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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652610
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Infections, Meningococcal Biological: MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A) Biological: Licensed GSK MenACWY vaccine (Menveo) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 996 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : September 7, 2018
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : June 11, 2019


Arm Intervention/treatment
Experimental: GSK3536820A ACWY_Liq Group
Approximately 486 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.
Biological: 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
Other Name: GSK3536820A

Active Comparator: ACWY Group
Approximately 486 healthy adults 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK' MenACWY vaccine formulation (Menveo).
Biological: Licensed GSK MenACWY vaccine (Menveo)
Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm




Primary Outcome Measures :
  1. Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup A for each vaccine group and between-groups ratios. [ Time Frame: At Day 29 ]
    hSBA titers against N.meningitidis serogroup A are calculated in terms of GMTs.


Secondary Outcome Measures :
  1. hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y for each vaccine group and between-groups ratios [ Time Frame: At Day 1 and Day 29 ]
    Geometric Mean Titers (GMTs) against each of the N. meningitidis serogroup A (except Day 29), C, W and Y

  2. Within-group Geometric Mean Ratios (GMRs) of GMTs against each of the N.meningitidis serogroups A, C, W and Y. [ Time Frame: At Day 29 ]
    Within group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1.

  3. 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-groups differences. [ Time Frame: At Day 29 ]

    The percentages of subjects with a ≥ 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs are computed by group and N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as:

    • for individuals, whose pre-vaccination titers are < the LOD (limit of detection), the post-vaccination titers must be ≥ 4-fold the LOD or ≥ the LLOQ (lower of limit of quantitation) whichever is greater;
    • for individuals, whose pre-vaccination titers are ≥ the LOD and ≤ the LLOQ, the post-vaccination titres must be at least four times the LLOQ;
    • for individuals whose pre-vaccination titers are > the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination titer.

  4. Percentages of subjects with hSBA titers ≥8 and ≥LLOQ against each of the N. meningitidis serogroups A, C, W and Y for each vaccine group and between-groups differences [ Time Frame: At Day 1 and Day 29 ]
    For each vaccine group the percentages of subjects with hSBA titer ≥8 and ≥LLOQ* and associated two-sided 95% Clopper-Pearson CIs are computed by the N. meningitidis serogroups A, C, W and Y on Day 1 and Day 29 Note*: ≥ LLOQ is to be assessed for each serogroup if the pre-defined LLOQ value for that serogroup is >8

  5. Number of subjects reporting any unsolicited adverse events (AEs) within 30 min after vaccination [ Time Frame: Within 30 min after vaccination at Day 1 ]
    An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.

  6. Number of subjects reporting solicited local and systemic AEs [ Time Frame: From Day 1 (6 hours) to Day 7 after vaccination ]
    Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after the vaccination.

  7. Number of subjects reporting other indicators of reactogenicity [ Time Frame: From Day 1 to Day 7 after vaccination ]
    Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after vaccination

  8. Number of subjects reporting any unsolicited AEs [ Time Frame: From Day 1 to Day 29 after vaccination ]
    An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.

  9. Number of subjects reporting serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs [ Time Frame: From Day 1 to Day 181 (during the entire study period) ]
    Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652610


Locations
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Australia, New South Wales
GSK Investigational Site
Blacktown, New South Wales, Australia, 2148
GSK Investigational Site
Kanwal, New South Wales, Australia, 2259
Australia, Queensland
GSK Investigational Site
Gold Coast, Queensland, Australia, 4222
GSK Investigational Site
Sherwood, Queensland, Australia, 4075
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
GSK Investigational Site
Murdoch, Western Australia, Australia, 6150
Australia
GSK Investigational Site
Melbourne, Australia
Belgium
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
Canada, British Columbia
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3M9
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 0G1
GSK Investigational Site
London, Ontario, Canada, N5W 6A2
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
GSK Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1L 0H8
Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4
Germany
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Hamburg, Germany, 22143
Italy
GSK Investigational Site
Chieti, Abruzzo, Italy, 66013
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Conegliano - Treviso, Italy, 31015
GSK Investigational Site
Massafra (TA), Italy, 74016
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03652610    
Other Study ID Numbers: 205343
V59_71 ( Other Identifier: Novartis )
2017-003692-61 ( EudraCT Number )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Meningitis
Liquid formulation
Meningococcal disease
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs