None listed
Conditions
Interventions
Intervention1: HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine: Three doses of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufactured by Human Biologicals Institute wil
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy infants (as determined by medical history, physical examination and clinical judgement of the investigator) of either gender of 6-8 weeks of age at the time of first dose of vaccination. 2. Born after a normal gestational period (36 â?? 42 weeks) with a birth weight >= 2.5 kg. 3. Plans to remain in the study area for the duration of the trial. 4. Written informed consent for participation obtained prior to screening from subjectâ??s parent/legally acceptable representative. 5. Ability of the subjectâ??s parent/ legally acceptable representative to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial in the 4 weeks preceding the trial vaccination. 2. Planned participation in another clinical trial during the present trial period. 3. History of immunization with any vaccine other than birth dose Polio, BCG and birth dose of Hepatitis B vaccines. 4. Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination except OPV. 5. Evidence of previous infection with Diphtheria, Tetanus, Pertussis, Hepatitis B and H. influenzae. 6. History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics. 7. Known personal or maternal history of HIV or hepatitis B seropositivity. 8. Infants having any intercurrent illness. 9. History of fever with temperature > 380C ( >100.40F) in last 3 days. 10. Known or suspected primary or acquired disease of the immune system. 11. Known or suspected malignancy, receipt of allergy immunotherapy, or immunosuppressive therapy. 12. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction. 13. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms. 14. Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial period. 15. Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs. 16. Any history or evidence of thrombocytopenia or a bleeding disorder or receipt of anticoagulants. 17. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of subjects achieving seroconversion and seroprotection against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type B four to six weeks after three doses of primary immunization with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine.Timepoint: Till 4 to 6 weeks post 3rd dose of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Till 4 to 6 weeks post 3rd dose of vaccination.Timepoint: Till 4 to 6 weeks post 3rd dose of vaccination | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Human Biologicals Institute
Outcome results
None listed