Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

Study Overview
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Brief Summary
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Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.

Detailed Description
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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.

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

Conditions
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Influenza, Acute Respiratory Infection

Intervention / Treatment
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* Biological: Influenza vaccine
* Biological: Control vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Influenza vaccine<br>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<br>* 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.<br>|
| Sham Comparator: Control vaccine<br>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<br>* 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.<br>* Other names: Varicella vaccine;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccination, Vaccines, Schoolchildren, Effectiveness, Intervention studies, Adolescents, Laboratory Confirmed Influenza