We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693380
First Posted: September 26, 2012
Last Update Posted: September 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Butantan Institute
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]
    RT-PCR confirmed influenza in respiratory secretions samples


Secondary Outcome Measures:
  • Acute Repiratory Infection (ARI) [ Time Frame: 6 months ]
    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 ]
    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.
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT01693380     History of Changes
Other Study ID Numbers: BUTANTAN
First Submitted: September 10, 2012
First Posted: September 26, 2012
Last Update Posted: September 26, 2012
Last Verified: September 2012

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs