Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Sanofi Pasteur Inc.0 sites1,540 target enrollmentOctober 19, 2018

ConditionsHealthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsNimenrix

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
Sponsor: Sanofi Pasteur Inc.
Enrollment: 1540
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 19, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi Pasteur Inc.

Eligibility Criteria

Inclusion Criteria

•\- Aged \= 42 to \= 89 days on the day of the first study visit
•\- Born at full term of pregnancy (\= 37 weeks) and with a birth weight \= 2\.5 kg
•\- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
•\- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
•\- Covered by health insurance according to local regulations
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1540
•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

Exclusion Criteria

•\- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
•\- Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
•\- Receipt or planned to receipt during the study period vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono\- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup\-containing vaccine)
•\- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella
•\- Receipt of immune globulins, blood or blood\-derived products since birth
•\- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti\-cancer chemotherapy or radiation therapy; or long\-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
•\- Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated
•\- Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
•\- Individuals with active tuberculosis
•\- History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically