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Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)
ISRCTN ISRCTN35754083
DOI 10.1186/ISRCTN35754083
ClinicalTrials.gov identifier
EudraCT number
Public title Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)
Scientific title
Acronym N/A
Serial number at source WHO/RPC007/759346-009
Study hypothesis 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.
Lay summary
Ethics approval 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)
Study design Randomised controlled trial
Countries of recruitment Ghana
Disease/condition/study domain Vaccination against meningococcal disease
Participants - inclusion criteria Healthy infants between 6 - 8 weeks of age at first vaccination.
Participants - exclusion criteria Any condition that may affect the health of the subject, or the interpretation of the results.
Anticipated start date 19/01/2005
Anticipated end date 07/10/2005
Status of trial Completed
Patient information material
Target number of participants 280 healthy male and female infants
Interventions 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.
Primary outcome measure(s) 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)
Secondary outcome measure(s) 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
Sources of funding World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18478093
Contact name Dr  Zarifah  Reed
  Address World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Email reedz@who.int
Sponsor GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)
  Address Dr Dominique Boutriau
Rue de l'institut 89
  City/town Rixensart
  Zip/Postcode B-1330
  Country Belgium
  Tel +32 (0)2 656 91 20
  Fax +32 (0)2 656 81 33
  Email dominique.boutriau@gskbio.com
  Sponsor website: http://www.gsk.com/worldwide/be.htm
Date applied 04/08/2004
Last edited 19/05/2008
Date ISRCTN assigned 22/09/2004
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