Meningitis, Meningococcal
Conditions
Keywords
Meningococcal disease, Liquid formulation, Meningitis
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.
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 40 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 |
| 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. |
Countries
Brazil, Estonia, Finland, France, Mexico, Russia, South Africa, Spain, Turkey (Türkiye)
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 420 |
| 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. | 424 |
| 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. | 427 |
| 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. | 419 |
| Total | 1,690 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 1 |
| Overall Study | Unknown reason | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 22.5 Years STANDARD_DEVIATION 9.4 | 22.2 Years STANDARD_DEVIATION 9.6 | 22.3 Years STANDARD_DEVIATION 9.8 | 22.0 Years STANDARD_DEVIATION 9.3 | 22.3 Years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized Black Or African American | 26 Participants | 22 Participants | 30 Participants | 26 Participants | 104 Participants |
| Race/Ethnicity, Customized Other | 58 Participants | 54 Participants | 83 Participants | 84 Participants | 279 Participants |
| Race/Ethnicity, Customized White | 332 Participants | 343 Participants | 311 Participants | 304 Participants | 1290 Participants |
| Sex: Female, Male Female | 232 Participants | 242 Participants | 259 Participants | 228 Participants | 961 Participants |
| Sex: Female, Male Male | 188 Participants | 182 Participants | 168 Participants | 191 Participants | 729 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 420 | 0 / 424 | 0 / 427 | 0 / 419 |
| other Total, other adverse events | 312 / 420 | 314 / 424 | 324 / 427 | 317 / 419 |
| serious Total, serious adverse events | 4 / 420 | 1 / 424 | 4 / 427 | 4 / 419 |
Outcome results
Primary
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios
hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.
Time frame: At Day 29
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios | 386.66 Titers |
| ACWY_1 Group | Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios | 318.34 Titers |
| GSK3536820A ACWY_Liq30 Group | Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios | 387.06 Titers |
| ACWY_2 Group | Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios | 348.89 Titers |
Comparison: 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 vaccination95% CI: [0.94, 1.57]ANCOVA
Comparison: 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.95% CI: [0.87, 1.42]ANCOVA
Secondary
hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios
hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroup A, C, W and Y.
Time frame: At Day 1 and Day 29
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 1 | 3.01 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 29 | 388.53 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 1 | 8.59 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 29 | 143.69 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 1 | 6.23 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 29 | 62.73 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 1 | 4.39 Titers |
| GSK3536820A ACWY_Liq24 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 29 | 116.42 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 29 | 63.92 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 1 | 5.8 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 29 | 319.06 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 29 | 105.11 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 1 | 4.21 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 29 | 157.74 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 1 | 7.06 Titers |
| ACWY_1 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 1 | 2.91 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 1 | 4.14 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 1 | 9.05 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 29 | 244.44 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 1 | 5.69 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 29 | 80.51 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 29 | 112.95 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 1 | 3.34 Titers |
| GSK3536820A ACWY_Liq30 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 29 | 394.16 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 1 | 8.7 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis C, Day 29 | 208.34 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 29 | 349 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis A, Day 1 | 3.16 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 1 | 5.74 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 29 | 118.04 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis Y, Day 1 | 4.19 Titers |
| ACWY_2 Group | hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios | Meningitis W, Day 29 | 73.08 Titers |
Comparison: 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 C95% CI: [0.58, 1.19]ANCOVA
Comparison: 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 W95% CI: [0.72, 1.24]ANCOVA
Comparison: 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 Y95% CI: [0.82, 1.44]ANCOVA
Comparison: 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 C95% CI: [0.79, 1.64]ANCOVA
Comparison: 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 W95% CI: [0.84, 1.45]ANCOVA
Comparison: 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 Y95% CI: [0.72, 1.26]ANCOVA
Secondary
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
Time frame: Within 30 minutes after vaccination at Day 1
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 2 Participants |
| ACWY_1 Group | Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 2 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 6 Participants |
| ACWY_2 Group | Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 6 Participants |
Secondary
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
Time frame: From Day 1 to Day 29 after vaccination
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 77 Participants |
| ACWY_1 Group | Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 91 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 101 Participants |
| ACWY_2 Group | Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 97 Participants |
Secondary
Number of Subjects Reported With Other Indicators of Reactogenicity
Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after any vaccination
Time frame: From Day 1 to Day 7 after vaccination
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, No | 357 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, Yes | 61 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, No | 328 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, Yes | 90 Participants |
| ACWY_1 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, Yes | 82 Participants |
| ACWY_1 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, No | 374 Participants |
| ACWY_1 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, Yes | 48 Participants |
| ACWY_1 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, No | 340 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, Yes | 59 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, No | 349 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, No | 366 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, Yes | 76 Participants |
| ACWY_2 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, No | 369 Participants |
| ACWY_2 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, Yes | 50 Participants |
| ACWY_2 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, Yes | 69 Participants |
| ACWY_2 Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, No | 350 Participants |
Secondary
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs
Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity
Time frame: From Day 1 to Day 181 (during the entire study period)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | AEs Leading to withdrawal | 0 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | Medically attended AEs | 88 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | SAEs | 4 Participants |
| ACWY_1 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | AEs Leading to withdrawal | 0 Participants |
| ACWY_1 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | Medically attended AEs | 69 Participants |
| ACWY_1 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | SAEs | 1 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | SAEs | 4 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | AEs Leading to withdrawal | 0 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | Medically attended AEs | 81 Participants |
| ACWY_2 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | AEs Leading to withdrawal | 0 Participants |
| ACWY_2 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | Medically attended AEs | 77 Participants |
| ACWY_2 Group | Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs | SAEs | 4 Participants |
Secondary
Number of Subjects Reported With Solicited Local and Systemic AEs
Assessed solicited local AEs were erythema, induration and pain at injection site. Assessed solicited systemic AEs were Arthralgia, chills, fatigue, fever (body temperature ≥38.0°C), headache, loss of appetite, myalgia and nausea.
Time frame: From Day 1 (6 hours) to Day 7 after vaccination
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Myalgia | 60 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fatigue | 174 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Loss of Appetite | 53 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Pain | 189 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Nausea | 54 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fever (Temperature >= 38 C) | 15 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Chills | 75 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Arthralgia | 45 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Induration | 50 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Headache | 164 Participants |
| GSK3536820A ACWY_Liq24 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Erythema | 48 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Headache | 151 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Induration | 51 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Pain | 181 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Loss of Appetite | 54 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Chills | 79 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Nausea | 48 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fatigue | 175 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Erythema | 51 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fever (Temperature >= 38 C) | 18 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Myalgia | 59 Participants |
| ACWY_1 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Arthralgia | 50 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Nausea | 42 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Arthralgia | 49 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Erythema | 58 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fatigue | 149 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fever (Temperature >= 38 C) | 15 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Headache | 169 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Induration | 54 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Loss of Appetite | 63 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Myalgia | 58 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Chills | 78 Participants |
| GSK3536820A ACWY_Liq30 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Pain | 202 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fever (Temperature >= 38 C) | 12 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Chills | 56 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Myalgia | 65 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fatigue | 147 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Erythema | 40 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Pain | 192 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Nausea | 46 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Induration | 39 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Arthralgia | 40 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Loss of Appetite | 34 Participants |
| ACWY_2 Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Headache | 157 Participants |
Secondary
Percentages of Subjects With ≥4 Fold Rise in hSBA Antibody Titers for Each of the N.Meningitidis Serogroups A, C,W and Y for Each Vaccine Group and Between-group Differences
The percentages of subjects with a ≥ 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs are computed by group and N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as: - for individuals, whose pre-vaccination titers are \< the LOD (limit of detection), the post-vaccination titers must be ≥ 4-fold the LOD or ≥ the LLOQ (lower limit of quantitation) whichever is greater; - for individuals whose pre-vaccination titers are ≥ the LOD and ≤ the LLOQ, the post-vaccination titers must be at least four times the LLOQ; - for individuals whose pre-vaccination titers are \> the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination titer.
Time frame: At Day 29
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis A | 92.29 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis C | 62.34 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis W | 59.41 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis Y | 71.77 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis C | 64.46 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis W | 60.57 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis Y | 73.33 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis A | 90.08 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis W | 66.58 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis C | 72.61 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis Y | 74.35 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis A | 91.57 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis Y | 77.19 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis C | 69.76 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis A | 91.69 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis W | 62.57 Percentage of subjects |
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.95% CI: [-1.94, 6.4]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.95% CI: [-8.94, 4.72]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.95% CI: [-8.11, 5.8]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.95% CI: [-7.88, 4.74]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.95% CI: [-4.29, 4.07]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.95% CI: [-3.63, 9.3]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.95% CI: [-2.89, 10.88]Miettinen and Nurminen score method
Comparison: Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.95% CI: [-8.91, 3.26]Miettinen and Nurminen score method
Secondary
Percentages of Subjects With hSBA Antibody Titers ≥8 Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Differences
For each vaccine group the percentage of subjects with hSBA titer ≥8 , and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis A, Day 1 | 12.07 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis A, Day 29 | 93.65 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis C, Day 1 | 48.48 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis C, Day 29 | 77.58 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis W, Day 1 | 31.66 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis W, Day 29 | 79.43 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis Y, Day 1 | 22.82 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis Y, Day 29 | 87.5 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis W, Day 29 | 80.87 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis W, Day 1 | 28.54 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis A, Day 29 | 92.19 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis Y, Day 29 | 85.46 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis Y, Day 1 | 21.86 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis C, Day 29 | 78.01 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis C, Day 1 | 41.52 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis A, Day 1 | 10.28 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis Y, Day 1 | 21.48 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis C, Day 1 | 50.63 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis C, Day 29 | 84.17 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis W, Day 1 | 28.8 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis W, Day 29 | 85.86 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis Y, Day 29 | 88.04 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis A, Day 1 | 13.53 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis A, Day 29 | 93.37 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis C, Day 1 | 50.26 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis C, Day 29 | 82.85 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis A, Day 29 | 94.01 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis A, Day 1 | 12.03 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis W, Day 1 | 30.05 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis Y, Day 29 | 87.56 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis Y, Day 1 | 22.34 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis W, Day 29 | 81.77 Percentage of subjects |
