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Influenza Immunization of Children in India

This study is currently recruiting participants.
Verified October 2012 by University of Colorado, Denver
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
International Clinical Epidemiology Network (INCLEN) TRUST
University of Alabama at Birmingham
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01680679
First received: September 4, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Biological: Inactivated Trivalent Influenza Vaccine (TIV)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influenza Immunization of Children in India

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Laboratory-confirmed influenza infection in vaccinated child [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory-confirmed influenza infection in household member of a vaccinated child. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3600
Study Start Date: May 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680679

Contacts
Contact: Wayne Sullender, MD 303-724-5694 wayne.sullender@ucdenver.edu
Contact: Shobha Broor, MD 91-11-26594926 shobha.broor@gmail.com

Locations
India
Comprehensive Rural Health Services Project Recruiting
Ballabgarh, Haryana, India
Principal Investigator: Shashi Kant, MD            
Sponsors and Collaborators
University of Colorado, Denver
All India Institute of Medical Sciences, New Delhi
International Clinical Epidemiology Network (INCLEN) TRUST
University of Alabama at Birmingham
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Wayne Sullender, MD University of Colorado, Denver
Principal Investigator: Shobha Broor, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01680679     History of Changes
Other Study ID Numbers: 12-0804, U01IP000475
Study First Received: September 4, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board
India: Institutional Review Board
India: Indian Council of Medical Research

Keywords provided by University of Colorado, Denver:
Influenza
India
Children
Trivalent Influenza Vaccine (TIV)
 Inactivated poliovirus vaccine (IPV)
Direct influenza vaccine effectiveness
Total influenza vaccine effectiveness
Indirect influenza vaccine effectiveness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013