Who is sponsoring NCT02005536?

NCT02005536 is sponsored by Sanofi Pasteur, a Sanofi Company.

What condition does NCT02005536 study?

NCT02005536 studies Poliomyelitis, Polio.

What drugs are being tested in NCT02005536?

Interventions: IMOVAX POLIO®: Inactive Poliovirus Vaccine.

What is the status of NCT02005536?

NCT02005536 is currently COMPLETED.

Last reviewed 2015-03-27 · How we verify

Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan

NCT02005536 Phase 4 COMPLETED Results posted

The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: * To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: * To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). * To investigate the safety after dosing of SP059 as 2nd booster.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 4
Status	COMPLETED
Enrolment	60
Start date	2013-12
Completion	2014-10

Conditions

Poliomyelitis
Polio

Interventions

IMOVAX POLIO®: Inactive Poliovirus Vaccine

Primary outcomes

Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® — Day 28 post-vaccination
A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.

Countries

Japan