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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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT03433482
Collaborator
(none)
1,707
Enrollment
49
Locations
4
Arms
15.6
Actual Duration (Months)
34.8
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.

Condition or Disease Intervention/Treatment Phase
  • Biological: MenACWY liquid
  • Biological: MenACWY
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1707 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Data will be collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity and immunogenicity) will all be unaware of which vaccine was administered. To do so, vaccine preparation and administration will be done by authorized medical personnel who will not participate in any of the study clinical evaluations.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Aug 30, 2018
Actual Primary Completion Date :
Jul 26, 2019
Actual Study Completion Date :
Dec 17, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.
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
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.
Other Names:
  • Menveo

    		•
    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
    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.
    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
    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.
    Other Names:
  • Menveo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios [At Day 29]

      hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.

    Secondary Outcome Measures

    1. hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios [At Day 1 and Day 29]

      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.

    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 [At Day 29]

      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.

    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 [At Day 29]

      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.

    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 [At Day 1 and Day 29]

      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.

    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 [At Day 1 and Day 29]

      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.

    6. Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination [Within 30 minutes after vaccination at Day 1]

      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.

    7. Number of Subjects Reported With Solicited Local and Systemic AEs [From Day 1 (6 hours) to Day 7 after vaccination]

      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.

    8. Number of Subjects Reported With Other Indicators of Reactogenicity [From Day 1 to Day 7 after vaccination]

      Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after any vaccination

    9. Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination [From Day 1 to Day 29 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.

    10. Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs [From Day 1 to Day 181 (during the entire study period)]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 40 Years
    Sexes Eligible for Study:
    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
    1. 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.

    1. Received immunoglobulins or any blood products within 180 days prior to informed consent.

    2. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.

    3. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

    4. 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.

    5. 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.

    1. Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).

    2. 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).

    3. Current or previous, confirmed or suspected disease caused by N. meningitidis.

    4. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.

    5. 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.

    1. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.

    2. Study personnel as an immediate family or household member.

    3. Pregnant or lactating women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Salvador Bahía Brazil 40420-000
    2 GSK Investigational Site Natal Rio Grande Do Norte Brazil 59025-050
    3 GSK Investigational Site Rio de Janeiro Brazil 22271-100
    4 GSK Investigational Site São Paulo Brazil 01228-200
    5 GSK Investigational Site São Paulo Brazil 04266-010
    6 GSK Investigational Site Tallinn Estonia 10117
    7 GSK Investigational Site Tallinn Estonia 11313
    8 GSK Investigational Site Tallinn Estonia
    9 GSK Investigational Site Tartu Estonia 50106
    10 GSK Investigational Site Espoo Finland 02230
    11 GSK Investigational Site Helsinki Finland 00100
    12 GSK Investigational Site Jarvenpaa Finland 04400
    13 GSK Investigational Site Oulu Finland 90220
    14 GSK Investigational Site Pori Finland 28100
    15 GSK Investigational Site Tampere Finland 33100
    16 GSK Investigational Site Angers France 49000
    17 GSK Investigational Site Nantes cedex 2 France 44277
    18 GSK Investigational Site Nice France 06300
    19 GSK Investigational Site Rosiers-d'Egletons France 19300
    20 GSK Investigational Site Tours France 37044
    21 GSK Investigational Site Merida Yucatán Mexico 97070
    22 GSK Investigational Site Durango Mexico 34000
    23 GSK Investigational Site Ekaterinburg Russian Federation 620028
    24 GSK Investigational Site Gatchina Russian Federation 188300
    25 GSK Investigational Site Moscow Russian Federation 115478
    26 GSK Investigational Site Murmansk Russian Federation 183038
    27 GSK Investigational Site Saint Petersburg Russian Federation 196240
    28 GSK Investigational Site Saint Petersburg Russian Federation 197022
    29 GSK Investigational Site St.Petersburg Russian Federation 191025
    30 GSK Investigational Site St.Petersburg Russian Federation 197089
    31 GSK Investigational Site Tomsk Russian Federation 634 050
    32 GSK Investigational Site Yaroslavl Russian Federation 150051
    33 GSK Investigational Site Pretoria Gauteng South Africa 0152
    34 GSK Investigational Site Bellville South Africa 7530
    35 GSK Investigational Site Barcelona Spain 08025
    36 GSK Investigational Site Barcelona Spain
    37 GSK Investigational Site Centelles (Barcelona) Spain 08540
    38 GSK Investigational Site Hospitalet de Llobregat Spain 08907
    39 GSK Investigational Site La Roca Del Valles (Barcelona) Spain 08430
    40 GSK Investigational Site Madrid Spain 28050
    41 GSK Investigational Site Quart De Poblet, Valencia Spain 46930
    42 GSK Investigational Site Sevilla Spain 41014
    43 GSK Investigational Site Valencia Spain 46011
    44 GSK Investigational Site Valencia Spain 46022
    45 GSK Investigational Site Valencia Spain 46200
    46 GSK Investigational Site Valencia Spain
    47 GSK Investigational Site Vic/ Barcelona Spain 08500
    48 GSK Investigational Site Eskisehir Turkey 26040
    49 GSK Investigational Site Izmir Turkey 35340

