Immunogenicity and safety study of an investigational quadrivalent meningococcal conjugate vaccine in infants and toddlers when administered using a 1+1 schedule in a National Immunization Schedule having a meningococcal Group B Vaccine as standard of care

Sanofi Pasteur0 sites700 target enrollmentMarch 20, 2018

DrugsBEXSERO (Meningococcal group B Vaccine (rDNA, component, adsorbed))

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Sanofi Pasteur
Enrollment: 700
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 20, 2018

End Date

TBD

Last Updated

5 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 study enrollment:
•1\) Aged \= 56 to \= 89 days on the day of the first study visit
•2\) Born at full term of pregnancy (\= 37 weeks) and with a birth weight \= 2\.5 kg (or 5 lb and 8 oz)
•3\) 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)
•4\) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 700
•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

•An individual fulfilling any of the following criteria is to be excluded from study enrollment:
•1\) Participation at the time of study enrollment (or in the 4 weeks preceding the first 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza 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
•3\) Previous vaccination against meningococcal disease with either the trial 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)
•4\) Previous vaccination with any pneumococcal, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or rotavirus vaccines. Receipt of BCG vaccine at birth is acceptable
•5\) Receipt of immune globulins, blood or blood\-derived since birth
•6\) Known or suspected congenital or acquired immunodeficiency, including Severe Combined Immunodeficiency disorder (SCID); 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
•7\) History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy
•8\) History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
•9\) History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease