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ISRCTN
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ISRCTN35754083
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ClinicalTrials.gov identifier
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Public title
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Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)
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Scientific title
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Acronym
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N/A
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Serial number at source
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WHO/RPC007/759346-009
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Study hypothesis
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The principal objective is to evaluate the immunogenicity, reactogenicity and safety of new heptavalent vaccine HibMenAMenC/DPTwHepB when compared to DPTwHepB/Hib in infants when administered at 6, 10 and 14 weeks of age, a schedule corresponding to that used under the EPI (Expanded Programme on Immunisation). In addition the study also aims to evaluate induction of long term immune response, and whether or not immune memory can be boosted by priming, first by measuring the persistence of response at age 12 months, and response following a small dose of plain polysaccharide vaccine at that age.
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Ethics approval
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Ethics approval received from:
1. World Health Organization (WHO) Ethics Review Committee on the 13th October 2003
2. Other review board approvals were around mid to late 2003:
2.1. Program for Appropriate Technology in Health (PATH) Human Subjects Protection Committee (HSPC) (USA)
2.2. National Ethics Committee of Ghana Health Service (Ghana)
2.3. Navrongo Health Research Center (Ghana)
2.4. London School of Hygiene and Tropical Medicine (UK)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Ghana
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Disease/condition/study domain
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Vaccination against meningococcal disease
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Participants - inclusion criteria
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Healthy infants between 6 - 8 weeks of age at first vaccination.
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Participants - exclusion criteria
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Any condition that may affect the health of the subject, or the interpretation of the results.
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Anticipated start date
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19/01/2005
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Anticipated end date
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07/10/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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280 healthy male and female infants
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Interventions
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Intramuscular administration of the vaccines at 6, 10 and 14 weeks of age:
Group 1: GlaxoSmithKline (GSK) Biologicals' Haemophilus influenzae type b (Hib)-meningitis AC (menAC) extemporaneously mixed with (GSK) Biologicals' TritanrixTM-Hepatitis B (HepB)
Group 2: (GSK) Biologicals' HiberixTM vaccine, extemporaneously mixed with (GSK) Biologicals' TritanrixTM-HepB.
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Primary outcome measure(s)
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1. Demonstrate immunogenicity of HibMenAMenC/DPTwHepB with respect to serum bacterial assay(SBA)-Men A and SBA-MenC
2. Demonstrate that HibMenAMenC/DPTwHepB is non-inferior to the control vaccine DPTwHepB/Hib with respect to immunogenicity of all common antigens (anti-PRP, anti-Diphtheria, anti-tetanus, anti-BP, anti-HBs)
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Secondary outcome measure(s)
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1. Evaluate antibody persistence induced by the primary vaccination with HibMenAMenC/DPTwHepB versus DPTwHepB/Hib with respect to immunogenicity of all antigens administered at 12 months of age
2. Evaluate immune memory induced by primary vaccination with HibMenAMenC/DPTwHepB by administering 10 micrograms of each meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) using unprimed subjects of DPTwHepB/Hib as control
3. Assess immunogenecity and safety of the primary vaccination after each vaccine dose and overall in the two study groups
4. To assess the reactogenicity and safety of the 10 micrograms of meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) in subjects primed with either HibMenAMenC/DPTwHepB or DPTwHepB/Hib
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Sources of funding
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World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18478093
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Contact name
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Dr
Zarifah
Reed
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Email
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reedz@who.int
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Sponsor
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GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)
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Address
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Dr Dominique Boutriau
Rue de l'institut 89
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City/town
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Rixensart
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Zip/Postcode
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B-1330
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Country
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Belgium
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Tel
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+32 (0)2 656 91 20
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Fax
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+32 (0)2 656 81 33
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Email
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dominique.boutriau@gskbio.com
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Sponsor website:
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http://www.gsk.com/worldwide/be.htm
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Date applied
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04/08/2004
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Last edited
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19/05/2008
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Date ISRCTN assigned
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22/09/2004
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