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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01693380
Other study ID # BUTANTAN
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2009
Est. completion date November 2009

Study information

Verified date April 2023
Source Butantan Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1742
Est. completion date November 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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.

Study Design


Intervention

Biological:
Influenza vaccine
Influenza vaccine: schoolchidren in the experimental group received IM administered: From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart. 9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
Control vaccine
Schoolchildren from 6 to 8 years of age: - One dose (0.5ml), IM administered, of Meningococcal C conjugate vaccine, and one dose (0.5ml), one month later, of varicella vaccine, IM administered.

Locations

Country Name City State
Brazil Butantan Institute Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participantes with any adverse event as a measure of safety and tolerability Any solicited or unsolicited adverse event 30 days after vaccination
Primary Laboratory confirmed influenza RT-PCR confirmed influenza in respiratory secretions samples June 01, 2009 to November 30, 2009
Secondary Acute Repiratory Infection (ARI) Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose 6 months
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