Infections, Meningococcal
Conditions
Keywords
Meningococcal disease, Booster vaccination, Meningitis, Antibody persistence
Brief summary
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
Detailed description
This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial. Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio. * Blood draws at Day 1, Day 4 and Day 29 * Blood draws at Day 1, Day 6 and Day 29
Interventions
BIOLOGICALMeningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
One intramuscular injection of MenACWY at Day 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals of 15 through 55 years of age on the day of informed consent or assent. 2. Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine. 3. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent. 4. Individuals who can comply with study procedures including follow-up. 5. Males Or Females of non-childbearing potential Or * Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Exclusion criteria
Each subject must not have: 1. History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration. 2. Current or previous, confirmed or suspected disease caused by N. meningitidis. 3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination. 4. Progressive, unstable or uncontrolled clinical conditions. 5. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 6. Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws. 7. Abnormal function of the immune system resulting from: 1. Clinical conditions. 2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination. 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination. 8. Received immunoglobulins or any blood products within 180 days prior to informed consent. 9. Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw. 10. Received an investigational or non-registered medicinal product within 30 days prior to study vaccination. 11. Study personnel as an immediate family or household member. 12. Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination. 13. Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination. 14. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | At Day 29 | Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers\< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Local and Systemic AEs | From Day 1 (6 hours) through Day 7 after vaccination | Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever \[defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)\]. Threshold for Erythema and Induration: Grade 0 (\<25 mm), Any (\>= 25 mm) |
| Number of Subjects Reporting Other Indicators of Reactogenicity | From Day 1 (6 hours) through Day 7 after vaccination | Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC) |
| Number of Subjects Reporting All Unsolicited AEs | From Day 1 through Day 29 after vaccination | An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. |
| Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | From Day 1 through Day 181 (entire study period) | Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed. |
| Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated. |
| Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | At day 1(pre-vaccination) , day 4, day 6 and day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated. |
| Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | At day 1(pre-vaccination), day 4, day 6 and day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Within 30 minutes after vaccination | An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. |
| Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | At day 1(pre-vaccination), day 4, day 6 and day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated. |
| Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | At day 1(pre-vaccination) , day 4, day 6 and day 29 | Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup |
| Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | At day 1(pre-vaccination), day 4, day 6 and day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated. |
| Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | At day 1(pre-vaccination) , day 4, day 6 and day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated. |
| Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | At Day 4 and Day 6 | Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers \<4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers. |
| hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29 | For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval. |
| Within Group hSBA Geometric Mean Ratios (GMRs) | At Day 4, Day 6, Day 29 compared to Day 1 | Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs. |
| Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | At day 1(pre-vaccination), day 4, day 6 and day 29 | For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Subjects were recruited from 1 center in Puerto Rico and 37 centers in Unites States.
Pre-assignment details
704 subjects were enrolled in this study. Out of the 704 enrolled, 701 received the study vaccine
Participants by arm
| Arm | Count |
|---|---|
| Menveo-Menveo Group Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1. | 301 |
| Menactra-Menveo Group Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1. | 300 |
| Naive Group Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1. | 100 |
| Total | 701 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 11 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Menveo-Menveo Group | Menactra-Menveo Group | Naive Group | Total |
|---|---|---|---|---|
| Age, Continuous | 17.1 Years STANDARD_DEVIATION 3.66 | 17.9 Years STANDARD_DEVIATION 4.54 | 38.8 Years STANDARD_DEVIATION 10.47 | 20.5 Years STANDARD_DEVIATION 9.25 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 6 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 14 Participants | 3 Participants | 21 Participants |
| Race/Ethnicity, Customized Black or African American | 24 Participants | 23 Participants | 12 Participants | 59 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Unspecified | 17 Participants | 23 Participants | 5 Participants | 45 Participants |
| Race/Ethnicity, Customized White | 251 Participants | 233 Participants | 79 Participants | 563 Participants |
| Sex: Female, Male Female | 144 Participants | 156 Participants | 68 Participants | 368 Participants |
| Sex: Female, Male Male | 157 Participants | 144 Participants | 32 Participants | 333 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 301 | 0 / 300 | 0 / 100 |
| other Total, other adverse events | 243 / 301 | 211 / 300 | 60 / 100 |
| serious Total, serious adverse events | 3 / 301 | 2 / 300 | 3 / 100 |
Outcome results
Primary
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers\< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
Time frame: At Day 29
Population: Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination \& provided evaluable serum samples at Day 29 with results available for atleast one serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre < 4 | 100 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Total seroresponse | 96.86 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre ≥ 4 | 94.94 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre < 4 | 97.97 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Total seroresponse | 95.85 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Total seroresponse | 96.54 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre < 4 | 100 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre ≥ 4 | 88.37 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre ≥ 4 | 94.77 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre ≥ 4 | 93.6 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Total seroresponse | 95.49 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre < 4 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre ≥ 4 | 93.75 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre < 4 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre < 4 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Total seroresponse | 93.24 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre < 4 | 97.56 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre ≥ 4 | 91.48 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre < 4 | 97.01 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Total seroresponse | 96.07 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre ≥ 4 | 93.79 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Total seroresponse | 96.45 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Total seroresponse | 94.29 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre ≥ 4 | 91.72 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre ≥ 4 | 93.26 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre < 4 | 97.50 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre ≥ 4 | 91.21 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Total seroresponse | 96.50 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre < 4 | 100 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre ≥ 4 | 93.68 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Total seroresponse | 95.77 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre < 4 | 100 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Total seroresponse | 94.56 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre < 4 | 98.74 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre ≥ 4 | 93.31 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Total seroresponse | 95.59 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Total seroresponse | 56.99 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre ≥ 4 | 58.00 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre < 4 | 64.71 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre < 4 | 55.56 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men C, Pre < 4 | 55.81 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Total seroresponse | 65.59 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Total seroresponse | 51.61 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men Y, Pre ≥ 4 | 46.15 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre ≥ 4 | 25.42 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Pre < 4 | 54.55 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men A, Pre ≥ 4 | 75.00 Percentage of subjects |
| Naive Group | Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. | hSBA-Men W, Total seroresponse | 35.87 Percentage of subjects |
Comparison: Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)95% CI: [21.76, 41.25]Miettinen & Nurminen score method
Comparison: Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)95% CI: [21.66, 41.17]Miettinen & Nurminen score method
Comparison: Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [21.89, 41.12]Miettinen & Nurminen score method
Comparison: Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-3.15, 3.36]Miettinen & Nurminen score method
Comparison: Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)95% CI: [28.54, 48.9]Miettinen & Nurminen score method
Comparison: Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)95% CI: [29.16, 49.46]Miettinen & Nurminen score method
Comparison: Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [29.03, 49.06]Miettinen & Nurminen score method
Comparison: Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-4.12, 2.92]Miettinen & Nurminen score method
Comparison: Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)95% CI: [49.49, 69.32]Miettinen & Nurminen score method
Comparison: Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)95% CI: [46.71, 66.88]Miettinen & Nurminen score method
Comparison: Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [48.32, 67.94]Miettinen & Nurminen score method
Comparison: Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-1.17, 6.62]Miettinen & Nurminen score method
Comparison: Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)95% CI: [35.11, 55.47]Miettinen & Nurminen score method
Comparison: Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)95% CI: [32.34, 53.04]Miettinen & Nurminen score method
Comparison: Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [33.92, 54.14]Miettinen & Nurminen score method
Comparison: Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-0.86, 6.3]Miettinen & Nurminen score method
Secondary
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.
For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.
Time frame: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 1 | 16.11 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 4 | 2.83 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 6 | 12.87 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 29 | 210.1 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 1 | 2.81 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 4 | 22.96 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 6 | 92.27 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 29 | 1159.93 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 1 | 22.07 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 4 | 25.9 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 6 | 112.49 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 29 | 1394.65 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 1 | 9.24 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 4 | 10.87 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 6 | 63.3 Titers |
| Menveo-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 29 | 1066.66 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 4 | 14.29 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 1 | 23.46 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 29 | 1007.62 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 29 | 1883.96 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 6 | 61.56 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 4 | 33.87 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 6 | 10.17 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 6 | 143.75 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 1 | 10.72 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 6 | 90.06 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 29 | 236.69 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 4 | 3 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 1 | 8.22 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 29 | 1057.66 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 4 | 12.12 Titers |
| Menactra-Menveo Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 1 | 2.95 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 4 | 18.21 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 1 | 13.17 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 4 | 11.47 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 6 | 91.18 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 29 | 1108.42 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 29 | 1037.19 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 1 | 22.75 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 4 | 29.53 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 6 | 62.44 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 6 | 126.84 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 29 | 1617.11 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 1 | 2.88 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 4 | 2.91 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 1 | 8.72 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 6 | 11.47 Titers |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 29 | 222.81 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 29 | 37.4 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 29 | 59.7 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 6 | 2.48 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 1 | 2.27 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 4 | 4.63 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 6 | 6.71 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 1 | 4.56 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 4 | 2.25 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 1 | 5.06 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 4 | 13.8 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men C, Day 4 | 6.69 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 6 | 15.98 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men Y, Day 6 | 6.44 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 1 | 12.21 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men A, Day 29 | 32.11 Titers |
| Naive Group | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. | hSBA-Men W, Day 29 | 55.31 Titers |
Comparison: Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)95% CI: [0.93, 1.7]
Comparison: Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)95% CI: [0.98, 1.82]
Comparison: Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [0.97, 1.72]
Comparison: Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.76, 1.17]
Comparison: Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)95% CI: [2.84, 9.47]
Comparison: Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)95% CI: [2.24, 7.5]
Comparison: Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [2.62, 8.15]
Comparison: Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.84, 1.91]
Comparison: Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)95% CI: [4.84, 8.85]
Comparison: Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)95% CI: [5.44, 9.98]
Comparison: Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [5.23, 9.21]
Comparison: Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.72, 1.1]
Comparison: Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)95% CI: [1.95, 6.04]
Comparison: Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)95% CI: [1.21, 3.77]
Comparison: Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [1.6, 4.64]
Comparison: Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [1.07, 2.4]
Comparison: Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)95% CI: [7.51, 25.19]
Comparison: Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)95% CI: [7.31, 24.66]
Comparison: Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [7.7, 24]
Comparison: Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.67, 1.56]
Comparison: Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)95% CI: [13.73, 27.51]
Comparison: Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)95% CI: [12.5, 25.12]
Comparison: Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [13.4, 25.73]
Comparison: Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.86, 1.4]
Comparison: Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)95% CI: [1.13, 3.11]
Comparison: Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)95% CI: [1.48, 4.08]
Comparison: Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [1.33, 3.44]
Comparison: Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.53, 1.1]
Comparison: Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)95% CI: [4.05, 12.22]
Comparison: Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)95% CI: [5.16, 15.66]
Comparison: Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [4.72, 13.35]
Comparison: Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.54, 1.14]
Comparison: Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)95% CI: [17.83, 35.65]
Comparison: Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)95% CI: [24.06, 48.23]
Comparison: Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [21.09, 40.52]
Comparison: Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.58, 0.94]
Comparison: Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)95% CI: [1.36, 4.07]
Comparison: Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)95% CI: [1.51, 4.54]
Comparison: Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [1.48, 4.14]
Comparison: Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.61, 1.33]
Comparison: Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)95% CI: [5.47, 17.64]
Comparison: Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)95% CI: [5.31, 17.19]
Comparison: Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [5.59, 16.79]
Comparison: Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.69, 1.54]
Comparison: Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)95% CI: [20.23, 40.2]
Comparison: Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)95% CI: [19.09, 38.02]
Comparison: Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [20.1, 38.26]
Comparison: Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.83, 1.35]
Secondary
Number of Subjects Reporting All Unsolicited AEs
An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
Time frame: From Day 1 through Day 29 after vaccination
Population: Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menveo-Menveo Group | Number of Subjects Reporting All Unsolicited AEs | 74 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting All Unsolicited AEs | 78 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting All Unsolicited AEs | 152 Participants |
| Naive Group | Number of Subjects Reporting All Unsolicited AEs | 22 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
Time frame: Within 30 minutes after vaccination
Population: Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menveo-Menveo Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 0 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 8 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 8 Participants |
| Naive Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 1 Participants |
Secondary
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)
Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.
