Staphylococcus Aureus Infection
Conditions
Brief summary
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
Interventions
BIOLOGICALComparator: Placebo (PBO)
Group 6: Placebo (PBO / PBO / PBO)
BIOLOGICALV710 Comparator: Placebo (PBO)
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with end stage kidney disease and is on hemodialysis * Female patients who are able to have children must have a negative urine pregnancy tests
Exclusion criteria
* Developed a serious infection within the past 12 months; allergy to the components of the vaccine * Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days * Received V710 vaccine before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination | Prevaccination to 56 days postvaccination | Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5. |
| Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths. | Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3. Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination | Prevaccination to 28 days postvaccination | Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5. |
| GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination | Prevaccination to 180 days postvaccination | Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5. |
| GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination | Prevaccination to 56 days postvaccination | Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4. |
| GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Prevaccination to 360 days post vaccination | Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V710 (60 mcg / 60 mcg) Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28. | 37 |
| V710 (60 mcg / PBO) Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28. | 37 |
| V710 (60 mcg / 60 mcg) + MAA Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28. | 38 |
| V710 (60 mcg / PBO) + MAA Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28. | 38 |
| V710 (90 mcg / 90 mcg) + MAA Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28. | 38 |
| Placebo (PBO / PBO) Participants who were vaccinated with Placebo on Day 1 and Day 28. | 18 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 0 | 2 | 0 | 0 | 4 | 2 | 1 | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 | 0 | 1 | 3 | 0 | 2 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | V710 (60 mcg / 60 mcg) | V710 (60 mcg / PBO) | V710 (60 mcg / 60 mcg) + MAA | V710 (60 mcg / PBO) + MAA | V710 (90 mcg / 90 mcg) + MAA | Placebo (PBO / PBO) | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized <50 years of age | 10 Participants | 14 Participants | 14 Participants | 5 Participants | 14 Participants | 6 Participants | 63 Participants |
| Age, Customized >=50 years of age | 27 Participants | 23 Participants | 24 Participants | 33 Participants | 24 Participants | 12 Participants | 143 Participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 19 Participants | 14 Participants | 16 Participants | 7 Participants | 84 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 19 Participants | 24 Participants | 22 Participants | 11 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 18 | 9 / 18 | 5 / 19 | 4 / 18 | 9 / 19 | 10 / 18 | 10 / 19 | 8 / 18 | 9 / 17 | 10 / 19 | 7 / 18 |
| serious Total, serious adverse events | 2 / 18 | 3 / 18 | 2 / 19 | 5 / 18 | 0 / 19 | 5 / 18 | 4 / 19 | 2 / 18 | 2 / 17 | 5 / 19 | 3 / 18 |
Outcome results
Primary
Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
Time frame: Prevaccination to 56 days postvaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V710 (60 mcg Without MAA) - Group 1 | Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination | 18.9 Ratio |
| V710 (60 mcg With MAA) - Group 3 | Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination | 15.1 Ratio |
| V710 (90 mcg With MAA) - Group 5 | Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination | 17.8 Ratio |
Primary
Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)
Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3. Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination.
Time frame: Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V710 (60 mcg Without MAA) - Group 1 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 1 Participants |
| V710 (60 mcg Without MAA) - Group 1 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 8 Participants |
| V710 (60 mcg Without MAA) - Group 1 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 1 Participants |
| V710 (60 mcg Without MAA) - Group 1 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (60 mcg Without MAA) - Group 1 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg With MAA) - Group 3 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 1 Participants |
| V710 (60 mcg With MAA) - Group 3 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg With MAA) - Group 3 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 2 Participants |
| V710 (60 mcg With MAA) - Group 3 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (60 mcg With MAA) - Group 3 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 9 Participants |
| V710 (90 mcg With MAA) - Group 5 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 0 Participants |
| V710 (90 mcg With MAA) - Group 5 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (90 mcg With MAA) - Group 5 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 5 Participants |
| V710 (90 mcg With MAA) - Group 5 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 0 Participants |
| V710 (90 mcg With MAA) - Group 5 | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 6 Participants |
| V710 (60 mcg / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 2 Participants |
| V710 (60 mcg / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 1 Participants |
| V710 (60 mcg / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 2 Participants |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 0 Participants |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 9 Participants |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / 60 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 4 Participants |
| V710 (60 mcg / 60 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 11 Participants |
| V710 (60 mcg / 60 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 2 Participants |
| V710 (60 mcg / 60 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / 60 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / PBO / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / PBO / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 4 Participants |
| V710 (60 mcg / PBO / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 10 Participants |
| V710 (60 mcg / PBO / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 0 Participants |
| V710 (60 mcg / PBO / 60 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / PBO / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 1 Participants |
| V710 (60 mcg / PBO / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (60 mcg / PBO / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 1 Participants |
| V710 (60 mcg / PBO / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 9 Participants |
| V710 (60 mcg / PBO / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 0 Participants |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 2 Participants |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 10 Participants |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 1 Participants |
| V710 (90 mcg / 90 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| V710 (90 mcg / 90 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 10 Participants |
| V710 (90 mcg / 90 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 1 Participants |
| V710 (90 mcg / 90 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 3 Participants |
| V710 (90 mcg / 90 mcg / PBO) + MAA | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 1 Participants |
| Placebo (PBO / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any vaccine-related SAE's (Day 1 - 360) | 0 Participants |
| Placebo (PBO / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any AE's involving Death (Day 1 - 360) | 2 Participants |
| Placebo (PBO / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any AE's (Day 1 - 14) | 7 Participants |
| Placebo (PBO / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Participants with any SAE's (Day 1 - 14) | 0 Participants |
| Placebo (PBO / PBO / PBO) | Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE) | Any SAE's with S. aureus infection (Day 1 - 360) | 1 Participants |
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints
Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.
Time frame: Prevaccination to 360 days post vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 5.9 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 30.3 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 13.0 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 8.7 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 13.6 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 19.4 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 22.2 Ratio |
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 26.5 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 19.9 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 7.3 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 5.6 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 4.0 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 12.1 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 3.4 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 13.4 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 14.6 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 36.3 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 5.5 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 9.2 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 4.0 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 10.3 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 3.9 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 7.0 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 7.8 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 3.6 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 4.1 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 24.6 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 3.5 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 9.8 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 7.8 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 6.9 Ratio |
| V710 (60 mcg / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 4.2 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 10.1 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 13.7 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 8.2 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 26.9 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 17.3 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 11.7 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 4.6 Ratio |
| V710 (60 mcg / 60 mcg / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 5.7 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 12.8 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 5.4 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 3.7 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 2.9 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 13.0 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 10.8 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 33.7 Ratio |
| V710 (60 mcg / 60 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 5.8 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 36.6 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 5.3 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 7.7 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 3.7 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 11.4 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 9.1 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 3.5 Ratio |
| V710 (60 mcg / PBO / 60 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 6.1 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 5.5 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 26.6 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 14.4 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 13.1 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 10.0 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 3.1 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 4.4 Ratio |
| V710 (60 mcg / PBO / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 3.9 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 16.3 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 8.5 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 19.5 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 10.7 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 24.4 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 6.6 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 11.3 Ratio |
| V710 (90 mcg / 90 mcg / 90 mcg) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 18.8 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 10.1 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 5.2 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 7.7 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 17.2 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 17.5 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 11.4 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 5.8 Ratio |
| V710 (90 mcg / 90 mcg / PBO) + MAA | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 25.4 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 270 | 0.9 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 56 | 1.1 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 1 | 30.2 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 84 | 1.6 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 210 | 1.1 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 360 | 1.5 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 28 | 1.2 Ratio |
| Placebo (PBO / PBO / PBO) | GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints | Day 180 | 1.0 Ratio |
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination
Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.
Time frame: Prevaccination to 56 days postvaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination | 9.6 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination | 11.8 Ratio |
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.
Time frame: Prevaccination to 180 days postvaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination | 8.5 Ratio |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination | 5.7 Ratio |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination | 7.6 Ratio |
Secondary
GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination
Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.
Time frame: Prevaccination to 28 days postvaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| V710 (60 mcg Without MAA) - Group 1 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination | 11.9 Ratio | 95% Confidence Interval 9 |
| V710 (60 mcg With MAA) - Group 3 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination | 12.9 Ratio | 95% Confidence Interval 12.9 |
| V710 (90 mcg With MAA) - Group 5 | GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination | 12.9 Ratio | — |