Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza
Information source: Butantan Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza; Acute Respiratory Infection
Intervention: Influenza vaccine (Biological); Control vaccine (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Butantan Institute Official(s) and/or principal investigator(s): Expedito J Luna, MD, Principal Investigator, Affiliation: University of Sao Paulo
Summary
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated
household members.
Clinical Details
Official title: Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Laboratory confirmed influenza
Secondary outcome: Acute Repiratory Infection (ARI)
Detailed description:
Children and adolescents play an important role in sustaining the transmission of influenza.
Moreover, with the occurrence of influenza in children, there are important socioeconomic
consequences to families affected by the disease, related to absenteeism, expenditure on
health services and medication use. This study presents an evaluation of direct and indirect
effectiveness of influenza vaccination in school age children and their unvaccinated
household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized
double-blind community trial, with six months of follow up. For the evaluation of vaccine
effectiveness, the influenza vaccine was used for the experimental group, and meningitis
conjugate and varicella vaccines for the control group. After vaccination, the volunteers
and their families were followed for six months, in order to identify cases of acute
respiratory infection (ARI) and to collect biological samples for testing with RT-PCR for
diagnosis of influenza.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- older than six years of age;
- live in the study area;
- parent consent to participate, by signing the Informed Consent Form;
- no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;
- no history no history anaphilaxis or hipersensitivity to any substances;
- no acute disease at the moment of vaccination
- no use of immunesupressant drugs;
- not have received any other vaccine in the previous six months;
- no participation in other clinical trial in the previous six months.
Exclusion Criteria:
- Any condition above mentioned.
Locations and Contacts
Butantan Institute, Sao Paulo 05503900, Brazil
Additional Information
http://www.butantan.gov.br/home/quem_somos.php#
Starting date: May 2009
Last updated: September 24, 2012
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