Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01346293
First received: April 29, 2011
Last updated: May 28, 2015
Last verified: May 2015
Results First Received: April 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

Reporting Groups
  Description
DTaP-IPV 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
DAPTACEL®+IPOL® 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®

Participant Flow:   Overall Study
    DTaP-IPV     DAPTACEL®+IPOL®  
STARTED     2743     629  
COMPLETED     2676     608  
NOT COMPLETED     67     21  
Protocol Violation                 30                 9  
Lost to Follow-up                 21                 8  
Withdrawal by Subject                 15                 4  
Unknown                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DTaP-IPV 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
DAPTACEL®+IPOL® 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 Total of all reporting groups

Baseline Measures
    DTaP-IPV     DAPTACEL®+IPOL®     Total  
Number of Participants  
[units: participants]
  2743     629     3372  
Age  
[units: participants]
     
<=18 years     2743     629     3372  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Years]
Mean (Standard Deviation)
  4.4  (0.5)     4.4  (0.5)     4.4  (0.5)  
Gender  
[units: participants]
     
Female     1330     306     1636  
Male     1413     323     1736  
Region of Enrollment  
[units: Participants]
     
United States     2743     629     3372  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

2.  Primary:   Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

3.  Primary:   Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

4.  Primary:   Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

5.  Primary:   Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

6.  Primary:   Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

7.  Other Pre-specified:   Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

8.  Other Pre-specified:   Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

9.  Other Pre-specified:   Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

10.  Other Pre-specified:   Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose   [ Time Frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination ]

11.  Other Pre-specified:   Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine   [ Time Frame: Day 0 up to Day 28 post-final vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com



Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01346293     History of Changes
Other Study ID Numbers: M5I02
U1111-1116-4842 ( Other Identifier: WHO )
Study First Received: April 29, 2011
Results First Received: April 23, 2015
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration