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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Meningitis, Meningococcal

Treatments

Biological: MenACWY
Biological: MenACWY liquid

Study type

Interventional

Funder types

Industry

Identifiers

NCT03433482
207467
2017-003456-23 (EudraCT Number)
V59_78 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,707 patients

Sex

All

Ages

10 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

  • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
  • 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).
  • Current or previous, confirmed or suspected disease caused by N. meningitidis.
  • Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.

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.
  • Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
  • Study personnel as an immediate family or household member.
  • Pregnant or lactating women.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,707 participants in 4 patient groups

GSK3536820A ACWY_Liq24 Group
Experimental group
Description:
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.
Treatment:
Biological: MenACWY liquid
ACWY_1 Group
Active Comparator group
Description:
Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
Treatment:
Biological: MenACWY
GSK3536820A ACWY_Liq30 Group
Experimental group
Description:
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.
Treatment:
Biological: MenACWY liquid
ACWY_2 Group
Active Comparator group
Description:
Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Treatment:
Biological: MenACWY

Trial documents
2

Trial contacts and locations

49

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Data sourced from clinicaltrials.gov

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