Pneumonia, Pneumococcal
Conditions
Brief summary
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
Interventions
BIOLOGICALV116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICALQIV
Single 0.5 mL IM injection
BIOLOGICALMatching Placebo for V116
Single 0.5 mL of sterile saline IM injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment * Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
Exclusion criteria
* History of IPD or other culture-positive pneumococcal disease * Known or suspected impairment of immunological function * Receipt of systemic corticosteroids or immunosuppressive therapy * Received any pneumococcal vaccine \<12 months prior to enrollment * Prior administration of PCV15 or PCV20 * Received any influenza vaccine \<6 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | Day 30 | GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay. |
| Number of Participants With Solicited Injection-site Adverse Events (AEs) | Up to 5 days post-vaccination | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. |
| Number of Participants With Solicited Systemic AEs | Up to 5 days post-vaccination | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia. |
| Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | Up to ~6 months postvaccination with V116 | A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. |
| Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group) | OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group) | The GMCs of serotype-specific IgG for the serotypes contained in V116 were determined using a pneumococcal electrochemiluminescence (Pn ECL) assay. |
| Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group) | OPA for the serotypes in V116 were determined using a MOPA. GMFR ratio is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. |
| GMFR Ratio of Serotype-specific IgG | Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group) | GMFR ratios for the serotype-specific IgG in V116 were determined using a Pn ECL. |
| GMFR in Influenza Strain-specific HAI | Day 1 (Baseline) and Day 30 (Postvaccination) | Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline. |
| Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | Day 30 | The percentage of participants with seroconversion is presented. Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 56 centers in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30. | 536 |
| Sequential Group (Placebo + QIV Followed by V116) Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30. | 536 |
| Total | 1,072 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 17 | 15 |
| Overall Study | Not reported | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Randomized by mistake without study treatment | 0 | 1 |
| Overall Study | Withdrawal by Subject | 12 | 12 |
Baseline characteristics
| Characteristic | Sequential Group (Placebo + QIV Followed by V116) | Total | Concomitant Group (V116 + QIV Followed by Placebo) |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 8.4 | 64.2 years STANDARD_DEVIATION 8.4 | 64.2 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 125 Participants | 252 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 409 Participants | 812 Participants | 403 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 101 Participants | 208 Participants | 107 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 21 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 412 Participants | 822 Participants | 410 Participants |
| Sex: Female, Male Female | 287 Participants | 584 Participants | 297 Participants |
| Sex: Female, Male Male | 249 Participants | 488 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 540 | 2 / 540 |
| other Total, other adverse events | 362 / 534 | 348 / 535 |
| serious Total, serious adverse events | 10 / 534 | 17 / 535 |
Outcome results
Primary
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses
OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.
Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
Population: All randomized participants without deviations from the protocol that may substantially affect immunogenicity. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 19A | 1830.1 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 11A | 2576.3 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 20A | 5172.8 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 8 | 1508.9 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 22F | 3194.9 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 12F | 1869.9 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 23A | 3358.2 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 7F | 2399.2 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 24F | 2996.5 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 15A | 4670.6 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 31 | 2997.4 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 9N | 5075.6 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 33F | 9032.5 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 15C | 3426.0 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 35B | 7701.4 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 6A | 2056.4 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 16F | 5371.5 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 10A | 3033.6 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 17F | 5783.8 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 23B | 934.3 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 3 | 209.2 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 23B | 1664.5 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 3 | 250.1 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 6A | 2608.2 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 7F | 3275.4 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 8 | 2135.7 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 9N | 7566.6 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 11A | 4051.1 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 12F | 2449.5 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 15A | 6559.7 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 15C | 4832.6 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 17F | 7924.3 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 19A | 2453.3 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 20A | 6986.9 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 22F | 4158.2 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 23A | 4319.9 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 24F | 4143.1 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 31 | 4390.6 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 33F | 10765.1 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 35B | 9940.2 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 10A | 3966.2 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses | 16F | 7757.2 Titers |
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.72, 0.97]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.66, 0.94]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.63, 0.85]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.61, 0.82]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.57, 0.79]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.65, 0.91]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.54, 0.75]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.62, 0.94]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.6, 0.85]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.58, 0.87]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.59, 0.81]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.62, 0.86]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.65, 0.85]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.63, 0.87]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.65, 0.91]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.63, 0.96]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.44, 0.72]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.61, 0.86]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.56, 0.83]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.95% CI: [0.7, 1.01]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of serotypes is \>0.50.95% CI: [0.67, 0.89]
Primary
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | A/H1N1 | 268.23 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | A/H3N2 | 128.07 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | B/Victoria | 70.02 Titers |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | B/Yamagata | 31.80 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | B/Yamagata | 35.86 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | A/H1N1 | 325.06 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | B/Victoria | 85.66 Titers |
| Sequential Group (Placebo + QIV Followed by V116) | GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) | A/H3N2 | 163.06 Titers |
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.95% CI: [0.7, 0.97]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.95% CI: [0.67, 0.93]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.95% CI: [0.7, 0.95]
Comparison: The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.95% CI: [0.78, 1]
Primary
Number of Participants With Solicited Injection-site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination and received QIV are included, according to actual vaccination received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Number of Participants With Solicited Injection-site Adverse Events (AEs) | 317 Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Number of Participants With Solicited Injection-site Adverse Events (AEs) | 314 Participants |
Primary
Number of Participants With Solicited Systemic AEs
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination and received QIV are included, according to actual vaccination received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Number of Participants With Solicited Systemic AEs | 219 Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Number of Participants With Solicited Systemic AEs | 224 Participants |
Primary
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized.
Time frame: Up to ~6 months postvaccination with V116
Population: All randomized participants who received at least 1 dose of study vaccination and received QIV are included, according to actual vaccination received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0 Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The GMCs of serotype-specific IgG for the serotypes contained in V116 were determined using a pneumococcal electrochemiluminescence (Pn ECL) assay.
Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
Population: All randomized participants without protocol deviations that may substantially affect the results of theimmunogenicity endpoint are included. Overall participants analyzed were the number of participantsrandomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available forthe respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 33F | 9.09 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 7F | 3.91 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 35B | 15.73 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 23A | 3.30 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 10A | 8.45 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 3 | 0.60 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 11A | 4.83 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 9N | 4.99 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 12F | 1.10 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 23B | 4.24 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 15A | 8.83 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 6A | 3.34 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 15C | 7.13 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 24F | 5.72 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 16F | 1.93 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 8 | 6.84 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 17F | 9.69 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 31 | 2.50 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 19A | 6.41 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 22F | 3.13 µg/mL |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 20A | 13.57 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 10A | 10.70 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 3 | 0.66 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 6A | 3.58 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 7F | 5.01 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 8 | 8.38 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 9N | 5.64 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 20A | 16.52 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 22F | 3.34 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 23A | 3.87 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 23B | 4.94 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 24F | 6.71 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 31 | 2.96 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 33F | 11.26 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 35B | 18.57 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 11A | 5.84 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 12F | 1.31 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 15A | 11.77 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 15C | 8.39 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 16F | 2.32 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 17F | 11.44 µg/mL |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 19A | 7.91 µg/mL |
95% CI: [0.8, 1.02]
95% CI: [0.79, 1.11]
95% CI: [0.67, 0.9]
95% CI: [0.7, 0.95]
95% CI: [0.75, 1.05]
95% CI: [0.67, 0.94]
95% CI: [0.72, 0.96]
95% CI: [0.69, 1.01]
95% CI: [0.63, 0.9]
95% CI: [0.71, 1.02]
95% CI: [0.7, 0.99]
95% CI: [0.72, 0.99]
95% CI: [0.71, 0.93]
95% CI: [0.7, 0.97]
95% CI: [0.8, 1.1]
95% CI: [0.7, 1.03]
95% CI: [0.72, 1.02]
95% CI: [0.69, 1.05]
95% CI: [0.72, 0.99]
95% CI: [0.69, 0.94]
95% CI: [0.72, 0.99]
Secondary
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA
OPA for the serotypes in V116 were determined using a MOPA. GMFR ratio is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
Population: All randomized participants without protocol deviations that may substantially affect the results of the immunogenicity endpoint and have all data available are included. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 24F | 31.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 6A | 9.4 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 7F | 8.1 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 8 | 9.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 9N | 6.2 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 10A | 10.4 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 11A | 13.0 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 12F | 37.4 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 15A | 7.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 15C | 25.0 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 16F | 9.9 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 17F | 10.4 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 19A | 3.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 20A | 6.7 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 22F | 13.7 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 3 | 5.2 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 31 | 29.8 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 35B | 5.5 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 23A | 17.0 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 23B | 42.9 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 33F | 5.5 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 16F | 11.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 3 | 6.7 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 24F | 33.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 6A | 13.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 17F | 15.1 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 7F | 9.8 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 23A | 25.5 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 8 | 10.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 19A | 5.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 9N | 8.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 33F | 6.3 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 10A | 11.1 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 20A | 8.5 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 11A | 15.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 35B | 6.3 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 12F | 46.8 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 22F | 16.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 15A | 8.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 23B | 60.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 15C | 30.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA | 31 | 40.3 Ratio |
Secondary
GMFR in Influenza Strain-specific HAI
Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.
Time frame: Day 1 (Baseline) and Day 30 (Postvaccination)
Population: All randomized participants without deviations from the protocol that may substantially affect immunogenicity, and who have both baseline and Day 30 data, are included. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR in Influenza Strain-specific HAI | A/H1N1 | 4.5 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR in Influenza Strain-specific HAI | A/H3N2 | 5.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR in Influenza Strain-specific HAI | B/Victoria | 3.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR in Influenza Strain-specific HAI | B/Yamagata | 1.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR in Influenza Strain-specific HAI | B/Yamagata | 2.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR in Influenza Strain-specific HAI | A/H1N1 | 5.7 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR in Influenza Strain-specific HAI | B/Victoria | 4.5 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR in Influenza Strain-specific HAI | A/H3N2 | 7.1 Ratio |
Secondary
GMFR Ratio of Serotype-specific IgG
GMFR ratios for the serotype-specific IgG in V116 were determined using a Pn ECL.
Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
Population: All randomized participants without protocol deviations that may substantially affect the results of the immunogenicity endpoint and have all data available are included. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 23B | 10.2 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 3 | 3.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 6A | 7.8 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 7F | 5.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 8 | 7.1 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 9N | 8.0 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 10A | 9.3 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 11A | 5.7 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 15A | 14.2 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 16F | 11.1 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 17F | 10.9 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 19A | 3.0 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 20A | 7.4 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 22F | 8.2 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 23A | 15.5 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 12F | 6.9 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 24F | 20.2 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 31 | 12.6 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 33F | 5.1 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 35B | 12.3 Ratio |
| Concomitant Group (V116 + QIV Followed by Placebo) | GMFR Ratio of Serotype-specific IgG | 15C | 11.0 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 31 | 15.3 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 17F | 13.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 3 | 4.1 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 23B | 10.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 6A | 8.4 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 19A | 3.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 7F | 7.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 35B | 14.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 8 | 8.7 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 20A | 8.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 9N | 9.0 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 24F | 23.5 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 10A | 11.4 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 22F | 9.0 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 11A | 7.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 12F | 7.9 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 33F | 6.2 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 15A | 19.5 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 15C | 12.3 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 23A | 17.3 Ratio |
| Sequential Group (Placebo + QIV Followed by V116) | GMFR Ratio of Serotype-specific IgG | 16F | 13.4 Ratio |
Secondary
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40
The percentage of participants with seroconversion is presented. Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay.
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect immunogenicity, and who have both baseline and Day 30 data, are included. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group (V116 + QIV Followed by Placebo) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | A/H3N2 | 63.8 Percentage of Participants |
| Concomitant Group (V116 + QIV Followed by Placebo) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | B/Yamagata | 23.3 Percentage of Participants |
| Concomitant Group (V116 + QIV Followed by Placebo) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | B/Victoria | 52.3 Percentage of Participants |
| Concomitant Group (V116 + QIV Followed by Placebo) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | A/H1N1 | 47.1 Percentage of Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | A/H1N1 | 55.6 Percentage of Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | A/H3N2 | 68.3 Percentage of Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | B/Victoria | 54.1 Percentage of Participants |
| Sequential Group (Placebo + QIV Followed by V116) | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 | B/Yamagata | 29.9 Percentage of Participants |