Direct and Indirect Protection by Influenza Vaccine Given to Children in India

Wayne Sullender, M.D.

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Inactivated polio vaccine (IPV); Biological: Inactivated Trivalent Influenza Vaccine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00934245

U01/IP000117-02

F090422004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,598 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,598 participants in 3 patient groups

Inactivated Polio Vaccine (IPV)

Active Comparator group

Description:

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

Treatment:

Biological: Inactivated polio vaccine (IPV)

Inactivated Trivalent Influenza Vaccine

Experimental group

Description:

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

Treatment:

Biological: Inactivated Trivalent Influenza Vaccine

Surveillance arm

No Intervention group

Description:

Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.