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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Inactivated Trivalent Influenza Vaccine
* Biological: Inactivated polio vaccine (IPV)


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inactivated Polio Vaccine (IPV)<br>Inactivated trivalent poliovirus vaccine (IPV) age Dose # doses/year 1 # doses year 2 and 3 6 mo -8y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 | Biological: Inactivated polio vaccine (IPV)<br>* 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..<br>* Other names: Imovax;|
| Experimental: Inactivated Trivalent Influenza Vaccine<br>Inactivated split virion trivalent influenza vaccine (TIV) age Dose # doses year 1 # doses year 2 and 3 6-35 mo 0.25 ml 2 1 3-8 y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 | Biological: Inactivated Trivalent Influenza Vaccine<br>* 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.<br>* Other names: split virion trivalent influenza vaccine, Vaxigrip;|
| No Intervention: Surveillance arm<br>Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-confirmed influenza infection in vaccinated child |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-confirmed influenza infection in household member of a vaccinated child |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct vaccine effectiveness, Indirect vaccine effectiveness