Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza (Xo_Gripe)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|