Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT01693380
First received: September 10, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Influenza
Acute Respiratory Infection
Biological: Influenza vaccine
Biological: Control vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009

Resource links provided by NLM:


Further study details as provided by Butantan Institute:

Primary Outcome Measures:
  • Laboratory confirmed influenza [ Time Frame: June 01, 2009 to November 30, 2009 ] [ Designated as safety issue: No ]
    RT-PCR confirmed influenza in respiratory secretions samples


Secondary Outcome Measures:
  • Acute Repiratory Infection (ARI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose


Other Outcome Measures:
  • Number of participantes with any adverse event as a measure of safety and tolerability [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]
    Any solicited or unsolicited adverse event


Enrollment: 1742
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.
Other Name: Influenza vaccine
Sham Comparator: 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.

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.

Other Names:
  • Meningococcal C conjugate vaccine
  • Varicella vaccine

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693380

Locations
Brazil
Butantan Institute
Sao Paulo, Brazil, 05503900
Sponsors and Collaborators
Butantan Institute
Investigators
Principal Investigator: Expedito J Luna, MD University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT01693380     History of Changes
Other Study ID Numbers: BUTANTAN
Study First Received: September 10, 2012
Last Updated: September 24, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Butantan Institute:
Influenza
Vaccination
Vaccines
Schoolchildren
Effectiveness
Intervention studies
Adolescents
Laboratory Confirmed Influenza

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on August 19, 2014