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT03433482
    Other Study ID Numbers:
    • 207467
    • V59_78
    • 2017-003456-23
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by GlaxoSmithKline
    Meningococcal disease
    Liquid formulation
    Meningitis
    Additional relevant MeSH terms:
    Meningitis, Meningococcal
    Meningitis

    Study Results

    Participant Flow

    Recruitment Details 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.
    Pre-assignment Detail Out of the 1707 subjects enrolled in the study (inclusive of phase 1 and 2), 1690 were exposed to the vaccination. Out of the 17 subjects excluded from study, 11 were not randomized, 5 were not administered any study treatment, 1 did not sign the informed consent form.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Period Title: Overall Study
    STARTED 420 424 427 419
    COMPLETED 419 424 423 418
    NOT COMPLETED 1 0 4 1

    Baseline Characteristics

    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group Total
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2. Total of all reporting groups
    Overall Participants 420 424 427 419 1690
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    22.5
    (9.4)
    22.2
    (9.6)
    22.3
    (9.8)
    22.0
    (9.3)
    22.3
    (9.5)
    Sex: Female, Male (Count of Participants)
    Female
    232
    55.2%
    242
    57.1%
    259
    60.7%
    228
    54.4%
    961
    56.9%
    Male
    188
    44.8%
    182
    42.9%
    168
    39.3%
    191
    45.6%
    729
    43.1%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian Or Alaska Native
    0
    0%
    1
    0.2%
    1
    0.2%
    2
    0.5%
    4
    0.2%
    Asian
    4
    1%
    4
    0.9%
    2
    0.5%
    3
    0.7%
    13
    0.8%
    Black Or African American
    26
    6.2%
    22
    5.2%
    30
    7%
    26
    6.2%
    104
    6.2%
    Other
    58
    13.8%
    54
    12.7%
    83
    19.4%
    84
    20%
    279
    16.5%
    White
    332
    79%
    343
    80.9%
    311
    72.8%
    304
    72.6%
    1290
    76.3%

    Outcome Measures

    1. Primary Outcome
    Title Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios
    Description hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.
    Time Frame At Day 29

    Outcome Measure Data

    Analysis Population Description
    Analysis is performed on the per protocol set for immunogenicity that includes subjects who received the vaccine did not have any protocol deviation leading to exclusion , who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 363 373 356 349
    Geometric Mean (95% Confidence Interval) [Titers]
    386.66
    318.34
    387.06
    348.89
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 24 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority is concluded if the lower limit of the two sided 95% confidence interval (CI) for the hSBA GMT ratio for serogroup A between the MenACWY liquid vaccine aged for approximately 24 months and the licensed MenACWY vaccine is > 0.5.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.94 to 1.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 30 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination.
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratios for serogroup A between the MenACWY liquid vaccine aged for approximately 30 months and the licensed MenACWY vaccine is > 0.5. Non-inferiority hypotheses testing will be conducted sequentially, starting from MenACWY liquid vaccine aged for approximately 24 months and subsequently with MenACWY liquid vaccine aged for approximately 30 months.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.87 to 1.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis is performed on the per protocol set for immunogenicity that includes subjects who received the vaccine did not have any protocol deviation leading to exclusion , who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 394 398 395 392
    Meningitis A, Day 1
    3.01
    2.91
    3.34
    3.16
    Meningitis A, Day 29
    388.53
    319.06
    394.16
    349
    Meningitis C, Day 1
    8.59
    7.06
    9.05
    8.7
    Meningitis C, Day 29
    143.69
    157.74
    244.44
    208.34
    Meningitis W, Day 1
    6.23
    5.8
    5.69
    5.74
    Meningitis W, Day 29
    62.73
    63.92
    80.51
    73.08
    Meningitis Y, Day 1
    4.39
    4.21
    4.14
    4.19
    Meningitis Y, Day 29
    116.42
    105.11
    112.95
    118.04
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY_Liq24 and ACWY_1, at Day 29 against serogroup C
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.84
    Confidence Interval (2-Sided) 95%
    0.58 to 1.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY_Liq24 and ACWY_1, at Day 29 against serogroup W
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.72 to 1.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY_Liq24 and ACWY_1, at Day 29 against serogroup Y
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.82 to 1.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY_Liq30 and ACWY_2, at Day 29 against serogroup C
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.14
    Confidence Interval (2-Sided) 95%
    0.79 to 1.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY_Liq30 and ACWY_2, at Day 29 against serogroup W
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    0.84 to 1.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY_Liq30 and ACWY_2, at Day 29 against serogroup Y
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT ratio
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.72 to 1.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis is performed on the per protocol set for immunogenicity that includes subjects who received the vaccine did not have any protocol deviation leading to exclusion , who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 385 390 386 377
    Meningitis A
    130.33
    108.39
    114.66
    106.79
    Meningitis C
    17.01
    21.68
    26.69
    23.85
    Meningitis W
    9.81
    10.77
    13.8
    12.48
    Meningitis Y
    26.53
    25.23
    27.18
    28.49
    4. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis is performed on the per protocol set for immunogenicity that includes subjects who received the vaccine did not have any protocol deviation leading to exclusion , who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 385 390 386 377
    Meningitis A
    92.29
    90.08
    91.57
    91.69
    Meningitis C
    62.34
    64.46
    72.61
    69.76
    Meningitis W
    59.41
    60.57
    66.58
    62.57
    Meningitis Y
    71.77
    73.33
    74.35
    77.19
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 2.21
    Confidence Interval (2-Sided) 95%
    -1.94 to 6.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -2.12
