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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04502693




Registration number
NCT04502693
Ethics application status
Date submitted
4/08/2020
Date registered
6/08/2020
Date last updated
5/03/2024

Titles & IDs
Public title
Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
Scientific title
A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults
Secondary ID [1] 0 0
2019-001666-15
Secondary ID [2] 0 0
205416
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - rMenB+OMV NZ vaccine
Other interventions - Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Combination Product - Placebo
Combination Product - MenABCWY-1
Combination Product - MenABCWY-2
Combination Product - MenABCWY-3

Experimental: MenB_0_2_6 Group - Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.

Experimental: MenB_0_6 Group - Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Experimental: ABCWY-1 Group - Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.

Experimental: ABCWY-2 Group - Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.

Experimental: ABCWY-3 Group - Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.

Active Comparator: ACWY Group - Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.

Experimental: ABCWY_Pooled - Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.
To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.


Combination Product: rMenB+OMV NZ vaccine
rMenB+OMV NZ vaccine was administered intramuscularly.

Other interventions: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
MenACWY vaccine was administered intramuscularly.

Combination Product: Placebo
Placebo was administered intramuscularly.

Combination Product: MenABCWY-1
Lot 1 of the MenABCWY vaccine was administered intramuscularly.

Combination Product: MenABCWY-2
Lot 2 of the MenABCWY vaccine was administered intramuscularly.

Combination Product: MenABCWY-3
Lot 3 of the MenABCWY vaccine was administered intramuscularly.
Intervention code [1] 0 0
Combination Product
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M), 2-dose(0,6-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY
Timepoint [1] 0 0
At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)
Primary outcome [2] 0 0
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose (0,2-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY
Timepoint [2] 0 0
At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)
Primary outcome [3] 0 0
Percentage of Participants Whose Sera Kill Greater Than or Equal to (>=) 70% of the Strains Tested Using Enc-hSBA at 1 Month After the 3-dose (0,2,6-M) Schedule of rMenB+OMV and 2-dose(0,6-M) Schedule of rMenB+OMV
Timepoint [3] 0 0
At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)
Primary outcome [4] 0 0
Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the 2-dose (0,2-M) Schedule of rMenB+OMV
Timepoint [4] 0 0
At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])
Primary outcome [5] 0 0
Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY
Timepoint [5] 0 0
At 1 month after the last vaccination of MenABCWY (Day 211)
Primary outcome [6] 0 0
Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline
Timepoint [6] 0 0
At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)
Primary outcome [7] 0 0
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group)
Timepoint [7] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)
Primary outcome [8] 0 0
Percentage of Blood Samples With Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose (Pooled Lots) and 2-dose(0,2-M) Schedule of rMenB+OMV
Timepoint [8] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])
Primary outcome [9] 0 0
Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the Last Vaccination in the ABCWY Group (Pooled Lots)
Timepoint [9] 0 0
At 1 month after the last vaccination of MenABCWY (Day 211)
Primary outcome [10] 0 0
Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration
Timepoint [10] 0 0
During 7 days after the first study intervention administration occurring at Day 1
Primary outcome [11] 0 0
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration
Timepoint [11] 0 0
During 7 days after the second study intervention administration occurring at Day 61
Primary outcome [12] 0 0
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration
Timepoint [12] 0 0
During 7 days after the third study intervention administration occurring at Day 181
Primary outcome [13] 0 0
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration
Timepoint [13] 0 0
During 7 days after the first study intervention administration occurring at Day 1
Primary outcome [14] 0 0
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration
Timepoint [14] 0 0
During 7 days after the second study intervention administration occurring at Day 61
Primary outcome [15] 0 0
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration
Timepoint [15] 0 0
During 7 days after the third study intervention administration occurring at Day 181
Primary outcome [16] 0 0
Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration
Timepoint [16] 0 0
During the 30 days after the first study intervention administration occurring at Day 1
Primary outcome [17] 0 0
Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration
Timepoint [17] 0 0
During the 30 days after the second study intervention administration occurring at Day 61
Primary outcome [18] 0 0
Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration
Timepoint [18] 0 0
During the 30 days after the third study intervention administration occurring at Day 181
Primary outcome [19] 0 0
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
Timepoint [19] 0 0
Throughout the study period (Day 1 to Day 361)
Secondary outcome [1] 0 0
Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline
Timepoint [1] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)
Secondary outcome [2] 0 0
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
Timepoint [2] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)
Secondary outcome [3] 0 0
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
Timepoint [3] 0 0
At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)
Secondary outcome [4] 0 0
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots)
Timepoint [4] 0 0
At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)
Secondary outcome [5] 0 0
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Timepoint [5] 0 0
At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])
Secondary outcome [6] 0 0
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Timepoint [6] 0 0
At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)
Secondary outcome [7] 0 0
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Timepoint [7] 0 0
At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])
Secondary outcome [8] 0 0
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Timepoint [8] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)
Secondary outcome [9] 0 0
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months)
Timepoint [9] 0 0
At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)
Secondary outcome [10] 0 0
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Timepoint [10] 0 0
At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)
Secondary outcome [11] 0 0
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Timepoint [11] 0 0
At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])
Secondary outcome [12] 0 0
hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Timepoint [12] 0 0
At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)
Secondary outcome [13] 0 0
hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Timepoint [13] 0 0
At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)
Secondary outcome [14] 0 0
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group
Timepoint [14] 0 0
At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
Secondary outcome [15] 0 0
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1)
Timepoint [15] 0 0
At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)
Secondary outcome [16] 0 0
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
Timepoint [16] 0 0
At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
Secondary outcome [17] 0 0
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
Timepoint [17] 0 0
1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)
Secondary outcome [18] 0 0
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group
Timepoint [18] 0 0
At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Eligibility
Key inclusion criteria
- Subjects or/and 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 or witnessed/thumb printed informed consent obtained from the
subject/parent(s)/LAR(s) of the subject prior to performance of any study specific
procedure.