Time frame: From Day 1 through Day 181 (entire study period)
Population: Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menveo-Menveo Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any MAAEs | 102 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any SAEs | 3 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any AEs leading to withdrawal | 0 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any MAAEs | 79 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any SAEs | 2 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any AEs leading to withdrawal | 0 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any AEs leading to withdrawal | 0 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any MAAEs | 181 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any SAEs | 5 Participants |
| Naive Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any MAAEs | 19 Participants |
| Naive Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any SAEs | 3 Participants |
| Naive Group | Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) | Any AEs leading to withdrawal | 0 Participants |
Secondary
Number of Subjects Reporting Other Indicators of Reactogenicity
Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)
Time frame: From Day 1 (6 hours) through Day 7 after vaccination
Population: Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for prophylaxis | 13 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.5 - 36.9 ºC) | 135 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.5 - 38.9 ºC) | 1 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for treatment | 18 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.0 - 38.4 ºC) | 1 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.0 - 37.4 ºC) | 83 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.0 - 36.4 ºC) | 68 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (>=40ºC) | 0 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.5 - 39.9 ºC) | 0 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.5 - 37.9 ºC) | 6 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.0 - 39.4 ºC) | 0 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.5 - 37.9 ºC) | 9 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.0 - 39.4 ºC) | 0 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.0 - 38.4 ºC) | 2 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.5 - 38.9 ºC) | 3 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.0 - 36.4 ºC) | 57 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (>=40ºC) | 0 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.5 - 36.9 ºC) | 141 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.5 - 39.9 ºC) | 0 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.0 - 37.4 ºC) | 77 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for treatment | 24 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for prophylaxis | 15 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.5 - 39.9 ºC) | 0 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for prophylaxis | 28 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for treatment | 42 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.0 - 36.4 ºC) | 125 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.5 - 36.9 ºC) | 276 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.0 - 37.4 ºC) | 160 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.5 - 37.9 ºC) | 15 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.0 - 38.4 ºC) | 3 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.5 - 38.9 ºC) | 4 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.0 - 39.4 ºC) | 0 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (>=40ºC) | 0 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.5 - 37.9 ºC) | 3 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (>=40ºC) | 0 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.0 - 39.4 ºC) | 0 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (37.0 - 37.4 ºC) | 33 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.5 - 36.9 ºC) | 45 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (36.0 - 36.4 ºC) | 16 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (39.5 - 39.9 ºC) | 0 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for treatment | 10 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Analgesics/antipyretics for prophylaxis | 5 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.5 - 38.9 ºC) | 0 Participants |
| Naive Group | Number of Subjects Reporting Other Indicators of Reactogenicity | Body temperature (38.0 - 38.4 ºC) | 0 Participants |
Secondary
Number of Subjects Reporting Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever \[defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)\]. Threshold for Erythema and Induration: Grade 0 (\<25 mm), Any (\>= 25 mm)
Time frame: From Day 1 (6 hours) through Day 7 after vaccination
Population: Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Local symptom | 119 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Systemic symptom | 162 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Induration | 15 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Erythema | 12 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Pain | 114 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Nausea | 48 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Fatigue | 113 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Myalgia | 55 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Arthralgia | 44 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Headache | 100 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any loss of apetite | 37 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any chills | 34 Participants |
| Menveo-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Fever | 2 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Erythema | 8 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Fever | 5 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any loss of apetite | 46 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Myalgia | 54 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Induration | 9 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Local symptom | 97 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Headache | 82 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Arthralgia | 38 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Nausea | 44 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Pain | 96 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Systemic symptom | 148 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any chills | 35 Participants |
| Menactra-Menveo Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Fatigue | 110 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any loss of apetite | 83 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Erythema | 20 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Pain | 210 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Fever | 7 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Nausea | 92 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Fatigue | 223 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any chills | 69 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Myalgia | 109 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Arthralgia | 82 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Headache | 182 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Local symptom | 216 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Systemic symptom | 310 Participants |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Induration | 24 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Headache | 21 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Myalgia | 15 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Erythema | 10 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Local symptom | 41 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Fatigue | 19 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Nausea | 13 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Induration | 8 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Systemic symptom | 35 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Pain | 40 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any Arthralgia | 13 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Fever | 0 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any chills | 10 Participants |
