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
A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
3 other identifiers
interventional
704
2 countries
37
Brief Summary
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2016
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Start
First participant enrolled
December 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2017
CompletedResults Posted
Study results publicly available
August 3, 2018
CompletedNovember 25, 2019
November 1, 2019
7 months
December 6, 2016
July 4, 2018
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers\< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo \&,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W \& Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo \& Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
At Day 29
Secondary Outcomes (16)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Within 30 minutes after vaccination
Number of Subjects Reporting Solicited Local and Systemic AEs
From Day 1 (6 hours) through Day 7 after vaccination
Number of Subjects Reporting Other Indicators of Reactogenicity
From Day 1 (6 hours) through Day 7 after vaccination
Number of Subjects Reporting All Unsolicited AEs
From Day 1 through Day 29 after vaccination
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)
From Day 1 through Day 181 (entire study period)
- +11 more secondary outcomes
Study Arms (3)
Menveo-Menveo Group
EXPERIMENTALApproximately 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.
Menactra-Menveo Group
EXPERIMENTALApproximately 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.
Naive Group
ACTIVE COMPARATORAproximately 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.
Interventions
One intramuscular injection of MenACWY at Day 1.
Eligibility Criteria
You may qualify if:
- Individuals of 15 through 55 years of age on the day of informed consent or assent.
- 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.
- 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.
- Individuals who can comply with study procedures including follow-up.
- 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.
You may not qualify if:
- Each subject must not have:
- History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration.
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws.
- Abnormal function of the immune system resulting from:
- Clinical conditions.
- Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
- Received immunoglobulins or any blood products within 180 days prior to informed consent.
- Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
- Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
- Study personnel as an immediate family or household member.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (37)
GSK Investigational Site
Birmingham, Alabama, 35211, United States
GSK Investigational Site
Huntsville, Alabama, 35802, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Anaheim, California, 92804, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
Sacramento, California, 95864, United States
GSK Investigational Site
San Jose, California, 95119, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Littleton, Colorado, 80128, United States
GSK Investigational Site
Pinellas Park, Florida, 33781, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Boise, Idaho, 83712, United States
GSK Investigational Site
Chicago, Illinois, 60604, United States
GSK Investigational Site
Wichita, Kansas, 67205-1138, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Louisville, Kentucky, 40207, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Omaha, Nebraska, 68144, United States
GSK Investigational Site
Binghamton, New York, 13901, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Fort Worth, Texas, 76135, United States
GSK Investigational Site
Plano, Texas, 75024, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
San Angelo, Texas, 76904, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Tomball, Texas, 77375, United States
GSK Investigational Site
Draper, Utah, 84020, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Salt Lake City, Utah, 84123, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
Ponce, 00716, Puerto Rico
Related Publications (1)
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.
PMID: 31495595BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 8, 2016
Study Start
December 8, 2016
Primary Completion
July 17, 2017
Study Completion
December 7, 2017
Last Updated
November 25, 2019
Results First Posted
August 3, 2018
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD is available via the Clinical Study Data Request site (click on the link provided below)