Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age

Phase 1

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

• Registration Number: EUCTR2016-000749-30-DE
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-21
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 918

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 12 to 23 months on the day of the first study visit
2) Subjects have received all recommended standard-of-care nonmeningococcal vaccinations according to his/her age as per local regulations.
3) Informed consent form (ICF) has been signed and dated by the parent/legally acceptable representative
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
5) Covered by health insurance if required by local regulations
6) Subjects have not received any meningococcal vaccine in the second year of life (i.e., from 12 months of age).
7) For Inclusion in Groups 1 and 2 (naive population, i.e. in Germany and Finland ) : Subjects must not have received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine).
8) For Inclusion in Groups 3 and 4 (primed population, i.e. in Spain and Hungary) : Subjects must have previously received at least 1 dose of licensed monovalent meningococcal C conjugate (MenC) vaccine during infancy (i.e., before 12 months of age)
Are the trial subjects under 18? yes
Number of subjects for this age range: 918
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

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation in the 4 weeks preceding the 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 (28 days) preceding the trial vaccination 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 study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
3) Receipt of immune globulins, blood or blood-derived products in the past 3 months
4) For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine)
5) For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C conjugate (MenC) vaccination received during infancy
6) 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)
7) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
8) At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with
anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or
to a vaccine containing any of the same substances
10) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
11) Personal history of Guillain-Barré syndrome (GBS)
12) Verbal report of thrombocytopenia as reported by the parent/legally acceptable representative contraindicating intramuscular vaccination in the Investigator’s opinion
13) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator’s opinion
14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified