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

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Zarifah Reed

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
reedz@who.int

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

WHO/RPC007/759346-009

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(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)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study 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

Pharmaceutical study type(s)

Phase

Not Specified

Drug/device/biological/vaccine name(s)

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 study start date

19/01/2005

Overall study end date

07/10/2005

Reason abandoned (if study stopped)

Participant inclusion criteria

Healthy infants between 6 - 8 weeks of age at first vaccination.

Participant type(s)

Patient

Age group

Child

Lower age limit

6 Weeks

Upper age limit

8 Weeks

Sex

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

Countries of recruitment

Ghana, Switzerland

Study participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

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

http://www.gsk.com/worldwide/be.htm

ROR

https://ror.org/00n3pea85

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs