Trial record 1 of 1 for:
A3L22
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
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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: NCT00619502 |
Recruitment Status :
Completed
First Posted : February 21, 2008
Results First Posted : April 3, 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: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Polio Pertussis Hepatitis B |
Intervention |
Biological: DTaP-IPV-HB-PRP~T vaccine |
Enrollment | 254 |
Participant Flow
Recruitment Details | Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey. |
Pre-assignment Details | A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DTaP-IPV-HepB-PRP~T | Pentaxim™ + Engerix B™ |
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All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. | All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. |
Period Title: Overall Study | ||
Started | 130 | 124 |
Completed | 122 | 114 |
Not Completed | 8 | 10 |
Reason Not Completed | ||
Lost to Follow-up | 8 | 10 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV-HepB-PRP~T | Pentaxim™ + Engerix B™ | Total | |
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All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. | All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 130 | 124 | 254 | |
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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 | 130 participants | 124 participants | 254 participants | |
<=18 years |
130 100.0%
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124 100.0%
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254 100.0%
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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 | 130 participants | 124 participants | 254 participants | |
17.6 (0.198) | 17.6 (0.279) | 17.6 (0.241) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 130 participants | 124 participants | 254 participants | |
Female |
56 43.1%
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54 43.5%
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110 43.3%
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Male |
74 56.9%
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70 56.5%
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144 56.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Turkey | Number Analyzed | 130 participants | 124 participants | 254 participants |
130 | 124 | 254 |
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: | NCT00619502 |
Other Study ID Numbers: |
A3L22 |
First Submitted: | February 11, 2008 |
First Posted: | February 21, 2008 |
Results First Submitted: | February 22, 2014 |
Results First Posted: | April 3, 2014 |
Last Update Posted: | May 13, 2016 |