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Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00254917
First received: November 15, 2005
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

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

Ages Eligible for Study:   6 Weeks to 19 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254917

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00254917     History of Changes
Other Study ID Numbers: E2I29
Study First Received: November 15, 2005
Last Updated: April 13, 2012
Health Authority: Philippines: Department of Health

Keywords provided by Sanofi:
Pentaxim

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on May 21, 2013