    Confidence Interval (2-Sided) 95%
    -8.94 to 4.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -1.16
    Confidence Interval (2-Sided) 95%
    -8.11 to 5.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -1.57
    Confidence Interval (2-Sided) 95%
    -7.88 to 4.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.12
    Confidence Interval (2-Sided) 95%
    -4.29 to 4.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 2.85
    Confidence Interval (2-Sided) 95%
    -3.63 to 9.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 4.01
    Confidence Interval (2-Sided) 95%
    -2.89 to 10.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -2.84
    Confidence Interval (2-Sided) 95%
    -8.91 to 3.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis is performed on the per protocol set for immunogenicity that includes subjects who received the vaccine did not have any protocol deviation leading to exclusion , who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 394 398 395 392
    Meningitis A, Day 1
    12.07
    10.28
    13.53
    12.03
    Meningitis A, Day 29
    93.65
    92.19
    93.37
    94.01
    Meningitis C, Day 1
    48.48
    41.52
    50.63
    50.26
    Meningitis C, Day 29
    77.58
    78.01
    84.17
    82.85
    Meningitis W, Day 1
    31.66
    28.54
    28.8
    30.05
    Meningitis W, Day 29
    79.43
    80.87
    85.86
    81.77
    Meningitis Y, Day 1
    22.82
    21.86
    21.48
    22.34
    Meningitis Y, Day 29
    87.5
    85.46
    88.04
    87.56
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.79
    Confidence Interval (2-Sided) 95%
    -2.69 to 6.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 6.96
    Confidence Interval (2-Sided) 95%
    0.01 to 13.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 3.13
    Confidence Interval (2-Sided) 95%
    -3.33 to 9.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    -4.86 to 6.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.46
    Confidence Interval (2-Sided) 95%
    -2.24 to 5.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.43
    Confidence Interval (2-Sided) 95%
    -6.32 to 5.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -1.43
    Confidence Interval (2-Sided) 95%
    -7.05 to 4.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 2.04
    Confidence Interval (2-Sided) 95%
    -2.81 to 6.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.50
    Confidence Interval (2-Sided) 95%
    -3.32 to 6.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 0.38
    Confidence Interval (2-Sided) 95%
    -6.60 to 7.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -1.26
    Confidence Interval (2-Sided) 95%
    -7.75 to 5.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.85
    Confidence Interval (2-Sided) 95%
    -6.69 to 4.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -4.24 to 2.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.32
    Confidence Interval (2-Sided) 95%
    -3.99 to 6.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 4.09
    Confidence Interval (2-Sided) 95%
    -1.11 to 9.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 0.48
    Confidence Interval (2-Sided) 95%
    -4.16 to 5.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis is performed on the per protocol set for immunogenicity that includes subjects who received the vaccine did not have any protocol deviation leading to exclusion , who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 394 398 395 392
    Meningitis A, Day 1
    12.86
    11.57
    15.38
    13.64
    Meningitis A, Day 29
    93.92
    92.19
    93.37
    94.01
    Meningitis C, Day 1
    55.84
    48.61
    61.01
    57.14
    Meningitis C, Day 29
    79.38
    80.37
    84.7
    84.7
    Meningitis W, Day 1
    32.45
    28.54
    29.32
    30.05
    Meningitis W, Day 29
    79.43
    80.87
    85.86
    81.77
    Meningitis Y, Day 1
    24.36
    22.86
    21.74
    22.86
    Meningitis Y, Day 29
    88.28
    86.22
    88.3
    87.56
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.29
    Confidence Interval (2-Sided) 95%
    -3.37 to 5.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 7.23
    Confidence Interval (2-Sided) 95%
    0.25 to 14.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    -2.57 to 10.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.49
    Confidence Interval (2-Sided) 95%
    -4.44 to 7.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.73
    Confidence Interval (2-Sided) 95%
