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

Sanofi Pasteur Inc.0 sites1,715 target enrollmentMay 6, 2016

ConditionsHealthy volunteers (active immunization against invasive meningococcal disease (IMD) caused by Meningococcal serogroups A, C, Y or W Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsMENVEO®; Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Adacel® (Tdap)GARDASIL®; Human papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers (active immunization against invasive meningococcal disease (IMD) caused by Meningococcal serogroups A, C, Y or W
Sponsor: Sanofi Pasteur Inc.
Enrollment: 1715
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 6, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi Pasteur Inc.

Eligibility Criteria

Inclusion Criteria

•\- Aged 10 to 17 years on the day of inclusion
•\- Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
•\- Assent form has been signed and dated by the subject
•\- Subject and parent legally acceptable representative are able to attend all scheduled visits and comply with all trial procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1715
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•\- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non\-childbearing potential, a female must be pre\-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
•\- Participation in the 4 weeks preceding the first trial vaccination(s) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•\- Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination(s) or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after any study vaccines. This exception includes monovalent influenza vaccines and multivalent influenza vaccines.
•\- Previous vaccination against meningococcal disease with either the trial vaccine or any mono\- or polyvalent polysaccharide or conjugate meningococcal vaccine containing A, C, Y, or W antigens.
•\- History of vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 4 years.
•\- Previous HPV vaccination
•\- Receipt of immune globulins, blood or blood\-derived products in the past 3 months
•\- 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•\- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
•\- 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)