Status:
COMPLETED
Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningococcal Infections
Eligibility:
All Genders
46-61 years
Phase:
PHASE3
Brief Summary
This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogrou...
Detailed Description
Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54 (NCT03205358) were eligible for enrollment. All participants received a single booster dose of MenACYW con...
Eligibility Criteria
Inclusion
- Participated in and completed (attended Visit 2) study MET54.
- Informed consent form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations).
- Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.
- Covered by health insurance where applicable.
Exclusion
- 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.
- 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 might 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 participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2.
- 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.
- 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
- At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
- 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.
- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- Personal history of Guillain-Barré syndrome.
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
- Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[°C\]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03476135
Start Date
February 27 2018
End Date
September 10 2018
Last Update
April 6 2022
Active Locations (8)
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1
Sanofi Pasteur Investigational Site 2460005
Espoo, Finland, 02230
2
Sanofi Pasteur Investigational Site 2460006
Helsinki, Finland, 00100
3
Sanofi Pasteur Investigational Site 2460002
Helsinki, Finland, 00930
4
Sanofi Pasteur Investigational Site 2460007
Jarvenpaa, Finland, 04400