None listed
Conditions
Interventions
Intervention1: DTaP-Hib combination vaccine: 0.5 mL/vial, 0.5 ml dose containing acellular pertussis vaccine titre â?¥ 4.0 IU
diphtheria vaccine titre â?¥ 30 IU
tetanus vaccine titre â?¥ 40 IU.
Hib conjugate vaccine: 0.5 mL/vial, 0.5 mL dose containing H influenza type b capsular polysaccharide � 10 µg.
Control Intervention1: PENTAXIM®: 0.5mL/vial, 0.5
Inactivated poliomyelitis virus (Type 1, 2 and 3 - 40D, 8D and 32D antigen units respectively) Conjugated Polysaccharide of Haemophilus influenzae type b - 10 µg
Sponsors
Wockhardt Limited
Medclin Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Full term (>=37 weeks) Indian children of either gender who have attained age >= 6 weeks 2. Subjects who are healthy as established by medical history & clinical examination and are eligible to receive primary immunization as per Universal Immunization Programme (UIP). 3. Parent or LAR of subject willing to give written informed consent and to comply to all study related procedures
Exclusion criteria
Exclusion criteria: 1. Pre-term or Low birth weight children ( 2. History of hypersensitivity to any of vaccines or vaccine components 3. History of any seizure / neurological or neuro-psychological disorder 4. Presence of congenital disorder /congenital infections or primary/acquired immuno-deficiency syndrome 5. Children with family history of congenital or hereditary immunodeficiency 6. History of exposure to immunosuppressive therapy after birth 7. History of HIV or HBV infection in the mother 8. Children who received blood or blood-derived products before enrolment 9. History of diphtheria, tetanus, pertussis, or Hemophilus influenza disease before enrolment or history of vaccination against diphtheria, tetanus, pertussis, or Hemophilus influenza 10. Planned administration of any other vaccine not foreseen by the study protocol within the period 30 days before inclusion or 30 days after the last dose of the vaccine except Rotavirus Vaccine, hepatitis B vaccine, Pneumococcal Conjugate Vaccine, Polio vaccine and any other vaccine given as a part of the national immunization schedule, allowed at that time of the study period. 11. Evidence of any chronic illness that could interfere with vaccine administration or evaluation 12. Planned or elective surgery during the study period. 13. Children suffering from acute febrile ( > 38°C) illness / or acute non-febrile systemic illness in the past one week. 14. Children with thrombocytopenia/ bleeding disorder / any medical condition contraindicating intramuscular injections 15. Children diagnosed of blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems 16. Concurrent participation in any other trial at any time during the study period 17. Any other condition, which in the opinion of the investigator might interfere with the trial conduct and completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Seroconversion rate to each component 2) Change in Geometric mean titers (GMT) of antibody to each component Timepoint: 4 weeks after 3rd dose of vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events / serious adverse events post vaccinationTimepoint: within 30 mins and 4 weeks post vaccination | — |
Countries
India
Contacts
Public ContactMr Ashish Mane
Wockhardt Limited
Outcome results
None listed