Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)

Butantan Institute

Status and phase: Completed; Phase 4

Conditions: Acute Respiratory Infection; Influenza

Treatments: Biological: Control vaccine; Biological: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01693380

BUTANTAN

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,742 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,742 participants in 2 patient groups

Influenza vaccine

Experimental group

Description:

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.

Treatment:

Biological: Influenza vaccine

Control vaccine

Sham Comparator group

Description:

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.

Treatment:

Biological: Control vaccine