Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00453570
First received: March 28, 2007
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.


Condition Intervention Phase
Diphtheria
Tetanus
Haemophilus Influenzae Type b
Pertussis
Poliomyelitis
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
Phase 3

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:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 19 months post-dose 1 ] [ Designated as safety issue: Yes ]

Enrollment: 792
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
Other Name: PENTAXIM™
Experimental: 2
DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
Other Name: PENTAXIM™
Active Comparator: 3
Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age
Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
0.5 mL, IM
Other Name: DTacP, Act-HIB™ and IMOVAX Polio™

  Eligibility

Ages Eligible for Study:   60 Days to 74 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 2 months (60 to 74 days) inclusive on the day of inclusion
  • Born at full term pregnancy (³36 weeks) with a birth weight ≥ 2.5 kg
  • Informed consent form signed by the parent(s) or other legal representative
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the trial inclusion
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Blood or blood-derived products received in the past
  • Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
  • Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
  • Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
  • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures
  • Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453570

Locations
China, Guangxi
Nanning, Guangxi, China, 530022
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00453570     History of Changes
Other Study ID Numbers: E2I42
Study First Received: March 28, 2007
Last Updated: April 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Diphteria
Tetanus
Haemophilus influenzae type b
Poliomyelitis
Pertussis

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Tetany
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
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on April 16, 2014