Clinical trial NCT03652610: 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
Official title: Immunogenicity, Reactogenicity and Safety of Two Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) in Healthy Adults 18 to 40 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: Meningitis
Liquid formulation
Meningococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 996
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios
timeFrame: At Day 29
Secondary outcomes:
measure: hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios
timeFrame: At Day 1 and Day 29
measure: Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y
timeFrame: At Day 29
measure: Percentages of Subjects With a ≥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
timeFrame: At Day 29
measure: Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences
timeFrame: At Day 1 and Day 29
measure: 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
timeFrame: At Day 1 and Day 29
measure: Number of Subjects Reported With Solicited Local and Systemic AEs
timeFrame: From Day 1 (6 hours) to Day 7 after vaccination
measure: Number of Subjects Reported With Other Indicators of Reactogenicity
timeFrame: From Day 1 to Day 7 after vaccination
measure: Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
timeFrame: From Day 1 to Day 29 after vaccination
measure: Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs)
timeFrame: From Day 1 to Day 181 (during the entire study period)
measure: Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
timeFrame: Within 30 minutes after vaccination at Day 1
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kanwal
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Gold Coast
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Sherwood
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Murdoch
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Melbourne
country: Australia
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Victoria
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Chieti
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Conegliano - Treviso
country: Italy
facility: GSK Investigational Site
city: Massafra (TA)
country: Italy
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.