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Completed

NCT Number: NCT01693380

Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

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

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Butantan Institute

São Paulo, 05503900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

influenza vaccine

Biological

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

Biological

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.

Other names: Meningococcal C conjugate vaccine, Varicella vaccine

Primary outcomes

  1. Laboratory confirmed influenza

    Time frame: June 01, 2009 to November 30, 2009

    RT-PCR confirmed influenza in respiratory secretions samples

Secondary outcomes

  1. Acute Repiratory Infection (ARI)

    Time frame: 6 months

    Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose

Other outcomes

  1. Number of participantes with any adverse event as a measure of safety and tolerability

    Time frame: 30 days after vaccination

    Any solicited or unsolicited adverse event

Sponsors and collaborators

Lead sponsor

Butantan Institute

Other Gov

Registry information

Official study title

Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009

Acronym: Xo_Gripe

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2012
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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