Influenza Immunization of Children in India
2 other identifiers
interventional
18,163
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 24, 2017
March 1, 2017
2 years
September 4, 2012
March 23, 2017
Conditions
Keywords
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 Trivalent Influenza Vaccine
EXPERIMENTALInactivated trivalent influenza vaccine (TIV), split virion
Inactivated Polio Vaccine
PLACEBO COMPARATORInactivated poliovirus vaccine (IPV), trivalent
Surveillance arm
NO INTERVENTIONThose ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.
Interventions
Eligibility Criteria
You may qualify if:
- All individuals in enrolled households will be eligible for enrollment into surveillance arm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- All India Institute of Medical Sciencescollaborator
- International Clinical Epidemiology Network (INCLEN) TRUSTcollaborator
- University of Alabama at Birminghamcollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (1)
Comprehensive Rural Health Services Project
Ballabgarh, Haryana, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne Sullender, MD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Shobha Broor, MD
All India Institute of Medical Sciences
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
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 24, 2017
Record last verified: 2017-03