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

Completed · Phase 3

Conditions studied: Infections, Meningococcal

In brief

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

Key facts

Study ID

NCT02986854

Run by

GlaxoSmithKline

People needed

704

Starts

2016-12-08

Expected to finish

2017-12-07

Last updated by the study team

2019-11-25

Who can join

Age: 15 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• 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.
• 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.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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