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

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GSK study ID
205352
See study documents
Clinicaltrials.gov ID
NCT02986854
See results summary
EudraCT ID
2016-003186-25
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Biological/vaccine: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
    • 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:

      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

      • 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:
    • 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
    Status
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    Location
    GSK Investigational Site
    Anaheim, California, United States, 92804
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bardstown, Kentucky, United States, 40004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Binghamton, New York, United States, 13901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Centennial, Colorado, United States, 80112
    Status
    Study Complete
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    Study documents

    Statistical analysis plan
    Available language(s): English
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    Protocol
    Available language(s): English
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    Clinical study report
    Available language(s): English
    Download document(s)

    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)
    Download document(s)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

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    Additional information
    Full CSR posting on GSK
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    Access to clinical trial data by researchers
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