Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201110000328305 Date of Approval: 17/10/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PsA-TT-007
Official scientific title A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of different schedules and formulations of a meningococcal A conjugate vaccine administered concomitantly with local EPI vaccines in healthy infants and toddlers
Brief summary describing the background and objectives of the trial The present study is a schedule evaluation study intended to evaluate the safety and immunogenicity of two different schedules of administration of the PsA-TT vaccine in infants and toddlers with two formulations of Group A Neisseria meningitidis purified polysaccharide - PsA 10µg and PsA 5µg - administered in a one-dose schedule at 9-12 months and in a two-dose schedule at 9-12 months and 15-18 months concomitantly with EPI vaccines, including a second dose of measles and rubella vaccines. Possible interferences with EPI vaccines administered concomitantly will be evaluated.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PsA TT 007
Disease(s) or condition(s) being studied Meningitis,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 03/01/2012
Actual trial start date 06/03/2012
Anticipated date of last follow up 31/07/2013
Actual Last follow-up date 30/09/2013
Anticipated target sample size (number of participants) 1500
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MenAfriVac (TM) 2A one dose between 9 and 12 months of age single vaccination at the same time as measles/yellow fever 300
Experimental Group MenAfriVac (TM) 1A two doses one between 9 and 12 months of age and another between 15 to 18 months of age two vaccinations (first at the same time as measles/yellow fever, second at the same time as measles/rubella) 300
Experimental Group PsA-TT 5ug 1B two doses one between 9 and 12 months of age and another between 15 to 18 months of age two vaccinations (first at the same time as measles/yellow fever, second at the same time as measles/rubella) 300
Experimental Group PsA-TT 5ug 2B One dose between 9 and 12 months of age single vaccination at the same time as measles/yellow fever 300
Control Group Control 9 and 15 months vaccinations standard vaccinations measles/yellow fever and measles/rubella vaccinations at 9 and 15 months respectively 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 9 months (window 9 to 12 months) 2. Written informed consent obtained from parent(s) or guardian(s) of the child 3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator 4. Parent(s) or guardian(s) 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 the local EPI schedule (1 dose of BCG, 3 doses of DTwPHibHep and 4 doses of OPV) 1.Previous vaccination against Neisseria meningitidis 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 immunization 4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination in the 28 days following 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 90 days prior to the administration of study vaccines or planned administration during the vaccine period 7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic corticosteroids, this means prednisone, or equivalent, ¿ 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 (as per investigator¿s judgment) 11. Acute disease at the time of enrollment (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 10 months 9 Month(s) 18 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2011 WHO ERC
Ethics Committee Address
Street address City Postal code Country
Avenue Appia 20 Geneva 27 1211 Switzerland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/10/2011 WIRB
Ethics Committee Address
Street address City Postal code Country
3535 7th Avenue SW Olympia WA 98508 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/11/2011 INRSP
Ethics Committee Address
Street address City Postal code Country
Bamako Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Seroconversion for meningococcal A (MenA) antibodies The proportion of subjects who show a seroconversion for meningococcal A (MenA) antibodies, i.e. a 4-fold increase in post-immunization serum titer with respect to pre-immunization serum titer, and the MenA antibody GMT at 28 days after each vaccine dose, as measured by rSBA assay.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CVD-Mali Ex-Institut Marchoux Bamako Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill & Melinda Gates Foundation 500 Fifth Avenue North Seattle WA 98102 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Serum Institute of India Ltd (SIIL) 212/2, Hadapsar Pune 411028 India Commercial Sector/Industry
Primary Sponsor PATH 2201 Westlake Avenue, Suite 200 Seattle WA 98121 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Agence Africaine de Recherche en Santé Humaine (AARSH) Route de Ngor Dakar Senegal
DiagnoSearch Life Sciences Ltd (DLS) Orchard Avenue, Hirnanadoni Business Park Mumbai 400076 India
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samba Ousmane Sow ssow@medicine.umaryland.edu +223 2023 6031 Ex-Institut Marchoux
City Postal code Country Position/Affiliation
Bamako Mali Director
Role Name Email Phone Street address
Public Enquiries Marie-Françoise Makadi mmakadi@path.org +33 4 50 28 43 70 13 chemin du Levant
City Postal code Country Position/Affiliation
Ferney-Voltaire 01210 France, Metropolitan Clinical Research Associate
Role Name Email Phone Street address
Scientific Enquiries Julie Chaumont jchaumont@path.org +33 4 50 28 08 11 13 chemin du Levant
City Postal code Country Position/Affiliation
Ferney-Voltaire 01210 France, Metropolitan Clinical Operations Manager
Role Name Email Phone Street address
Scientific Enquiries Julie Chaumont jchaumont@path.org +33 4 50 28 08 11 13 chemin du Levant
City Postal code Country Position/Affiliation
Ferney-Voltaire 01210 France, Metropolitan Clinical Operations Manager
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information