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Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

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: NCT00254917
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 15, 2005
First Posted Date  ICMJE November 17, 2005
Last Update Posted Date April 16, 2012
Study Start Date  ICMJE October 2003
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2008)
To provide information concerning the safety of PENTAXIM™ Vaccine. [ Time Frame: 20 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
Official Title  ICMJE Not Provided
Brief Summary

The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.

WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.

To assess the safety of Pentaxim.

Detailed Description

Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:

Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.

Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.

All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Polio
  • Pertussis
  • Haemophilus Influenzae Type B
Intervention  ICMJE Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™
Study Arms  ICMJE
  • Experimental: 1
    Concommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age
    Intervention: Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
  • Experimental: 2
    Concommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age.
    Intervention: Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2008)
387
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
  • Healthy male or female newborn
  • Age ranging from birth to 48 hours of life (included)
  • Birth weight >2.5 kg and gestational age >37 weeks
  • Born to HBs antigen-negative mother

Exclusion Criteria:

  • Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
  • Infant presently enrolled or scheduled to be enrolled in another clinical trial
  • Infant with moderate or severe illness, mainly infectious diseases
  • Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
  • Infant with severe congenital defects or abnormalities
  • Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
  • Known immunological deficiency (including a known HIV seropositive mother)
  • Administration of vaccine since birth (other than BCG)
  • Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 19 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254917
Other Study ID Numbers  ICMJE E2I29
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP