Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

NCT04502693 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2054162019-001666-15
• Study Type: interventional
• Target: 3,657
• Locations: 7 countries
• Sites: 112

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.

Conditions

Infections, Meningococcal

Keywords

Bexsero; Menveo; MenABCWY; Effectiveness; Invasive meningococcal disease; Meningitis

Outcome Measures

Primary Outcomes (19)

• 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

  The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\_0\_2\_6 group and 1 month after the 2 dose schedule in MenB\_0\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

  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)

• 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

  The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB\_0\_2\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

  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)

• 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

  The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.

  At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)

• 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

  The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.

  At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])

• 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

  Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.

  At 1 month after the last vaccination of MenABCWY (Day 211)

• 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

  Four-fold rise is defined as: If the pre-vaccination hSBA titer is \< 4, then post-vaccination hSBA titer should be \>= 16 . If the pre-vaccination hSBA titer is \>= limit of detection (LOD) but \< LL of quantification (LLOQ), then post-vaccination hSBA titer should be \>= 4 times the LLOQ. If the pre-vaccination hSBA titer is \>= LLOQ, then post-vaccination hSBA titer should be \>= 4 times the pre-vaccination hSBA titer. As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

  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)

• 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)

  The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

  At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)

• 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

  The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

  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])

• 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)

  The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.

  At 1 month after the last vaccination of MenABCWY (Day 211)

• Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration

  Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During 7 days after the first study intervention administration occurring at Day 1

• Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration

  Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During 7 days after the second study intervention administration occurring at Day 61

• Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration

  Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During 7 days after the third study intervention administration occurring at Day 181

• Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration

  Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During 7 days after the first study intervention administration occurring at Day 1

• Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration

  Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During 7 days after the second study intervention administration occurring at Day 61

• Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration

  Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During 7 days after the third study intervention administration occurring at Day 181

• Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During the 30 days after the first study intervention administration occurring at Day 1

• Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During the 30 days after the second study intervention administration occurring at Day 61

• Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  During the 30 days after the third study intervention administration occurring at Day 181

• Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs

  A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.

  Throughout the study period (Day 1 to Day 361)

Secondary Outcomes (18)

• 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

  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)

• 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

  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)

• 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

  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)

• 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)

  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)

• 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)

  At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])

Study Arms (7)

MenB_0_2_6 Group

EXPERIMENTAL

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.

Combination Product: rMenB+OMV NZ vaccine; Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)

MenB_0_6 Group

EXPERIMENTAL

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.

Combination Product: rMenB+OMV NZ vaccine; Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY); Combination Product: Placebo

ABCWY-1 Group

EXPERIMENTAL

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.

Combination Product: Placebo; Combination Product: MenABCWY-1

ABCWY-2 Group

EXPERIMENTAL

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.

Combination Product: Placebo; Combination Product: MenABCWY-2

ABCWY-3 Group

EXPERIMENTAL

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.

Combination Product: Placebo; Combination Product: MenABCWY-3

ACWY Group

ACTIVE COMPARATOR

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.

Combination Product: rMenB+OMV NZ vaccine; Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY); Combination Product: Placebo

ABCWY_Pooled

EXPERIMENTAL

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: MenABCWY-1; Combination Product: MenABCWY-2; Combination Product: MenABCWY-3

Interventions

rMenB+OMV NZ vaccine COMBINATION_PRODUCT

rMenB+OMV NZ vaccine was administered intramuscularly.

Also known as: Bexsero

ACWY Group; MenB_0_2_6 Group; MenB_0_6 Group

Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) BIOLOGICAL

MenACWY vaccine was administered intramuscularly.

Also known as: Menveo

ACWY Group; MenB_0_2_6 Group; MenB_0_6 Group

Placebo COMBINATION_PRODUCT

Placebo was administered intramuscularly.

Also known as: NaCl, saline solution

ABCWY-1 Group; ABCWY-2 Group; ABCWY-3 Group; ACWY Group; MenB_0_6 Group

MenABCWY-1 COMBINATION_PRODUCT

Lot 1 of the MenABCWY vaccine was administered intramuscularly.

ABCWY-1 Group; ABCWY_Pooled

MenABCWY-2 COMBINATION_PRODUCT

Lot 2 of the MenABCWY vaccine was administered intramuscularly.

ABCWY-2 Group; ABCWY_Pooled

MenABCWY-3 COMBINATION_PRODUCT

Lot 3 of the MenABCWY vaccine was administered intramuscularly.

ABCWY-3 Group; ABCWY_Pooled

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (112)

GSK Investigational Site

Chandler, Arizona, 85286, United States

Location

GSK Investigational Site

Glendale, Arizona, 85308, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Bell Gardens, California, 90201, United States

Location

GSK Investigational Site

Canoga Park, California, 91304, United States

Location

GSK Investigational Site

Garden Grove, California, 92840, United States

Location

GSK Investigational Site

Inglewood, California, 90301, United States

Location

GSK Investigational Site

Los Gatos, California, 95032, United States

Location

GSK Investigational Site

Cutler Bay, Florida, 33157, United States

Location

GSK Investigational Site

Lake City, Florida, 32055, United States

Location

GSK Investigational Site

Miami, Florida, 33126, United States

Location

GSK Investigational Site

Miami, Florida, 33144, United States

Location

GSK Investigational Site

Miami, Florida, 33165, United States

Location

GSK Investigational Site

Miami, Florida, 33174, United States

Location

GSK Investigational Site

Miami, Florida, 33186, United States

Location

GSK Investigational Site

Orlando, Florida, 32801, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Orlando, Florida, 32808, United States

