Clinical trial NCT03433482: 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
Official title: Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis, Meningococcal
Keywords: Meningococcal disease
Liquid formulation
Meningitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 1707
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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:

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 Representative(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 parent(s)/LAR(s) of the subject prior to performing 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 the enrolment.
4. A male or female ≥10 to ≤40 YoA at the time of the 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.

Exclusion Criteria:

1. Child in care
2. Anaphylaxis following the administration of vaccine.
3. Any (clinical) condition that in the judgment of the investigator would make intramuscular injection unsafe \&/represents a contraindication to intramuscular vaccination and blood draws.
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
5. Progressive, unstable or uncontrolled clinical conditions.
6. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
7. 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.
8. 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.
9. Received immunoglobulins or any blood products within 180 days prior to informed consent.
10. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
12. 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.
13. 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.
14. Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
15. 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).
16. Current or previous, confirmed or suspected disease caused by N. meningitidis.
17. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
18. 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.
19. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
20. Study personnel as an immediate family or household member.
21. Pregnant or lactating women.

Primary outcomes:
measure: Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios
timeFrame: At Day 29
Secondary outcomes:
measure: hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios
timeFrame: At Day 1 and Day 29
measure: Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group
timeFrame: At Day 29
measure: 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
timeFrame: At Day 29
measure: 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
timeFrame: At Day 1 and Day 29
measure: 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
timeFrame: At Day 1 and Day 29
measure: Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
timeFrame: Within 30 minutes after vaccination at Day 1
measure: Number of Subjects Reported With Solicited Local and Systemic AEs
timeFrame: From Day 1 (6 hours) to Day 7 after vaccination
measure: Number of Subjects Reported With Other Indicators of Reactogenicity
timeFrame: From Day 1 to Day 7 after vaccination
measure: Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
timeFrame: From Day 1 to Day 29 after vaccination
measure: Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs
timeFrame: From Day 1 to Day 181 (during the entire study period)
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahía
city: Natal
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Norte
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Nantes cedex 2
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Rosiers-d'Egletons
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Gatchina
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Murmansk
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St.Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St.Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Centelles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: GSK Investigational Site
city: La Roca Del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Quart De Poblet, Valencia
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vic/ Barcelona
country: Spain
facility: GSK Investigational Site
city: Eskisehir
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vir Singh P, Tiberi P, Di Domenico GF, Romolini V, Mzolo T, Costantini M, Akhund T, Basile V, Lattanzi M, Pellegrini M. Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis. Drug Saf. 2023 Jan;46(1):99-108. doi: 10.1007/s40264-022-01242-8. Epub 2022 Nov 11.