Skip to main content
OpenTrials
Completed

NCT Number: NCT00934245

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Comprehensive Rural Health Services Project (CRHSP)

Ballabgarh, Haryana, India

About this study

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.

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 a vaccine (streptomycin, neomycin, and polymyxin B)

Treatment and study plan

Inactivated trivalent influenza vaccine

Biological

Vaccine administration will occur twice, one month apart, in the first year of participation in the study. This will occur as TIV vaccine becomes available in India, in the early autumn. Subsequent years will provide one immunization. Due to the inclusion of the pandemic 2009 influenza A H1N1 virus in the 2010-2011 northern hemisphere vaccine formulation and recommendations that children should receive 2 doses of this vaccine this study will administer 2 doses of vaccine in the second year of the study.

Other names: split virion trivalent influenza vaccine, Vaxigrip

Inactivated Polio Vaccine (IPV)

Biological

Vaccine administration will occur twice, one month apart, in the first year of participation in the study to parallel administration of TIV (experimental intervention). Subsequent years will provide one immunization except 2011 schedule modified to accommodate changes in TIV schedule as per above..

Other names: Imovax

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

Wayne Sullender, M.D.

Other

Collaborators

  • All India Institute of Medical Sciences
  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2009
Registry last updated
Feb 22, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.