Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)

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

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

Study Overview

• Status: Completed
• Conditions: Influenza; Acute Respiratory Infection
• Intervention / Treatment: Biological: Influenza vaccine; Biological: Control 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.

• Study Type: Interventional
• Enrollment (Actual): 1742
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05503900
    • Butantan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory confirmed influenza	RT-PCR confirmed influenza in respiratory secretions samples	June 01, 2009 to November 30, 2009

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Repiratory Infection (ARI)	Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participantes with any adverse event as a measure of safety and tolerability	Any solicited or unsolicited adverse event	30 days after vaccination

Collaborators and Investigators

• Sponsor: Butantan Institute
• Investigators: Principal Investigator: Expedito J Luna, MD, University of Sao Paulo

Publications and helpful links

Helpful Links

• http://www.butantan.gov.br/home/quem_somos.php#

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Influenza; Vaccines; Vaccination; Effectiveness; Schoolchildren; Intervention studies; Laboratory Confirmed Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Respiratory Tract Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BUTANTAN