Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009

ID
Name
BUTANTAN
Description
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
Trial arms
Trial start
2009-05-01
Estimated PCD
2009-06-01
Trial end
2009-11-01
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Influenza vaccine
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.
Arms:
Control vaccine
Other names:
Meningococcal C conjugate vaccine, Varicella vaccine
Size
1742
Primary endpoint
Laboratory confirmed influenza
June 01, 2009 to November 30, 2009
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1742, 'type': 'ACTUAL'}}
Updated at
2023-04-04

1 organization

2 products

2 indications

Organization
Butantan Institute
Product
Influenza vaccine
Indication
Influenza
Indication
Acute Respiratory Infection
Product
Control vaccine