | October 22, 2013 |
Last Update Posted: | October 22, 2013 |