Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)
|ClinicalTrials.gov Identifier: NCT01693380|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza Acute Respiratory Infection||Biological: Influenza vaccine Biological: Control vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1742 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||November 2009|
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:
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.
- Laboratory confirmed influenza [ Time Frame: June 01, 2009 to November 30, 2009 ]RT-PCR confirmed influenza in respiratory secretions samples
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693380
|Sao Paulo, Brazil, 05503900|
|Principal Investigator:||Expedito J Luna, MD||University of Sao Paulo|