    -1.94 to 5.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.99
    Confidence Interval (2-Sided) 95%
    -6.66 to 4.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -1.43
    Confidence Interval (2-Sided) 95%
    -7.05 to 4.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq24 Group, ACWY_1 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 2.06
    Confidence Interval (2-Sided) 95%
    -2.67 to 6.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    -3.32 to 6.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 3.87
    Confidence Interval (2-Sided) 95%
    -3.00 to 10.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.73
    Confidence Interval (2-Sided) 95%
    -7.24 to 5.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -1.12
    Confidence Interval (2-Sided) 95%
    -6.99 to 4.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -4.24 to 2.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 0.00
    Confidence Interval (2-Sided) 95%
    -5.16 to 5.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 4.09
    Confidence Interval (2-Sided) 95%
    -1.11 to 9.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection GSK3536820A ACWY_Liq30 Group, ACWY_2 Group
    Comments Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage of subjects
    Estimated Value 0.73
    Confidence Interval (2-Sided) 95%
    -3.88 to 5.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported unsolicited adverse events data for the defined period.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 420 424 427 419
    Count of Participants [Participants]
    2
    0.5%
    2
    0.5%
    6
    1.4%
    6
    1.4%
    8. Secondary Outcome
    Title Number of Subjects Reported With Solicited Local and Systemic AEs
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the solicited safety set that includes all enrolled subjects who received a study vaccination and reported solicited adverse events data for the defined period.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 418 422 425 419
    Arthralgia
    45
    10.7%
    50
    11.8%
    49
    11.5%
    40
    9.5%
    Chills
    75
    17.9%
    79
    18.6%
    78
    18.3%
    56
    13.4%
    Erythema
    48
    11.4%
    51
    12%
    58
    13.6%
    40
    9.5%
    Fatigue
    174
    41.4%
    175
    41.3%
    149
    34.9%
    147
    35.1%
    Fever (Temperature >= 38 C)
    15
    3.6%
    18
    4.2%
    15
    3.5%
    12
    2.9%
    Headache
    164
    39%
    151
    35.6%
    169
    39.6%
    157
    37.5%
    Induration
    50
    11.9%
    51
    12%
    54
    12.6%
    39
    9.3%
    Loss of Appetite
    53
    12.6%
    54
    12.7%
    63
    14.8%
    34
    8.1%
    Myalgia
    60
    14.3%
    59
    13.9%
    58
    13.6%
    65
    15.5%
    Nausea
    54
    12.9%
    48
    11.3%
    42
    9.8%
    46
    11%
    Pain
    189
    45%
    181
    42.7%
    202
    47.3%
    192
    45.8%
    9. Secondary Outcome
    Title Number of Subjects Reported With Other Indicators of Reactogenicity
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the solicited safety set that includes all enrolled subjects who received a study vaccination and reported solicited adverse events data for the defined period.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 418 422 425 419
    Analgesic/Antipyretic Prevention, No
    357
    85%
    374
    88.2%
    366
    85.7%
    369
    88.1%
    Analgesic/Antipyretic Prevention, Yes
    61
    14.5%
    48
    11.3%
    59
    13.8%
    50
    11.9%
    Analgesic/Antipyretic Treatment, No
    328
    78.1%
    340
    80.2%
    349
    81.7%
    350
    83.5%
    Analgesic/Antipyretic Treatment, Yes
    90
    21.4%
    82
    19.3%
    76
    17.8%
    69
    16.5%
    10. Secondary Outcome
    Title Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported unsolicited adverse events data for the defined period.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 420 424 427 419
    Count of Participants [Participants]
    77
    18.3%
    91
    21.5%
    101
    23.7%
    97
    23.2%
    11. Secondary Outcome
    Title Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported unsolicited adverse events data for the defined period.
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    Measure Participants 420 424 427 419
    AEs Leading to withdrawal
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    SAEs
    4
    1%
    1
    0.2%
    4
    0.9%
    4
    1%
    Medically attended AEs
    88
    21%
    69
    16.3%
    81
    19%
    77
    18.4%

