PsA-TT-006

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2010030001913177
• Date of registration: 05/02/2010
• Primary sponsor: PATH
• Public title: PsA-TT-006
• Scientific title: A Phase III, observer-blind, randomized, active controlled study
• Date of first enrolment: 2010-02-22
• Target sample size: 6000
• Recruitment status: Closed to recruitment: follow up complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010030001913177
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: Jacques HERVE
• Affiliation: Clinical Operations Manager

• Name: Marie-Pierre PREZIOSI
• Affiliation: Medical Officer

Key inclusion & exclusion criteria

Inclusion criteria: 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)

Exclusion criteria: 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


Age minimum: 1 Year
Age maximum: 29 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Meningitis

Primary Outcome(s)

Evaluation of the safety up to 3 months after a single dose of the PsA-TT vaccine (10microgrammes)

Source(s) of Monetary Support

PATH MVP