A Phase 4 interventional study of Influenza vaccine and Control vaccine in Influenza and Acute Respiratory Infection, sponsored by Butantan Institute. Completed at 1 site in Brazil. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Butantan Institute · Phase 4, Interventional, and Prevention
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
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.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 1,742 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Butantan Institute is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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
Laboratory confirmed influenza
RT-PCR confirmed influenza in respiratory secretions samples
Time frame: June 01, 2009 to November 30, 2009
Acute Repiratory Infection (ARI)
Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose
Time frame: 6 months
Number of participantes with any adverse event as a measure of safety and tolerability
Any solicited or unsolicited adverse event
Time frame: 30 days after vaccination
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Butantan Institute