Trial record 1 of 1 for:
AL204
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
![]() |
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: NCT00514709 |
Recruitment Status :
Completed
First Posted : August 10, 2007
Results First Posted : November 14, 2013
Last Update Posted : August 2, 2016
|
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Hepatitis B Influenza |
Interventions |
Biological: DTaP-HB PRP~T Combined Vaccine Biological: DTaP-HB-PRP~T vaccine Biological: Oral Polio Vaccine |
Enrollment | 1843 |
Participant Flow
Recruitment Details | Participants were randomized and enrolled from 06 August 2007 to 29 July 2008 in 2 clinic centers in the Philippines. |
Pre-assignment Details | A total of 1843 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 |
---|---|---|
![]() |
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201 (NCT00348881). | Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881). |
Period Title: Overall Study | ||
Started | 1230 | 613 |
Completed | 1230 | 613 |
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 | |
---|---|---|---|---|
![]() |
Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201. | Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201. | Total of all reporting groups | |
Overall Number of Baseline Participants | 1230 | 613 | 1843 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1230 participants | 613 participants | 1843 participants | |
<=18 years |
1230 100.0%
|
613 100.0%
|
1843 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 | 1230 participants | 613 participants | 1843 participants | |
15.1 (1.96) | 15.1 (1.95) | 15.1 (1.96) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 1230 participants | 613 participants | 1843 participants | |
Female |
629 51.1%
|
302 49.3%
|
931 50.5%
|
|
Male |
601 48.9%
|
311 50.7%
|
912 49.5%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
Philippines | Number Analyzed | 1230 participants | 613 participants | 1843 participants |
1230 | 613 | 1843 |
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: | NCT00514709 |
Other Study ID Numbers: |
AL204 |
First Submitted: | August 9, 2007 |
First Posted: | August 10, 2007 |
Results First Submitted: | September 9, 2013 |
Results First Posted: | November 14, 2013 |
Last Update Posted: | August 2, 2016 |