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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Inactivated Trivalent Influenza Vaccine (TIV); Biological: Inactivated poliovirus vaccine (IPV), trivalent

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.

• Study Type: Interventional
• Enrollment (Actual): 18163
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Haryana
    • Ballabgarh, Haryana, India
      • Comprehensive Rural Health Services Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inactivated Trivalent Influenza Vaccine; Inactivated trivalent influenza vaccine (TIV), split virion	Biological: Inactivated Trivalent Influenza Vaccine (TIV)
Placebo Comparator: Inactivated Polio Vaccine; Inactivated poliovirus vaccine (IPV), trivalent	Biological: Inactivated poliovirus vaccine (IPV), trivalent
No Intervention: Surveillance arm; Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Laboratory-confirmed influenza infection in vaccinated child	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Laboratory-confirmed influenza infection in household member of a vaccinated child.	1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of Alabama at Birmingham; All India Institute of Medical Sciences, New Delhi; Centers for Disease Control and Prevention; International Clinical Epidemiology Network (INCLEN) TRUST
• Investigators: Principal Investigator: Wayne Sullender, MD, University of Colorado, Denver; Principal Investigator: Shobha Broor, MD, All India Institute of Medical Sciences, New Delhi

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 4, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Children; Influenza; India; Trivalent Influenza Vaccine (TIV); Inactivated poliovirus vaccine (IPV); Direct influenza vaccine effectiveness; Total influenza vaccine effectiveness; Indirect influenza vaccine effectiveness
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 13-0210; U01IP000475 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No