Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

Influenza Clinical Trial

— Xo_Gripe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693380
• Other study ID #: BUTANTAN
• Status: Completed
• Phase: Phase 4
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: April 2023
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1742
• Est. completion date: November 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Butantan Institute	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participantes with any adverse event as a measure of safety and tolerability	Any solicited or unsolicited adverse event	30 days after vaccination
Primary	Laboratory confirmed influenza	RT-PCR confirmed influenza in respiratory secretions samples	June 01, 2009 to November 30, 2009
Secondary	Acute Repiratory Infection (ARI)	Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose	6 months