Clinical trial NCT00934245: Direct and Indirect Protection by Influenza Vaccine Given to Children in India
Official title: Direct and Indirect Protection by Influenza Vaccine Given to Children in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
India
Children
Trivalent Influenza Vaccine (TIV)
Inactivated poliovirus vaccine (IPV)
Direct vaccine effectiveness
Indirect vaccine effectiveness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: Centers for Disease Control and Prevention
First posted: 2009-07-08
Enrollment: 4598
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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)

Primary outcomes:
measure: Laboratory-confirmed influenza infection in vaccinated child
timeFrame: 1 year
Secondary outcomes:
measure: Laboratory-confirmed influenza infection in household member of a vaccinated child
timeFrame: 1 year
Other outcomes:
Locations:
city: Ballabgarh
country: India
facility: Comprehensive Rural Health Services Project (CRHSP)
state: Haryana
Study officials:
affiliation: University of Alabama at Birmingham
name: Wayne Sullender, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Shobha Broor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Anand Krishnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.