Direct and Indirect Protection by Influenza Vaccine Given to Children in India
- Conditions
- Influenza
- Interventions
- Biological: Inactivated polio vaccine (IPV)Biological: Inactivated Trivalent Influenza Vaccine
- Registration Number
- NCT00934245
- Lead Sponsor
- Wayne Sullender, M.D.
- Brief Summary
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.
- Detailed Description
Influenza is an important cause of illness among children and adults in the United States. Influenza is likely also an important cause of illness in India, but published data on influenza infections in India are limited, especially for children. Although influenza vaccines are used routinely in the United States, including in young children, influenza vaccines have not seen widespread use in India. This is likely due to the lack of information from India about disease burden due to influenza and because the influenza vaccines have never been tested for efficacy in India. In addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4598
- 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 from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of a vaccine (streptomycin, neomycin, and polymyxin B)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inactivated Polio Vaccine (IPV) Inactivated polio vaccine (IPV) Inactivated trivalent poliovirus vaccine (IPV) age Dose # doses/year 1 # doses year 2 and 3 6 mo -8y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 Inactivated Trivalent Influenza Vaccine Inactivated Trivalent Influenza Vaccine Inactivated split virion trivalent influenza vaccine (TIV) age Dose # doses year 1 # doses year 2 and 3 6-35 mo 0.25 ml 2 1 3-8 y 0.5 ml 2 1 9-10 y 0.5 ml 1 1
- Primary Outcome Measures
Name Time Method Laboratory-confirmed influenza infection in vaccinated child 1 year
- Secondary Outcome Measures
Name Time Method Laboratory-confirmed influenza infection in household member of a vaccinated child 1 year
Trial Locations
- Locations (1)
Comprehensive Rural Health Services Project (CRHSP)
🇮🇳Ballabgarh, Haryana, India