Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

Phase 4

Completed

• Conditions: Influenza; Acute Respiratory Infection
• Interventions: Biological: Control vaccine; Biological: Influenza vaccine

• Registration Number: NCT01693380
• Lead Sponsor: Butantan Institute

Brief Summary

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

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2009-06
• Study Completion: 2009-11
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1742

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control vaccine	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.
Influenza vaccine	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.

Primary Outcome Measures

Name	Time	Method
Laboratory confirmed influenza	June 01, 2009 to November 30, 2009	RT-PCR confirmed influenza in respiratory secretions samples

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Butantan Institute; 🇧🇷 Sao Paulo, Brazil