| Naive Group | Number of Subjects Reporting Solicited Local and Systemic AEs | Any loss of apetite | 6 Participants |
Secondary
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 1 | 75.43 Percentage of subjects |
| Menveo-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 4 | 81.94 Percentage of subjects |
| Menveo-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 6 | 93.84 Percentage of subjects |
| Menveo-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 4 | 82.61 Percentage of subjects |
| Menactra-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 6 | 97.86 Percentage of subjects |
| Menactra-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 1 | 76.95 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 6 | 95.8 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 4 | 82.27 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 29 | 100 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 1 | 76.18 Percentage of subjects |
| Naive Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 29 | 84.78 Percentage of subjects |
| Naive Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 4 | 62.5 Percentage of subjects |
| Naive Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 1 | 61.29 Percentage of subjects |
| Naive Group | Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 8, Day 6 | 63.64 Percentage of subjects |
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [3.46, 25.39]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [5, 26.89]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [4.91, 25.62]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-8.51, 5.5]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [5.25, 34.83]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [5.88, 35.5]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [6.53, 34.58]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-9.67, 8.4]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [16.78, 45.45]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [21.29, 49.2]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [19.3, 47.13]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-9.45, 0.74]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [9.28, 23.95]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [9.28, 23.95]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [9.28, 23.94]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-1.31, 1.35]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y
Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers \<4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.
Time frame: At Day 4 and Day 6
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 4 | 0 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 4 | 4.76 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 4 | 1.39 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 6 | 39.84 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 6 | 36.36 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 6 | 39.31 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 4 | 0.81 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 4 | 3.74 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 4 | 2.8 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 6 | 65.31 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 6 | 44.21 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 6 | 51.39 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 4 | 9.52 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 4 | 1.63 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 4 | 2.78 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 6 | 64.52 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 6 | 46.49 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 6 | 50.34 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 4 | 8.06 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 4 | 7.5 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 4 | 7.75 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 6 | 63.46 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 6 | 40.66 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 6 | 48.95 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 6 | 57.14 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 4 | 30 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 6 | 33.63 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 6 | 42.31 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 6 | 75.81 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 4 | 4.63 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 4 | 8.76 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 6 | 42.86 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 6 | 31.43 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 4 | 10.14 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 4 | 2.17 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 6 | 75 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 4 | 4.38 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 6 | 64.71 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 4 | 2.6 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 4 | 0 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 4 | 8.14 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 6 | 38.64 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 4 | 9.8 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 4 | 6.67 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 4 | 2.56 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 6 | 48.2 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 6 | 22.22 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 6 | 49.29 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 6 | 41.53 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 4 | 5.75 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 4 | 5.7 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 4 | 5.71 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 6 | 65 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 4 | 6.09 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 4 | 5.1 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 6 | 49.82 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 4 | 21.57 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 4 | 3.03 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 6 | 70.18 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 4 | 6.38 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 6 | 69.49 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 6 | 53 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 6 | 44.69 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 6 | 49.82 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 6 | 41.42 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 4 | 1.67 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 4 | 2.38 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 4 | 7.38 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 4 | 1.77 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 6 | 36.86 