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Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
This study is ongoing, but not recruiting participants.
First Received: November 15, 2005   Last Updated: April 4, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00255021
  Purpose

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.


Condition Intervention Phase
Diphtheria
Tetanus
Poliomyelitis
Haemophilus Infections
Pertussis
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
Phase IV

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 186
Study Start Date: December 2005
Estimated Study Completion Date: June 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM

  Eligibility

Ages Eligible for Study:   2 Months to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 53 to 70 days inclusive on the day of inclusion

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid 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.
  • Mother known as seropositive to HIV or hepatitis B
  • Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])
  • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
  • 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 (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255021

Locations
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur, Inc ( Medical Director )
Study ID Numbers: E2I34
Study First Received: November 15, 2005
Last Updated: April 4, 2008
ClinicalTrials.gov Identifier: NCT00255021     History of Changes
Health Authority: Thailand: Food and Drug Administration

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

Study placed in the following topic categories:
Haemophilus Infections
Bacterial Infections
Spinal Cord Diseases
Haemophilus Influenzae
Central Nervous System Diseases
Picornaviridae Infections
Whooping Cough
Cough
Diphtheria
Tetanus
Gram-Negative Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Central Nervous System Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections
Degenerative Motor System Disease
Motor Neuron Disease

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

ClinicalTrials.gov processed this record on September 02, 2009