Trial record 1 of 1 for:
A3L02
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
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ClinicalTrials.gov Identifier: NCT00831311 |
Recruitment Status :
Completed
First Posted : January 28, 2009
Results First Posted : November 21, 2013
Last Update Posted : December 17, 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: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Poliomyelitis |
Interventions |
Biological: DTaP-IPV-HB-PRP~T Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine |
Enrollment | 624 |
Participant Flow
Recruitment Details | Participants were enrolled and treated from 26 October 2004 to 10 November 2005 in 1 clinical center in Argentina. |
Pre-assignment Details | A total of 624 participants who met the inclusion but no exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | Group 1: DTaP-IPV-Hep B-PRP~T | Group 2: PENTAXIM™ and ENGERIX B® |
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Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age. | Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age. |
Period Title: Overall Study | ||
Started | 312 | 312 |
Completed | 300 | 304 |
Not Completed | 12 | 8 |
Reason Not Completed | ||
Definitive Contraindication | 3 | 3 |
Lost to Follow-up | 3 | 0 |
Physician Decision | 0 | 1 |
Withdrawal by Subject | 6 | 4 |
Baseline Characteristics
Arm/Group Title | Group 1: DTaP-IPV-Hep B-PRP~T | Group 2: PENTAXIM™ and ENGERIX B® | Total | |
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Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age. | Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age. | Total of all reporting groups | |
Overall Number of Baseline Participants | 312 | 312 | 624 | |
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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 | 312 participants | 312 participants | 624 participants | |
<=18 years |
312 100.0%
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312 100.0%
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624 100.0%
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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 | 312 participants | 312 participants | 624 participants | |
1.76 (0.12) | 1.77 (0.11) | 1.76 (0.11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 312 participants | 312 participants | 624 participants | |
Female |
148 47.4%
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147 47.1%
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295 47.3%
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Male |
164 52.6%
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165 52.9%
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329 52.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Argentina | Number Analyzed | 312 participants | 312 participants | 624 participants |
312 | 312 | 624 |
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: | NCT00831311 |
Other Study ID Numbers: |
A3L02 |
First Submitted: | January 27, 2009 |
First Posted: | January 28, 2009 |
Results First Submitted: | September 19, 2013 |
Results First Posted: | November 21, 2013 |
Last Update Posted: | December 17, 2013 |