Trial record 1 of 1 for:
A3L16
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
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ClinicalTrials.gov Identifier: NCT00303316 |
Recruitment Status :
Completed
First Posted : March 16, 2006
Results First Posted : February 22, 2013
Last Update Posted : February 22, 2013
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B |
Intervention |
Biological: DTaP-IPV//PRP~T combined vaccine |
Enrollment | 458 |
Participant Flow
Recruitment Details | Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina. |
Pre-assignment Details | A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTacP-IPV-Hep B-PRP~T Group | PENTAXIM™ and ENGERIX B® Group |
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Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). |
Period Title: Overall Study | ||
Started | 232 | 226 |
Completed | 230 | 223 |
Not Completed | 2 | 3 |
Reason Not Completed | ||
Protocol Violation | 1 | 0 |
Lost to Follow-up | 0 | 1 |
Withdrawal by Subject | 1 | 2 |
Baseline Characteristics
Arm/Group Title | DTacP-IPV-Hep B-PRP~T Group | PENTAXIM™ and ENGERIX B® Group | Total | |
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Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | Total of all reporting groups | |
Overall Number of Baseline Participants | 232 | 226 | 458 | |
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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 | 232 participants | 226 participants | 458 participants | |
<=18 years |
232 100.0%
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226 100.0%
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458 100.0%
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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 | 232 participants | 226 participants | 458 participants | |
17.6 (0.436) | 17.7 (0.492) | 17.6 (0.465) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 232 participants | 226 participants | 458 participants | |
Female |
107 46.1%
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107 47.3%
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214 46.7%
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Male |
125 53.9%
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119 52.7%
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244 53.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Argentina | Number Analyzed | 232 participants | 226 participants | 458 participants |
232 | 226 | 458 |
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 |
ClinicalTrials.gov Identifier: | NCT00303316 |
Other Study ID Numbers: |
A3L16 |
First Submitted: | March 13, 2006 |
First Posted: | March 16, 2006 |
Results First Submitted: | December 11, 2012 |
Results First Posted: | February 22, 2013 |
Last Update Posted: | February 22, 2013 |