Influenza Clinical Trial
Official title:
Direct and Indirect Protection by Influenza Vaccine Given to Children in India
The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. The comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (IPV). The study will also provide information on the amount of disease produced by influenza in the study population.
Status | Completed |
Enrollment | 4598 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years of age. - All individuals in enrolled households will be eligible for enrollment into surveillance arm. Exclusion Criteria: - Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of a vaccine (streptomycin, neomycin, and polymyxin B) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
India | Comprehensive Rural Health Services Project (CRHSP) | Ballabgarh | Haryana |
Lead Sponsor | Collaborator |
---|---|
Wayne Sullender, M.D. | All India Institute of Medical Sciences, New Delhi, Centers for Disease Control and Prevention |
India,
Mir MA, Lal RB, Sullender W, Singh Y, Garten R, Krishnan A, Broor S. Genetic diversity of HA1 domain of hemagglutinin gene of pandemic influenza H1N1pdm09 viruses in New Delhi, India. J Med Virol. 2012 Mar;84(3):386-93. doi: 10.1002/jmv.23205. — View Citation
Sullender W, Fowler K, Krishnan A, Gupta V, Moulton LH, Lafond K, Widdowson MA, Lal RB, Broor S. Design and initiation of a study to assess the direct and indirect effects of influenza vaccine given to children in rural India. Vaccine. 2012 Jul 27;30(35):5235-9. doi: 10.1016/j.vaccine.2012.06.002. Epub 2012 Jun 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laboratory-confirmed influenza infection in vaccinated child | 1 year | No | |
Secondary | Laboratory-confirmed influenza infection in household member of a vaccinated child | 1 year | No |
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