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CompletedNCT03433482Updated Feb 17, 2021Results posted

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

A Phase 2 interventional study of MenACWY liquid and MenACWY in Meningitis, Meningococcal, sponsored by GlaxoSmithKline. Completed at 49 sites in 9 countries. Open to participants aged 10 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
1,707
Allocation
Randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Meningitis, Meningococcal

Keywords

  • Meningococcal disease
  • Liquid formulation
  • Meningitis
03

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,707 participants (actual)

Study arms

  • Experimental
    GSK3536820A ACWY_Liq24 Group

    Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1.

    Biological: MenACWY liquid

  • Active comparator
    ACWY_1 Group

    Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.

    Biological: MenACWY

  • Experimental
    GSK3536820A ACWY_Liq30 Group

    Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.

    Biological: MenACWY liquid

  • Active comparator
    ACWY_2 Group

    Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.

    Biological: MenACWY

Interventions

  • BiologicalMenACWY 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.

  • BiologicalMenACWY

    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.

    Also known as: Menveo

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At Day 29

Secondary outcomes

  1. 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.

    Time frame: At Day 1 and Day 29

  2. 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.

    Time frame: At Day 29

  3. 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.

    Time frame: At Day 29

  4. 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.

    Time frame: At Day 1 and Day 29

  5. 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.

    Time frame: At Day 1 and Day 29

  6. 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.

    Time frame: Within 30 minutes after vaccination at Day 1

  7. 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.

    Time frame: From Day 1 (6 hours) to Day 7 after vaccination

  8. 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

    Time frame: From Day 1 to Day 7 after vaccination

  9. 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.

    Time frame: From Day 1 to Day 29 after vaccination

  10. 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

    Time frame: From Day 1 to Day 181 (during the entire study period)

06

Results

Posted Feb 17, 2021

Participant flow

Enrollment was defined with 2 parallel groups per phase, in a 2-phase staggered design: Subjects in both experimental groups receiving investigational vaccine aged for approximately 24 months and 30 months in phase 1 and phase 2 respectively. Both comparator groups subjects in phase 1 and 2 of the study receiving licensed vaccine.

Participant flow — Overall Study
MilestoneGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Started420424427419
Completed419424423418
Not completed1041
Withdrew: Lost to follow-up1011
Withdrew: Withdrawal by subject0010
Withdrew: Unknown reason0020

Outcome measures

PrimaryAdjusted 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.

Time frame:
At Day 29
Reported as:
Geometric mean · Titers
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios
TitersGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios386.66 (319.47 to 467.97)318.34 (264.14 to 383.67)387.06 (322.72 to 464.24)348.89 (290.09 to 419.61)
Statistical analysis
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · ANCOVA · Gmt ratio: 1.21 · 95% CI 0.94 to 1.57Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · ANCOVA · Gmt ratio: 1.11 · 95% CI 0.87 to 1.42Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.
SecondaryhSBA 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.

Time frame:
At Day 1 and Day 29
Reported as:
Geometric mean · Titers
hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios
TitersGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Meningitis A, Day 13.01 (2.69 to 3.36)2.91 (2.60 to 3.24)3.34 (2.94 to 3.79)3.16 (2.78 to 3.59)
Meningitis A, Day 29388.53 (320.61 to 470.84)319.06 (264.39 to 385.03)394.16 (326.72 to 475.50)349 (288.45 to 422.27)
Meningitis C, Day 18.59 (7.40 to 9.98)7.06 (6.09 to 8.20)9.05 (7.77 to 10.53)8.7 (7.46 to 10.14)
Meningitis C, Day 29143.69 (109.13 to 189.20)157.74 (119.39 to 208.42)244.44 (182.20 to 327.96)208.34 (154.96 to 280.11)
Meningitis W, Day 16.23 (5.17 to 7.50)5.8 (4.83 to 6.95)5.69 (4.75 to 6.82)5.74 (4.78 to 6.90)
Meningitis W, Day 2962.73 (49.93 to 78.81)63.92 (51.11 to 79.94)80.51 (64.66 to 100.24)73.08 (58.45 to 91.36)
Meningitis Y, Day 14.39 (3.78 to 5.10)4.21 (3.63 to 4.89)4.14 (3.58 to 4.79)4.19 (3.62 to 4.86)
Meningitis Y, Day 29116.42 (94.03 to 144.15)105.11 (85.17 to 129.71)112.95 (91.55 to 139.34)118.04 (95.27 to 146.25)
Statistical analysis
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · ANCOVA · Gmt ratio: 0.84 · 95% CI 0.58 to 1.19Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · ANCOVA · Gmt ratio: 0.94 · 95% CI 0.72 to 1.24Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · ANCOVA · Gmt ratio: 1.09 · 95% CI 0.82 to 1.44Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · ANCOVA · Gmt ratio: 1.14 · 95% CI 0.79 to 1.64Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · ANCOVA · Gmt ratio: 1.10 · 95% CI 0.84 to 1.45Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · ANCOVA · Gmt ratio: 0.96 · 95% CI 0.72 to 1.26Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.
SecondaryWithin-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.

Time frame:
At Day 29
Reported as:
Geometric mean · Ratio
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group
RatioGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Meningitis A130.33 (105.49 to 161.02)108.39 (88.14 to 133.30)114.66 (93.75 to 140.22)106.79 (87.05 to 131.01)
Meningitis C17.01 (13.00 to 22.25)21.68 (16.52 to 28.46)26.69 (20.22 to 35.22)23.85 (18.04 to 31.54)
Meningitis W9.81 (7.84 to 12.27)10.77 (8.65 to 13.41)13.8 (11.08 to 17.19)12.48 (9.98 to 15.61)
Meningitis Y26.53 (21.14 to 33.28)25.23 (20.18 to 31.54)27.18 (21.66 to 34.10)28.49 (22.60 to 35.92)
SecondaryPercentages 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.

Time frame:
At Day 29
Reported as:
Number · Percentage of subjects
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
Percentage of subjectsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Meningitis A92.29 (89.04 to 94.81)90.08 (86.59 to 92.92)91.57 (88.19 to 94.24)91.69 (88.28 to 94.36)
Meningitis C62.34 (57.29 to 67.20)64.46 (59.39 to 69.29)72.61 (67.80 to 77.05)69.76 (64.85 to 74.36)
Meningitis W59.41 (54.23 to 64.44)60.57 (55.51 to 65.46)66.58 (61.55 to 71.34)62.57 (57.39 to 67.54)
Meningitis Y71.77 (66.95 to 76.25)73.33 (68.65 to 77.66)74.35 (69.69 to 78.64)77.19 (72.62 to 81.33)
Statistical analysis
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 2.21 · 95% CI -1.94 to 6.40
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -2.12 · 95% CI -8.94 to 4.72
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -1.16 · 95% CI -8.11 to 5.80
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -1.57 · 95% CI -7.88 to 4.74
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.12 · 95% CI -4.29 to 4.07
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 2.85 · 95% CI -3.63 to 9.30
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 4.01 · 95% CI -2.89 to 10.88
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -2.84 · 95% CI -8.91 to 3.26
SecondaryPercentages 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.

