Tetanus Clinical Trial
Official title:
Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China
Verified date | December 2011 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined
vaccine in support of registration of this product in China
Primary Objectives:
- To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4
and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria,
Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine
given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP)
antigens, one month after the three-dose primary vaccination.
- To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine
administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis
Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with
Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose
primary vaccination.
Secondary Objectives:
- To describe the safety after administration of the study vaccines.
- To describe in each group the immunogenicity of the study vaccines one month after the
primary vaccination and before and one month after the booster vaccination.
Status | Completed |
Enrollment | 1056 |
Est. completion date | December 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Days to 89 Days |
Eligibility |
Inclusion Criteria : - Aged 2 months on the day of inclusion - Born at full term pregnancy (= 36 weeks) with a birth weight = 2.5 kg - Informed consent form signed by the parent(s) or legal representative - Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria : - Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination - Planned participation in another clinical trial during the present trial period - Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy - Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances - Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator - Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response - Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination) - History of seizures - Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity - History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically) - Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine - Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial - Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination - History of contraindication to vaccination with pertussis-containing vaccine - Febrile illness (axillary temperature =37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment Temporary contraindications that must be resolved before vaccination: - Acute febrile illness within the 72 hours preceding the vaccination, or temperature =37.1°C present at this visit - Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination) - Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months |
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 | Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. | One month post-vaccination | No | |
Secondary | Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine. | 0-7 days post-vaccination and entire study duration | Yes |
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