None listed
Conditions
Interventions
Intervention1: H. Influenzae Type B vaccine of SIIL (SII HibPro): 3 doses of 0.5 ml at 6, 10 and 14 weeks of age
Control Intervention1: Other formulation of H. Influenzae Type B vaccine of SIIL (SII H
Sponsors
Serum Institute of India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity- Long term seroprotectionTimepoint: On day 0 and 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Occurrence of any solicited adverse reaction, unsolicited adverse event or any serious adverse event. Immunogenicity: Short term SeroprotectionTimepoint: Safety assessment on day 0, 28, 56 and 84. Immunogenicity assessment on day 0 and 84. | — |
Countries
India
Contacts
Public ContactDr. Prasad Kulkarni
Serum Institute of India Ltd
Outcome results
None listed