None listed
Conditions
Interventions
Intervention1: Pentavac (DTPw-HB+Hib) vaccine of SIIL: 3 doses of 0.5 ml at 6, 10 and 14 weeks of age
Control Intervention1: Tritanrix-HB-Hib of GSK: 3 doses of 0.5 ml at 6, 10 and 14 weeks of age
Sponsors
Serum Institute of India Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1)Normal healthy infants of age 6-8 weeks at the time of the first vaccination2) Parents/Legal Guardian of subject willing to give written informed consent 3)Parents/Legal Guardian willing to comply with study protocol.4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.5)The participant should be the resident of study area.
Exclusion criteria
Exclusion criteria: 1)Infant subject participating in other clinical trial or planned participation in another clinical trial 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component 4)Infant with chronic illness. 5)Infant who receive blood or blood?derived products in the past. 6)Known history of a bleeding disorder. 7)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of solicited adverse reaction within 3 days of each vaccine dose.Timepoint: within 3 days of each vaccine dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Occurrence of unsolicited adverse eventsTimepoint: within 28 days following the administration of each vaccine dose. | — |
Countries
India
Contacts
Public ContactDR. PRASAD KULKARNI
Serum Institute of India Research Foundation
Outcome results
None listed