This trial is active, not recruiting.

Condition influenza
Treatments inactivated trivalent influenza vaccine (tiv), inactivated poliovirus vaccine (ipv), trivalent
Phase phase 4
Sponsor University of Colorado, Denver
Collaborator All India Institute of Medical Sciences, New Delhi
Start date May 2012
End date March 2016
Trial size 3600 participants
Trial identifier NCT01680679, 13-0210, U01IP000475


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Inactivated trivalent influenza vaccine (TIV), split virion
inactivated trivalent influenza vaccine (tiv)
(Placebo Comparator)
Inactivated poliovirus vaccine (IPV), trivalent
inactivated poliovirus vaccine (ipv), trivalent
(No Intervention)
Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.

Primary Outcomes

Laboratory-confirmed influenza infection in vaccinated child
time frame: 1 year

Secondary Outcomes

Laboratory-confirmed influenza infection in household member of a vaccinated child.
time frame: 1 year

Eligibility Criteria

Male or female participants from 6 months up to 10 years old.

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.

Additional Information

Official title Influenza Immunization of Children in India
Principal investigator Wayne Sullender, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.