A clinical trial to assess the immunogenicity and Safety of two different formulations of Haemophilus Influenzae Type-B Vaccine (SII HibPRO) of Serum Institute of India Limited in Indian Infants.
- Registration Number
- CTRI/2009/091/000616
- Lead Sponsor
- Serum Institute of India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 218
1) Normal healthy infants of age 6-8 weeks at the time of first vaccination 2) Parents of subject willing to give written informed consent 3) Free of obvious health problems as established by medical history and physical examination.
1) Infant subject participating in other clinical trial. 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy. 3) Infant with history of allergy or systemic hypersensitivity. 4) Infant with any chronic illness. 5)Infant who received blood or blood derived products in the past. 6) Known history of a bleeding disorder 7) Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or making it unlikely the subject could complete the protocol 8) History of febrile illness is a temporary exclusion criterion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method