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ISRCTN
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ISRCTN95974322
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ClinicalTrials.gov identifier
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Public title
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Brazilian pentavalent vaccine
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Scientific title
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Immunogenicity and safety of Brazilian combined vaccine against diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib)
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Acronym
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N/A
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Serial number at source
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ASCLIN/001/2007
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Study hypothesis
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The Brazilian combined diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib) vaccine is as immunogenic and safe as the current DTPw/Hib and HB vaccines administered separately.
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Ethics approval
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Ethics approval received from the Fiocruz Ethics Committee on the 14th January 2007 (ref: 400/07).
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Study design
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Multicentre, non-inferiority randomised controlled trial, partially blinded.
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type B diseases
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Participants - inclusion criteria
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Healthy newborns (newborns and infants up to 7 months of age, of both sexes) whose parents/tutors understand the risk and benefits of the trial and agree to participate with written and informed consent.
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Participants - exclusion criteria
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Newborns or mothers:
1. Hepatitis B surface antigen (HBsAg) positive
2. Human immunodeficiency virus (HIV) seropositive
3. With positive serology for syphilis
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Anticipated start date
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17/03/2008
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Anticipated end date
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30/09/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1200 volunteers
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Interventions
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1. Experimental group: vaccine (DTPw/HB/Hib) at 2, 4 and 6 months of age
2. Control group: DTPw/Hib and HB vaccines in concomitant injections at different sites
Both groups will receive HB vaccine at birth.
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Primary outcome measure(s)
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Antibody titres to diphtheria, tetanus, pertussis, haemophilus influenzae (PRP) and hepatitis B, and seroprotection rate, measured after third dose, shoud be non-inferior to that from the reference vaccines (DTP/Hib and HB vaccines given separately).
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Secondary outcome measure(s)
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1. Adverse event after each dose shoud be equivalent to reference vaccines
2. Consistency of production evaluated by equivalence in immunogenicity and safety of three lots of the experimental vaccine DTPw/HB/Hib
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Sources of funding
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1. Brazilian Ministry of Health (Brazil)
2. Brazilian Ministry of Science and Technology (Brazil)
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Trial website
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Publications
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Contact name
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Dr
Luiz Antônio Bastos
Camacho
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Address
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Rua Leoplodo Bulhões 1480/820
Manguinhos
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City/town
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Rio de Janeiro
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Zip/Postcode
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21041-210
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Country
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Brazil
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Tel
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+55 21 2598 2630
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Email
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luiz.camacho@ensp.fiocruz.br
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Sponsor
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Bio-Manguinhos/Fiocruz (Brazil)
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Address
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c/o Akira Homma
Director
Avenida Brasil 4365
Manguinhos
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City/town
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Rio de Janeiro
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Zip/Postcode
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21040-900
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Country
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Brazil
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Sponsor website:
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http://www.bio.fiocruz.br
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Date applied
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25/06/2008
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Last edited
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30/06/2008
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Date ISRCTN assigned
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30/06/2008
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