Location

GSK Investigational Site

Oviedo, Florida, 32765, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Adairsville, Georgia, 30103, United States

Location

GSK Investigational Site

Buford, Georgia, 30519, United States

Location

GSK Investigational Site

Columbus, Georgia, 31904, United States

Location

GSK Investigational Site

Hinesville, Georgia, 31313, United States

Location

GSK Investigational Site

Nampa, Idaho, 83686, United States

Location

GSK Investigational Site

Oak Brook, Illinois, 60523, United States

Location

GSK Investigational Site

Wichita, Kansas, 67205, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40243, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Beverly, Massachusetts, 01915, United States

Location

GSK Investigational Site

Fall River, Massachusetts, 02721, United States

Location

GSK Investigational Site

Grosse Pointe Woods, Michigan, 48236, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

GSK Investigational Site

Petal, Mississippi, 39465, United States

Location

GSK Investigational Site

Missoula, Montana, 59804, United States

Location

GSK Investigational Site

Missoula, Montana, 59808, United States

Location

GSK Investigational Site

The Bronx, New York, 10455, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Dayton, Ohio, 45419, United States

Location

GSK Investigational Site

Grants Pass, Oregon, 97527, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29607, United States

Location

GSK Investigational Site

North Charleston, South Carolina, 29405, United States

Location

GSK Investigational Site

West Columbia, South Carolina, 29169, United States

Location

GSK Investigational Site

Laredo, Texas, 78041, United States

Location

GSK Investigational Site

Plano, Texas, 75024, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Kaysville, Utah, 84037, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Murray, Utah, 84107, United States

Location

GSK Investigational Site

Orem, Utah, 84057, United States

Location

GSK Investigational Site

Roy, Utah, 84067, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84121, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Syracuse, Utah, 84075, United States

Location

GSK Investigational Site

Falls Church, Virginia, 22044, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Suffolk, Virginia, 23435, United States

Location

GSK Investigational Site

Cheney, Washington, 99004, United States

Location

GSK Investigational Site

Spokane, Washington, 99202, United States

Location

GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Gold Coast, Queensland, 4222, Australia

Location

GSK Investigational Site

Taringa, Queensland, 4068, Australia

Location

GSK Investigational Site

Tarragindi, Queensland, 4121, Australia

Location

GSK Investigational Site

Geelong, Victoria, 3220, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3010, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Calgary, Alberta, T3B 6A8, Canada

Location

GSK Investigational Site

Edmonton, Alberta, T5A 4L8, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 4H4, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

London, Ontario, N5W 6A2, Canada

Location

GSK Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3T 1C5, Canada

Location

GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

GSK Investigational Site

Québec, Quebec, G1E 7G9, Canada

Location

GSK Investigational Site

Québec, G1V 4G2, Canada

Location

GSK Investigational Site

České Budejovice, 370 06, Czechia

Location

GSK Investigational Site

České Budějovice, 37008, Czechia

Location

GSK Investigational Site

Hradec Králové, 500 02, Czechia

Location

GSK Investigational Site

Jindřichův Hradec, 37701, Czechia

Location

GSK Investigational Site

Kladno, 272 80, Czechia

Location

GSK Investigational Site

Mělník, 27601, Czechia

Location

GSK Investigational Site

Pardubice, 53003, Czechia

Location

GSK Investigational Site

Pardubice, 53009, Czechia

Location

GSK Investigational Site

Prague, 160 00, Czechia

Location

GSK Investigational Site

Příbram, 261 01, Czechia

Location

GSK Investigational Site

Trutnov, 541 01, Czechia

Location

GSK Investigational Site

Týnec nad Sázavou, 257 41, Czechia

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tallinn, 10617, Estonia

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Adana, 01330, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, 06590, Turkey (Türkiye)

Location

GSK Investigational Site

Eskişehir, 26040, Turkey (Türkiye)

Location

GSK Investigational Site

Izmir, 35340, Turkey (Türkiye)

Location

GSK Investigational Site

Kayseri, 38030, Turkey (Türkiye)

Location

Related Publications (1)

• Nolan T, Bhusal C, Beran J, Bloch M, Cetin BS, Dinleyici EC, Drazan D, Kokko S, Koski S, Laajalahti O, Langley JM, Ramet M, Richmond PC, Silas P, Tapiero B, Tiong F, Tipton M, Ukkonen B, Ulukol B, Lattanzi M, Trapani M, Willemsen A, Toneatto D; QUINTET study group. Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial. Lancet Infect Dis. 2025 May;25(5):560-573. doi: 10.1016/S1473-3099(24)00667-4. Epub 2024 Dec 5.

  PMID: 39647494 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Interventions

4CMenB vaccine; MenACWY; Meningococcal Vaccines; Saline Solution

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

8664357343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blinded study. Recipients \& study evaluators will be unaware of vaccine administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: August 14, 2020
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CZ (12); TU (5); FI (10); AU (7); CA (12); ES (2); US (64)