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

NCT03433482 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 207467V59_782017-003456-23
• Study Type: interventional
• Target: 1,707
• Locations: 8 countries
• Sites: 45

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

Keywords

Meningococcal disease; Liquid formulation; Meningitis

Outcome Measures

Primary Outcomes (1)

• Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios

  hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.

  At Day 29

Secondary Outcomes (10)

• hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios

  At Day 1 and Day 29

• Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group

  At Day 29

• Percentages of Subjects With ≥4 Fold Rise in hSBA Antibody Titers for Each of the N.Meningitidis Serogroups A, C,W and Y for Each Vaccine Group and Between-group Differences

  At Day 29

• Percentages of Subjects With hSBA Antibody Titers ≥8 Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Differences

  At Day 1 and Day 29

• Percentages of Subjects With hSBA Titers ≥LLOQ Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences

  At Day 1 and Day 29

Study Arms (4)

GSK3536820A ACWY_Liq24 Group

EXPERIMENTAL

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.

Biological: MenACWY liquid

ACWY_1 Group

ACTIVE COMPARATOR

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

Biological: MenACWY

GSK3536820A ACWY_Liq30 Group

EXPERIMENTAL

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.

Biological: MenACWY liquid

ACWY_2 Group

ACTIVE COMPARATOR

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

Biological: MenACWY

Interventions

MenACWY liquid 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.

GSK3536820A ACWY_Liq24 Group; GSK3536820A ACWY_Liq30 Group

MenACWY 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.

Also known as: Menveo

ACWY_1 Group; ACWY_2 Group

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• Written informed assent obtained for subjects below legal age of consent, if required by local regulations at the time of the enrolment.
• A male or female ≥10 to ≤40 YoA at the time of the vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• 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
• 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.

You may not qualify if:

• Child in care
• Anaphylaxis following the administration of vaccine.
• Any (clinical) condition that in the judgment of the investigator would make intramuscular injection unsafe \&/represents a contraindication to intramuscular vaccination and blood draws.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
• 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.
• 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.
• 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.
• Received immunoglobulins or any blood products within 180 days prior to informed consent.
• Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (49)

GSK Investigational Site

Salvador, Estado de Bahia, 40420-000, Brazil

Location

GSK Investigational Site

Natal, Rio Grande do Norte, 59025-050, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 22271-100, Brazil

Location

GSK Investigational Site

São Paulo, 01228-200, Brazil

Location

GSK Investigational Site

São Paulo, 04266-010, Brazil

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tallinn, 11313, Estonia

Location

GSK Investigational Site

Tallinn, Estonia

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Angers, 49000, France

Location

GSK Investigational Site

Nantes, 44277, France

Location

GSK Investigational Site

Nice, 06300, France

Location

GSK Investigational Site

Rosiers-d'Égletons, 19300, France

Location

GSK Investigational Site

Tours, 37044, France

Location

GSK Investigational Site

Mérida, Yucatán, 97070, Mexico

Location

GSK Investigational Site

Durango, 34000, Mexico

Location

GSK Investigational Site

Gatchina, 188300, Russia

Location

GSK Investigational Site

Moscow, 115478, Russia

Location

GSK Investigational Site

Murmansk, 183038, Russia

Location

GSK Investigational Site

Saint Petersburg, 191025, Russia

Location

GSK Investigational Site

Saint Petersburg, 196240, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Saint Petersburg, 197089, Russia

Location

GSK Investigational Site

Tomsk, 634 050, Russia

Location

GSK Investigational Site

Yaroslavl, 150051, Russia

Location

GSK Investigational Site

Yekaterinburg, 620028, Russia

Location

GSK Investigational Site

Pretoria, Gauteng, 0152, South Africa

Location

GSK Investigational Site

Bellville, 7530, South Africa

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, Spain

Location

GSK Investigational Site

Centelles (Barcelona), 08540, Spain

Location

GSK Investigational Site

L'Hospitalet de Llobregat, 08907, Spain

Location

GSK Investigational Site

La Roca Del Valles (Barcelona), 08430, Spain

Location

GSK Investigational Site

Madrid, 28050, Spain

Location

GSK Investigational Site

Quart de Poblet, Valencia, 46930, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Valencia, 46011, Spain

Location

GSK Investigational Site

Valencia, 46022, Spain

Location

GSK Investigational Site

Valencia, 46200, Spain

Location

GSK Investigational Site

Valencia, Spain

Location

GSK Investigational Site

Vic/ Barcelona, 08500, Spain

Location

GSK Investigational Site

Eskişehir, 26040, Turkey (Türkiye)

Location

GSK Investigational Site

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36369456 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections; Meningitis

Interventions

MenACWY; Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity and immunogenicity) will all be unaware of which vaccine was administered. To do so, vaccine preparation and administration will be done by authorized medical personnel who will not participate in any of the study clinical evaluations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: August 30, 2018
• Primary Completion: July 26, 2019
• Study Completion: December 17, 2019
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

ME (2); ES (13); TU (2); ZA (2); BR (5); RU (10); FR (5); FI (6)