Clinical trial NCT02986854: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Meningococcal disease
Booster vaccination
Meningitis
Antibody persistence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 704
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial.

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

Eligibility 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:

   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.

Primary outcomes:
measure: 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:
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
timeFrame: Within 30 minutes after vaccination
measure: Number of Subjects Reporting Solicited Local and Systemic AEs
timeFrame: From Day 1 (6 hours) through Day 7 after vaccination
measure: Number of Subjects Reporting Other Indicators of Reactogenicity
timeFrame: From Day 1 (6 hours) through Day 7 after vaccination
measure: Number of Subjects Reporting All Unsolicited AEs
timeFrame: From Day 1 through Day 29 after vaccination
measure: 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)
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y
timeFrame: At Day 4 and Day 6
measure: 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
measure: Within Group hSBA Geometric Mean Ratios (GMRs)
timeFrame: At Day 4, Day 6, Day 29 compared to Day 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Littleton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Pinellas Park
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: San Angelo
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: Draper
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.