    Adverse Events

    Time Frame 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)
    Adverse Event Reporting Description
    Arm/Group Title GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Arm/Group Description 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 Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1. 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. Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
    All Cause Mortality
    GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/420 (0%) 0/424 (0%) 0/427 (0%) 0/419 (0%)
    Serious Adverse Events
    GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/420 (1%) 1/424 (0.2%) 4/427 (0.9%) 4/419 (1%)
    Congenital, familial and genetic disorders
    Phimosis 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Gastrointestinal disorders
    Appendicitis noninfective 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Infections and infestations
    Otitis externa 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Tooth abscess 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Soft tissue injury 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Tibia fracture 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Nervous system disorders
    Tension headache 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Psychiatric disorders
    Depression 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Reproductive system and breast disorders
    Adnexa uteri pain 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Ovarian cyst ruptured 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Other (Not Including Serious) Adverse Events
    GSK3536820A ACWY_Liq24 Group ACWY_1 Group GSK3536820A ACWY_Liq30 Group ACWY_2 Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 312/420 (74.3%) 314/424 (74.1%) 324/427 (75.9%) 317/419 (75.7%)
    Blood and lymphatic system disorders
    Anaemia 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Lymphadenopathy 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 1/419 (0.2%) 1
    Cardiac disorders
    Tachycardia 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Eye disorders
    Eye paraesthesia 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Vision blurred 1/420 (0.2%) 2 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Gastrointestinal disorders
    Abdominal distension 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Abdominal pain 4/420 (1%) 4 4/424 (0.9%) 4 4/427 (0.9%) 4 6/419 (1.4%) 7
    Abdominal pain lower 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Abdominal pain upper 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Dental caries 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Diarrhoea 3/420 (0.7%) 4 0/424 (0%) 0 6/427 (1.4%) 6 5/419 (1.2%) 5
    Enteritis 1/420 (0.2%) 1 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Gastritis 1/420 (0.2%) 1 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Nausea 54/420 (12.9%) 56 48/424 (11.3%) 49 43/427 (10.1%) 45 46/419 (11%) 46
    Odynophagia 0/420 (0%) 0 1/424 (0.2%) 1 2/427 (0.5%) 2 0/419 (0%) 0
    Oesophagitis 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Toothache 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Vomiting 1/420 (0.2%) 1 0/424 (0%) 0 1/427 (0.2%) 1 1/419 (0.2%) 1
    General disorders
    Administration site erythema 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Administration site induration 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Administration site pain 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Application site erythema 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Application site warmth 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Chills 77/420 (18.3%) 78 79/424 (18.6%) 81 78/427 (18.3%) 78 56/419 (13.4%) 57
    Discomfort 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Facial pain 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Fatigue 175/420 (41.7%) 175 175/424 (41.3%) 179 150/427 (35.1%) 157 147/419 (35.1%) 150
    Induration 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Injection site erythema 50/420 (11.9%) 51 51/424 (12%) 52 59/427 (13.8%) 68 42/419 (10%) 47
    Injection site haematoma 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Injection site induration 52/420 (12.4%) 53 51/424 (12%) 51 54/427 (12.6%) 62 39/419 (9.3%) 43
    Injection site oedema 1/420 (0.2%) 1 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Injection site pain 190/420 (45.2%) 193 182/424 (42.9%) 183 205/427 (48%) 214 194/419 (46.3%) 201
    Injection site pruritus 2/420 (0.5%) 3 3/424 (0.7%) 3 2/427 (0.5%) 2 2/419 (0.5%) 2
    Injection site rash 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Injection site scab 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Malaise 1/420 (0.2%) 1 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Oedema 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Pain 0/420 (0%) 0 0/424 (0%) 0 2/427 (0.5%) 2 2/419 (0.5%) 2
    Pyrexia 20/420 (4.8%) 21 19/424 (4.5%) 20 19/427 (4.4%) 19 14/419 (3.3%) 14
    Vaccination site pain 0/420 (0%) 0 1/424 (0.2%) 1 1/427 (0.2%) 1 0/419 (0%) 0
    Vessel puncture site induration 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Vessel puncture site pain 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Immune system disorders
    Allergy to arthropod sting 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Drug hypersensitivity 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Infections and infestations
    Abscess limb 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Abscess oral 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Acute sinusitis 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Balanitis candida 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Bronchitis 0/420 (0%) 0 3/424 (0.7%) 3 0/427 (0%) 0 1/419 (0.2%) 1
    Conjunctivitis 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Enterobiasis 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Gastroenteritis 1/420 (0.2%) 1 1/424 (0.2%) 1 1/427 (0.2%) 1 1/419 (0.2%) 1
    Helicobacter infection 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Herpes simplex 1/420 (0.2%) 1 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Hordeolum 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Influenza 1/420 (0.2%) 1 2/424 (0.5%) 2 3/427 (0.7%) 3 3/419 (0.7%) 3
