A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age

NCT ID: NCT03652610

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 996 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2019-06-11

Brief Summary

MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GSK3536820A ACWY_Liq Group

Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.

Group Type: EXPERIMENTAL

MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)

Intervention Type: BIOLOGICAL

Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

ACWY Group

Healthy adults 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).

Group Type: ACTIVE_COMPARATOR

Licensed GSK MenACWY vaccine (Menveo)

Intervention Type: BIOLOGICAL

Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

Interventions

MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)

Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

Intervention Type: BIOLOGICAL

Licensed GSK MenACWY vaccine (Menveo)

Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK3536820A

Eligibility Criteria

Inclusion Criteria

1. Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Respresentative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.

2. Written informed consent obtained from the subject/from the parents(s)/LAR(s) of the subject prior to performance of any study specific procedure.

3. Written informed assent obtained for subjects below legal age of consent, if required by local regulations, at the time of enrolment.

4. A male or female between, and including, ≥18 to ≤40 YoA at the time of the first vaccination.

5. Healthy subjects as established by medical history and clinical examination before entering into the study.

6. Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

7. Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period. (approximately 1 month after vaccination).

Exclusion Criteria

1. Anaphylaxis following the administration of vaccine

2. Any (clinical) condition that in the judgment of the investigator would make intramuscular injection unsafe and/or represents a contraindication to intramuscular vaccination and blood draws.

3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.

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. Hypersensitivity to the active substances or to any of the excipients of the vaccine, including diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components.

7. Abnormal function of the immune system resulting from:

• Clinical conditions.
• Systemic administration of corticosteroids (Per os [PO]/ Intravenous [IV]/ Intramuscular [IM]) for more than 14 consecutive days within 90 days prior to informed consent, and until the Day 29 blood draw.
• Administration of antineoplastic and immuno-modulating agents or radiotherapy within 90 days prior to informed consent, and until the Day 29 blood draw.

8. Received immunoglobulins or any blood products within 180 days prior to informed consent.

9. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.

10. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

11. History of any meningococcal vaccination.

12. Individuals who received any other vaccines within 7 days (for inactivated vaccines) or 14 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines*.

• In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Summary of Product Characteristics (SmPC) or Prescribing Information and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.

13. Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).

14. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. (pharmaceutical product or device).

15. Current or previous, confirmed or suspected disease caused by N. meningitidis.

16. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.

17. Acute disease and/or fever within 3 days prior to study vaccination. Note: enrolment may be postponed/delayed until such transient circumstances have ended.

• Fever is defined as body temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

18. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.

19. Study personnel as an immediate family or household member.

20. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Blacktown, New South Wales, Australia

GSK Investigational Site

Kanwal, New South Wales, Australia

GSK Investigational Site

Gold Coast, Queensland, Australia

GSK Investigational Site

Sherwood, Queensland, Australia

GSK Investigational Site

Adelaide, South Australia, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Murdoch, Western Australia, Australia

GSK Investigational Site

Melbourne, , Australia

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Mirabel, Quebec, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Chieti, Abruzzo, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Conegliano - Treviso, , Italy

GSK Investigational Site

Massafra (TA), , Italy

Countries

Australia; Belgium; Canada; Germany; Italy

References

Vir Singh P, Tiberi P, Di Domenico GF, Romolini V, Mzolo T, Costantini M, Akhund T, Basile V, Lattanzi M, Pellegrini M. Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis. Drug Saf. 2023 Jan;46(1):99-108. doi: 10.1007/s40264-022-01242-8. Epub 2022 Nov 11.

Reference Type: DERIVED

PMID: 36369456 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V59_71

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003692-61

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205343

Identifier Type: -

Identifier Source: org_study_id