PsA-TT-007

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201110000328305
• Date of registration: 17/10/2011
• Primary sponsor: PATH
• Public title: PsA-TT-007
• 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
• Date of first enrolment: 2012-03-06
• Target sample size: 1500
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000328305
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: Julie Chaumont
• Affiliation: Clinical Operations Manager

• Name: Marie-Fran?oise Makadi
• Affiliation: Clinical Research Associate

Key inclusion & exclusion criteria

Inclusion criteria: 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)

Exclusion criteria: 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

Age minimum: 9 Month
Age maximum: 18 Month
Gender: Both

Health Condition(s) or Problem(s) studied

Meningitis

Primary Outcome(s)

Seroconversion for meningococcal A (MenA) antibodies

Source(s) of Monetary Support

Bill & Melinda Gates Foundation