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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01680679
Other study ID # 13-0210
Secondary ID U01IP000475
Status Completed
Phase Phase 4
First received September 4, 2012
Last updated March 23, 2017
Start date May 2012
Est. completion date May 2014

Study information

Verified date March 2017
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18163
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 10 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Inactivated Trivalent Influenza Vaccine (TIV)

Inactivated poliovirus vaccine (IPV), trivalent


Locations

Country Name City State
India Comprehensive Rural Health Services Project Ballabgarh Haryana

Sponsors (5)

Lead Sponsor Collaborator
University of Colorado, Denver All India Institute of Medical Sciences, New Delhi, Centers for Disease Control and Prevention, International Clinical Epidemiology Network (INCLEN) TRUST, University of Alabama at Birmingham

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Laboratory-confirmed influenza infection in vaccinated child 1 year
Secondary Laboratory-confirmed influenza infection in household member of a vaccinated child. 1 year
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