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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003722-16 | EudraCT Number |
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The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenB+MenACWY Group | Experimental | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91. |
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| MenB Group | Experimental | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
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| MenACWY Group | Experimental | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) | Combination Product | 1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | During 7 days after the rMenB+OMV NZ vaccination at Day 1 |
| Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | During 7 days after the rMenB+OMV NZ vaccination at Day 61 |
| Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | During 7 days after the rMenB+OMV NZ vaccination at Day 91 |
| Number of Participants With Solicited Local AEs After the Vaccination With MenACWY | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade. | During 7 days after the MenACWY vaccination at Day 1 |
| Number of Participants With Solicited Local AEs After the Vaccination With MenACWY | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade. | During 7 days after the MenACWY vaccination at Day 61 |
| Measure | Description | Time Frame |
|---|---|---|
| hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination | Immune response to MenACWY given with or without rMenB+OMV NZ, as measured by ectrochemiluminescence-based multiplex (ECL) GMCs against each of the serogroups A, C, W and Y. ECL (validated assay) was used because ELISA is not validated. | At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups) |
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Inclusion Criteria:
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' 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.
Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
Healthy participants as established by medical history and clinical examination before entering the study.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study if the participant:
Exclusion Criteria:
Medical conditions
Progressive, unstable, or uncontrolled clinical conditions.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
Abnormal function of the immune system resulting from:
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
Current or previous, confirmed, or suspected disease caused by N. meningitidis.
Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
History of neuroinflammatory or autoimmune condition.
Recurrent history or un-controlled neurological disorders or seizures.
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
• Participant concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product, will not be enrolled.
Other exclusions
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85238 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Out of 945 participants enrolled, only 940 were randomized into the three treatment groups. After randomization, two participants did not receive the vaccination, so only 938 participants were included in the Exposed Set and started the study.
The study ended on Day 271 for participants who had not reached Day 271 when Protocol Amendment 7 took effect, and on Day 451 for those who had already passed Day 271.
Safety follow-up period for each participant was from Day 1 up to Day 451 or Day 271 for participants who have not reached Day 271 at the time Protocol Amendment 7 took effect.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenB+MenACWY Group | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91. |
| FG001 | MenB Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2022 | Dec 24, 2024 |
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This is an Observer-blinded study. Recipients & study evaluators were unaware of vaccine administered.
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| Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) | Biological | 1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group. |
|
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| Placebo | Combination Product | 1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group. |
|
|
| Number of Participants With Solicited Local AEs After the Vaccination With MenACWY | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade. | During 7 days after the MenACWY vaccination at Day 91 |
| Number of Participants With Solicited Local AEs After the Vaccination With Placebo | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | During 7 days after the Placebo vaccination at Day 1 |
| Number of Participants With Solicited Local AEs After the Vaccination With Placebo | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | During 7 days after the Placebo vaccination at Day 91 |
| Number of Participants With Solicited Systemic AEs | Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache. | During 7 days after the first study intervention administration occurring at Day 1 |
| Number of Participants With Solicited Systemic AEs | Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache. | During 7 days after the second study intervention administration occurring at Day 61 |
| Number of Participants With Solicited Systemic AEs | Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache. | During 7 days after the third study intervention administration occurring at Day 91 |
| Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) | Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. | During 30 days after the first study intervention administration occurring at Day 1 |
| Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) | Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. | During 30 days after the second study intervention administration occurring at Day 61 |
| Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) | Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. | During 30 days after the third study intervention administration occurring at Day 91 |
| Number of Participants With Any AEs/SAEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | During 30 days after the first study intervention administration occurring at Day 1 |
| Number of Participants With Any AEs/SAEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | During 30 days after the second study intervention administration occurring at Day 61 |
| Number of Participants With Any AEs/SAEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | During 30 days after the third study intervention administration occurring at Day 91 |
| Number of Participants With Any Medically Attended AEs | Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. | During 30 days after the first study intervention administration occurring at Day 1 |
| Number of Participants With Any Medically Attended AEs | Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. | During 30 days after the second study intervention administration occurring at Day 61 |
| Number of Participants With Any Medically Attended AEs | Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. | During 30 days after the third study intervention administration occurring at Day 91 |
| Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs | SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure. | Throughout the study period (Day 1 to Day 271) |
| Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI) | AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. | Throughout the study period (Day 1 to Day 271) |
| Number of Participants With Any SAEs and AEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | During safety follow-up (Day 271 to Day 451) |
| Number of Participants Who Received rMenB+OMV NZ With AESI | AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. | During safety follow-up (Day 271 to Day 451) |
| Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios | hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]). | At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups) |
| hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios | hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y. | At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups) |
| hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios | hSBA titers were measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) and expressed in GMTs. | At Day 31 (1 month after first vaccination with rMenB+OMV NZ) |
| Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline). | At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1) |
| GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline). | At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1) |
| Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]). | At Day 31 (one month after the first rMenB+OMV NZ vaccination) |
| Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]). | At Day 91 (1 month after the second rMenB+OMV NZ vaccination) |
| Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >= LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer. | At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1) |
| Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >=LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer. | At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1) |
| Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination | The immune response to MenACWY vaccines is expressed in terms of percentage of participants with hSBA titers >=LLOQ for each of the serogroup Men A, Men C, Men W and Men Y. | At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31) |
| GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination | Immune response to MenACWY given with or without rMenB+OMV NZ was measured by bactericidal activity against the four serogroups Men A, Men C, Men W and Men Y in terms of GMRs at one month after MenACWY vaccination compared to the baseline at Day 1/Month 0. GMR was measured within-group. | At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1) |
| Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination | The immune response to MenACWY vaccine is evaluated by measuring percentage of participants with 4-fold increase for the four serogroups Men A, Men C, Men W and Men Y. The Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer | At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1) |
| Bell Gardens |
| California |
| 90201 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90027 | United States |
| GSK Investigational Site | Oakland | California | 94611 | United States |
| GSK Investigational Site | Roseville | California | 95661 | United States |
| GSK Investigational Site | Sacramento | California | 95815 | United States |
| GSK Investigational Site | San Jose | California | 95119 | United States |
| GSK Investigational Site | Santa Clara | California | 95051 | United States |
| GSK Investigational Site | Walnut Creek | California | 94596 | United States |
| GSK Investigational Site | Wellington | Florida | 33470 | United States |
| GSK Investigational Site | Boise | Idaho | 83702 | United States |
| GSK Investigational Site | Nampa | Idaho | 83686 | United States |
| GSK Investigational Site | Nampa | Idaho | 83687 | United States |
| GSK Investigational Site | Evansville | Indiana | 47715 | United States |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40291 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70508 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68504 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68505 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68526 | United States |
| GSK Investigational Site | Cortland | New York | 13045 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28226 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Corvallis | Oregon | 97330 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | United States |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15025 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15234 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29414 | United States |
| GSK Investigational Site | Sioux Falls | South Dakota | 57108 | United States |
| GSK Investigational Site | Austin | Texas | 75010 | United States |
| GSK Investigational Site | Austin | Texas | 78613 | United States |
| GSK Investigational Site | Austin | Texas | 78726 | United States |
| GSK Investigational Site | Dallas | Texas | 75230-2571 | United States |
| GSK Investigational Site | Dallas | Texas | 75251 | United States |
| GSK Investigational Site | Houston | Texas | 77584 | United States |
| GSK Investigational Site | Plano | Texas | 75024 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | Victoria | Texas | 77901 | United States |
| GSK Investigational Site | Waxahachie | Texas | 75165 | United States |
| GSK Investigational Site | Orem | Utah | 84057 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | United States |
| GSK Investigational Site | South Jordan | Utah | 84095 | United States |
| GSK Investigational Site | Syracuse | Utah | 84075 | United States |
| GSK Investigational Site | Falls Church | Virginia | 22044 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | United States |
| GSK Investigational Site | Chiavari GE | 16043 | Italy |
| GSK Investigational Site | Foggia | 71122 | Italy |
| GSK Investigational Site | Milan | 20122 | Italy |
| GSK Investigational Site | Milan | 20162 | Italy |
Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| FG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MenB+MenACWY Group | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91. |
| BG001 | MenB Group | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| BG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the electronic diary (eDiary) for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 7 days after the rMenB+OMV NZ vaccination at Day 1 |
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| Primary | Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. | Posted | Count of Participants | Participants | During 7 days after the rMenB+OMV NZ vaccination at Day 61 |
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| Primary | Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. | Posted | Count of Participants | Participants | During 7 days after the rMenB+OMV NZ vaccination at Day 91 |
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| Primary | Number of Participants With Solicited Local AEs After the Vaccination With MenACWY | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. | Posted | Count of Participants | Participants | During 7 days after the MenACWY vaccination at Day 1 |
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| Primary | Number of Participants With Solicited Local AEs After the Vaccination With MenACWY | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade. | Analysis was performed on the ES, which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. 1 participant in MenB Group received wrong study treatment at Day 61 (MenACWY vaccine instead of rMenB+OMV NZ), hence was considered in the analysis population. | Posted | Count of Participants | Participants | During 7 days after the MenACWY vaccination at Day 61 |
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| Primary | Number of Participants With Solicited Local AEs After the Vaccination With MenACWY | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. | Posted | Count of Participants | Participants | During 7 days after the MenACWY vaccination at Day 91 |
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| Primary | Number of Participants With Solicited Local AEs After the Vaccination With Placebo | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. | Posted | Count of Participants | Participants | During 7 days after the Placebo vaccination at Day 1 |
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| Primary | Number of Participants With Solicited Local AEs After the Vaccination With Placebo | Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the ES, which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. Allocation per group is based on the treatment administered. 1 participant in MenACWY Group received wrong study treatment at Day 91 (placebo instead of rMenB+OMV NZ), hence was considered in the analysis population. | Posted | Count of Participants | Participants | During 7 days after the Placebo vaccination at Day 91 |
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| Primary | Number of Participants With Solicited Systemic AEs | Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. | Posted | Count of Participants | Participants | During 7 days after the first study intervention administration occurring at Day 1 |
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| Primary | Number of Participants With Solicited Systemic AEs | Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. | Posted | Count of Participants | Participants | During 7 days after the second study intervention administration occurring at Day 61 |
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| Primary | Number of Participants With Solicited Systemic AEs | Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment and had the eDiary for solicited events completed after the administration of study treatment and for whom data were available during the specified period. | Posted | Count of Participants | Participants | During 7 days after the third study intervention administration occurring at Day 91 |
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| Primary | Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) | Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the first study intervention administration occurring at Day 1 |
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| Primary | Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) | Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the second study intervention administration occurring at Day 61 |
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| Primary | Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) | Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the third study intervention administration occurring at Day 91 |
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| Primary | Number of Participants With Any AEs/SAEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the first study intervention administration occurring at Day 1 |
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| Primary | Number of Participants With Any AEs/SAEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the second study intervention administration occurring at Day 61 |
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| Primary | Number of Participants With Any AEs/SAEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the third study intervention administration occurring at Day 91 |
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| Primary | Number of Participants With Any Medically Attended AEs | Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the first study intervention administration occurring at Day 1 |
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| Primary | Number of Participants With Any Medically Attended AEs | Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the second study intervention administration occurring at Day 61 |
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| Primary | Number of Participants With Any Medically Attended AEs | Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | During 30 days after the third study intervention administration occurring at Day 91 |
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| Primary | Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs | SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure. | Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study treatment. | Posted | Count of Participants | Participants | Throughout the study period (Day 1 to Day 271) |
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| Primary | Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI) | AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints were included in the analysis. | Posted | Count of Participants | Participants | Throughout the study period (Day 1 to Day 271) |
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| Primary | Number of Participants With Any SAEs and AEs Leading to Withdrawal | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints (during safety follow-up period from Day 271 to Day 451) were included in the analysis. | Posted | Count of Participants | Participants | During safety follow-up (Day 271 to Day 451) |
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| Primary | Number of Participants Who Received rMenB+OMV NZ With AESI | AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. | Analysis was performed on the Exposed set (ES). Only participants with data available at specified timepoints (during safety follow-up period from Day 271 to Day 451) were included in the analysis. | Posted | Count of Participants | Participants | During safety follow-up (Day 271 to Day 451) |
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| Primary | Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios | hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]). | Analysis was performed on the Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups) |
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| Primary | hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios | hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y. | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups) |
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| Secondary | hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination | Immune response to MenACWY given with or without rMenB+OMV NZ, as measured by ectrochemiluminescence-based multiplex (ECL) GMCs against each of the serogroups A, C, W and Y. ECL (validated assay) was used because ELISA is not validated. | Not Posted | At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups) | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios | hSBA titers were measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) and expressed in GMTs. | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 31 (1 month after first vaccination with rMenB+OMV NZ) |
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| Secondary | Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline). | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1) |
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| Secondary | GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline). | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1) |
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| Secondary | Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]). | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 31 (one month after the first rMenB+OMV NZ vaccination) |
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| Secondary | Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]). | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 91 (1 month after the second rMenB+OMV NZ vaccination) |
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| Secondary | Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >= LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer. | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1) |
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| Secondary | Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination | The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >=LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer. | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1) |
