Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

NCT01693380 | Completed Phase 4 DMC

• 1 other identifier: BUTANTAN
• Study Type: interventional
• Target: 1,742
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza; Acute Respiratory Infection

Keywords

Influenza; Vaccination; Vaccines; Schoolchildren; Effectiveness; Intervention studies; Adolescents; Laboratory Confirmed Influenza

Outcome Measures

Primary Outcomes (1)

• Laboratory confirmed influenza

  RT-PCR confirmed influenza in respiratory secretions samples

  June 01, 2009 to November 30, 2009

Secondary Outcomes (1)

• Acute Repiratory Infection (ARI)

  6 months

Other Outcomes (1)

• Number of participantes with any adverse event as a measure of safety and tolerability

  30 days after vaccination

Study Arms (2)

Influenza vaccine

EXPERIMENTAL

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

Control vaccine

SHAM COMPARATOR

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

Interventions

Influenza vaccine BIOLOGICAL

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.

Influenza vaccine

Control vaccine BIOLOGICAL

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.

Also known as: Meningococcal C conjugate vaccine, Varicella vaccine

Control vaccine

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any condition above mentioned.

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (1)

Butantan Institute

São Paulo, 05503900, Brazil

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; serogroup C meningococcal conjugate vaccine; Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Herpesvirus Vaccines

Study Officials

• Expedito J Luna, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 26, 2012
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

BR (1)