Last updated: 02/18/2020 07:30:12
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
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentages of subjects with human Serum Bactericidal Antibody (hSBA) seroresponse against Neisseria meningitidis serogroups A, C, W and Y.
Timeframe: At Day 29
Secondary outcomes:
Number of subjects reporting any unsolicited adverse events (AEs)
Timeframe: Within 30 minutes after vaccination
Number of subjects reporting solicited local and systemic AEs
Timeframe: From Day 1 (6 hours) through Day 7 after vaccination
Number of subjects reporting other indicators of reactogenicity
Timeframe: From Day 1 (6 hours) through Day 7 after vaccination
Number of subjects reporting all unsolicited AEs
Timeframe: From Day 1 through Day 29 after vaccination
Number of subjects reporting medically-attended AEs (MAAEs), AEs leading to withdrawal and serious AEs (SAEs)
Timeframe: From Day 1 through Day 181 (entire study period)
Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup A
Timeframe: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup C
Timeframe: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentage of subjects with hSBA titer ≥8 against N. meningitidis serogroup W
Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of subjects with hSBA titer ≥8 against N. meningitidis serogroup Y
Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup A
Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup C
Timeframe: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup W
Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of subjects with hSBA titer ≥16 against N. meningitidis serogroup Y
Timeframe: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y
Timeframe: At Day 4 and Day 6
hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup A, C, W and Y.
Timeframe: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Within group hSBA Geometric Mean Ratios (GMRs)
Timeframe: At Day 4, Day 6, Day 29 compared to Day 1
Interventions:
Enrollment:
704
Primary completion date:
2017-17-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Mary Tipton et al. (2019) 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. 37(42):6171-6179.
Medical condition
Infections, Meningococcal
Product
GSK3536820A
Collaborators
Not applicable
Study date(s)
December 2016 to December 2017
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15 - 55 years
Accepts healthy volunteers
Yes
- 1. Individuals of 15 through 55 years of age on the day of informed consent or assent.
- 2. Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older
- Each subject must not have:
- 1. History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
1. Individuals of 15 through 55 years of age on the day of informed consent or assent. 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
Exclusion criteria:
- Each subject must not have: 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: a. Clinical conditions. b. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination. c. 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.
Trial location(s)
Location
GSK Investigational Site
Anaheim, California, United States, 92804
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Binghamton, New York, United States, 13901
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35211
Status
Study Complete
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60604
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76135
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35802
Status
Study Complete
Location
GSK Investigational Site
Littleton, Colorado, United States, 80128
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40207
Status
Study Complete
Location
GSK Investigational Site
Pinellas Park, Florida, United States, 33781
Status
Study Complete
Location
GSK Investigational Site
Ponce, Puerto Rico, Puerto Rico, 00716
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95815
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95864
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84123
Status
Study Complete
Location
GSK Investigational Site
San Angelo, Texas, United States, 76904
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95119
Status
Study Complete
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Wichita, Kansas, United States, 67205-1138
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2017-17-07
Actual study completion date
2017-07-12
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Participate in clinical trial
Additional information
Full CSR posting on GSK
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