Trial record 1 of 1 for:
A3L17
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
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ClinicalTrials.gov Identifier: NCT00831753 |
Recruitment Status :
Completed
First Posted : January 29, 2009
Results First Posted : April 2, 2014
Last Update Posted : May 13, 2016
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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: Single (Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Hepatitis B |
Interventions |
Biological: DTaP IPV HB PRP~T vaccine Biological: DTaP-HB-IPV and Haemophilus influenzae type b |
Enrollment | 263 |
Participant Flow
Recruitment Details | Participants were enrolled from 23 May 2008 to 18 July 2008 at 1 clinical center in Peru. |
Pre-assignment Details | A total of 263 participants who met the inclusion and exclusion criteria were randomized and vaccinated in the study. |
Arm/Group Title | DTaP-IPV-Hep B-PRP~T Group | Infanrix Hexa™ Group |
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All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively. | All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively. |
Period Title: Overall Study | ||
Started | 132 | 131 |
Completed | 132 | 131 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV-Hep B-PRP~T Group | Infanrix Hexa™ Group | Total | |
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All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively. | All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively. | Total of all reporting groups | |
Overall Number of Baseline Participants | 132 | 131 | 263 | |
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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 | 132 participants | 131 participants | 263 participants | |
<=18 years |
132 100.0%
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131 100.0%
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263 100.0%
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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 | 132 participants | 131 participants | 263 participants | |
1.75 (0.132) | 1.72 (0.123) | 1.74 (0.128) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 132 participants | 131 participants | 263 participants | |
Female |
58 43.9%
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74 56.5%
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132 50.2%
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Male |
74 56.1%
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57 43.5%
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131 49.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Peru | Number Analyzed | 132 participants | 131 participants | 263 participants |
132 | 131 | 263 |
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: | NCT00831753 |
Other Study ID Numbers: |
A3L17 |
First Submitted: | January 27, 2009 |
First Posted: | January 29, 2009 |
Results First Submitted: | February 14, 2014 |
Results First Posted: | April 2, 2014 |
Last Update Posted: | May 13, 2016 |