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| A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACYW polysaccharide vaccine and a hib conjugate vaccine, administered in healthy toddlers 12 - 23 months of age |
| ISRCTN | ISRCTN78147026 |
| ClinicalTrials.gov identifier | |
| Public title | A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACYW polysaccharide vaccine and a hib conjugate vaccine, administered in healthy toddlers 12 - 23 months of age |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | RPC178 |
| Study hypothesis | The present study is pivotal, designed as a non-inferiority trial to evaluate the immunogenicity and the safety of one dose of 10 µg of PsA-TT vaccine. Immunological memory and persistence of antibodies induced by a single intramuscular injection of the study vaccine will also be evaluated. The immunogenicity will be assessed against that of a licensed meningococcal polysaccharide ACYW vaccine. The three-group design will allow comparison of the PsA-TT vaccine (study vaccine group) safety profile with that of two licensed vaccines: the meningococcal ACYW tetravalent polysaccharide vaccine (Mencevax - reference vaccine group), and the Hib-conjugate vaccine (Hiberix - control vaccine group). The booster study is expected to provide evidence that the PsA-TT conjugate vaccine is able to prime immunological memory. Antibody persistence will be evaluated at eight months (i.e. before the booster dose), one year and two years after the first dose. |
| Ethics approval |
This protocol has been approved by the following institutions:
1. Human Subjects Protection Committee at PATH, USA 2. University of Maryland Baltimore Institutional Review Board (IRB), USA 3. Comité d'Ethique de la Faculté de Médecine, de Pharmacie et d'Odonto-Stomatologie, Mali 4. Medical Research Council Scientific Coordinating Committee, The Gambia 5. Medical Research Council Gambia Government Ethics Committee, The Gambia 6. World Health Organization (WHO) Research Ethics Review Committee |
| Study design | A phase II, observer-blind, randomised, active controlled study |
| Countries of recruitment | Gambia, Mali |
| Disease/condition/study domain | Meningococcal A disease |
| Participants - inclusion criteria |
1. Age 12 to 23 months of age (both included)
2. Written informed consent obtained from the mother, father, or guardian of the child 3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator 4. Mother, father, or guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits 5. Residence in the study area 6. Fully vaccinated according to local Expanded Program on Immunisation (EPI) schedule |
| Participants - exclusion criteria |
1. Previous vaccination against serogroup A Neisseria meningitidis
2. Known exposure to serogroup A Neisseria meningitidis during the three previous months 3. History of allergic disease or known hypersensitivity to any component of the three study vaccines 4. History of Serious Adverse Reactions (SAR) following administration of vaccines included in the local program of immunization 5. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination 6. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines 7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the vaccine period 8. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone or equivalent, 0.5 mg/kg/day [topical steroids are allowed]) 9. A family history of congenital or hereditary immunodeficiency 10. History of meningitis or seizures or any neurological disorder 11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment) 12. 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 13. 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 14. 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 15. Non-residence in the study area or intent to move out within one year |
| Anticipated start date | 28/08/2006 |
| Anticipated end date | 28/11/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 600 |
| Interventions |
The intervention is vaccination at day zero of one of the three vaccines: study vaccine, reference vaccine (Mencevax) or control vaccine (Hiberix) , followed by a booster vaccination 32 weeks later with one of the three vaccines, study vaccine, reference vaccine (1/5th of a dose) or control vaccine. Subjects will be randomised in a 1:1:1 ratio.
Principle Investigator contacts: Professor Samba Sow Centre pour les Vaccins en Développement (CVD) BP 251 Bamako Mali Dr Brown Okoko PO Box 273 Banjul, Fajara The Gambia As well as the SIIL, this trial was also sponsored by: Program for Appropriate Technology in Health (PATH) 1455 NW Leary Way Seattle WA 98107 United States of America Sponsor website: http://www.path.org This trial was accepted and approved by the ISRCTN on the 18th September, but assigned an ISRCTN on the 21/09/06 due to technical reasons. The date of the ISRCTN assignment should be taken as the 18th September 2006. |
| Primary outcome measure(s) | 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 rank Signaling Block Age (rSBA) assay. |
| Secondary outcome measure(s) |
1. The percentage of subjects with local and systemic adverse events, including solicited adverse reactions and events, and Serious Adverse Events (SAEs), as measured at four and 28 days after the primary vaccination (reactogenicity and short-term safety)
2. The percentage of subjects with local and systemic adverse events, including solicited adverse reactions and events, and SAEs, as measured at four and 28 days after the booster vaccination (reactogenicity and short-term safety) 3. 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 the Enzyme-Linked ImmunoadSorbent 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. |
| Sources of funding | Bill & Melinda Gates Foundation (UK) - Grant |
| Trial website | |
| Publications | |
| Contact name | Dr Marie-Pierre Preziosi |
| Address |
World Health Organization
20 Avenue Appia |
| City/town | Geneva-27 |
| Zip/Postcode | CH-1211 |
| Country | Switzerland |
| Tel | +41 (0)22 791 3744 |
| Fax | +41 (0)22 791 4860 |
| preziosim@who.int | |
| Sponsor | Serum Institute of India Limited (SIIL) (India) |
| Address | 212/2, Hadapsar |
| City/town | Pune |
| Zip/Postcode | 411028 |
| Country | India |
| Sponsor website: | http://www.seruminstitute.com |
| Date applied | 20/09/2006 |
| Last edited | 08/09/2008 |
| Date ISRCTN assigned | 21/09/2006 |
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| © 2010 ISRCTN unless otherwise stated. | |
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