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Influenza Immunization of Children in India

Influenza Immunization of Children in India

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01680679
Enrollment
18163
Registered
2012-09-07
Start date
2012-05-31
Completion date
2014-05-31
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct influenza vaccine effectiveness, Total influenza vaccine effectiveness, Indirect influenza vaccine effectiveness

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALInactivated Trivalent Influenza Vaccine (TIV)
BIOLOGICALInactivated poliovirus vaccine (IPV), trivalent

Sponsors

All India Institute of Medical Sciences
CollaboratorOTHER
International Clinical Epidemiology Network (INCLEN) TRUST
CollaboratorNETWORK
University of Alabama at Birmingham
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Laboratory-confirmed influenza infection in vaccinated child1 year

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026