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

Meningitis, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433482
• Other study ID #: 207467
• Secondary ID: V59_782017-00345
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: January 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• 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 aged for different lengths of time by storage at 2-8ºC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1707
• Est. completion date: December 17, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 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 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.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• MenACWY liquid
At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.
• MenACWY
At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY_1) or in phase 2 of the study (subjects randomized to study arm ACWY_2), administered by intramuscular injection in the deltoid of the non-dominant arm.

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Natal	Rio Grande Do Norte
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Angers
France	GSK Investigational Site	Nantes cedex 2
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Rosiers-d'Egletons
France	GSK Investigational Site	Tours
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Merida	Yucatán
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Gatchina
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Murmansk
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	St.Petersburg
Russian Federation	GSK Investigational Site	St.Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Yaroslavl
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Pretoria	Gauteng
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Centelles (Barcelona)
Spain	GSK Investigational Site	Hospitalet de Llobregat
Spain	GSK Investigational Site	La Roca Del Valles (Barcelona)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Quart De Poblet, Valencia
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vic/ Barcelona
Turkey	GSK Investigational Site	Eskisehir
Turkey	GSK Investigational Site	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Brazil,  Estonia,  Finland,  France,  Mexico,  Russian Federation,  South Africa,  Spain,  Turkey, 

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 are 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 serogroup A, C, W and Y.	At Day 1 and Day 29
Secondary	Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group	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 =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 are computed by group and 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 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 titer.	At Day 29
Secondary	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	For each vaccine group the percentage of subjects with hSBA titer =8 , and its associated two-sided 95% Clopper-Pearson CIs are 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 percentages of subjects with hSBA titer =LLOQ, and its associated two-sided 95% Clopper-Pearson CIs are 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 Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination	An unsolicited adverse event (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
Secondary	Number of Subjects Reported With Solicited Local and Systemic AEs	Assessed solicited local AEs were erythema, induration and pain at injection site. Assessed solicited systemic AEs were Arthralgia, chills, fatigue, fever (body temperature =38.0°C), headache, loss of appetite, myalgia and nausea.	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 any vaccination	From Day 1 to Day 7 after vaccination
Secondary	Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination	An unsolicited adverse event (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 Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs	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)