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OpenTrials
Completed

NCT Number: NCT01680679

Influenza Immunization of Children in India

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.

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Key information

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Comprehensive Rural Health Services Project

Ballabgarh, Haryana, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inactivated Trivalent Influenza Vaccine (TIV)

Biological

Inactivated poliovirus vaccine (IPV), trivalent

Biological

Primary outcomes

  1. Laboratory-confirmed influenza infection in vaccinated child

    Time frame: 1 year

Secondary outcomes

  1. Laboratory-confirmed influenza infection in household member of a vaccinated child.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • All India Institute of Medical Sciences
  • Centers for Disease Control and Prevention
  • International Clinical Epidemiology Network (INCLEN) TRUST
  • University of Alabama at Birmingham

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 7, 2012
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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