Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00619502
First received: February 11, 2008
Last updated: February 22, 2014
Last verified: February 2014
Results First Received: February 22, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Diphtheria
Polio
Pertussis
Hepatitis B
Intervention: Biological: DTaP-IPV-HB-PRP~T vaccine

  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
Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
DTaP-IPV-HepB-PRP~T 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.
Pentaxim™ + Engerix B™ 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.

Participant Flow:   Overall Study
    DTaP-IPV-HepB-PRP~T     Pentaxim™ + Engerix B™  
STARTED     130     124  
COMPLETED     122     114  
NOT COMPLETED     8     10  
Lost to Follow-up                 8                 10  



  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-HepB-PRP~T 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.
Pentaxim™ + Engerix B™ 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 Total of all reporting groups

Baseline Measures
    DTaP-IPV-HepB-PRP~T     Pentaxim™ + Engerix B™     Total  
Number of Participants  
[units: participants]
  130     124     254  
Age  
[units: participants]
     
<=18 years     130     124     254  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Months]
Mean ± Standard Deviation
  17.6  ± 0.198     17.6  ± 0.279     17.6  ± 0.241  
Gender  
[units: participants]
     
Female     56     54     110  
Male     74     70     144  
Region of Enrollment  
[units: Participants]
     
Turkey     130     124     254  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™   [ Time Frame: Day 0 before and Day 30 Post-booster vaccination ]

2.  Primary:   Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T   [ Time Frame: Day 0 before and Day 30 post-booster vaccination ]

3.  Primary:   Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T   [ Time Frame: Day 0 up to Day 7 post-booster vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00619502     History of Changes
Other Study ID Numbers: A3L22
Study First Received: February 11, 2008
Results First Received: February 22, 2014
Last Updated: February 22, 2014
Health Authority: Turkey: Ministry of Health