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 6 | 28.57 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 6 | 35.44 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 6 | 5.88 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 4 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 4 | 7.14 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 4 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre ≥ 4, Day 6 | 9.52 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 6 | 13.04 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 6 | 4.55 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 4 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre ≥ 4, Day 6 | 20 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 4 | 6.25 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre ≥ 4, Day 4 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Total seroresponse, Day 4 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 6 | 11.11 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 4 | 6.25 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Pre < 4, Day 4 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 6 | 25 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men Y, Total seroresponse, Day 6 | 9.09 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 4 | 3.23 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Pre < 4, Day 4 | 5 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre ≥ 4, Day 6 | 3.57 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Pre < 4, Day 4 | 11.76 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men C, Total seroresponse, Day 6 | 11.36 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men A, Pre < 4, Day 6 | 2.56 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y | hSBA-Men W, Total seroresponse, Day 6 | 11.36 Percentages of subjects |
Comparison: Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)95% CI: [-6.08, 4.94]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [-5.32, 6.21]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [-5.68, 4.09]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-4.98, 3.01]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [22.38, 44.07]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [14.67, 36.13]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [19.42, 37.97]Miettinen & Nurminen score method
Comparison: Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-3.25, 18.81]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [-14.26, 2.35]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [-8.7, 9.98]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [-11.35, 4.9]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-12.25, -0.57]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [25.37, 50.92]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [22.14, 47.9]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [24.79, 47.57]Miettinen & Nurminen score method
Comparison: Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-8.44, 14.73]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [-14.28, 2.31]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [-7.4, 11.6]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [-10.7, 5.66]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-13.89, -1.8]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [24.35, 49.88]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [23.23, 48.95]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [24.8, 47.56]Miettinen & Nurminen score method
Comparison: Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-10.51, 12.6]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [0.15, 13.36]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [-3.15, 9.24]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [-1.41, 9.55]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-2.48, 9.54]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)95% CI: [25.76, 50.29]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)95% CI: [33.89, 58.34]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [30.79, 52.37]Miettinen & Nurminen score method
Comparison: Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-19.61, 3.45]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 1 | 8.3 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 4 | 8.33 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 29 | 98.28 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 6 | 45.89 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 4 | 8.7 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 29 | 97.52 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 1 | 9.57 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 6 | 41.43 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 6 | 43.71 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 1 | 8.93 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 29 | 97.9 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 4 | 8.51 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 29 | 66.67 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 1 | 1.08 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 4 | 2.08 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 16, Day 6 | 4.55 Percentage of subjects |
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [2.08, 11.23]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [3.28, 12.74]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [2.87, 10.78]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-6.1, 3.49]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [-3.04, 12.44]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [-2.71, 13.01]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [-2.66, 10.9]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-7.27, 6.43]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [28.85, 50.63]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [24.39, 46.34]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [27.61, 46.33]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-7.04, 15.83]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [22.68, 41.79]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [21.85, 41.08]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [22.39, 41.38]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-1.81, 3.52]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C
Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
Time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 1 | 47.22 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 4 | 54.17 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 6 | 82.07 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 29 | 99.66 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 4 | 44.93 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 6 | 81.29 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 29 | 99.64 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 1 | 38.08 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 6 | 81.69 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 4 | 49.65 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 29 | 99.65 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 1 | 42.71 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 29 | 69.89 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 4 | 29.17 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 1 | 17.2 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 16, Day 6 | 31.82 Percentage of subjects |
