Trial record 1 of 1 for:
M5I02
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
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ClinicalTrials.gov Identifier: NCT01346293 |
Recruitment Status :
Completed
First Posted : May 2, 2011
Results First Posted : May 29, 2015
Last Update Posted : June 3, 2015
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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 |
Tetanus Diphtheria Pertussis Measles Polio |
Interventions |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus |
Enrollment | 3372 |
Participant Flow
Recruitment Details | The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico. |
Pre-assignment Details | A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. |
Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
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Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
Period Title: Overall Study | ||
Started | 2743 | 629 |
Completed | 2676 | 608 |
Not Completed | 67 | 21 |
Reason Not Completed | ||
Protocol Violation | 30 | 9 |
Lost to Follow-up | 21 | 8 |
Withdrawal by Subject | 15 | 4 |
Other | 1 | 0 |
Baseline Characteristics
Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® | Total | |
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Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® | Total of all reporting groups | |
Overall Number of Baseline Participants | 2743 | 629 | 3372 | |
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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 | 2743 participants | 629 participants | 3372 participants | |
<=18 years |
2743 100.0%
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629 100.0%
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3372 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: Years |
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Number Analyzed | 2743 participants | 629 participants | 3372 participants | |
4.4 (0.5) | 4.4 (0.5) | 4.4 (0.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2743 participants | 629 participants | 3372 participants | |
Female |
1330 48.5%
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306 48.6%
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1636 48.5%
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Male |
1413 51.5%
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323 51.4%
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1736 51.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 2743 participants | 629 participants | 3372 participants |
2743 | 629 | 3372 |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT01346293 |
Other Study ID Numbers: |
M5I02 U1111-1116-4842 ( Other Identifier: WHO ) |
First Submitted: | April 29, 2011 |
First Posted: | May 2, 2011 |
Results First Submitted: | April 23, 2015 |
Results First Posted: | May 29, 2015 |
Last Update Posted: | June 3, 2015 |