Clinical trial NCT04318548: Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
Official title: A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Meningitis
Invasive meningococcal disease
Bexsero
Menveo
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 945
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.


Eligibility criteria: Inclusion Criteria:

* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' 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.
* Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
* Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
* Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
* A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
* Healthy participants as established by medical history and clinical examination before entering the study.
* Female participants 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 participants of childbearing potential may be enrolled in the study if the participant:

  * 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 and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Medical conditions

* Progressive, unstable, or uncontrolled clinical conditions.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Abnormal function of the immune system resulting from:

  * Clinical conditions.
  * Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
  * Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
* Current or previous, confirmed, or suspected disease caused by N. meningitidis.
* Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
* History of neuroinflammatory or autoimmune condition.
* Recurrent history or un-controlled neurological disorders or seizures.

Prior/Concomitant therapy

* Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period.
* Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
* Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo, Menactra or MenQuadfi).

Prior/Concurrent clinical study experience

• Participant concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product, will not be enrolled.

Other exclusions

* Child in care.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any study personnel or immediate dependents, family, or household member.

Primary outcomes:
measure: Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
timeFrame: During 7 days after the rMenB+OMV NZ vaccination at Day 1
measure: Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
timeFrame: During 7 days after the rMenB+OMV NZ vaccination at Day 61
measure: Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
timeFrame: During 7 days after the rMenB+OMV NZ vaccination at Day 91
measure: Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
timeFrame: During 7 days after the MenACWY vaccination at Day 1
measure: Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
timeFrame: During 7 days after the MenACWY vaccination at Day 61
measure: Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
timeFrame: During 7 days after the MenACWY vaccination at Day 91
measure: Number of Participants With Solicited Local AEs After the Vaccination With Placebo
timeFrame: During 7 days after the Placebo vaccination at Day 1
measure: Number of Participants With Solicited Local AEs After the Vaccination With Placebo
timeFrame: During 7 days after the Placebo vaccination at Day 91
measure: Number of Participants With Solicited Systemic AEs
timeFrame: During 7 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Solicited Systemic AEs
timeFrame: During 7 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Solicited Systemic AEs
timeFrame: During 7 days after the third study intervention administration occurring at Day 91
measure: Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
timeFrame: During 30 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
timeFrame: During 30 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
timeFrame: During 30 days after the third study intervention administration occurring at Day 91
measure: Number of Participants With Any AEs/SAEs Leading to Withdrawal
timeFrame: During 30 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Any AEs/SAEs Leading to Withdrawal
timeFrame: During 30 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Any AEs/SAEs Leading to Withdrawal
timeFrame: During 30 days after the third study intervention administration occurring at Day 91
measure: Number of Participants With Any Medically Attended AEs
timeFrame: During 30 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Any Medically Attended AEs
timeFrame: During 30 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Any Medically Attended AEs
timeFrame: During 30 days after the third study intervention administration occurring at Day 91
measure: Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs
timeFrame: Throughout the study period (Day 1 to Day 271)
measure: Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)
timeFrame: Throughout the study period (Day 1 to Day 271)
measure: Number of Participants With Any SAEs and AEs Leading to Withdrawal
timeFrame: During safety follow-up (Day 271 to Day 451)
measure: Number of Participants Who Received rMenB+OMV NZ With AESI
timeFrame: During safety follow-up (Day 271 to Day 451)
measure: Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios
timeFrame: At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)
measure: hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios
timeFrame: At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)
Secondary outcomes:
measure: hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination
timeFrame: At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)
measure: hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios
timeFrame: At Day 31 (1 month after first vaccination with rMenB+OMV NZ)
measure: Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
timeFrame: At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
measure: GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
timeFrame: At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
measure: Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
timeFrame: At Day 31 (one month after the first rMenB+OMV NZ vaccination)
measure: Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
timeFrame: At Day 91 (1 month after the second rMenB+OMV NZ vaccination)
measure: Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
timeFrame: At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
measure: Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
timeFrame: At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1)
measure: Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
timeFrame: At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31)
measure: GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
timeFrame: At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1)
measure: Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
timeFrame: At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bell Gardens
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Santa Clara
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Wellington
country: United States
facility: GSK Investigational Site
state: Florida
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Cortland
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Corvallis
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Victoria
country: United States
facility: GSK Investigational Site
state: Texas
city: Waxahachie
country: United States
facility: GSK Investigational Site
state: Texas
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
city: Falls Church
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Chiavari GE
country: Italy
facility: GSK Investigational Site
city: Foggia
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: