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

Sanofi Pasteur0 sites464 target enrollmentJanuary 22, 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

January 22, 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 as per local regulation, and Informed Consent Form has been signed and dated by the parent/ legally acceptable representative and by the participant if she/he turns 18 years old during the study
•\- 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: 464
•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.