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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03652610
Other study ID # 205343
Secondary ID V59_712017-00369
Status Completed
Phase Phase 2
First received
Last updated
Start date September 7, 2018
Est. completion date June 11, 2019

Study information

Verified date January 2021
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 996
Est. completion date June 11, 2019
Est. primary completion date January 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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). 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


Related Conditions & MeSH terms


Intervention

Biological:
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
Licensed GSK MenACWY vaccine (Menveo)
Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

Locations

Country Name City State
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Blacktown New South Wales
Australia GSK Investigational Site Gold Coast Queensland
Australia GSK Investigational Site Kanwal New South Wales
Australia GSK Investigational Site Melbourne
Australia GSK Investigational Site Melbourne Victoria
Australia GSK Investigational Site Murdoch Western Australia
Australia GSK Investigational Site Sherwood Queensland
Belgium GSK Investigational Site Gent
Belgium GSK Investigational Site Leuven
Canada GSK Investigational Site Brampton Ontario
Canada GSK Investigational Site Halifax Nova Scotia
Canada GSK Investigational Site London Ontario
Canada GSK Investigational Site Mirabel Quebec
Canada GSK Investigational Site Pointe-Claire Quebec
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site Sherbrooke Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Truro Nova Scotia
Canada GSK Investigational Site Victoria British Columbia
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Essen Nordrhein-Westfalen
Germany GSK Investigational Site Goch Nordrhein-Westfalen
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Wuerzburg Bayern
Italy GSK Investigational Site Chieti Abruzzo
Italy GSK Investigational Site Conegliano - Treviso
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Massafra (TA)

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Germany,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer. At Day 29
Secondary hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroups A, C, W and Y. At Day 1 and Day 29
Secondary Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1. At Day 29
Secondary 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 The percentages of subjects with a = 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs were computed by group and for each N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as: for individuals, whose pre-vaccination titers are < the LOD (limit of detection), the post-vaccination titers must be = 4-fold the LOD or = the LLOQ (lower of limit of quantitation) whichever is greater; for individuals, whose pre-vaccination titers are = the LOD and = the LLOQ, the post-vaccination titers must be at least four times the LLOQ; for individuals whose pre-vaccination titers are > the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination At Day 29
Secondary 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 For each vaccine group the percentage of subjects with hSBA titer =8, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y. At Day 1 and Day 29
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 For each vaccine group the percentage of subjects with hSBA titer =LLOQ, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y. At Day 1 and Day 29
Secondary Number of Subjects Reported With Solicited Local and Systemic AEs Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after the vaccination. From Day 1 (6 hours) to Day 7 after vaccination
Secondary Number of Subjects Reported With Other Indicators of Reactogenicity Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after vaccination From Day 1 to Day 7 after vaccination
Secondary Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. From Day 1 to Day 29 after vaccination
Secondary Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity From Day 1 to Day 181 (during the entire study period)
Secondary Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Within 30 minutes after vaccination at Day 1
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