Influenza Immunization of Children in India

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Inactivated poliovirus vaccine (IPV), trivalent; Biological: Inactivated Trivalent Influenza Vaccine (TIV)

Study type: Interventional

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

Identifiers

NCT01680679

13-0210

U01IP000475 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. It will also determine whether the best time to immunize in a country like India that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.

Full description

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 contributed to by the lack of information from India about disease burden due to influenza and because influenza vaccines have not 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. The study described here is an extension of an earlier study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza in the fall. The current study will administer influenza vaccine in the spring prior to the summer monsoon rains that are associated with peaks of influenza activity in parts of India. Reduction of influenza infections among the influenza immunized children and their household members will be compared to the children and household members in the control vaccine group.

Enrollment: 18,163 patients

Sex: All

Ages: 6 months to 10 years old

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 the vaccines.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18,163 participants in 3 patient groups, including a placebo group

Inactivated Trivalent Influenza Vaccine

Experimental group

Description:

Inactivated trivalent influenza vaccine (TIV), split virion

Treatment:

Biological: Inactivated Trivalent Influenza Vaccine (TIV)

Inactivated Polio Vaccine

Placebo Comparator group

Description:

Inactivated poliovirus vaccine (IPV), trivalent

Treatment:

Biological: Inactivated poliovirus vaccine (IPV), trivalent

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.