Time frame:
At Day 1 and Day 29
Reported as:
Number · Percentage of subjects
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
Percentage of subjectsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Meningitis A, Day 112.07 (8.98 to 15.77)10.28 (7.45 to 13.74)13.53 (10.24 to 17.40)12.03 (8.91 to 15.77)
Meningitis A, Day 2993.65 (90.70 to 95.89)92.19 (89.03 to 94.67)93.37 (90.37 to 95.66)94.01 (91.06 to 96.21)
Meningitis C, Day 148.48 (43.44 to 53.53)41.52 (36.61 to 46.55)50.63 (45.59 to 55.67)50.26 (45.19 to 55.31)
Meningitis C, Day 2977.58 (73.10 to 81.63)78.01 (73.52 to 82.06)84.17 (80.10 to 87.70)82.85 (78.67 to 86.51)
Meningitis W, Day 131.66 (27.01 to 36.61)28.54 (24.14 to 33.26)28.8 (24.30 to 33.62)30.05 (25.46 to 34.96)
Meningitis W, Day 2979.43 (75.07 to 83.34)80.87 (76.62 to 84.64)85.86 (82.00 to 89.17)81.77 (77.54 to 85.50)
Meningitis Y, Day 122.82 (18.75 to 27.31)21.86 (17.90 to 26.25)21.48 (17.51 to 25.89)22.34 (18.27 to 26.83)
Meningitis Y, Day 2987.5 (83.77 to 90.64)85.46 (81.57 to 88.80)88.04 (84.42 to 91.08)87.56 (83.85 to 90.69)
Statistical analysis
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.79 · 95% CI -2.69 to 6.32
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 6.96 · 95% CI 0.01 to 13.84
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 3.13 · 95% CI -3.33 to 9.58
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 0.96 · 95% CI -4.86 to 6.80
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.46 · 95% CI -2.24 to 5.22
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.43 · 95% CI -6.32 to 5.46
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -1.43 · 95% CI -7.05 to 4.18
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 2.04 · 95% CI -2.81 to 6.90
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.50 · 95% CI -3.32 to 6.33
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 0.38 · 95% CI -6.60 to 7.35
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -1.26 · 95% CI -7.75 to 5.23
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.85 · 95% CI -6.69 to 4.98
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.64 · 95% CI -4.24 to 2.96
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.32 · 95% CI -3.99 to 6.64
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 4.09 · 95% CI -1.11 to 9.33
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 0.48 · 95% CI -4.16 to 5.13
SecondaryPercentages 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.

Time frame:
At Day 1 and Day 29
Reported as:
Number · Percentage of subjects
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
Percentage of subjectsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Meningitis A, Day 112.86 (9.67 to 16.64)11.57 (8.56 to 15.17)15.38 (11.89 to 19.43)13.64 (10.32 to 17.54)
Meningitis A, Day 2993.92 (91.01 to 96.10)92.19 (89.03 to 94.67)93.37 (90.37 to 95.66)94.01 (91.06 to 96.21)
Meningitis C, Day 155.84 (50.78 to 60.81)48.61 (43.58 to 53.66)61.01 (56.01 to 65.85)57.14 (52.08 to 62.10)
Meningitis C, Day 2979.38 (75.01 to 83.30)80.37 (76.02 to 84.23)84.7 (80.67 to 88.17)84.7 (80.67 to 88.17)
Meningitis W, Day 132.45 (27.76 to 37.42)28.54 (24.14 to 33.26)29.32 (24.80 to 34.16)30.05 (25.46 to 34.96)
Meningitis W, Day 2979.43 (75.07 to 83.34)80.87 (76.62 to 84.64)85.86 (82.00 to 89.17)81.77 (77.54 to 85.50)
Meningitis Y, Day 124.36 (20.18 to 28.93)22.86 (18.83 to 27.31)21.74 (17.75 to 26.16)22.86 (18.76 to 27.38)
Meningitis Y, Day 2988.28 (84.63 to 91.32)86.22 (82.41 to 89.48)88.3 (84.70 to 91.30)87.56 (83.85 to 90.69)
Statistical analysis
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.29 · 95% CI -3.37 to 5.99
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 7.23 · 95% CI 0.25 to 14.13
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 3.92 · 95% CI -2.57 to 10.39
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.49 · 95% CI -4.44 to 7.44
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.73 · 95% CI -1.94 to 5.46
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.99 · 95% CI -6.66 to 4.70
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -1.43 · 95% CI -7.05 to 4.18
  • GSK3536820A ACWY_Liq24 Group vs ACWY_1 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 2.06 · 95% CI -2.67 to 6.80
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 1.75 · 95% CI -3.32 to 6.83
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 3.87 · 95% CI -3.00 to 10.71
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.73 · 95% CI -7.24 to 5.77
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -1.12 · 95% CI -6.99 to 4.75
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: -0.64 · 95% CI -4.24 to 2.96
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 0.00 · 95% CI -5.16 to 5.16
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 4.09 · 95% CI -1.11 to 9.33
  • GSK3536820A ACWY_Liq30 Group vs ACWY_2 Group · Miettinen and Nurminen score method · Difference in percentage of subjects: 0.73 · 95% CI -3.88 to 5.37
SecondaryNumber 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.

