Influenza Immunization of Children in India

Influenza Clinical Trial

Official title:

Influenza Immunization of Children in India

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
• 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

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