Influenza, Acute Respiratory Infection
Conditions
Keywords
Influenza, Vaccination, Vaccines, Schoolchildren, Effectiveness, Intervention studies, Adolescents, Laboratory Confirmed Influenza
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.
Interventions
BIOLOGICALInfluenza 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.
BIOLOGICALControl 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.
Sponsors
Butantan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory confirmed influenza | June 01, 2009 to November 30, 2009 | RT-PCR confirmed influenza in respiratory secretions samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Repiratory Infection (ARI) | 6 months | Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participantes with any adverse event as a measure of safety and tolerability | 30 days after vaccination | Any solicited or unsolicited adverse event |
Countries
Brazil
Outcome results
None listed