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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934245
• Other study ID #: F090422004
• Secondary ID: U01/IP000117-02
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2009
• Last updated: February 21, 2013
• Start date: September 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review BoardIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4598
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• 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..

Locations

Country	Name	City	State
India	Comprehensive Rural Health Services Project (CRHSP)	Ballabgarh	Haryana

Sponsors (3)

Lead Sponsor	Collaborator
Wayne Sullender, M.D.	All India Institute of Medical Sciences, New Delhi, Centers for Disease Control and Prevention

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory-confirmed influenza infection in vaccinated child		1 year	No
Secondary	Laboratory-confirmed influenza infection in household member of a vaccinated child		1 year	No