Time frame:
Within 30 minutes after vaccination at Day 1
Reported as:
Count of participants · Participants
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
ParticipantsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination2266
SecondaryNumber 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.

Time frame:
From Day 1 (6 hours) to Day 7 after vaccination
Reported as:
Count of participants · Participants
Number of Subjects Reported With Solicited Local and Systemic AEs
ParticipantsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Arthralgia45504940
Chills75797856
Erythema48515840
Fatigue174175149147
Fever (Temperature >= 38 C)15181512
Headache164151169157
Induration50515439
Loss of Appetite53546334
Myalgia60595865
Nausea54484246
Pain189181202192
SecondaryNumber 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

Time frame:
From Day 1 to Day 7 after vaccination
Reported as:
Count of participants · Participants
Number of Subjects Reported With Other Indicators of Reactogenicity
ParticipantsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Analgesic/Antipyretic Prevention, No357374366369
Analgesic/Antipyretic Prevention, Yes61485950
Analgesic/Antipyretic Treatment, No328340349350
Analgesic/Antipyretic Treatment, Yes90827669
SecondaryNumber 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.

Time frame:
From Day 1 to Day 29 after vaccination
Reported as:
Count of participants · Participants
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
ParticipantsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination779110197
SecondaryNumber 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

Time frame:
From Day 1 to Day 181 (during the entire study period)
Reported as:
Count of participants · Participants
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs
ParticipantsGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
AEs Leading to withdrawal0000
SAEs4144
Medically attended AEs88698177

Adverse events

Collected over Solicited AEs were collected from Day 1 to Day 7 after vaccination and Unsolicited AEs from Day 1 to Day 29 after vaccination. SAEs were collected from Day 1 to Day 181 (during the entire study period). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK3536820A ACWY_Liq24 Group0/420 (0%)4/420 (1%)312/420 (74.3%)
ACWY_1 Group0/424 (0%)1/424 (0.2%)314/424 (74.1%)
GSK3536820A ACWY_Liq30 Group0/427 (0%)4/427 (0.9%)324/427 (75.9%)
ACWY_2 Group0/419 (0%)4/419 (1%)317/419 (75.7%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
PhimosisCongenital, familial and genetic disorders0/4200/4240/4271/419
Otitis externaInfections and infestations0/4200/4240/4271/419
Tension headacheNervous system disorders0/4200/4240/4271/419
Adnexa uteri painReproductive system and breast disorders0/4200/4240/4271/419
Appendicitis noninfectiveGastrointestinal disorders1/4200/4240/4270/419
Tooth abscessInfections and infestations1/4200/4240/4270/419
Soft tissue injuryInjury, poisoning and procedural complications1/4200/4240/4270/419
Ovarian cyst rupturedReproductive system and breast disorders1/4200/4240/4270/419
Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/4201/4240/4270/419
Post procedural haemorrhageInjury, poisoning and procedural complications0/4200/4241/4270/419
Most frequent other events
Showing 10 of 141
Most frequent other events
EventGSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 Group
Injection site painGeneral disorders190/420182/424205/427194/419
HeadacheNervous system disorders168/420155/424178/427162/419
FatigueGeneral disorders175/420175/424150/427147/419
ChillsGeneral disorders77/42079/42478/42756/419
MyalgiaMusculoskeletal and connective tissue disorders63/42062/42458/42765/419
Decreased appetiteMetabolism and nutrition disorders54/42054/42463/42734/419
Injection site erythemaGeneral disorders50/42051/42459/42742/419
NauseaGastrointestinal disorders54/42048/42443/42746/419
Injection site indurationGeneral disorders52/42051/42454/42739/419
ArthralgiaMusculoskeletal and connective tissue disorders50/42053/42449/42740/419

Baseline characteristics

Age, Continuous
Age, Continuous(Years)GSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 GroupTotal
Mean22.5 ± 9.422.2 ± 9.622.3 ± 9.822.0 ± 9.322.3 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)GSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 GroupTotal
Female232242259228961
Male188182168191729
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)GSK3536820A ACWY_Liq24 GroupACWY_1 GroupGSK3536820A ACWY_Liq30 GroupACWY_2 GroupTotal
American Indian Or Alaska Native01124
Asian442313
Black Or African American26223026104
Other58548384279
White3323433113041290
07

