A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccines in Healthy Toddlers

Sanofi Pasteur0 sitesDecember 30, 2014

DrugsNimenrix

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Sanofi Pasteur
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 30, 2014

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi Pasteur

Eligibility Criteria

Inclusion Criteria

•An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
•1\) Aged 12 to 23 months on the day of the first study visit
•2\) Born at full term of pregnancy (\= 37 weeks) or with a birth weight \= 2\.5 kg (5\.5 pounds)
•3\) Informed consent form (ICF) has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
•4\) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
•5\) Covered by health insurance where applicable
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 200
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

•An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
•1\) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•2\) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines
•3\) Previous vaccination against meningococcal disease with either the trial vaccine or mono\-, or polyvalent polysaccharide or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y
•4\) Receipt of immune globulins, blood, or blood\-derived products in the past 3 months
•5\) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti\-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long\-term systemic corticosteroid therapy (\= 2mg/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•6\) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
•7\) At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
•8\) Known systemic hypersensitivity to any of the vaccine components, history of a life\-threatening reaction to the vaccines used in the trial, or to a vaccine containing any of the same substances
•9\) Known systemic hypersensitivity to latex