Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

NCT ID: NCT01693380

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1742 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

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.

Conditions

Influenza; Acute Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Influenza vaccine

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Control vaccine

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Meningococcal C conjugate vaccine; Varicella vaccine

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Butantan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Expedito J Luna, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Butantan Institute

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

BUTANTAN

Identifier Type: -

Identifier Source: org_study_id