Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
NCT ID: NCT01111968
Last Updated: 2013-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
266 participants
INTERVENTIONAL
2010-01-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
pandmeic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
pandemic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
pandmeic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
pandemic vaccine 13
15µg of A/H1N1 with no adjuvant
pandmic vaccine 13
15µg of A/H1N1 with no adjuvant
placebo group 14
placebo
placebo group 14
All elements of the vaccine but antigen and adjuvant
Interventions
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pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandmeic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
pandmeic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
pandmic vaccine 13
15µg of A/H1N1 with no adjuvant
placebo group 14
All elements of the vaccine but antigen and adjuvant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 ≤ 50 years
* Able to understand every required study procedure
* Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
* Normal values for pre-stablished laboratory assays
* Accpetance to participate and sign the consent form
Exclusion Criteria
* Be on immunossupressive or stimulant therapy
* Have egg alergy
* Have past history of alergy to sazonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Female on breasthfeeding
* Confirmed prior infection by pandemic influenza A
* Participation in another clinical trial in the last 6 months
* Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
18 Years
50 Years
ALL
Yes
Sponsors
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Hospital Universitario da USP
UNKNOWN
University of Sao Paulo
OTHER
Butantan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Lucia MA Campos, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Children´s Institute - School of Medicine of University of Sao Paulo
Locations
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Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Centro de Pesquisa Clínica do Hospital Universitário da USP
São Paulo, São Paulo, Brazil
Countries
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References
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Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.
Other Identifiers
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BUTVAC - Influenza A (H1N1)
Identifier Type: -
Identifier Source: org_study_id
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