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.95% CI: [-2.69, 6.32]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.95% CI: [0.01, 13.84]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.95% CI: [-3.33, 9.58]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.95% CI: [-4.86, 6.8]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.95% CI: [-2.24, 5.22]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.95% CI: [-6.32, 5.46]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.95% CI: [-7.05, 4.18]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.95% CI: [-2.81, 6.9]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.95% CI: [-3.32, 6.33]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.95% CI: [-6.6, 7.35]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.95% CI: [-7.75, 5.23]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.95% CI: [-6.69, 4.98]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.95% CI: [-4.24, 2.96]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.95% CI: [-3.99, 6.64]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.95% CI: [-1.11, 9.33]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.95% CI: [-4.16, 5.13]Miettinen and Nurminen score method
Secondary
Percentages of Subjects With hSBA Titers ≥LLOQ Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences
For each vaccine group the percentages of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis A, Day 1 | 12.86 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis A, Day 29 | 93.92 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis C, Day 1 | 55.84 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis C, Day 29 | 79.38 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis W, Day 1 | 32.45 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis W, Day 29 | 79.43 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis Y, Day 1 | 24.36 Percentage of subjects |
| GSK3536820A ACWY_Liq24 Group | 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 | Meningitis Y, Day 29 | 88.28 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis W, Day 29 | 80.87 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis W, Day 1 | 28.54 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis A, Day 29 | 92.19 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis Y, Day 29 | 86.22 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis Y, Day 1 | 22.86 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis C, Day 29 | 80.37 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis C, Day 1 | 48.61 Percentage of subjects |
| ACWY_1 Group | 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 | Meningitis A, Day 1 | 11.57 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis Y, Day 1 | 21.74 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis C, Day 1 | 61.01 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis C, Day 29 | 84.7 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis W, Day 1 | 29.32 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis W, Day 29 | 85.86 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis Y, Day 29 | 88.3 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis A, Day 1 | 15.38 Percentage of subjects |
| GSK3536820A ACWY_Liq30 Group | 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 | Meningitis A, Day 29 | 93.37 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis C, Day 1 | 57.14 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis C, Day 29 | 84.7 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis A, Day 29 | 94.01 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis A, Day 1 | 13.64 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis W, Day 1 | 30.05 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis Y, Day 29 | 87.56 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis Y, Day 1 | 22.86 Percentage of subjects |
| ACWY_2 Group | 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 | Meningitis W, Day 29 | 81.77 Percentage of subjects |
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 195% CI: [-3.37, 5.99]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 195% CI: [0.25, 14.13]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 195% CI: [-2.57, 10.39]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 195% CI: [-4.44, 7.44]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 2995% CI: [-1.94, 5.46]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 2995% CI: [-6.66, 4.7]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 2995% CI: [-7.05, 4.18]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 2995% CI: [-2.67, 6.8]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 195% CI: [-3.32, 6.83]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 195% CI: [-3, 10.71]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 195% CI: [-7.24, 5.77]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 195% CI: [-6.99, 4.75]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 2995% CI: [-4.24, 2.96]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 2995% CI: [-5.16, 5.16]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 2995% CI: [-1.11, 9.33]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 2995% CI: [-3.88, 5.37]Miettinen and Nurminen score method
Secondary
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group
Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1.
Time frame: At Day 29
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis A | 130.33 Ratio |
| GSK3536820A ACWY_Liq24 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis C | 17.01 Ratio |
| GSK3536820A ACWY_Liq24 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis W | 9.81 Ratio |
| GSK3536820A ACWY_Liq24 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis Y | 26.53 Ratio |
| ACWY_1 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis C | 21.68 Ratio |
| ACWY_1 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis W | 10.77 Ratio |
| ACWY_1 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis Y | 25.23 Ratio |
| ACWY_1 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis A | 108.39 Ratio |
| GSK3536820A ACWY_Liq30 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis W | 13.8 Ratio |
| GSK3536820A ACWY_Liq30 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis C | 26.69 Ratio |
| GSK3536820A ACWY_Liq30 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis Y | 27.18 Ratio |
| GSK3536820A ACWY_Liq30 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis A | 114.66 Ratio |
| ACWY_2 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis Y | 28.49 Ratio |
| ACWY_2 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis C | 23.85 Ratio |
| ACWY_2 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis A | 106.79 Ratio |
| ACWY_2 Group | Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group | Meningitis W | 12.48 Ratio |