Study locations

49 sites
  • GSK Investigational Site
    Salvador, Bahía 40420-000, Brazil
  • GSK Investigational Site
    Natal, Rio Grande Do Norte 59025-050, Brazil
  • GSK Investigational Site
    Rio de Janeiro, 22271-100, Brazil
  • GSK Investigational Site
    São Paulo, 01228-200, Brazil
  • GSK Investigational Site
    São Paulo, 04266-010, Brazil
  • GSK Investigational Site
    Tallinn, 10117, Estonia
  • GSK Investigational Site
    Tallinn, 11313, Estonia
  • GSK Investigational Site
    Tallinn, Estonia
  • GSK Investigational Site
    Tartu, 50106, Estonia
  • GSK Investigational Site
    Espoo, 02230, Finland
  • GSK Investigational Site
    Helsinki, 00100, Finland
  • GSK Investigational Site
    Jarvenpaa, 04400, Finland
  • GSK Investigational Site
    Oulu, 90220, Finland
  • GSK Investigational Site
    Pori, 28100, Finland
  • GSK Investigational Site
    Tampere, 33100, Finland
  • GSK Investigational Site
    Angers, 49000, France
  • GSK Investigational Site
    Nantes cedex 2, 44277, France
  • GSK Investigational Site
    Nice, 06300, France
  • GSK Investigational Site
    Rosiers-d'Egletons, 19300, France
  • GSK Investigational Site
    Tours, 37044, France
  • GSK Investigational Site
    Merida, Yucatán 97070, Mexico
  • GSK Investigational Site
    Durango, 34000, Mexico
  • GSK Investigational Site
    Ekaterinburg, 620028, Russian Federation
  • GSK Investigational Site
    Gatchina, 188300, Russian Federation
  • GSK Investigational Site
    Moscow, 115478, Russian Federation
  • GSK Investigational Site
    Murmansk, 183038, Russian Federation
  • GSK Investigational Site
    Saint Petersburg, 196240, Russian Federation
  • GSK Investigational Site
    Saint Petersburg, 197022, Russian Federation
  • GSK Investigational Site
    St.Petersburg, 191025, Russian Federation
  • GSK Investigational Site
    St.Petersburg, 197089, Russian Federation
  • GSK Investigational Site
    Tomsk, 634 050, Russian Federation
  • GSK Investigational Site
    Yaroslavl, 150051, Russian Federation
  • GSK Investigational Site
    Pretoria, Gauteng 0152, South Africa
  • GSK Investigational Site
    Bellville, 7530, South Africa
  • GSK Investigational Site
    Barcelona, 08025, Spain
  • GSK Investigational Site
    Barcelona, Spain
  • GSK Investigational Site
    Centelles (Barcelona), 08540, Spain
  • GSK Investigational Site
    Hospitalet de Llobregat, 08907, Spain
  • GSK Investigational Site
    La Roca Del Valles (Barcelona), 08430, Spain
  • GSK Investigational Site
    Madrid, 28050, Spain
  • GSK Investigational Site
    Quart De Poblet, Valencia, 46930, Spain
  • GSK Investigational Site
    Sevilla, 41014, Spain
  • GSK Investigational Site
    Valencia, 46011, Spain
  • GSK Investigational Site
    Valencia, 46022, Spain
  • GSK Investigational Site
    Valencia, 46200, Spain
  • GSK Investigational Site
    Valencia, Spain
  • GSK Investigational Site
    Vic/ Barcelona, 08500, Spain
  • GSK Investigational Site
    Eskisehir, 26040, Turkey
  • GSK Investigational Site
    Izmir, 35340, Turkey
08

References and documents

Publications

  • 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. PubMed 36369456 ↗

Study documents

  • Study protocol · Feb 8, 2019
  • Statistical analysis plan · Jul 11, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

09

Registry details

Key details

Study ID
NCT03433482
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 14, 2018
Start date
Aug 30, 2018
Primary completion
Jul 26, 2019
Completion
Dec 17, 2019
Results posted
Feb 17, 2021
Last update
Feb 17, 2021

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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