Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly with Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru

Sanofi Pasteur SA0 sites792 target enrollmentMay 26, 2014

Overview

No summary available.

Registry

who.int

Start Date

May 26, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur SA

•1\) Aged 12 to 13 months on the day of inclusion.
•2\) Born at full term of pregnancy (\=37 weeks) and with a birth weight \=2\.5 kg as reported by the parent/legally acceptable representative.
•3\) Subject in good health, based on medical history and physical examination.
•4\) Subject has completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively.
•5\) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations).
•6\) Subject and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 792
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range

•1\) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
•2\) Planned participation in another clinical trial during the present trial period.
•3\) Planned receipt of any vaccine in the 4 weeks following first trial vaccination.
•4\) Previous vaccination against YF, hepatitis A or measles, mumps and rubella.
•5\) Receipt of blood or blood\-derived products in the past 3 months which might interfere with assessment of the immune response.
•6\) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti\-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long\-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
•7\) Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative.
•8\) History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative.
•9\) Personal history of YF or dengue infection/disease as reported by the
•parent/legally acceptable representative.