Tetanus Clinical Trial
Verified date | April 2012 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 792 |
Est. completion date | January 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Days to 74 Days |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine | 1 Month post-dose 3 | No | |
Secondary | To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine | 19 months post-dose 1 | Yes |
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