PsA-TT-006

Not Applicable

• Conditions: Nervous System Diseases; Meningitis

• Registration Number: PACTR2010030001913177
• Lead Sponsor: PATH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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