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

Brief Summary

Official Title: “Direct and Indirect Protection by Influenza Vaccine Given to Children in India”

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.

  • 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
  • Study Primary Completion Date: July 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.
  • 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..

Arms, Groups and Cohorts in this Clinical Trial

  • 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
  • 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
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Laboratory-confirmed influenza infection in vaccinated child
    • Time Frame: 1 year
      Safety Issue?: No

Secondary Measures

  • Laboratory-confirmed influenza infection in household member of a vaccinated child
    • Time Frame: 1 year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Wayne Sullender, M.D.
  • Collaborator
    • All India Institute of Medical Sciences, New Delhi
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Wayne Sullender, M.D., Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Wayne Sullender, MD, Principal Investigator, University of Alabama at Birmingham
    • Shobha Broor, MD, Principal Investigator, All India Institute of Medical Sciences, New Delhi
    • Anand Krishnan, MD, Principal Investigator, All India Institute of Medical Sciences, New Delhi

References

Sullender W, Fowler K, Krishnan A, Gupta V, Moulton LH, Lafond K, Widdowson MA, Lal RB, Broor S. Design and initiation of a study to assess the direct and indirect effects of influenza vaccine given to children in rural India. Vaccine. 2012 Jul 27;30(35):5235-9. doi: 10.1016/j.vaccine.2012.06.002. Epub 2012 Jun 16.

Mir MA, Lal RB, Sullender W, Singh Y, Garten R, Krishnan A, Broor S. Genetic diversity of HA1 domain of hemagglutinin gene of pandemic influenza H1N1pdm09 viruses in New Delhi, India. J Med Virol. 2012 Mar;84(3):386-93. doi: 10.1002/jmv.23205.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00934245