Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
NCT ID: NCT02986854
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
704 participants
INTERVENTIONAL
2016-12-08
2017-12-07
Brief Summary
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Detailed Description
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Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio.
* Blood draws at Day 1, Day 4 and Day 29
* Blood draws at Day 1, Day 6 and Day 29
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Menveo-Menveo Group
Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.
Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
One intramuscular injection of MenACWY at Day 1.
Menactra-Menveo Group
Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.
Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
One intramuscular injection of MenACWY at Day 1.
Naive Group
Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1.
Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
One intramuscular injection of MenACWY at Day 1.
Interventions
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Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
One intramuscular injection of MenACWY at Day 1.
Eligibility Criteria
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Inclusion Criteria
2. Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine.
3. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
4. Individuals who can comply with study procedures including follow-up.
5. Males Or Females of non-childbearing potential Or
* Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Exclusion Criteria
1. History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration.
2. Current or previous, confirmed or suspected disease caused by N. meningitidis.
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
4. Progressive, unstable or uncontrolled clinical conditions.
5. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
6. Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws.
7. Abnormal function of the immune system resulting from:
1. Clinical conditions.
2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
8. Received immunoglobulins or any blood products within 180 days prior to informed consent.
9. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
10. Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
11. Study personnel as an immediate family or household member.
12. Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
13. Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.
14. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
15 Years
55 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Jose, California, United States
GSK Investigational Site
Centennial, Colorado, United States
GSK Investigational Site
Littleton, Colorado, United States
GSK Investigational Site
Pinellas Park, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Boise, Idaho, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Binghamton, New York, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Plano, Texas, United States
GSK Investigational Site
Plano, Texas, United States
GSK Investigational Site
San Angelo, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Tomball, Texas, United States
GSK Investigational Site
Draper, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
Ponce, , Puerto Rico
Countries
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References
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Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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V59_77
Identifier Type: OTHER
Identifier Source: secondary_id
2016-003186-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
205352
Identifier Type: -
Identifier Source: org_study_id
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