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Phase 2 N=1,690 Randomized Quadruple-blind Prevention

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

Meningitis, Meningococcal

Enrolled (actual)
1,690
Serious AEs
0.8%
Results posted
Feb 2021
Primary outcome: Primary: Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios — 386.66; 318.34; 387.06; 348.89 Titers

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
MenACWY liquid (Biological); MenACWY (Biological)
Age
Pediatric, Adult · 10+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios
386.66; 318.34; 387.06; 348.89
SECONDARY
hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios
3.01; 2.91; 3.34; 3.16; 388.53; 319.06
SECONDARY
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group
130.33; 108.39; 114.66; 106.79; 17.01; 21.68
SECONDARY
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
92.29; 90.08; 91.57; 91.69; 62.34; 64.46
SECONDARY
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
12.07; 10.28; 13.53; 12.03; 93.65; 92.19
SECONDARY
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
12.86; 11.57; 15.38; 13.64; 93.92; 92.19
SECONDARY
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
2; 2; 6; 6
SECONDARY
Number of Subjects Reported With Solicited Local and Systemic AEs
45; 50; 49; 40; 75; 79
SECONDARY
Number of Subjects Reported With Other Indicators of Reactogenicity
357; 374; 366; 369; 61; 48
SECONDARY
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
77; 91; 101; 97
SECONDARY
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs
0; 0; 0; 0; 4; 1

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.

Eligibility Criteria

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 (pha
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03433482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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