Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly with 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents - NA

SANOFI PASTEUR0 sites464 target enrollmentJune 15, 2021

ConditionsMeningococcal infection 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: Meningococcal infection
Sponsor: SANOFI PASTEUR
Enrollment: 464
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

June 15, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SANOFI PASTEUR

Eligibility Criteria

Inclusion Criteria

•\- Aged 10 to 17 years on the day of inclusion (10 to 17 years means from the day of the 10th birthday to the day before the 18th birthday)
•\- Meningococcal C conjugate (MenC) naïve participants or participants having received monovalent MenC priming in infancy (\< 2 years of age)
•\- Assent form has been signed and dated by the participant, and informed consent form has been signed and dated by the parent/ legally acceptable representative
•\- Participants and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
•\- Covered by health insurance, if required by local regulations.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•\- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non\-childbearing potential, a female must be pre\-menarche
•\- Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup\-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age
•\- 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 any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
•\- History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years
•\- Previous human papilloma virus (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
•\- Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease. At high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease)