None listed
Conditions
Interventions
Intervention1: DTP-HB-Hib Vaccine of Serum Institute of India administered by Disposable-Syringe Jet Injector: Three doses of 0.5 ml i.m. to be administered by Disposable-Syringe Jet Injector with int
Sponsors
Serum Institute of India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Normal healthy infants of age 6-8 weeks at the time of the first vaccination 2)Born after a normal gestation period (36-42 weeks). 3)Parents/legal guardians of subjects willing to give written informed consent and 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 during the present trial period 2)Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy. 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. 4)Infant with any chronic illness including hepatic, renal, respiratory, CVS, endocrine and neurological illness. 5)Infants who have receive blood or bloodâ??derived products in the past. 6)History of diphtheria, tetanus, pertussis, and hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically). 7)Previous history of vaccination against the diphtheria, tetanus, pertussis or Hib or hepatitis B. 8)Known history of a bleeding disorder contraindicating intramuscular vaccination 9)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode. 10)History of febrile illness at the time of inclusion is a temporary exclusion criterion. 11)Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives 12)Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and % sero-positivity and GMT for B. PertussisTimepoint: 28 days (4 weeks) after last dose of vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse eventsTimepoint: 84 days;Solicited adverse reactionsTimepoint: within 4 days following the administration of each vaccine dose;Unsolicited adverse eventTimepoint: 84 days | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd.
Outcome results
None listed