Contact information
Type
Scientific
Primary contact
Dr Zarifah Reed
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
reedz@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WHO/RPC007/759346-009
Study information
Scientific title
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Vaccination against meningococcal disease
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
HibMenAMenC/DPTwHepB, DPTwHepB/Hib vaccines
Primary outcome measure
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 measures
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
Overall trial start date
19/01/2005
Overall trial end date
07/10/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy infants between 6 - 8 weeks of age at first vaccination.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
280 healthy male and female infants
Participant exclusion criteria
Any condition that may affect the health of the subject, or the interpretation of the results.
Recruitment start date
19/01/2005
Recruitment end date
07/10/2005
Locations
Countries of recruitment
Ghana
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)
Sponsor details
Dr Dominique Boutriau
Rue de l'institut 89
Rixensart
B-1330
Belgium
+32 (0)2 656 91 20
dominique.boutriau@gskbio.com
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18478093
Publication citations
-
Results
Hodgson A, Forgor AA, Chandramohan D, Reed Z, Binka F, Bevilacqua C, Boutriau D, Greenwood B, A phase II, randomized study on an investigational DTPw-HBV/Hib-MenAC conjugate vaccine administered to infants in Northern Ghana., PLoS ONE, 2008, 3, 5, e2159, doi: 10.1371/journal.pone.0002159.