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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03652610




Registration number
NCT03652610
Ethics application status
Date submitted
28/08/2018
Date registered
29/08/2018

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
V59_71
Secondary ID [2] 0 0
205343
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
Treatment: Other - MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)
Treatment: Other - Licensed GSK MenACWY vaccine (Menveo)

Experimental: GSK3536820A ACWY_Liq Group - 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.

Active comparator: ACWY Group - Healthy adults 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).


Treatment: Other: 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

Treatment: Other: Licensed GSK MenACWY vaccine (Menveo)
Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios
Timepoint [1] 0 0
At Day 29
Secondary outcome [1] 0 0
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios
Timepoint [1] 0 0
At Day 1 and Day 29
Secondary outcome [2] 0 0
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y
Timepoint [2] 0 0
At Day 29
Secondary outcome [3] 0 0
Percentages of Subjects With a =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
Timepoint [3] 0 0
At Day 29
Secondary outcome [4] 0 0
Percentages of Subjects With hSBA Titers =8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences
Timepoint [4] 0 0
At Day 1 and Day 29
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
At Day 1 and Day 29
Secondary outcome [6] 0 0
Number of Subjects Reported With Solicited Local and Systemic AEs
Timepoint [6] 0 0
From Day 1 (6 hours) to Day 7 after vaccination
Secondary outcome [7] 0 0
Number of Subjects Reported With Other Indicators of Reactogenicity
Timepoint [7] 0 0
From Day 1 to Day 7 after vaccination
Secondary outcome [8] 0 0
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
Timepoint [8] 0 0
From Day 1 to Day 29 after vaccination
Secondary outcome [9] 0 0
Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs)
Timepoint [9] 0 0
From Day 1 to Day 181 (during the entire study period)
Secondary outcome [10] 0 0
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
Timepoint [10] 0 0
Within 30 minutes after vaccination at Day 1

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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 2
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
7/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/06/2019
Sample size
Target
Accrual to date
Final
996
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [2] 0 0
GSK Investigational Site - Kanwal
Recruitment hospital [3] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [4] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [5] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [6] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [7] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
4222 - Gold Coast
Recruitment postcode(s) [4] 0 0
4075 - Sherwood
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Germany
State/province [7] 0 0
Bayern
Country [8] 0 0
Germany
State/province [8] 0 0
Nordrhein-Westfalen
Country [9] 0 0
Germany
State/province [9] 0 0
Rheinland-Pfalz
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Italy
State/province [12] 0 0
Abruzzo
Country [13] 0 0
Italy
State/province [13] 0 0
Liguria
Country [14] 0 0
Italy
State/province [14] 0 0
Conegliano - Treviso
Country [15] 0 0
Italy
State/province [15] 0 0
Massafra (TA)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03652610