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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

Page last updated: August 20, 2015

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