A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy subjects 2 to 29 years of age
| ISRCTN | ISRCTN87739946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87739946 |
| Secondary identifying numbers | RPC217; PsA-TT-003 |
- Submission date
- 14/08/2007
- Registration date
- 14/08/2007
- Last edited
- 05/03/2019
- 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 Marie-Pierre Preziosi
Scientific
Scientific
Initiative for Vaccine Research
World Health Organization (WHO)
Department of Immunisation, Vaccines and Biologicals (IVB)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3744 |
|---|---|
| preziosim@who.int |
Dr Samba Sow
Scientific
Scientific
Centre pour les Vaccins en Developpement (CVD) Mali
Centre National d'Appui a la lutte contre la Maladie (CNAM)
Ministere de la Sante
Ex-Institut Marchoux
Bamako
BP 251
Mali
| Phone | +223 (0)674 8947 |
|---|---|
| ssow@medicine.umaryland.edu |
Dr Brown Okoko
Scientific
Scientific
Medical Research Council (MRC) Laboratories
PO Box 273
Fajara
-
Gambia
| Phone | +220 (0)779 2510 |
|---|---|
| bokoko@mrc.gm |
Dr Aldiouma Diallo
Scientific
Scientific
Institut de Recherche pour le Développement (IRD)
BP 1386
Dakar
CP 18524
Senegal
| Phone | +220 (0)654 1333 |
|---|---|
| diallo@ird.sn |
Study information
| Study design | Phase II/III observer-blind randomised active-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy subjects 2 to 29 years of age |
| Study objectives | To compare the immunogenicity of a single dose of the PsA-TT vaccine with that of the Meningococcal A component of the PsACWY vaccine at 28 days after vaccination. |
| Ethics approval(s) | 1. The Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethic Committee, 30/07/2007, ref: L2007.56 2. Ethics committee of the National Center for Scientific Research (Centre National de la Recherche Scientifique [CNRS]), 08/08/2007, ref: 127MSPM/DS/CNRS 3. Ethics committee of the Faculty of Medicine Pharmacy and Odonto-stomatology (Faculte de Medecine de Pharmacie et d'Odonto-Stomatologie [FMPOS]), 23/07/2007, ref: 0750/FMPOS |
| Health condition(s) or problem(s) studied | Bacterial meningitis |
| Intervention | 1. One 0.5 ml dose out of a decadose vial of PsA-TT vaccine will be injected intramuscularly (IM) in the right deltoid 2. One 0.5 ml dose of PsACWY vaccine will be injected IM in the right deltoid |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | PsA-TT, PsACWY |
| Primary outcome measure | The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e. a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by rabbit complement Serum Bactericidal Assay (rSBA). |
| Secondary outcome measures | Safety: 1. The percentage of subjects with local and systemic post-immunisation reactions during the first four days, adverse events and Serious Adverse Events (SAEs), as measured at 4 and 28 days after vaccination (reactogenicity and short-term safety) 2. The percentage of subjects with SAEs during the entire study duration, as measured at 182 days (6 months) and 364 days (1 year) (long-term safety) Immunogenicity: 1. The percentage of subjects with anti-MenPsA titre greater than or equal to 1:8 (defined as seroprotection to MenA) at 28 days after a single vaccine dose, as measured by rSBA assay. The percentage of subjects with anti-MenPsA titer greater than or equal to 1:128 (defined as long-term seroprotection to MenA) will be also considered 2. Geometric Mean Titres (GMTs) for anti-MenPsA antibodies at 28 days after a single vaccine dose, as measured by rSBA assay 3. Evaluation of reverse cumulative distribution curves for MenPsA antibody titres at 28 days after a single vaccine dose, as measured by rSBA assay 4. The percentage of subjects who show a seroconversion for anti-MenPsA total Immunoglobulin G (IgG), i.e. a two-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration, at 28 days after a single vaccine dose, as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The percentage of subjects with a four-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration will be also considered |
| Overall study start date | 20/08/2007 |
| Completion date | 20/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 900 |
| Key inclusion criteria | A subject will be eligible for inclusion if ALL of the following apply at the time of enrolment: 1. Age 2 to 29 years of age (both included) 2. Written informed consent obtained from the subject (for subjects equal to 18 years of age)/parents or legal guardian (for subjects less than 18 years of age) 3. Written informed assent from the subject if and as appropriate within the participating community (e.g., for subjects equal to 13 years of age in the Malian site, for subjects equal to 15 years of age in the Senegal site or for subjects equal to 12 years of age in the Gambia site) 4. Free of obvious health problems as established by medical history including physical examination and clinical judgement of the investigator 5. Subject/parents, or legal guardian capable and willing to come/bring their child or to receive home visits for all follow-up visits 6. Residence in the study area 7. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule (for subjects 2 to 3 years of age only) |
| Key exclusion criteria | Subjects with any of the following criteria at study entry will not be eligible for participation: 1. Previous vaccination against Neisseria meningitidis during the six previous years 2. Known exposure to Neisseria meningitidis during the three previous months 3. History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunisation 4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination 5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines 6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period 7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (Including systemic corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids including inhaled steroids are allowed) 8. A family history of congenital or hereditary immunodeficiency 9. History of meningitis or seizures or any neurological disorder 10. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgement) 11. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion 12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives 13. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study 14. Non residence in the study area or intent to move out within one year 15. Pregnancy or lactation (a negative pregnancy test will be required before vaccination for all women of childbearing potential) 16. Previous inclusion of five family members in the study (i.e., subjects belonging to the same family - biological father, mother, child, and brothers and sisters may be included up to a maximum of five members from the same family) |
| Date of first enrolment | 20/08/2007 |
| Date of final enrolment | 20/09/2008 |
Locations
Countries of recruitment
- Gambia
- Mali
- Senegal
- Switzerland
Study participating centre
Initiative for Vaccine Research
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
Serum Institute of India Limited (SIIL)
Industry
Industry
212/2, Hadapsar
Pune
411 028
India
| Website | http://www.seruminstitute.com/ |
|---|
Program for Appropriate Technology in Health (PATH)
Research organisation
Research organisation
1455 NW Leary Way
Seattle
WA 98107
United States of America
Serum Institute of India (India)
Not defined
Not defined
| Website | http://www.seruminstitute.com/ |
|---|---|
"ROR" |
https://ror.org/04jk2xb11 |
Funders
Funder type
Charity
Bill and Melinda Gates Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
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 | 16/06/2011 | Yes | No | |
| Results article | results | 15/11/2015 | Yes | No | |
| Results article | results | 15/11/2015 | Yes | No | |
| Results article | results | 15/11/2015 | Yes | No | |
| Results article | results | 15/11/2015 | Yes | No | |
| Results article | results | 15/11/2015 | Yes | No |
Editorial Notes
05/03/2019: Internal review.
31/08/2016: Publication references added.
