Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
NCT ID: NCT00255021
Last Updated: 2012-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
186 participants
INTERVENTIONAL
2005-12-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM
Interventions
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Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
2 Months
2 Months
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Bangkok, , Thailand
Countries
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Related Links
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Related Info
Other Identifiers
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E2I34
Identifier Type: -
Identifier Source: org_study_id
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