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 |
| Secondary identifying numbers | WHO/RPC007/759346-009 |
- 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
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| reedz@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| 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 |
| Completion date | 07/10/2005 |
Eligibility
| 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 |
| 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
CH-1211
Switzerland
Sponsor information
GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)
Industry
Industry
Dr Dominique Boutriau
Rue de l'institut 89
Rixensart
B-1330
Belgium
| Phone | +32 (0)2 656 91 20 |
|---|---|
| dominique.boutriau@gskbio.com | |
| Website | http://www.gsk.com/worldwide/be.htm |
"ROR" |
https://ror.org/00n3pea85 |
Funders
Funder type
Research organisation
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
