Influenza
Conditions
Keywords
Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct vaccine effectiveness, Indirect vaccine effectiveness
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.
Interventions
BIOLOGICALInactivated 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.
BIOLOGICALInactivated 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..
Sponsors
All India Institute of Medical Sciences
Centers for Disease Control and Prevention
Wayne Sullender, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed influenza infection in vaccinated child | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed influenza infection in household member of a vaccinated child | 1 year |
Countries
India
Outcome results
None listed