A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

NCT ID: NCT03433482

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1707 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2019-12-17

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 aged for different lengths of time by storage at 2-8ºC.

Conditions

Meningitis, Meningococcal

Study Design

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

Study Groups

GSK3536820A ACWY_Liq24 Group

Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1.

Group Type: EXPERIMENTAL

MenACWY liquid

Intervention Type: BIOLOGICAL

At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY\_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY\_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.

ACWY_1 Group

Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.

Group Type: ACTIVE_COMPARATOR

MenACWY

Intervention Type: BIOLOGICAL

At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY\_1) or in phase 2 of the study (subjects randomized to study arm ACWY\_2), administered by intramuscular injection in the deltoid of the non-dominant arm.

GSK3536820A ACWY_Liq30 Group

Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.

Group Type: EXPERIMENTAL

MenACWY liquid

Intervention Type: BIOLOGICAL

At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY\_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY\_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.

ACWY_2 Group

Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.

Group Type: ACTIVE_COMPARATOR

MenACWY

Intervention Type: BIOLOGICAL

At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY\_1) or in phase 2 of the study (subjects randomized to study arm ACWY\_2), administered by intramuscular injection in the deltoid of the non-dominant arm.

Interventions

MenACWY liquid

At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY\_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY\_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.

Intervention Type: BIOLOGICAL

MenACWY

At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY\_1) or in phase 2 of the study (subjects randomized to study arm ACWY\_2), administered by intramuscular injection in the deltoid of the non-dominant arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

Menveo

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 Representative(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 parent(s)/LAR(s) of the subject prior to performing 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 the enrolment.

4. A male or female ≥10 to ≤40 YoA at the time of the 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.

Exclusion Criteria

1. Child in care

2. Anaphylaxis following the administration of vaccine.

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

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

5. Progressive, unstable or uncontrolled clinical conditions.

6. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.

7. 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.

8. Abnormal function of the immune system resulting from:

• Clinical conditions.
• Systemic administration of corticosteroids within 90 days prior to informed consent, and until the Day 29 blood draw.
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent, and until the Day 29 blood draw.

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

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

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

12. History of any meningococcal vaccination, with the exception of previous meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age.

13. Individuals who received any other vaccines within 7 days (for inactivated vaccines) or 14 days 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 is organized 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 Prescribing Information and according to the local governmental recommendations and provided a written approval of the sponsor is obtained.

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

15. 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).

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

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

18. 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.

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

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

21. Pregnant or lactating women.

• Minimum Eligible Age: 10 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

Salvador, Estado de Bahia, Brazil

GSK Investigational Site

Natal, Rio Grande do Norte, Brazil

GSK Investigational Site

Rio de Janeiro, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Angers, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Nice, , France

GSK Investigational Site

Rosiers-d'Égletons, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Mérida, Yucatán, Mexico

GSK Investigational Site

Durango, , Mexico

GSK Investigational Site

Gatchina, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Murmansk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Pretoria, Gauteng, South Africa

GSK Investigational Site

Bellville, , South Africa

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Centelles (Barcelona), , Spain

GSK Investigational Site

L'Hospitalet de Llobregat, , Spain

GSK Investigational Site

La Roca Del Valles (Barcelona), , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Quart de Poblet, Valencia, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Vic/ Barcelona, , Spain

GSK Investigational Site

Eskişehir, , Turkey (Türkiye)

GSK Investigational Site

Izmir, , Turkey (Türkiye)

Countries

Brazil; Estonia; Finland; France; Mexico; Russia; South Africa; Spain; Turkey (Türkiye)

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_78

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003456-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

207467

Identifier Type: -

Identifier Source: org_study_id