Clinical trial NCT01680679: Influenza Immunization of Children in India
Official title: Influenza Immunization of 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 influenza vaccine effectiveness
Total influenza vaccine effectiveness
Indirect influenza vaccine effectiveness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: International Clinical Epidemiology Network (INCLEN) TRUST
name: University of Alabama at Birmingham
name: Centers for Disease Control and Prevention
First posted: 2012-09-07
Enrollment: 18163
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. It will also determine whether the best time to immunize in a country like India that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.

Detailed description: 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 contributed to by the lack of information from India about disease burden due to influenza and because influenza vaccines have not 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. The study described here is an extension of an earlier study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza in the fall. The current study will administer influenza vaccine in the spring prior to the summer monsoon rains that are associated with peaks of influenza activity in parts of India. Reduction of influenza infections among the influenza immunized children and their household members will be compared to the children and household members in the control vaccine group.

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 the vaccines.

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
state: Haryana
Study officials:
affiliation: University of Colorado, Denver
name: Wayne Sullender, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Shobha Broor, MD
role: PRINCIPAL_INVESTIGATOR
References: