Trial record 1 of 1 for:
M5A07
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
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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: NCT00772928 |
Recruitment Status :
Completed
First Posted : October 15, 2008
Results First Posted : February 12, 2010
Last Update Posted : February 1, 2012
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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: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Haemophilus Infection Pertussis Polio |
Intervention |
Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® |
Enrollment | 1167 |
Participant Flow
Recruitment Details | Study participants were enrolled from 30 October 2003 to 29 March 2004 in 23 medical clinics in the US. |
Pre-assignment Details | A total of 1167 subjects that met the inclusion and exclusion criteria were enrolled, 1166 were vaccinated. |
Arm/Group Title | Pentacel™ Concurrently With Prevnar® | Pentacel™ Staggered Schedule With Prevnar® |
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Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine | Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). |
Period Title: Overall Study | ||
Started | 587 | 579 |
Completed | 543 | 538 |
Not Completed | 44 | 41 |
Reason Not Completed | ||
Lost to Follow-up | 9 | 6 |
Protocol Violation | 10 | 12 |
Withdrawal by Subject | 25 | 22 |
Did not receive vaccine | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Pentacel™ Concurrently With Prevnar® | Pentacel™ Staggered Schedule With Prevnar® | Total | |
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Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine | Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). | Total of all reporting groups | |
Overall Number of Baseline Participants | 587 | 579 | 1166 | |
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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 | 587 participants | 579 participants | 1166 participants | |
<=18 years |
587 100.0%
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579 100.0%
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1166 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 | 587 participants | 579 participants | 1166 participants | |
2.2 (0.29) | 2.1 (0.28) | 2.1 (0.29) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 587 participants | 579 participants | 1166 participants | |
Female |
278 47.4%
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259 44.7%
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537 46.1%
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Male |
309 52.6%
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320 55.3%
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629 53.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 587 participants | 579 participants | 1166 participants |
587 | 579 | 1166 |
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: | NCT00772928 |
Other Study ID Numbers: |
M5A07 |
First Submitted: | October 13, 2008 |
First Posted: | October 15, 2008 |
Results First Submitted: | September 23, 2009 |
Results First Posted: | February 12, 2010 |
Last Update Posted: | February 1, 2012 |