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| Secondary | Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination | The immune response to MenACWY vaccines is expressed in terms of percentage of participants with hSBA titers >=LLOQ for each of the serogroup Men A, Men C, Men W and Men Y. | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31) |
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| Secondary | GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination | Immune response to MenACWY given with or without rMenB+OMV NZ was measured by bactericidal activity against the four serogroups Men A, Men C, Men W and Men Y in terms of GMRs at one month after MenACWY vaccination compared to the baseline at Day 1/Month 0. GMR was measured within-group. | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1) |
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| Secondary | Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination | The immune response to MenACWY vaccine is evaluated by measuring percentage of participants with 4-fold increase for the four serogroups Men A, Men C, Men W and Men Y. The Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer | Analysis was performed on the Per Protocol Set (PPS). Only those participants with data available at specified timepoint were included in analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1) |
|
Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MenB+MenACWY Group | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91. | 0 | 310 | 2 | 310 | 293 | 310 |
| EG001 | MenB Group | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. | 0 | 308 | 4 | 308 | 293 | 308 |
| EG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. | 0 | 320 | 7 | 320 | 289 | 320 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | v27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | v27.0 | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | v27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | v27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | v27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | v27.0 | Systematic Assessment |
| |
| Os trigonum | Congenital, familial and genetic disorders | v27.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | v27.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | v27.0 | Systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | v27.0 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | v27.0 | Systematic Assessment |
| |
| Polycystic ovarian syndrome | Endocrine disorders | v27.0 | Systematic Assessment |
| |
| Astigmatism | Eye disorders | v27.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | v27.0 | Systematic Assessment |
| |
| Episcleritis | Eye disorders | v27.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | v27.0 | Systematic Assessment |
| |
| Myopia | Eye disorders | v27.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | v27.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | v27.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Salivary gland mucocoele | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | v27.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | v27.0 | Systematic Assessment |
| |
| Administration site induration | General disorders | v27.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | v27.0 | Systematic Assessment |
| |
| Administration site swelling | General disorders | v27.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | v27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | v27.0 | Systematic Assessment |
| |
| Chills | General disorders | v27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | v27.0 | Systematic Assessment |
| |
| Feeling of body temperature change | General disorders | v27.0 | Systematic Assessment |
| |
| Induration | General disorders | v27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | v27.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | v27.0 | Systematic Assessment |
| |
| Injection site hypoaesthesia | General disorders | v27.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | v27.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | v27.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | v27.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | v27.0 | Systematic Assessment |
| |
| Malaise | General disorders | v27.0 | Systematic Assessment |
| |
| Pain | General disorders | v27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | v27.0 | Systematic Assessment |
| |
| Swelling | General disorders | v27.0 | Systematic Assessment |
| |
| Vaccination site bruising | General disorders | v27.0 | Systematic Assessment |
| |
| Vaccination site erythema | General disorders | v27.0 | Systematic Assessment |
| |
| Vaccination site rash | General disorders | v27.0 | Systematic Assessment |
| |
| Vaccination site swelling | General disorders | v27.0 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | v27.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Bacterial vulvovaginitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | v27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Pilonidal disease | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Pyuria | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Stitch abscess | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | v27.0 | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Breast procedural complication | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Distal clavicular osteolysis | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Open globe injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Suture related complication | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Torus fracture | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | v27.0 | Systematic Assessment |
| |
| Arthroscopy | Investigations | v27.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | v27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | v27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | v27.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | v27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Bone swelling | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Medial tibial stress syndrome | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | v27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | v27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | v27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | v27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | v27.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | v27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | v27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | v27.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | v27.0 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | v27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | v27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Sensitive skin | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | v27.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | v27.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2024 | Dec 24, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
| D022401 | Meningococcal Vaccines |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Pain |
|
| Swelling |
|
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| OG002 |
| MenACWY Group |
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| OG002 |
| MenACWY Group |
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
|
|
|
|
|
|
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| MenB Group |
Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| MenB Group |
Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
| MenB Group |
Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
|
|
|
|
|
|
|
|
|
|
Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
|
|
| OG001 |
| MenB Group |
Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| OG002 | MenACWY Group | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
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Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.
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