Pneumococcal Infections
Conditions
Brief summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries. The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.
Interventions
DRUGV114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.
DRUGPrevenar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
DRUGVaxelis™
Intramuscular 0.5 mL single dose
DRUGM-M-R®II
Subcutaneous 0.5 mL single dose
DRUGVARIVAX™
Subcutaneous 0.5 mL single dose
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Days to 111 Days
Healthy volunteers
Yes
Inclusion criteria
* Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent. * Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Exclusion criteria
* Was born prior to 37 weeks of gestation. * Has a history of invasive pneumococcal disease (IPD) or known history of other culture positive pneumococcal disease. * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid containing vaccine. * Has any contraindication to the concomitant study vaccines being administered in the study. * Has a known or suspected impairment of immunological function. * Has a history of congenital or acquired immunodeficiency. * Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection. * Has, or his/her mother has, a documented hepatitis B surface antigen - positive test. * Has known or history of functional or anatomic asplenia. * Has failure to thrive based on the clinical judgement of the investigator. * Has a bleeding disorder contraindicating intramuscular vaccination. * Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders). * Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders. * Has received a dose of any pneumococcal vaccine prior to study entry. * Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry. * Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry. * Has received a blood transfusion or blood products, including immunoglobulins. * Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case by-case basis for approval by the Sponsor. * Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study. * Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | 30 days after Dose 3 | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. |
| Percentage of Participants With a Solicited Injection-site Adverse Event | Day 1 to Day 14 after each vaccination | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling. |
| Percentage of Participants With a Solicited Systemic Adverse Event | Day 1 to Day 14 after each vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts). |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | Up to approximately 6 months after Dose 3 (up to approximately 16 months) | A serious adverse event (SAE) is an AE that results in death, is life-threatening, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized. |
| Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | 30 days after Dose 3 | The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | 30 days after Dose 3 | Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3. |
| Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | 30 days after Dose 2 | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay. |
| GMC of Serotype-specific IgG 30 Days After Dose 2 | 30 days after Dose 2 | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay. |
| Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | 30 days after Dose 3 | OPA for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was measured using a multiplex opsonophagocytic assay (MOPA). |
| Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | 30 days after Dose 3 | Sera from participants was used to measure GMT of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. |
Countries
Denmark, Finland, Italy, Norway, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements). | 595 |
| Prevenar 13™ Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements). | 596 |
| Total | 1,191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Physician Decision | 3 | 3 |
| Overall Study | Withdrawal by Parent/Guardian | 16 | 12 |
Baseline characteristics
| Characteristic | V114 | Prevenar 13™ | Total |
|---|---|---|---|
| Age, Continuous | 12.4 weeks STANDARD_DEVIATION 1.4 | 12.5 weeks STANDARD_DEVIATION 1.4 | 12.4 weeks STANDARD_DEVIATION 1.4 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65-84 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 595 Participants | 596 Participants | 1191 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity Hispanic or Latino | 26 Participants | 22 Participants | 48 Participants |
| Ethnicity Not Hispanic or Latino | 564 Participants | 570 Participants | 1134 Participants |
| Ethnicity Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity Unknown | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 12 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 579 Participants | 579 Participants | 1158 Participants |
| Sex: Female, Male Female | 272 Participants | 289 Participants | 561 Participants |
| Sex: Female, Male Male | 323 Participants | 307 Participants | 630 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 595 | 0 / 596 |
| other Total, other adverse events | 590 / 595 | 592 / 594 |
| serious Total, serious adverse events | 30 / 595 | 28 / 594 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Time frame: 30 days after Dose 3
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 1 | 1.28 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 6B | 4.56 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 7F | 2.78 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 9V | 2.14 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 14 | 5.35 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 3 | 0.85 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 4 | 1.41 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 5 | 2.08 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 6A | 3.21 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 18C | 2.10 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 19A | 4.74 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 19F | 4.08 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 23F | 1.58 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 22F | 6.06 µg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 33F | 3.28 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 33F | 0.07 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 6A | 5.36 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 5 | 3.35 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 6B | 5.12 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 19F | 5.18 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 7F | 3.74 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 22F | 0.09 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 9V | 3.07 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 18C | 2.48 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 14 | 6.83 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 1 | 2.20 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 23F | 1.77 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 3 | 0.65 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 19A | 6.38 µg/mL |
| Prevenar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 | Serotype 4 | 2.00 µg/mL |
Comparison: Serotype 1p-value: <0.00195% CI: [0.54, 0.63]t-test, 1 sided
Comparison: Serotype 3p-value: <0.00195% CI: [1.2, 1.43]t-test, 1 sided
Comparison: Serotype 4p-value: <0.00195% CI: [0.63, 0.78]t-test, 1 sided
Comparison: Serotype 5p-value: <0.00195% CI: [0.56, 0.68]t-test, 1 sided
Comparison: Serotype 6Ap-value: <0.00195% CI: [0.54, 0.67]t-test, 1 sided
Comparison: Serotype 6Bp-value: <0.00195% CI: [0.79, 1]t-test, 1 sided
Comparison: Serotype 7Fp-value: <0.00195% CI: [0.69, 0.81]t-test, 1 sided
Comparison: Serotype 9Vp-value: <0.00195% CI: [0.64, 0.76]t-test, 1 sided
Comparison: Serotype 14p-value: <0.00195% CI: [0.7, 0.87]t-test, 1 sided
Comparison: Serotype 18Cp-value: <0.00195% CI: [0.77, 0.92]t-test, 1 sided
Comparison: Serotype 19Ap-value: <0.00195% CI: [0.68, 0.82]t-test, 1 sided
Comparison: Serotype 19Fp-value: <0.00195% CI: [0.72, 0.87]t-test, 1 sided
Comparison: Serotype 23Fp-value: <0.00195% CI: [0.81, 1]t-test, 1 sided
Comparison: Serotype 22Fp-value: <0.00195% CI: [61.73, 75.65]t-test, 1 sided
Comparison: Serotype 33Fp-value: <0.00195% CI: [44.45, 54.01]t-test, 1 sided
Primary
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay.
Time frame: 30 days after Dose 3
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 1 | 96.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 3 | 92.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 7F | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 14 | 99.2 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 18C | 99.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 19A | 99.6 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 22F | 99.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 4 | 96.6 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 5 | 99.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 6A | 99.2 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 6B | 99.2 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 9V | 99.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 19F | 99.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 23F | 97.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 33F | 99.2 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 7F | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 1 | 99.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 4 | 98.5 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 3 | 82.3 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 6B | 99.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 19F | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 9V | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 5 | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 14 | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 19A | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 18C | 99.4 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 6A | 99.4 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 23F | 96.9 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 33F | 2.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 | Serotype 22F | 5.4 Percentage of participants |
Comparison: Serotype 1p-value: <0.00195% CI: [-4.3, -0.6]Miettinen & Nurminen method
Comparison: Serotype 3p-value: <0.00195% CI: [6.6, 14.6]Miettinen & Nurminen method
Comparison: Serotype 4p-value: <0.00195% CI: [-4, 0]Miettinen & Nurminen method
Comparison: Serotype 5p-value: <0.00195% CI: [-1.4, 0.8]Miettinen & Nurminen method
Comparison: Serotype 6Ap-value: <0.00195% CI: [-1.5, 1]Miettinen & Nurminen method
Comparison: Serotype 6Bp-value: <0.00195% CI: [-1.2, 1.5]Miettinen & Nurminen method
Comparison: Serotype 7Fp-value: <0.00195% CI: [-0.4, 1.4]Miettinen & Nurminen method
Comparison: Serotype 9Vp-value: <0.00195% CI: [-0.8, 1.2]Miettinen & Nurminen method
Comparison: Serotype 14p-value: <0.00195% CI: [-1.7, 0.7]Miettinen & Nurminen method
Comparison: Serotype 18Cp-value: <0.00195% CI: [-0.6, 1.5]Miettinen & Nurminen method
Comparison: Serotype 19Ap-value: <0.00195% CI: [-1.3, 0.7]Miettinen & Nurminen method
Comparison: Serotype 19Fp-value: <0.00195% CI: [-0.8, 1.2]Miettinen & Nurminen method
Comparison: Serotype 23Fp-value: <0.00195% CI: [-1.2, 3]Miettinen & Nurminen method
Comparison: Serotype 22Fp-value: <0.00195% CI: [91.6, 95.8]Miettinen & Nurminen method
Comparison: Serotype 33Fp-value: <0.00195% CI: [95.4, 98.4]Miettinen & Nurminen method
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 treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Time frame: Day 1 to Day 14 after each vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site pain | 63.0 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site induration | 57.0 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site swelling | 46.4 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site erythema | 60.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site erythema | 65.5 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site swelling | 44.1 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site induration | 59.1 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site pain | 59.6 Percentage of participants |
Comparison: Injection-site erythemap-value: =0.0595% CI: [-11, 0]Miettinen & Nurminen method
Comparison: Injection-site indurationp-value: =0.4695% CI: [-7.7, 3.5]Miettinen & Nurminen method
Comparison: Injection-site painp-value: =0.22595% CI: [-2.1, 8.9]Miettinen & Nurminen method
Comparison: Injection-site swellingp-value: =0.4395% CI: [-3.4, 7.9]Miettinen & Nurminen method
Primary
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).
Time frame: Day 1 to Day 14 after each vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Decreased appetite | 54.8 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Irritability | 96.3 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Somnolence | 77.3 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Urticaria | 16.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Urticaria | 21.4 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Decreased appetite | 58.2 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Somnolence | 77.9 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Irritability | 94.1 Percentage of participants |
Comparison: Decreased appetitep-value: =0.22995% CI: [-9.1, 2.2]Miettinen & Nurminen method
Comparison: Irritabilityp-value: =0.07795% CI: [-0.2, 4.7]Miettinen & Nurminen method
Comparison: Somnolencep-value: =0.79395% CI: [-5.4, 4.1]Miettinen & Nurminen method
Comparison: Urticariap-value: =0.04595% CI: [-9.1, -0.1]Miettinen & Nurminen method
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life-threatening, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Time frame: Up to approximately 6 months after Dose 3 (up to approximately 16 months)
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.3 Percentage of participants |
| Prevenar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.3 Percentage of participants |
Comparison: Vaccine-related SAEs95% CI: [-0.9, 0.9]
Secondary
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3
Sera from participants was used to measure GMT of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA.
Time frame: 30 days after Dose 3
Population: All randomized participants in the OPA Subset without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 3 | 320.4 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 6B | 2691.6 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 14 | 3449.4 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 7F | 5819.2 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 4 | 2290.8 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 9V | 2192.1 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 18C | 2203.1 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 1 | 152.2 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 19A | 2839.1 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 5 | 855.5 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 19F | 1748.4 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 22F | 2927.9 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 23F | 3650.2 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 6A | 3316.8 Titer |
| V114 | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 33F | 13334.7 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 6A | 4649.1 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 14 | 2360.2 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 23F | 6776.2 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 33F | 1557.9 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 1 | 184.0 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 3 | 296.2 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 4 | 2842.0 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 5 | 1024.5 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 9V | 2745.1 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 6B | 2658.7 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 7F | 7839.0 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 18C | 2003.4 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 19A | 3843.6 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 19F | 2067.0 Titer |
| Prevenar 13™ | Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 | Serotype 22F | 29.3 Titer |
Secondary
GMC of Serotype-specific IgG 30 Days After Dose 2
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay.
Time frame: 30 days after Dose 2
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 5 | 1.14 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 6A | 0.67 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 6B | 0.42 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 7F | 1.69 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 9V | 1.55 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 22F | 3.16 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 33F | 0.30 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 18C | 1.18 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 1 | 1.39 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 3 | 1.10 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 4 | 1.74 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 14 | 5.59 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 19A | 1.70 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 19F | 2.79 μg/mL |
| V114 | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 23F | 0.71 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 14 | 5.48 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 5 | 1.26 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 1 | 1.70 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 6A | 1.53 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 19F | 4.04 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 19A | 2.35 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 7F | 2.18 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 4 | 1.59 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 6B | 0.24 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 22F | 0.04 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 9V | 1.55 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 33F | 0.04 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 23F | 0.54 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 18C | 1.58 μg/mL |
| Prevenar 13™ | GMC of Serotype-specific IgG 30 Days After Dose 2 | Serotype 3 | 0.61 μg/mL |
Comparison: Serotype 195% CI: [0.75, 0.89]
Comparison: Serotype 395% CI: [1.66, 1.98]
Comparison: Serotype 495% CI: [0.99, 1.21]
Comparison: Serotype 595% CI: [0.81, 1.01]
Comparison: Serotype 6A95% CI: [0.38, 0.5]
Comparison: Serotype 6B95% CI: [1.46, 2.05]
Comparison: Serotype 7F95% CI: [0.71, 0.84]
Comparison: Serotype 9V95% CI: [0.9, 1.12]
Comparison: Serotype 1495% CI: [0.89, 1.18]
Comparison: Serotype 18C95% CI: [0.68, 0.82]
Comparison: Serotype 19A95% CI: [0.64, 0.81]
Comparison: Serotype 19F95% CI: [0.62, 0.77]
Comparison: Serotype 23F95% CI: [1.16, 1.51]
Comparison: Serotype 22F95% CI: [73.12, 89.75]
Comparison: Serotype 33F95% CI: [6.82, 8.94]
Secondary
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay.
Time frame: 30 days after Dose 2
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 3 | 96.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 4 | 97.6 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 5 | 92.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 6A | 77.2 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 18C | 93.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 23F | 75.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 1 | 97.2 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 6B | 59.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 7F | 98.6 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 9V | 94.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 14 | 96.6 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 19A | 94.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 19F | 98.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 22F | 97.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 33F | 49.5 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 14 | 96.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 3 | 78.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 6B | 40.3 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 4 | 98.2 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 33F | 1.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 5 | 91.2 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 7F | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 6A | 91.4 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 19A | 96.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 18C | 94.4 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 19F | 99.4 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 9V | 94.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 23F | 66.7 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 22F | 2.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 | Serotype 1 | 98.2 Percentage of participants |
Secondary
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3
OPA for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was measured using a multiplex opsonophagocytic assay (MOPA).
Time frame: 30 days after Dose 3
Population: All randomized participants in the OPA Subset without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 1: % ≥1:9 dilution | 98.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 3: % ≥1:19 dilution | 99.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 4: % ≥1:34 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 5: % ≥1:27 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 18C: % ≥1:115 dilution | 99.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 19A : % ≥1:31 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 19F: % ≥1:113 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 22F: % ≥1:15 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 33F: % ≥1:20 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 6A: % ≥1:232 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 6B: % ≥1:40 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 7F: % ≥1:61 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 9V: % ≥1:151 dilution | 99.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 14: % ≥1:62 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 23F: % ≥1:55 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 9V: % ≥1:151 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 1: % ≥1:9 dilution | 97.9 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 5: % ≥1:27 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 3: % ≥1:19 dilution | 97.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 23F: % ≥1:55 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 4: % ≥1:34 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 6A: % ≥1:232 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 6B: % ≥1:40 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 14: % ≥1:62 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 18C: % ≥1:115 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 19F: % ≥1:113 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 19A : % ≥1:31 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 7F: % ≥1:61 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 33F: % ≥1:20 dilution | 98.9 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 | Serotype 22F: % ≥1:15 dilution | 26.4 Percentage of participants |
Secondary
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3
Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3.
Time frame: 30 days after Dose 3
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Poliovirus 1: % w/ Nab ≥1:8 dilution | 99.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Diphtheria toxoid: % ≥0.1 IU/mL | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - FHA: % ≥5 EU/mL | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - PT: % ≥5 EU/mL | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - FIM 2/3: % ≥20 EU/m L | 99.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Hib-PRP: % ≥0.15 μg/mL | 96.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Tetanus toxoid: % ≥0.1 IU/mL | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Poliovirus 2: % w/ Nab ≥1:8 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | HBsAg: % ≥10 mIU/mL | 99.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Poliovirus 3: % w/ Nab ≥1:8 dilution | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - PRN: % ≥5 EU/mL | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Poliovirus 3: % w/ Nab ≥1:8 dilution | 100.0 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Tetanus toxoid: % ≥0.1 IU/mL | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - PT: % ≥5 EU/mL | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - PRN: % ≥5 EU/mL | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Hib-PRP: % ≥0.15 μg/mL | 97.9 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | HBsAg: % ≥10 mIU/mL | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - FHA: % ≥5 EU/mL | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Pertussis - FIM 2/3: % ≥20 EU/m L | 99.6 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Poliovirus 1: % w/ Nab ≥1:8 dilution | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Poliovirus 2: % w/ Nab ≥1:8 dilution | 99.8 Percentage of participants |
| Prevenar 13™ | Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 | Diphtheria toxoid: % ≥0.1 IU/mL | 99.8 Percentage of participants |
Comparison: Diphtheria toxoidp-value: <0.00195% CI: [-0.6, 1]Miettinen & Nurminen method
Comparison: Tetanus toxoidp-value: <0.00195% CI: [-0.6, 1]Miettinen & Nurminen method
Comparison: Pertussis - PTp-value: <0.00195% CI: [-0.6, 1]Miettinen & Nurminen method
Comparison: Pertussis - FHAp-value: <0.00195% CI: [-0.6, 1]Miettinen & Nurminen method
Comparison: Pertussis - FIM 2/3p-value: <0.00195% CI: [-0.8, 1.2]Miettinen & Nurminen method
Comparison: Pertussis - PRNp-value: <0.00195% CI: [-0.8, 1.2]Miettinen & Nurminen method
Comparison: Hib-PRPp-value: <0.00195% CI: [-3.3, 0.9]Miettinen & Nurminen method
Comparison: HBsAgp-value: <0.00195% CI: [-2, 0.5]Miettinen & Nurminen method
Comparison: Poliovirus 1p-value: <0.00195% CI: [-0.9, 0.9]Miettinen & Nurminen method
Comparison: Poliovirus 2p-value: <0.00195% CI: [-0.6, 1.1]Miettinen & Nurminen method
Comparison: Poliovirus 3p-value: <0.00195% CI: [-0.8, 0.7]Miettinen & Nurminen method