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Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)

This study has been completed.
Information provided by (Responsible Party):
Butantan Institute Identifier:
First received: September 10, 2012
Last updated: September 24, 2012
Last verified: September 2012
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.

Condition Intervention Phase
Acute Respiratory Infection
Biological: Influenza vaccine
Biological: Control vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009

Resource links provided by NLM:

Further study details as provided by Butantan Institute:

Primary Outcome Measures:
  • Laboratory confirmed influenza [ Time Frame: June 01, 2009 to November 30, 2009 ]
    RT-PCR confirmed influenza in respiratory secretions samples

Secondary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 1742
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine

Schoolchildren from 6 to 8 years received two intra-muscular doses of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009.

Schoolchildren above 8 years received one intra-muscular dose of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009.

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.
Sham Comparator: Control vaccine

Schoolchildren received one intra-muscular dose of 0.5 ml of Meningococcal C conjugate vaccine.

Schoolchildren under nine years of age received also one intra-muscular dose of 0.5 ml of varicella vaccine one month after the Meningococcal C vaccine.

Biological: 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.

Other Names:
  • Meningococcal C conjugate vaccine
  • Varicella vaccine

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.

Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01693380

Butantan Institute
Sao Paulo, Brazil, 05503900
Sponsors and Collaborators
Butantan Institute
Principal Investigator: Expedito J Luna, MD University of Sao Paulo
  More Information

Additional Information:
Responsible Party: Butantan Institute Identifier: NCT01693380     History of Changes
Other Study ID Numbers: BUTANTAN
Study First Received: September 10, 2012
Last Updated: September 24, 2012

Keywords provided by Butantan Institute:
Intervention studies
Laboratory Confirmed Influenza

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017