Butantan Institute
São Paulo, 05503900, Brazil
NCT Number: NCT01693380
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
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Notify Me6 year–18 year
All sexes
Interventional
Phase 4
São Paulo, 05503900, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Influenza vaccine: schoolchidren in the experimental group received IM administered:
Schoolchildren from 6 to 8 years of age:
Other names: Meningococcal C conjugate vaccine, Varicella vaccine
Time frame: June 01, 2009 to November 30, 2009
RT-PCR confirmed influenza in respiratory secretions samples
Time frame: 6 months
Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose
Time frame: 30 days after vaccination
Any solicited or unsolicited adverse event
Butantan Institute
Other Gov
Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009
Acronym: Xo_Gripe
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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