Trial record 1 of 1 for:
AL205
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
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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: NCT00534833 |
Recruitment Status :
Completed
First Posted : September 26, 2007
Results First Posted : November 21, 2013
Last Update Posted : November 21, 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: 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 |
Participant Flow
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 |
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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 |
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 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 | |
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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 | 182 participants | 180 participants | 362 participants | |
<=18 years |
182 100.0%
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180 100.0%
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362 100.0%
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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: Months |
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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 |
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Number Analyzed | 182 participants | 180 participants | 362 participants | |
Female |
97 53.3%
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88 48.9%
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185 51.1%
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Male |
85 46.7%
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92 51.1%
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177 48.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Philippines | Number Analyzed | 182 participants | 180 participants | 362 participants |
182 | 180 | 362 |
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: | 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 |