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

NCT00934245 | Completed Phase 4 DMC

• 2 other identifiers: F090422004U01/IP000117-02
• Study Type: interventional
• Target: 4,598
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

Influenza; India; Children; Trivalent Influenza Vaccine (TIV); Inactivated poliovirus vaccine (IPV); Direct vaccine effectiveness; Indirect vaccine effectiveness

Outcome Measures

Primary Outcomes (1)

• Laboratory-confirmed influenza infection in vaccinated child

  1 year

Secondary Outcomes (1)

• Laboratory-confirmed influenza infection in household member of a vaccinated child

  1 year

Study Arms (3)

Inactivated Polio Vaccine (IPV)

ACTIVE COMPARATOR

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)

Inactivated Trivalent Influenza Vaccine

EXPERIMENTAL

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

Surveillance arm

NO INTERVENTION

Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.

Interventions

Inactivated Trivalent Influenza Vaccine BIOLOGICAL

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.

Also known as: split virion trivalent influenza vaccine, Vaxigrip

Inactivated Trivalent Influenza Vaccine

Inactivated polio vaccine (IPV) BIOLOGICAL

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..

Also known as: Imovax

Inactivated Polio Vaccine (IPV)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals in enrolled households will be eligible for enrollment into surveillance arm.

Sponsors & Collaborators

• Wayne Sullender, M.D.: lead
• All India Institute of Medical Sciences: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Comprehensive Rural Health Services Project (CRHSP)

Ballabgarh, Haryana, India

Location

Related Publications (3)

• 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.

  PMID: 22709952 BACKGROUND

• 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.

  PMID: 22246823 BACKGROUND

• Sullender WM, Fowler KB, Gupta V, Krishnan A, Ram Purakayastha D, Srungaram Vln R, Lafond KE, Saha S, Palomeque FS, Gargiullo P, Jain S, Lal R, Widdowson MA, Broor S. Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial. Lancet Glob Health. 2019 Jul;7(7):e940-e950. doi: 10.1016/S2214-109X(19)30079-8.

  PMID: 31200893 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip; Poliovirus Vaccine, Inactivated; Rabies Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Wayne Sullender, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Shobha Broor, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Anand Krishnan, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

IN (1)