- Written informed assent obtained from the subject (if applicable) prior to performing
any study specific procedure.

- A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364
days) at the time of the first vaccination.

- Healthy subjects as established by medical history physical examination and clinical
judgment of the investigator before entering into the study.

- Subjects who are either unvaccinated with MenACWY vaccine or have received a single
previous dose of MenACWY vaccine can participate in the study, if they have received
it at least 4 years prior to informed consent and assent as applicable (with the
exception of meningococcal C vaccination, if the last dose of MenC was received at =24
months of age).

- 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 until 30 days after completion of
Visit 6.

- A female is considered to be of non-childbearing potential prior to menarche
and after natural or induced menopause. Natural menopause is recognized to
have occurred after 12 consecutive months of amenorrhea for which there is
no other obvious pathological or physiological cause. Induced menopause is
recognized to have occurred after hysterectomy, after bilateral
oophorectomy, or iatrogenic ablation of ovarian function.
Minimum age
10 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions

- Current or previous, confirmed or suspected disease caused by N. meningitidis.

- Household contact with and/or intimate exposure to an individual with laboratory
confirmed N. meningitidis infection within 60 days of enrolment.

- Progressive, unstable or uncontrolled clinical conditions.

- Clinical conditions representing a contraindication to intramuscular vaccination and
blood draws.

- Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures.
History of febrile convulsions should not lead to exclusion.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine(s)/product(s).

- Hypersensitivity, including allergy, to any component of vaccines, including
diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment
whose use is foreseen in this study.

- Abnormal function or modification of the immune system resulting from:

- Autoimmune disorders or immunodeficiency syndromes.

- Systemic administration of corticosteroids (PO/IV/IM) for more than 14
consecutive days within 90 days prior to study vaccination until the
post-vaccination 3 blood sample (Visit 6). This will mean prednisone - =20 mg/day
(for adult subjects) or =0.5 mg/kg/day (for paediatric subjects), or equivalent.
Inhaled and topical steroids are allowed.

- Administration of antineoplastic and immunomodulating agents or radiotherapy
within 90 days prior to study vaccination.

- Administration of long-acting immune-modifying drugs at any time during the study
period (e.g. infliximab).

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

Prior/Concomitant therapy

- Use of any investigational or non-registered product other than the study
vaccine(s)/product(s) during the period starting 30 days before the first dose of
study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study
period.

- Previous vaccination against any group B meningococcal vaccine at any time prior to
informed consent and assent as applicable.

- Administration of immunoglobulins and/or any blood products or plasma derivatives
during the period starting 90 days before the first dose of study vaccine/ product or
planned administration during the study period until the post-vaccination 3 blood
sample (Visit 6).

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs during the period starting 90 days prior to the
vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For
corticosteroids, this will mean prednisone =20 mg/day (for adult subjects) or =0.5
mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are
allowed.

Prior/Concurrent clinical study experience

• 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.

Other exclusions

- Child in care.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- History of /current chronic alcohol abuse and/or drug abuse as determined by the
investigator.

- Any study personnel or immediate dependants, family, or household member.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2022
Sample size
Target
Accrual to date
Final
3657
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [3] 0 0
GSK Investigational Site - Taringa
Recruitment hospital [4] 0 0
GSK Investigational Site - Tarragindi
Recruitment hospital [5] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [6] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [7] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4222 - Gold Coast
Recruitment postcode(s) [3] 0 0
4068 - Taringa
Recruitment postcode(s) [4] 0 0
4121 - Tarragindi
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3010 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Québec
Country [31] 0 0
Czechia
State/province [31] 0 0
Ceske Budejovice
Country [32] 0 0
Czechia
State/province [32] 0 0
Hradec Kralove
Country [33] 0 0
Czechia
State/province [33] 0 0
Jindrichuv Hradec
Country [34] 0 0
Czechia
State/province [34] 0 0
Kladno
Country [35] 0 0
Czechia
State/province [35] 0 0
Melnik
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Czechia
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Pardubice
Country [37] 0 0
Czechia
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Praha 6
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Pribram
Country [39] 0 0
Czechia
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Trutnov
Country [40] 0 0
Czechia
State/province [40] 0 0
Tynec nad Sazavou
Country [41] 0 0
Czechia
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Ceské Budejovice
Country [42] 0 0
Estonia
State/province [42] 0 0
Tallinn
Country [43] 0 0
Finland
State/province [43] 0 0
Espoo
Country [44] 0 0
Finland
State/province [44] 0 0
Helsinki
Country [45] 0 0
Finland
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Jarvenpaa
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Finland
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Kokkola
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Finland
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Oulu
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Pori
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Seinajoki
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State/province [50] 0 0
Tampere
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Turku
Country [52] 0 0
Turkey
State/province [52] 0 0
Adana
Country [53] 0 0
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State/province [53] 0 0
Ankara
Country [54] 0 0
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State/province [54] 0 0
Eskisehir
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Izmir
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Kayseri

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's
licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's
investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy
adolescents and young adults. The immunogenicity and safety were evaluated in the study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04502693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
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Email 0 0
Contact person for scientific queries