Pneumococcal Infections
Conditions
Brief summary
This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.
Interventions
BIOLOGICALV114
Single 0.5 mL injection
BIOLOGICALQIV
Single 0.5 mL injection
BIOLOGICALMatching Placebo for V114
Single 0.5 mL 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
* In good health. Any underlying chronic illness must be documented to be in stable condition. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) not a woman of childbearing potential (WOCBP) OR b) a WOCBP who agrees to use 1 of the contraceptive methods as defined in the protocol during the treatment period and for at least 6 weeks after the last dose of study intervention.
Exclusion criteria
* History of invasive pneumococcal disease (IPD, positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years before Visit 1 (Day 1) * Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine * Known hypersensitivity to any component of influenza vaccines, including egg protein, or following a previous dose of any influenza vaccine. * Known or suspected impairment of immunological function * Experienced Guillain-Barré syndrome within 6 weeks of receiving a previous influenza vaccination * Coagulation disorder contraindicating intramuscular vaccinations. * History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1) * Prior administration of any PCV (e.g., Prevnar 13®) or is expected to receive any pneumococcal vaccine during the study outside of the protocol. * Prior administration of PNEUMOVAX®23 ≤12 months before Visit 1 (Note: individuals who received PNEUMOVAX®23 \>12 months prior to Visit 1 are eligible for this study.) * Previous receipt of influenza vaccine during the 2018/2019 flu season or expected to receive any influenza vaccine during the study outside of the protocol * Received systemic corticosteroids (≥20 mg/day prednisone equivalent) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry. * Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination (Note: Topical, ophthalmic, intra-articular or soft-tissue \[e.g., bursa, tendon steroid injections\], and inhaled/nebulized steroids are permitted). * Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Received a blood transfusion or blood products, including immunoglobulin within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion. * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study. * Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator. * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event | Up to Day 5 after vaccination | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection-site AEs included injection-site erythema /redness, pain /tenderness, swelling. |
| Percentage of Participants With a Solicited Systemic Adverse Event | Up to Day 14 after any vaccination | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs included myalgia/muscle pain, arthralgia/joint pain, headache, and fatigue/tiredness. |
| Percentage of Participants With a Vaccine-Related Serious Adverse Event | Up to 7 months | A serious adverse event (SAE) is an AE that results in death, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. |
| Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group) | Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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. |
| GMT of Influenza Strain-Specific Hemagglutination Inhibition | Day 30 | Activity for the 4 strains contained in QIV vaccine was determined using an hemagglutination inhibition (HAI) assay. Serotype-specific HAI GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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 |
|---|---|---|
| GMFR of Influenza Strain-Specific HAI | Baseline (Day 1) and Day 30 | Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group) | Serotype-specific IgG GMC ratios (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. |
| Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | Baseline (Day 1) and Day 30 | Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion for HAI responses is defined as achieving either 1) a 4-fold rise in influenza strain-specific HAI titer from Baseline to Day 30 among participants who are seropositive at Baseline (HAI titer ≥1:10) or 2) a influenza strain-specific HAI titer of ≥1:40 at Day 30 among participants who are seronegative at Baseline (HAI titer \<1:10). |
| Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | Day 30 | Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion is defined as achieving a 4-fold rise from baseline to postvaccination among participants who are seropositive at baseline (HAI titer ≥ 1:10) or a titer of ≥ 1:40 at postvaccination among participants who are seronegative at baseline (HAI titer \< 1:10). |
| Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively) | Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| GMFR in Pneumococcal Serotype-Specific IgG | Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively) | Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively) | Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR were calculated from baseline to postvaccination. |
| Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively) | Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR are calculated from baseline to postvaccination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Concomitant Group Participants received a single 0.5 mL intramuscular (IM) injection of V114 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. | 599 |
| Non-Concomitant Group 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 V114 on Day 30. | 598 |
| Total | 1,197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Physician Decision | 2 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 7 |
Baseline characteristics
| Characteristic | Concomitant Group | Non-Concomitant Group | Total |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 8.3 | 64.2 years STANDARD_DEVIATION 8.1 | 64.2 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 120 Participants | 119 Participants | 239 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 471 Participants | 472 Participants | 943 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 30 Participants | 55 Participants |
| Race (NIH/OMB) Black or African American | 73 Participants | 63 Participants | 136 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 493 Participants | 495 Participants | 988 Participants |
| Sex: Female, Male Female | 330 Participants | 342 Participants | 672 Participants |
| Sex: Female, Male Male | 269 Participants | 256 Participants | 525 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 600 | 0 / 600 |
| other Total, other adverse events | 458 / 600 | 473 / 596 |
| serious Total, serious adverse events | 22 / 600 | 14 / 596 |
Outcome results
Primary
Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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 V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 901.3 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 3563.2 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 3022.8 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 2859.6 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 | 396.1 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 3208.4 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 137.9 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 2523.2 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 5564.2 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 2243.4 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 | 140.1 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 2206.2 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 3904.0 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 8142.9 Titers |
| Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 2024.8 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 9807.4 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 2228.6 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 3802.7 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 | 211.5 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 147.4 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 1078.5 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 | 500.6 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 6615.9 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 4436.5 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 4119.5 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 2874.1 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 3849.0 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 2473.9 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 2932.5 Titers |
| Non-Concomitant Group | Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 2592.2 Titers |
Comparison: Serotype 1p-value: 0.00495% CI: [0.54, 0.82]cLDA
Comparison: Serotype 3p-value: <0.00195% CI: [0.81, 1.09]cLDA
Comparison: Serotype 4p-value: <0.00195% CI: [0.69, 1.01]cLDA
Comparison: Serotype 5p-value: <0.00195% CI: [0.64, 0.98]cLDA
Comparison: Serotype 6Ap-value: <0.00195% CI: [0.71, 1]cLDA
Comparison: Serotype 6Bp-value: <0.00195% CI: [0.74, 1.04]cLDA
Comparison: Serotype 7Fp-value: <0.00195% CI: [0.75, 0.99]cLDA
Comparison: Serotype 9Vp-value: <0.00195% CI: [0.86, 1.15]cLDA
Comparison: Serotype 14p-value: <0.00195% CI: [0.77, 1.08]cLDA
Comparison: Serotype 18Cp-value: <0.00195% CI: [0.68, 0.92]cLDA
Comparison: Serotype 19Ap-value: <0.00195% CI: [0.73, 0.95]cLDA
Comparison: Serotype 19Fp-value: <0.00195% CI: [0.89, 1.17]cLDA
Comparison: Serotype 22Fp-value: <0.00195% CI: [0.64, 0.91]cLDA
Comparison: Serotype 23Fp-value: <0.00195% CI: [0.7, 1.03]cLDA
Comparison: Serotype 33Fp-value: <0.00195% CI: [0.72, 0.96]cLDA
Primary
GMT of Influenza Strain-Specific Hemagglutination Inhibition
Activity for the 4 strains contained in QIV vaccine was determined using an hemagglutination inhibition (HAI) assay. Serotype-specific HAI GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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: Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | B-Victoria | 35.53 Titers |
| Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | H1N1 | 124.82 Titers |
| Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | H3N2 | 87.85 Titers |
| Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | B-Yamagata | 33.47 Titers |
| Non-Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | B-Yamagata | 33.13 Titers |
| Non-Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | B-Victoria | 36.88 Titers |
| Non-Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | H3N2 | 85.62 Titers |
| Non-Concomitant Group | GMT of Influenza Strain-Specific Hemagglutination Inhibition | H1N1 | 115.00 Titers |
Comparison: H1N1p-value: <0.00195% CI: [0.94, 1.25]cLDA
Comparison: H3N2p-value: <0.00195% CI: [0.9, 1.17]cLDA
Comparison: B-Victoriap-value: <0.00195% CI: [0.86, 1.08]cLDA
Comparison: B-Yamagatap-value: <0.00195% CI: [0.9, 1.13]cLDA
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection-site AEs included injection-site erythema /redness, pain /tenderness, swelling.
Time frame: Up to Day 5 after vaccination
Population: All randomized participants who received at least 1 dose of study vaccination were included. Of the 598 randomized to non-concomitant group, 1 received vaccination with concomitant group and was included (concomitant=600); 1 received 2 doses and was excluded (non-concomitant=596).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-Site Erythema /Redness | 10.7 Percentage of Participants |
| Concomitant Group | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-Site Pain /Tenderness | 68.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-Site Swelling | 14.2 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-Site Swelling | 16.3 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-Site Erythema /Redness | 11.6 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-Site Pain /Tenderness | 71.1 Percentage of Participants |
Comparison: Injection-Site Erythemap-value: 0.61795% CI: [-4.5, 2.7]Miettinen & Nurminen
Comparison: Injection-Site Painp-value: 0.3295% CI: [-7.8, 2.6]Miettinen & Nurminen
Comparison: Injection-Site Swellingp-value: 0.3195% CI: [-6.2, 2]Miettinen & Nurminen
Primary
Percentage of Participants With a Solicited Systemic Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs included myalgia/muscle pain, arthralgia/joint pain, headache, and fatigue/tiredness.
Time frame: Up to Day 14 after any vaccination
Population: All randomized participants who received at least 1 dose of study vaccination were included. Of the 598 randomized to non-concomitant group, 1 received vaccination with concomitant group and was included (concomitant=600); 1 received 2 doses and was excluded (non-concomitant=596).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Joint Pain /Arthralgia | 9.3 Percentage of Participants |
| Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Tiredness/Fatigue | 27.2 Percentage of Participants |
| Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Headache | 21.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Muscle Pain /Myalgia | 23.7 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Muscle Pain /Myalgia | 21.3 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Joint Pain /Arthralgia | 11.6 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Headache | 23.7 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Solicited Systemic Adverse Event | Tiredness/Fatigue | 30.0 Percentage of Participants |
Comparison: Arthralgiap-value: 0.20595% CI: [-5.8, 1.2]Miettinen & Nurminen
Comparison: Fatiguep-value: 0.27395% CI: [-8, 2.3]Miettinen & Nurminen
Comparison: Headachep-value: 0.37295% CI: [-6.9, 2.6]Miettinen & Nurminen
Comparison: Myalgiap-value: 0.32995% CI: [-2.4, 7.1]Miettinen & Nurminen
Primary
Percentage of Participants With a Vaccine-Related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.
Time frame: Up to 7 months
Population: All randomized participants who received at least 1 dose of study vaccination were included. Of the 598 randomized to non-concomitant group, 1 received vaccination with concomitant group and was included (concomitant=600); 1 received 2 doses and was excluded (non-concomitant=596).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Percentage of Participants With a Vaccine-Related Serious Adverse Event | 0 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With a Vaccine-Related Serious Adverse Event | 0 Percentage of Participants |
95% CI: [-0.6, 0.6]
Secondary
Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG)
Serotype-specific IgG GMC ratios (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated.
Time frame: 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 6.07 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 14 | 8.30 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 0.75 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 18C | 9.99 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 6B | 7.11 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 13.43 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 5 | 4.65 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 19F | 8.68 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 4.68 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 3.29 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 4 | 1.47 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 23F | 5.68 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 9V | 3.84 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 9.19 µg/mL |
| Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 1 | 4.19 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 10.69 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 1 | 5.41 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 0.86 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 4 | 1.86 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 5 | 5.23 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 8.29 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 6B | 9.26 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 5.33 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 9V | 4.26 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 14 | 9.80 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 18C | 12.75 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 15.09 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 19F | 9.75 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 4.33 µg/mL |
| Non-Concomitant Group | Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG) | Serotype 23F | 6.82 µg/mL |
Comparison: Serotype 195% CI: [0.67, 0.89]
Comparison: Serotype 395% CI: [0.76, 0.99]
Comparison: Serotype 495% CI: [0.68, 0.91]
Comparison: Serotype 595% CI: [0.77, 1.02]
Comparison: Serotype 6A95% CI: [0.61, 0.87]
Comparison: Serotype 6B95% CI: [0.64, 0.91]
Comparison: Serotype 7F95% CI: [0.76, 1.01]
Comparison: Serotype 9V95% CI: [0.79, 1.03]
Comparison: Serotype 1495% CI: [0.73, 0.99]
Comparison: Serotype 18C95% CI: [0.68, 0.91]
Comparison: Serotype 19A95% CI: [0.78, 1.02]
Comparison: Serotype 19F95% CI: [0.77, 1.03]
Comparison: Serotype 22F95% CI: [0.65, 0.89]
Comparison: Serotype 23F95% CI: [0.7, 0.98]
Comparison: Serotype 33F95% CI: [0.75, 0.99]
Secondary
Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA
Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 4 | 9.4 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 14 | 3.9 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 6A | 10.5 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 18C | 9.8 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 3 | 4.7 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 19A | 6.2 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 6B | 17.6 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 19F | 5.2 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 5 | 8.1 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 22F | 15.9 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 7F | 9.2 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 23F | 13.9 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 9V | 5.8 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 33F | 4.3 Ratio |
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 1 | 8.0 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 33F | 4.6 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 1 | 11.8 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 3 | 4.8 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 7F | 8.0 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 4 | 11.5 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 5 | 10.2 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 6A | 12.1 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 6B | 20.5 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 9V | 5.3 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 14 | 4.1 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 18C | 11.6 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 19A | 6.6 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 19F | 4.7 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 22F | 20.6 Ratio |
| Non-Concomitant Group | Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA | Serotype 23F | 11.9 Ratio |
Secondary
GMFR in Pneumococcal Serotype-Specific IgG
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 6A | 15.6 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 14 | 3.8 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 3 | 4.4 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 18C | 11.2 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 6B | 14.0 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 19A | 6.4 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 5 | 3.5 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 19F | 8.1 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 7F | 6.7 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 22F | 7.6 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 4 | 5.3 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 23F | 10.7 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 9V | 5.9 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 33F | 5.5 Ratio |
| Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 1 | 6.1 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 33F | 6.0 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 1 | 7.5 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 3 | 5.1 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 4 | 6.5 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 5 | 4.0 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 6A | 19.9 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 6B | 17.8 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 7F | 7.2 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 9V | 6.6 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 14 | 4.4 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 18C | 12.9 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 19A | 6.8 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 19F | 8.9 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 22F | 10.1 Ratio |
| Non-Concomitant Group | GMFR in Pneumococcal Serotype-Specific IgG | Serotype 23F | 11.9 Ratio |
Secondary
GMFR of Influenza Strain-Specific HAI
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Baseline (Day 1) and Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group | GMFR of Influenza Strain-Specific HAI | H1N1 | 4.2 Ratio |
| Concomitant Group | GMFR of Influenza Strain-Specific HAI | H3N2 | 2.2 Ratio |
| Concomitant Group | GMFR of Influenza Strain-Specific HAI | B-Victoria | 2.1 Ratio |
| Concomitant Group | GMFR of Influenza Strain-Specific HAI | B-Yamagata | 2.3 Ratio |
| Non-Concomitant Group | GMFR of Influenza Strain-Specific HAI | B-Yamagata | 2.3 Ratio |
| Non-Concomitant Group | GMFR of Influenza Strain-Specific HAI | H1N1 | 4.2 Ratio |
| Non-Concomitant Group | GMFR of Influenza Strain-Specific HAI | B-Victoria | 2.2 Ratio |
| Non-Concomitant Group | GMFR of Influenza Strain-Specific HAI | H3N2 | 2.2 Ratio |
Secondary
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion for HAI responses is defined as achieving either 1) a 4-fold rise in influenza strain-specific HAI titer from Baseline to Day 30 among participants who are seropositive at Baseline (HAI titer ≥1:10) or 2) a influenza strain-specific HAI titer of ≥1:40 at Day 30 among participants who are seronegative at Baseline (HAI titer \<1:10).
Time frame: Baseline (Day 1) and Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | H1N1 | 48.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | H3N2 | 27.8 Percentage of Participants |
| Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | B-Victoria | 29.2 Percentage of Participants |
| Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | B-Yamagata | 31.1 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | B-Yamagata | 30.5 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | H1N1 | 48.3 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | B-Victoria | 28.7 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI | H3N2 | 25.3 Percentage of Participants |
Secondary
Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR are calculated from baseline to postvaccination.
Time frame: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 6B | 74.9 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 14 | 39.8 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 1 | 54.8 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 18C | 67.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 6A | 77.3 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 19A | 59.3 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 3 | 46.8 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 19F | 63.7 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 4 | 53.7 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 22F | 56.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 7F | 60.2 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 23F | 67.4 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 5 | 38.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 33F | 50.4 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 9V | 54.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 33F | 53.9 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 5 | 40.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 6A | 79.2 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 6B | 79.1 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 7F | 59.6 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 1 | 60.8 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 4 | 57.2 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 9V | 55.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 14 | 43.0 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 18C | 68.9 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 19A | 60.1 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 19F | 66.7 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 22F | 64.9 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 23F | 69.7 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG | Serotype 3 | 50.6 Percentage of Participants |
Secondary
Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA
Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR were calculated from baseline to postvaccination.
Time frame: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 22F | 64.2 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 1 | 57.8 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 3 | 54.7 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 4 | 63.1 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 5 | 60.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 6A | 71.1 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 6B | 72.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 7F | 63.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 9V | 54.9 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 14 | 38.6 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 18C | 67.4 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 19A | 53.7 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 19F | 53.7 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 23F | 73.1 Percentage of Participants |
| Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 33F | 44.1 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 23F | 67.2 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 9V | 53.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 1 | 66.3 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 19F | 48.8 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 3 | 54.8 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 14 | 40.9 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 4 | 66.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 22F | 67.5 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 5 | 63.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 18C | 70.3 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 6A | 75.6 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 33F | 44.9 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 6B | 76.1 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 19A | 57.1 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA | Serotype 7F | 59.7 Percentage of Participants |
Secondary
Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion is defined as achieving a 4-fold rise from baseline to postvaccination among participants who are seropositive at baseline (HAI titer ≥ 1:10) or a titer of ≥ 1:40 at postvaccination among participants who are seronegative at baseline (HAI titer \< 1:10).
Time frame: Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | H1N1 | 85.9 Percentage of Participants |
| Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | H3N2 | 77.4 Percentage of Participants |
| Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | B-Victoria | 55.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | B-Yamagata | 52.4 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | B-Yamagata | 50.8 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | H1N1 | 84.7 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | B-Victoria | 54.9 Percentage of Participants |
| Non-Concomitant Group | Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40 | H3N2 | 79.2 Percentage of Participants |