    Injection site cellulitis 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Laryngitis 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Nasopharyngitis 7/420 (1.7%) 7 15/424 (3.5%) 15 6/427 (1.4%) 7 6/419 (1.4%) 6
    Oral candidiasis 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Oral herpes 1/420 (0.2%) 1 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Otitis media 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Paronychia 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Pharyngitis 1/420 (0.2%) 1 0/424 (0%) 0 2/427 (0.5%) 3 1/419 (0.2%) 1
    Pharyngitis streptococcal 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Pharyngotonsillitis 2/420 (0.5%) 2 0/424 (0%) 0 1/427 (0.2%) 1 2/419 (0.5%) 2
    Pneumonia 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Respiratory tract infection 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 2/419 (0.5%) 2
    Respiratory tract infection viral 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Rhinitis 3/420 (0.7%) 3 4/424 (0.9%) 4 5/427 (1.2%) 5 7/419 (1.7%) 7
    Sinusitis 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 2/419 (0.5%) 2
    Tonsillitis 2/420 (0.5%) 2 0/424 (0%) 0 0/427 (0%) 0 2/419 (0.5%) 2
    Tracheitis 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Tracheobronchitis 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Upper respiratory tract infection 8/420 (1.9%) 8 8/424 (1.9%) 8 7/427 (1.6%) 7 4/419 (1%) 4
    Upper respiratory tract infection bacterial 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Urethritis 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Urinary tract infection 0/420 (0%) 0 2/424 (0.5%) 2 1/427 (0.2%) 1 2/419 (0.5%) 2
    Viral infection 0/420 (0%) 0 1/424 (0.2%) 1 3/427 (0.7%) 3 0/419 (0%) 0
    Vulvovaginal mycotic infection 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Injury, poisoning and procedural complications
    Animal bite 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Contusion 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 1/419 (0.2%) 1
    Fall 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Hand fracture 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Joint dislocation 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Ligament sprain 1/420 (0.2%) 1 1/424 (0.2%) 1 0/427 (0%) 0 1/419 (0.2%) 1
    Limb injury 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Metabolism and nutrition disorders
    Decreased appetite 54/420 (12.9%) 55 54/424 (12.7%) 56 63/427 (14.8%) 64 34/419 (8.1%) 36
    Iron deficiency 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 50/420 (11.9%) 52 53/424 (12.5%) 53 49/427 (11.5%) 55 40/419 (9.5%) 41
    Back pain 0/420 (0%) 0 1/424 (0.2%) 1 5/427 (1.2%) 5 4/419 (1%) 4
    Muscle spasms 1/420 (0.2%) 1 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Myalgia 63/420 (15%) 63 62/424 (14.6%) 62 58/427 (13.6%) 63 65/419 (15.5%) 68
    Neck pain 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 1/419 (0.2%) 1
    Pain in extremity 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 1/419 (0.2%) 1
    Tendonitis 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Torticollis 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Nervous system disorders
    Burning sensation 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Dizziness 1/420 (0.2%) 2 1/424 (0.2%) 1 1/427 (0.2%) 1 4/419 (1%) 4
    Epilepsy 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Generalised tonic-clonic seizure 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Headache 168/420 (40%) 177 155/424 (36.6%) 164 178/427 (41.7%) 200 162/419 (38.7%) 188
    Intercostal neuralgia 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Migraine 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Paraesthesia 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 2/419 (0.5%) 2
    Presyncope 0/420 (0%) 0 1/424 (0.2%) 1 1/427 (0.2%) 1 0/419 (0%) 0
    Sciatica 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Somnolence 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 1/419 (0.2%) 1
    Tremor 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Psychiatric disorders
    Bulimia nervosa 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Insomnia 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Irritability 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Renal and urinary disorders
    Hypertonic bladder 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Dysmenorrhoea 1/420 (0.2%) 1 0/424 (0%) 0 1/427 (0.2%) 1 4/419 (1%) 4
    Endometriosis 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Polycystic ovaries 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Cough 2/420 (0.5%) 2 0/424 (0%) 0 2/427 (0.5%) 2 2/419 (0.5%) 2
    Dysphonia 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Epistaxis 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Nasal congestion 1/420 (0.2%) 1 0/424 (0%) 0 1/427 (0.2%) 1 1/419 (0.2%) 2
    Nasal obstruction 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Oropharyngeal pain 0/420 (0%) 0 1/424 (0.2%) 1 3/427 (0.7%) 3 1/419 (0.2%) 1
    Pharyngeal erythema 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Respiratory disorder 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Rhinitis allergic 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Rhinorrhoea 1/420 (0.2%) 1 0/424 (0%) 0 3/427 (0.7%) 3 0/419 (0%) 0
    Sneezing 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermal cyst 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Dermatitis 1/420 (0.2%) 1 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Dermatitis allergic 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0
    Dermatitis atopic 2/420 (0.5%) 2 0/424 (0%) 0 0/427 (0%) 0 0/419 (0%) 0
    Dermatitis contact 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Hand dermatitis 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Ingrowing nail 0/420 (0%) 0 1/424 (0.2%) 1 0/427 (0%) 0 0/419 (0%) 0
    Pruritus 0/420 (0%) 0 0/424 (0%) 0 0/427 (0%) 0 1/419 (0.2%) 1
    Rash 0/420 (0%) 0 0/424 (0%) 0 1/427 (0.2%) 1 0/419 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email GSKClinicalSupportHD@gsk.com
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT03433482
    Other Study ID Numbers:
    • 207467
    • V59_78
    • 2017-003456-23
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Jan 1, 2021