Infections, Meningococcal
Conditions
Keywords
Meningitis, Liquid formulation, Meningococcal disease
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.
Interventions
BIOLOGICALMenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)
Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
BIOLOGICALLicensed GSK MenACWY vaccine (Menveo)
Single dose administered at Day 1, 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
18 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 Respresentative(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 parents(s)/LAR(s) of the subject prior to performance of 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 enrolment. 4. A male or female between, and including, ≥18 to ≤40 YoA at the time of the first 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. (approximately 1 month after vaccination).
Exclusion criteria
1. Anaphylaxis following the administration of vaccine 2. Any (clinical) condition that in the judgment of the investigator would make intramuscular injection unsafe and/or represents a contraindication to intramuscular vaccination and blood draws. 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection. 4. Progressive, unstable or uncontrolled clinical conditions. 5. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 6. 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. 7. Abnormal function of the immune system resulting from: * Clinical conditions. * Systemic administration of corticosteroids (Per os \[PO\]/ Intravenous \[IV\]/ Intramuscular \[IM\]) for more than 14 consecutive days within 90 days prior to informed consent, and until the Day 29 blood draw. * Administration of antineoplastic and immuno-modulating agents or radiotherapy within 90 days prior to informed consent, and until the Day 29 blood draw. 8. Received immunoglobulins or any blood products within 180 days prior to informed consent. 9. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. 10. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 11. History of any meningococcal vaccination. 12. Individuals who received any other vaccines within 7 days (for inactivated vaccines) or 14 days (for live vaccines) 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 (e.g.: a pandemic) is organised 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 Summary of Product Characteristics (SmPC) or Prescribing Information and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained. 13. Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). 14. 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). 15. Current or previous, confirmed or suspected disease caused by N. meningitidis. 16. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination. 17. 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. 18. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw. 19. Study personnel as an immediate family or household member. 20. 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 were calculated in terms of GMTs adjusted for pre-vaccination titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | 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 a ≥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 were computed by group and for each 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 of 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 |
| Percentages of Subjects With hSBA 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 were 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 percentage of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs were 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 serogroups A, C, W and Y. |
| 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 vaccination |
| Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | From Day 1 to Day 29 after vaccination | An 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 AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | 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 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 Solicited Local and Systemic AEs | From Day 1 (6 hours) to Day 7 after vaccination | Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after the vaccination. |
Countries
Australia, Belgium, Canada, Germany, Italy
Participant flow
Recruitment details
Subjects were enrolled from 8 centers in Australia, 2 in Belgium, 10 in Canada, 6 in Germany and 4 in Italy.Planned age range in this study was 18-40 years.But 1 subject aged 44 years not meeting inclusion criteria was enrolled & vaccinated in GSK3536820A ACWY\_Liq Group & therefore was considered for all analyses except per protocol set for immunogenicity analyses
Pre-assignment details
Among 996 enrolled subjects, 16 subjects didn't receive any treatment and ICF documentation was not retrievable for 1 subject.
Participants by arm
| Arm | Count |
|---|---|
| GSK3536820A ACWY_Liq Group Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS. | 490 |
| ACWY Group Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo). | 489 |
| Total | 979 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | ACWY Group | Total | GSK3536820A ACWY_Liq Group |
|---|---|---|---|
| Age, Continuous | 31.9 Years STANDARD_DEVIATION 5.8 | 31.8 Years STANDARD_DEVIATION 5.8 | 31.7 Years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 27 Participants | 67 Participants | 40 Participants |
| Race/Ethnicity, Customized Black Or African American | 8 Participants | 12 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 26 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 439 Participants | 866 Participants | 427 Participants |
| Sex: Female, Male Female | 305 Participants | 614 Participants | 309 Participants |
| Sex: Female, Male Male | 184 Participants | 365 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 490 | 0 / 489 |
| other Total, other adverse events | 336 / 490 | 335 / 489 |
| serious Total, serious adverse events | 6 / 490 | 9 / 489 |
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 were calculated in terms of GMTs adjusted for pre-vaccination titer.
Time frame: At Day 29
Population: Analysis was 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_Liq Group | Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios | 185.16 Titers |
| ACWY Group | Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios | 211.33 Titers |
Comparison: To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination95% CI: [0.64, 1.2]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 serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Population: Analysis was 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_Liq 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 | 2.79 Titers |
| GSK3536820A ACWY_Liq 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 | 182.96 Titers |
| GSK3536820A ACWY_Liq 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 | 11.41 Titers |
| GSK3536820A ACWY_Liq 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 | 153.95 Titers |
| GSK3536820A ACWY_Liq 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 | 9.6 Titers |
| GSK3536820A ACWY_Liq 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 | 59.74 Titers |
| GSK3536820A ACWY_Liq 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_Liq 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 | 60.29 Titers |
| ACWY 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 | 54.99 Titers |
| ACWY 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 | 2.97 Titers |
| ACWY 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 | 10.92 Titers |
| ACWY 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 | 213.42 Titers |
| ACWY 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 | 4.75 Titers |
| ACWY 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 | 12.05 Titers |
| ACWY 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 | 54.12 Titers |
| ACWY 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 | 139.63 Titers |
Comparison: To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 2995% CI: [0.84, 1.68]ANCOVA
Comparison: To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 2995% CI: [0.96, 1.58]ANCOVA
Comparison: To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 2995% CI: [0.9, 1.58]ANCOVA
Secondary
Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs)
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 any adverse events data in the defined period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | Aes leading to withdrawal | 0 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | MAEs | 79 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | SAEs | 6 Participants |
| ACWY Group | Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | Aes leading to withdrawal | 0 Participants |
| ACWY Group | Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | MAEs | 84 Participants |
| ACWY Group | Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) | SAEs | 9 Participants |
Secondary
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
An 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_Liq Group | Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 5 Participants |
| ACWY Group | Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 5 Participants |
Secondary
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
An 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_Liq Group | Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 117 Participants |
| ACWY Group | Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 111 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 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 any indicators of reactogenicity data for the defined period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, Yes | 36 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, No | 453 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, Yes | 80 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, No | 409 Participants |
| ACWY Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, No | 408 Participants |
| ACWY Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, Yes | 40 Participants |
| ACWY Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Treatment, Yes | 79 Participants |
| ACWY Group | Number of Subjects Reported With Other Indicators of Reactogenicity | Analgesic/Antipyretic Prevention, No | 447 Participants |
Secondary
Number of Subjects Reported With Solicited Local and Systemic AEs
Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after the vaccination.
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 any solicited adverse events data for the defined period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fatigue | 159 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Induration | 25 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fever (Temperature >= 38 C) | 7 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Arthralgia | 43 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Headache | 158 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Erythema | 28 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Loss of Appetite | 31 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Chills | 42 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Myalgia | 58 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Nausea | 49 Participants |
| GSK3536820A ACWY_Liq Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Pain | 200 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Nausea | 50 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Erythema | 28 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Induration | 24 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Pain | 182 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Arthralgia | 46 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Chills | 40 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fatigue | 159 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Fever (Temperature >= 38 C) | 10 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Headache | 165 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Loss of Appetite | 40 Participants |
| ACWY Group | Number of Subjects Reported With Solicited Local and Systemic AEs | Myalgia | 58 Participants |
Secondary
Percentages of Subjects With a ≥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 were computed by group and for each 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 of 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
Time frame: At Day 29
Population: Analysis was 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_Liq Group | Percentages of Subjects With a ≥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 | 79.8 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With a ≥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 | 56.3 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With a ≥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 | 44.7 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With a ≥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 | 63.3 Percentages of subjects |
| ACWY Group | Percentages of Subjects With a ≥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 | 58 Percentages of subjects |
| ACWY Group | Percentages of Subjects With a ≥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 | 83.7 Percentages of subjects |
| ACWY Group | Percentages of Subjects With a ≥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 | 40.2 Percentages of subjects |
| ACWY Group | Percentages of Subjects With a ≥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 | 54.4 Percentages 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: [-9.3, 1.52]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: [-4.7, 8.43]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: [-1.97, 11.01]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: [-1.11, 11.57]Miettinen and Nurminen score method
Secondary
Percentages of Subjects With hSBA 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 were computed for each of the N. meningitidis serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Population: Analysis was 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_Liq Group | Percentages of Subjects With hSBA 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 | 8.7 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 82.8 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 53.8 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 74.5 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 39.8 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 73.3 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 22.7 Percentages of subjects |
| GSK3536820A ACWY_Liq Group | Percentages of Subjects With hSBA 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 | 77.2 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 76 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 11.2 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 45.7 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 86.4 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 25.5 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 54.4 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 73.1 Percentages of subjects |
| ACWY Group | Percentages of Subjects With hSBA 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 | 74.9 Percentages of subjects |
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 195% CI: [-6.47, 1.49]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 195% CI: [-6.99, 5.83]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 195% CI: [-12.33, 0.47]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 195% CI: [-8.3, 2.76]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 2995% CI: [-8.65, 1.21]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 2995% CI: [-6.12, 5.33]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 2995% CI: [-5.49, 6.02]Miettinen and Nurminen score method
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 2995% CI: [-4.33, 6.62]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 percentage of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Population: Analysis was 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_Liq 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 | 10.5 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 82.8 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 61.2 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 76.5 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 41.3 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 73.3 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 23.8 Percentages of subjects |
| GSK3536820A ACWY_Liq 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 | 77.8 Percentages of subjects |
| ACWY 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 | 77.3 Percentages of subjects |
| ACWY 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 | 13.5 Percentages of subjects |
| ACWY 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 | 47.3 Percentages of subjects |
| ACWY 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 | 86.7 Percentages of subjects |
| ACWY 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 | 26.3 Percentages of subjects |
| ACWY 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 | 62.3 Percentages of subjects |
| ACWY 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 | 73.5 Percentages of subjects |
| ACWY 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 | 76.5 Percentages of subjects |
Comparison: Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 2995% CI: [-8.87, 0.96]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: [-7.24, 1.37]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: [-7.34, 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 195% CI: [-12.35, 0.5]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: [-8.15, 3.06]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: [-5.52, 5.65]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: [-5.92, 5.57]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: [-4.89, 5.9]Miettinen and Nurminen score method
Secondary
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y
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 was 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_Liq Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis A | 65.24 Ratio |
| GSK3536820A ACWY_Liq Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis C | 13.17 Ratio |
| GSK3536820A ACWY_Liq Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis W | 6.1 Ratio |
| GSK3536820A ACWY_Liq Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis Y | 14.64 Ratio |
| ACWY Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis Y | 11.48 Ratio |
| ACWY Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis A | 73.01 Ratio |
| ACWY Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis W | 4.8 Ratio |
| ACWY Group | Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y | Meningitis C | 11.07 Ratio |