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.: PACTR2010030001913177 Date of Approval: 09/02/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PsA-TT-006
Official scientific title A Phase III, observer-blind, randomized, active controlled study
Brief summary describing the background and objectives of the trial Evaluation of the safety of one dose of a Meningococcal A Conjugate Vaccine administered to healthy subjects 1 to 29 years of agae, Bamako, Mali
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PsA TT 006
Disease(s) or condition(s) being studied Meningitis,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 22/02/2010
Actual trial start date 22/02/2010
Anticipated date of last follow up 07/01/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 6000
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Silver coated randomisation numbers books Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Silver coated randomisation numbers books Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study vaccines PsA-TT one dose of 10microgrammes one injection intramuscular injection 4000
Control Group Reference Vaccine Mencevax PsACWY one dose of 200 microgrammes one injection intramuscular injection 2000 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age 1 to 29 years of age (both included) 2-Written informed consent obtained from the subject (for subjects ¿18 years of age) / parents or guardian (for subjects < 18 years of age) 3-Written informed assent obtained from the subject (for subjects ¿ 10 years and < 18 years of age as appropriate within the site participating community) 4-Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator 5-Subject / parents or guardian capable and willing to come / bring their child or to receive home visits for them / their child for all follow-up visits 6-Residence in the study area 7-Fully vaccinated according to the local EPI schedule (for subjects 1 to 2 years of age) 1-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 2-Administration of any other vaccine within 30 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination 3-Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines 4-Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever (axillary temperature ¿ 38°C)) is a temporary exclusion. 5-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 6-Non residence in the study area or intent to move out within 3 months 7-Pregnancy or lactation. A negative pregnancy test will be required before vaccination for all women of childbearing potential, i.e. postmenarcheal and /or married women 8-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 1 Year(s) 29 Year(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 05/01/2010 WHO ERC
Ethics Committee Address
Street address City Postal code Country
20, avenue Appia Geneva 27 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluation of the safety up to 3 months after a single dose of the PsA-TT vaccine (10microgrammes) 4 days 28 days 84 days
Primary Outcome Evaluation of the safety up to 3 months after a single dose of the PsA-TT vaccine (10microgrammes) 4 days after vaccination 28 days after vaccination 84 days after vaccination
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
PATH MVP 2201 Westlake Avenue, Suite 200 Seattle WA 98121 United States of America
PATH MVP 2201 Westlake Avenue, Suite 200 Seattle WA 98121 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PATH 2201 Westlake Avenue, Suite 200 Seattle WA 98121 United States of America Charities/Societies/Foundation
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
Dr Samba Sow CVD Mali Bamako Mali
Dr Samba Sow CVD Mali Bamako Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samba SOW ssow@medicine.umaryland.edu 00 233 2023 6031 CVD Mali
City Postal code Country Position/Affiliation
Bamako Mali Principal Investigator
Role Name Email Phone Street address
Public Enquiries Jacques HERVE JHERVE@PATH.ORG 00 33 450 28 08 13 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 Marie-Pierre PREZIOSI preziosim@who.int 00 41 22 791 37 44 20 avenue Appia
City Postal code Country Position/Affiliation
Geneva 27 1211 Switzerland Medical Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information