Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers

Phase 1

• Conditions: Healthy meningococcal vaccine primed male and female children aged 4-5 years who were previously vaccinated 3 years (± 45 days) earlier at 12 to 23 months of age in study MET54; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-001993-40-FI
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-18
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible
for trial enrollment:
1) Participated in and completed (attended Visit 2) study MET54

2) Informed consent form has been signed and dated by the parent(s) or
another legally acceptable representative (and by an independent
witness, if required by local regulations)

3) 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: 188
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 a gap of at least
2 weeks before or after the study vaccines. This exception includes
monovalent pandemic influenza vaccines and multivalent influenza
vaccines. If the subject is due to receive vaccination(s) recommended
for his / her age by the national immunization schedule at the time of
the study, the subject will be recommended to complete his/her
immunization schedule after Visit 2.

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 vaccine) with the exception of the single dose of
meningococcal vaccine administered as part of study MET54

4) Receipt of immune globulins, blood or blood-derived products in the
past 3 months

5) 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)

6) History of meningococcal infection, confirmed either clinically,
serologically, or microbiologically

7) 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 traveling to countries with
high endemic or epidemic disease)

8) Known systemic hypersensitivity to any of the vaccine components, or
history of a life-threatening reaction to the vaccine used in the trial or to
a vaccine containing any of the same substances

9) Verbal report of thrombocytopenia, contraindicating intramuscular
vaccination in the Investigator’s opinion

10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
inclusion, contraindicating intramuscular vaccination

11) Personal history of Guillain-Barré syndrome (GBS)

12) Personal history of an Arthus-like reaction after vaccination with a
tetanus toxoid-containing vaccine

13) Chronic illness that, in the opinion of the Investigator, is at a stage
where it might interfere with trial conduct or completion

14) 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

15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to
the first blood draw.

16) 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