ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00934245
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : February 22, 2013
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Wayne Sullender, M.D., University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Inactivated Trivalent Influenza Vaccine Biological: Inactivated polio vaccine (IPV) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Direct and Indirect Protection by Influenza Vaccine Given to Children in India
Study Start Date : September 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Laboratory-confirmed influenza infection in vaccinated child [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Laboratory-confirmed influenza infection in household member of a vaccinated child [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Centers for Disease Control and Prevention
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

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
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by Wayne Sullender, M.D., 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
Vaccines
Immunologic Factors
Physiological Effects of Drugs