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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02986854

V59_77 (Other Identifier)

205352

2016-003186-25 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 704 patients

Sex: All

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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704 participants in 3 patient groups

Menveo-Menveo Group

Experimental group

Description:

Approximately 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.

Treatment:

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

Menactra-Menveo Group

Experimental group

Description:

Approximately 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.

Treatment:

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

Naive Group

Active Comparator group

Description:

Aproximately 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.

Treatment:

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