Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)

ISRCTN	ISRCTN35754083
DOI	https://doi.org/10.1186/ISRCTN35754083
Protocol serial number	WHO/RPC007/759346-009
Sponsor	GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)
Funder	World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Submission date: 04/08/2004
Registration date: 22/09/2004
Last edited: 19/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Zarifah Reed
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	reedz@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	HibMenAMenC/DPTwHepB, DPTwHepB/Hib vaccines
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)
Key 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
Completion date	07/10/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	8 Weeks
Sex	All
Target sample size at registration	280
Key inclusion criteria	Healthy infants between 6 - 8 weeks of age at first vaccination.
Key exclusion criteria	Any condition that may affect the health of the subject, or the interpretation of the results.
Date of first enrolment	19/01/2005
Date of final enrolment	07/10/2005

Locations

Countries of recruitment

Ghana
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	14/05/2008		Yes	No