Direct and Indirect Protection by Influenza Vaccine Given to Children in India
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Inactivated Trivalent Influenza Vaccine Biological: Inactivated polio vaccine (IPV) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Direct and Indirect Protection by Influenza Vaccine Given to Children in India |
- Laboratory-confirmed influenza infection in vaccinated child [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Laboratory-confirmed influenza infection in household member of a vaccinated child [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 4598 |
| Study Start Date: | September 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Inactivated Polio Vaccine (IPV)
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)
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..
Other Name: Imovax
|
|
Experimental: Inactivated Trivalent Influenza Vaccine
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
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.
Other Name: split virion trivalent influenza vaccine, Vaxigrip
|
|
No Intervention: Surveillance arm
Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members.
|
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| Genders Eligible for Study: | Both |
| Accepts 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:
- Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of a vaccine (streptomycin, neomycin, and polymyxin B)
Contacts and Locations| India | |
| Comprehensive Rural Health Services Project (CRHSP) | |
| Ballabgarh, Haryana, India | |
| Principal Investigator: | Wayne Sullender, MD | University of Alabama at Birmingham |
| Principal Investigator: | Shobha Broor, MD | All India Institute of Medical Sciences, New Delhi |
| Principal Investigator: | Anand Krishnan, MD | All India Institute of Medical Sciences, New Delhi |
More Information
Publications:
| Responsible Party: | Wayne Sullender, M.D., Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00934245 History of Changes |
| Other Study ID Numbers: | F090422004, U01/IP000117-02 |
| Study First Received: | July 6, 2009 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Institutional Review Board India: Institutional Review Board India: Drugs Controller General of India |
Keywords provided by University of Alabama at Birmingham:
|
Influenza India Children Trivalent Influenza Vaccine (TIV) |
Inactivated poliovirus vaccine (IPV) Direct vaccine effectiveness Indirect vaccine effectiveness |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013