Direct and Indirect Protection by Influenza Vaccine Given to Children in India

This study has been completed.
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Wayne Sullender, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00934245
First received: July 6, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. The comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (IPV). The study will also provide information on the amount of disease produced by influenza in the study population.


Condition Intervention Phase
Influenza
Biological: Inactivated Trivalent Influenza Vaccine
Biological: Inactivated polio vaccine (IPV)
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: Direct and Indirect Protection by Influenza Vaccine Given to Children in India

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

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 ]

Enrollment: 4598
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Inactivated Polio Vaccine (IPV)
Inactivated trivalent poliovirus vaccine (IPV) age Dose # doses/year 1 # doses year 2 and 3 6 mo -8y 0.5 ml 2 1 9-10 y 0.5 ml 1 1
Biological: Inactivated polio vaccine (IPV)
Vaccine administration will occur twice, one month apart, in the first year of participation in the study to parallel administration of TIV (experimental intervention). Subsequent years will provide one immunization except 2011 schedule modified to accommodate changes in TIV schedule as per above..
Other Name: Imovax
Experimental: Inactivated Trivalent Influenza Vaccine
Inactivated split virion trivalent influenza vaccine (TIV) age Dose # doses year 1 # doses year 2 and 3 6-35 mo 0.25 ml 2 1 3-8 y 0.5 ml 2 1 9-10 y 0.5 ml 1 1
Biological: Inactivated Trivalent Influenza Vaccine
Vaccine administration will occur twice, one month apart, in the first year of participation in the study. This will occur as TIV vaccine becomes available in India, in the early autumn. Subsequent years will provide one immunization. Due to the inclusion of the pandemic 2009 influenza A H1N1 virus in the 2010-2011 northern hemisphere vaccine formulation and recommendations that children should receive 2 doses of this vaccine this study will administer 2 doses of vaccine in the second year of the study.
Other Name: split virion trivalent influenza vaccine, Vaxigrip
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:

Influenza is an important cause of illness among children and adults in the United States. Influenza is likely also an important cause of illness in India, but published data on influenza infections in India are limited, especially for children. 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 due to the lack of information from India about disease burden due to influenza and because the influenza vaccines have never 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.

  Eligibility

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 a vaccine (streptomycin, neomycin, and polymyxin B)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934245

Locations
India
Comprehensive Rural Health Services Project (CRHSP)
Ballabgarh, Haryana, India
Sponsors and Collaborators
Wayne Sullender, M.D.
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Wayne Sullender, MD University of Alabama at Birmingham
Principal Investigator: Shobha Broor, MD All India Institute of Medical Sciences, New Delhi
Principal Investigator: Anand Krishnan, MD All India Institute of Medical Sciences, New Delhi
  More Information

Publications:
Responsible Party: Wayne Sullender, M.D., Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00934245     History of Changes
Other Study ID Numbers: F090422004, U01/IP000117-02
Study First Received: July 6, 2009
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board
India: Institutional Review Board
India: Drugs Controller General of India

Keywords provided by University of Alabama at Birmingham:
Influenza
India
Children
Trivalent Influenza Vaccine (TIV)
Inactivated poliovirus vaccine (IPV)
Direct vaccine effectiveness
Indirect 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 October 19, 2014