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [19.55, 38.83]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [10.48, 29.69]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [15.79, 33.21]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [1.01, 17.16]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [8.82, 38.9]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [-0.44, 29.86]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [5.32, 33.08]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-2.45, 20.68]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [34.09, 63.67]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [33.21, 63.01]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [34.42, 62.6]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-8.3, 9.92]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [21.34, 39.75]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [21.32, 39.74]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [21.35, 39.73]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-1.6, 1.67]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 1 | 65.74 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 4 | 68.75 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 6 | 89.04 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 4 | 76.81 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 6 | 92.14 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 1 | 66.31 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 6 | 90.56 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 4 | 72.7 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 29 | 100 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 1 | 66.02 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 29 | 80.43 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 4 | 54.17 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 1 | 48.39 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W | hSBA-Men W ≥ 16, Day 6 | 50 Percentage of subjects |
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [5.85, 28.67]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [6.39, 29.25]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [6.85, 28.28]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-8.32, 7.2]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [-0.98, 30.38]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [7.3, 38.16]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [4.14, 33.37]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-18.34, 2.38]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [23.76, 54.07]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [27.08, 56.98]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [25.91, 55.15]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-10.2, 3.89]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [12.74, 28.83]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [12.74, 28.83]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [12.75, 28.83]Miettinen & Nurminen score method
Comparison: Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-1.31, 1.35]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
Time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 1 | 39.02 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 4 | 39.16 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 6 | 80.69 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 4 | 39.13 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 6 | 80 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 29 | 98.58 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 1 | 34.88 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 6 | 80.35 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 4 | 39.15 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 29 | 99.3 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 1 | 36.97 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 29 | 64.52 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 4 | 20.83 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 1 | 17.2 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 16, Day 6 | 31.82 Percentage of subjects |
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [11.44, 30.6]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [7.34, 26.43]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [10.09, 27.43]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-3.8, 12.04]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [2.92, 30.99]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [2.83, 31.06]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [3.83, 29.39]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-11.35, 11.39]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [32.64, 62.38]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [31.87, 61.79]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [33.04, 61.31]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-8.6, 10.04]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [26.5, 45.62]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [24.94, 44.28]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)95% CI: [25.78, 44.93]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [0.1, 3.6]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Time frame: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 1 | 12.46 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 4 | 11.11 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 6 | 53.42 Percentages of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 29 | 98.62 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 4 | 13.04 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 6 | 47.14 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 29 | 98.94 Percentages of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 1 | 14.89 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 6 | 50.35 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 4 | 12.06 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 29 | 98.78 Percentages of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 1 | 13.66 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 29 | 70.97 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 4 | 4.17 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 1 | 4.3 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A | hSBA-Men A ≥ 8, Day 6 | 9.09 Percentages of subjects |
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [1.23, 13.41]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [3.54, 16.14]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)95% CI: [2.72, 13.58]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-8.17, 3.24]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [-3.57, 14.15]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [-1.77, 16.52]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [-2.34, 13.48]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-9.84, 5.82]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [30.25, 54.6]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [23.93, 48.58]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [28.15, 49.72]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-5.31, 17.71]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [19.25, 37.65]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [19.6, 37.95]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [19.5, 37.76]Miettinen & Nurminen score method
Comparison: Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-2.56, 1.86]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 1 | 61.11 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 4 | 70.83 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 6 | 87.59 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 4 | 60.14 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 6 | 92.09 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 29 | 99.64 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 1 | 53.74 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 6 | 89.79 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 4 | 65.6 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 29 | 99.82 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 1 | 57.47 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 29 | 87.1 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 4 | 43.75 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 1 | 33.33 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C | hSBA-Men C ≥ 8, Day 6 | 43.18 Percentage of subjects |
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [16.23, 38.27]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [8.78, 31.03]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [13.28, 33.86]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-0.76, 15.42]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [11.04, 42.14]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [0.04, 31.9]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [6.73, 36.11]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-0.42, 21.6]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [28.65, 58.93]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [33.45, 63.13]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [31.52, 60.59]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-11.84, 2.69]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [7.53, 21.22]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [7.1, 20.89]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [7.34, 21.05]Miettinen & Nurminen score method
Comparison: Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-0.96, 1.99]Miettinen & Nurminen score method
Secondary
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 1 | 54.01 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 4 | 55.24 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 6 | 85.52 Percentage of subjects |
| Menveo-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 29 | 100 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 4 | 55.8 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 6 | 87.86 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 29 | 99.64 Percentage of subjects |
| Menactra-Menveo Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 1 | 46.98 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 6 | 86.67 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 4 | 55.52 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 29 | 99.82 Percentage of subjects |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 1 | 50.53 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 29 | 77.42 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 4 | 33.33 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 1 | 32.26 Percentage of subjects |
| Naive Group | Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y | hSBA-Men Y ≥ 8, Day 6 | 45.45 Percentage of subjects |
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)95% CI: [10.19, 32.25]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)95% CI: [3.15, 25.29]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [7.44, 27.92]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-1.2, 15.17]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)95% CI: [5.57, 36.37]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)95% CI: [6.05, 37]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [6.89, 35.38]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-12.11, 11.03]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)95% CI: [24.26, 54.95]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)95% CI: [26.71, 57.17]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [26.12, 55.55]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-10.41, 5.73]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)95% CI: [15.26, 32.08]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)95% CI: [14.86, 31.74]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)95% CI: [15.08, 31.9]Miettinen & Nurminen score method
Comparison: Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)95% CI: [-0.96, 1.99]Miettinen & Nurminen score method
Secondary
Within Group hSBA Geometric Mean Ratios (GMRs)
Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.
Time frame: At Day 4, Day 6, Day 29 compared to Day 1
Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 4/Day 1 | 1.05 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 4/Day 1 | 1.12 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 6/Day 1 | 6.09 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 29/Day 1 | 71.72 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 6/Day 1 | 7.25 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 6/Day 1 | 4.58 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 4/Day 1 | 1.02 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 4/Day 1 | 1.35 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 29/Day 1 | 63.63 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 29/Day 1 | 75.02 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 29/Day 1 | 116.58 Ratios |
| Menveo-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 6/Day 1 | 5.71 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 29/Day 1 | 123.41 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 4/Day 1 | 1.07 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 6/Day 1 | 3.25 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 29/Day 1 | 80.13 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 4/Day 1 | 1.35 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 6/Day 1 | 7.94 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 29/Day 1 | 97.13 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 4/Day 1 | 1.4 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 6/Day 1 | 6.27 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 29/Day 1 | 80.61 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 4/Day 1 | 1.31 Ratios |
| Menactra-Menveo Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 6/Day 1 | 8.59 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 4/Day 1 | 1.21 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 6/Day 1 | 3.87 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 29/Day 1 | 119.91 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 4/Day 1 | 1.33 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 6/Day 1 | 5.98 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 6/Day 1 | 7.22 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 29/Day 1 | 77.5 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 6/Day 1 | 7.58 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 4/Day 1 | 1.04 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 4/Day 1 | 1.23 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 29/Day 1 | 71.5 Ratios |
| Pooled Group (Menveo-Menveo and Menactra-Menveo) | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 29/Day 1 | 83.29 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 29/Day 1 | 4.57 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 29/Day 1 | 14.14 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 4/Day 1 | 1.14 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 6/Day 1 | 1.48 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men W, Day 6/Day 1 | 1.32 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 6/Day 1 | 1.09 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 29/Day 1 | 11.81 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 4/Day 1 | 0.99 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 4/Day 1 | 1.21 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men A, Day 4/Day 1 | 0.99 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men C, Day 6/Day 1 | 1.45 Ratios |
| Naive Group | Within Group hSBA Geometric Mean Ratios (GMRs) | hSBA-Men Y, Day 29/Day 1 | 8.21 Ratios |