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Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254917
First Posted: November 17, 2005
Last Update Posted: April 16, 2012
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.
Information provided by (Responsible Party):
Sanofi
  Purpose

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.


Condition Intervention Phase
Diphtheria Tetanus Polio Pertussis Haemophilus Influenzae Type B Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the safety of PENTAXIM™ Vaccine. [ Time Frame: 20 months ]

Enrollment: 387
Study Start Date: October 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Concommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age
Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™
Experimental: 2
Concommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age.
Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
0.5 mL, IM
Other Name: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 19 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254917


Locations
Philippines
Manila, Philippines
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
  More Information

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00254917     History of Changes
Other Study ID Numbers: E2I29
First Submitted: November 15, 2005
First Posted: November 17, 2005
Last Update Posted: April 16, 2012
Last Verified: April 2012

Keywords provided by Sanofi:
Pentaxim

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs