Pneumococcal Infections
Conditions
Brief summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
Interventions
BIOLOGICALV114
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.
BIOLOGICALPCV13
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
\- Japanese male or female
Exclusion criteria
* Has a history of invasive pneumococcal disease (IPD) * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine * 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 a history of autoimmune disease * Has a known neurologic or cognitive behavioral disorder * Has received a dose of any pneumococcal vaccine prior to study entry * Has received a blood transfusion or blood products, including immunoglobulins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | 30 Days after Dose 3, up to a total of 11 months | The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay. |
| Percentage of Participants With Solicited Injection-Site Adverse Events | Day 1 to Day 14 post any vaccination, up to a total of 13.5 months | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling. |
| Percentage of Participants With Solicited Systemic Adverse Events | Day 1 to Day 14 post any vaccination, up to a total of 13.5 months | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria. |
| Percentage of Participants With Vaccine-Related Serious Adverse Events | ~1 month after Dose 4, up to a total of 14 months | A serious adverse event (SAE) is an AE that 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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study. |
| Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | 30 Days after Dose 3, up to a total of 11 months | The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | 30 days after Dose 3, up to a total of 11 months | The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay. |
| Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | 30 Days after Dose 4, up to a total of 14 months | The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay. |
| GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | 30 Days after Dose 4, up to a total of 14 months | The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay. |
| Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | 30 Days after Dose 3, up to a total of 11 months | The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay. |
| GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | 30 Days after Dose 4, up to a total of 14 months | The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay. |
Countries
Japan
Participant flow
Recruitment details
This study enrolled healthy Japanese infants at 2 to 6 months of age.
Pre-assignment details
694 infants were randomized in a 1:1 ratio with stratification into 3 categories by age category (2 months, 3 months and 4 to 6 months of age), to receive either V114 or Pneumococcal 13-valent Conjugate Vaccine (PCV13).
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. | 347 |
| PCV13 Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. | 347 |
| Total | 694 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal By Parent/Guardian | 8 | 6 |
Baseline characteristics
| Characteristic | V114 | PCV13 | Total |
|---|---|---|---|
| Age, Continuous | 2.4 months STANDARD_DEVIATION 0.4 | 2.4 months STANDARD_DEVIATION 0.4 | 2.4 months STANDARD_DEVIATION 0.4 |
| 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) | 347 Participants | 347 Participants | 694 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 (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 347 Participants | 347 Participants | 694 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 347 Participants | 347 Participants | 694 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 166 Participants | 173 Participants | 339 Participants |
| Sex: Female, Male Male | 181 Participants | 174 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 347 | 0 / 347 |
| other Total, other adverse events | 340 / 347 | 340 / 346 |
| serious Total, serious adverse events | 24 / 347 | 23 / 346 |
Outcome results
Primary
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.
Time frame: 30 Days after Dose 3, up to a total of 11 months
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 4 (Shared) | 2.98 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 9V (Shared) | 3.09 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 6B (Shared) | 2.46 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 14 (Shared) | 8.99 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 5 (Shared) | 2.59 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 18C (Shared) | 2.85 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 3 (Shared) | 2.63 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 19A (Shared) | 3.44 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 6A (Shared) | 2.51 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 19F (Shared) | 4.24 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 1 (Shared) | 2.39 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 23F (Shared) | 2.42 μg/mL |
| V114 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 7F (Shared) | 4.38 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 23F (Shared) | 2.95 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 1 (Shared) | 3.95 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 3 (Shared) | 1.42 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 4 (Shared) | 3.54 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 5 (Shared) | 3.35 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 6B (Shared) | 4.17 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 7F (Shared) | 5.22 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 9V (Shared) | 3.55 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 14 (Shared) | 12.03 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 18C (Shared) | 3.85 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 19A (Shared) | 5.28 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 19F (Shared) | 5.65 μg/mL |
| PCV13 | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | Serotype 6A (Shared) | 4.45 μg/mL |
Comparison: Serotype 1: IgG GMC Ratiop-value: <0.00195% CI: [0.55, 0.67]Linear model
Comparison: Serotype 3: IgG GMC Ratiop-value: <0.00195% CI: [1.67, 2.05]Linear model
Comparison: Serotype 4: IgG GMC Ratiop-value: <0.00195% CI: [0.76, 0.93]Linear model
Comparison: Serotype 5: IgG GMC Ratiop-value: <0.00195% CI: [0.69, 0.87]Linear model
Comparison: Serotype 6A: IgG GMC Ratiop-value: =0.01995% CI: [0.5, 0.63]Linear model
Comparison: Serotype 6B: IgG GMC Ratiop-value: =0.01595% CI: [0.51, 0.68]Linear model
Comparison: Serotype 7F: IgG GMC Ratiop-value: <0.00195% CI: [0.75, 0.94]Linear model
Comparison: Serotype 9V: IgG GMC Ratiop-value: <0.00195% CI: [0.78, 0.97]Linear model
Comparison: Serotype 14: IgG GMC Ratiop-value: <0.00195% CI: [0.66, 0.85]Linear model
Comparison: Serotype 18C: IgG GMC Ratiop-value: <0.00195% CI: [0.67, 0.82]Linear model
Comparison: Serotype 19A: IgG GMC Ratiop-value: <0.00195% CI: [0.59, 0.72]Linear model
Comparison: Serotype 19F: IgG GMC Ratiop-value: <0.00195% CI: [0.69, 0.82]Linear model
Primary
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Time frame: 30 Days after Dose 3, up to a total of 11 months
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 6A (Shared) | 99.1 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 14 (Shared) | 99.4 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 3 (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 18C (Shared) | 98.8 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 6B (Shared) | 95.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 19A (Shared) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 5 (Shared) | 98.8 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 19F (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 7F (Shared) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 23F (Shared) | 97.9 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 1 (Shared) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 22F (Unique to V114) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 9V (Shared) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 33F (Unique to V114) | 90.9 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 4 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 33F (Unique to V114) | NA Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 1 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 3 (Shared) | 97.7 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 4 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 5 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 6A (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 6B (Shared) | 98.8 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 7F (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 9V (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 14 (Shared) | 99.7 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 18C (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 19A (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 19F (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 23F (Shared) | 99.7 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | Serotype 22F (Unique to V114) | NA Percentage of Participants |
Comparison: Serotype 1: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.7, 0.8]Miettinen and Nurminen
Comparison: Serotype 3: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [1, 4.5]Miettinen and Nurminen
Comparison: Serotype 4: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.1, 1.1]Miettinen and Nurminen
Comparison: Serotype 5: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-3, -0.1]Miettinen and Nurminen
Comparison: Serotype 6A: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-2.6, 0.2]Miettinen and Nurminen
Comparison: Serotype 6B: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-6.9, -1.3]Miettinen and Nurminen
Comparison: Serotype 7F: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.7, 0.8]Miettinen and Nurminen
Comparison: Serotype 9V: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.7, 0.8]Miettinen and Nurminen
Comparison: Serotype 14: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.9, 1.1]Miettinen and Nurminen
Comparison: Serotype 18C: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-3, -0.1]Miettinen and Nurminen
Comparison: Serotype 19A: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.7, 0.8]Miettinen and Nurminen
Comparison: Serotype 19F: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-1.1, 1.1]Miettinen and Nurminen
Comparison: Serotype 23F: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [-4, -0.2]Miettinen and Nurminen
Comparison: Serotype 22F: Participants With IgG ≥0.35 μg/mLp-value: <0.00195% CI: [0.4, 4.3]Miettinen and Nurminen
Comparison: Serotype 33F: Participants With IgG ≥0.35 μg/mLp-value: =0.04895% CI: [-10.6, -3.5]Miettinen and Nurminen
Primary
Percentage of Participants With Solicited Injection-Site Adverse Events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site erythema | 88.2 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site induration | 81.0 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site pain | 31.1 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site swelling | 75.8 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site swelling | 79.8 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site erythema | 89.3 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site pain | 24.0 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Injection-Site Adverse Events | Injection site induration | 81.2 Percentage of Participants |
Comparison: Injection site erythemap-value: =0.64195% CI: [-5.9, 3.6]Miettinen & Nurminen
Comparison: Injection site indurationp-value: =0.93795% CI: [-6.1, 5.6]Miettinen & Nurminen
Comparison: Injection site painp-value: =0.03695% CI: [0.5, 13.8]Miettinen & Nurminen
Comparison: Injection site swellingp-value: =0.20895% CI: [-10.2, 2.2]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Systemic Adverse Events
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
Time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Decreased appetite | 23.9 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Irritability | 66.6 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Somnolence | 55.9 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Urticaria | 4.0 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Systemic Adverse Events | Urticaria | 4.3 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Systemic Adverse Events | Decreased appetite | 24.3 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Systemic Adverse Events | Somnolence | 54.9 Percentage of Participants |
| PCV13 | Percentage of Participants With Solicited Systemic Adverse Events | Irritability | 60.7 Percentage of Participants |
Comparison: Decreased appetitep-value: =0.91295% CI: [-6.7, 6]Miettinen & Nurminen
Comparison: Irritabilityp-value: =0.10895% CI: [-1.3, 13]Miettinen & Nurminen
Comparison: Somnolencep-value: =0.79295% CI: [-6.4, 8.4]Miettinen & Nurminen
Comparison: Urticariap-value: =0.84395% CI: [-3.5, 2.8]Miettinen & Nurminen
Primary
Percentage of Participants With Vaccine-Related Serious Adverse Events
A serious adverse event (SAE) is an AE that 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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Time frame: ~1 month after Dose 4, up to a total of 14 months
Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With Vaccine-Related Serious Adverse Events | 0.3 Percentage of Participants |
| PCV13 | Percentage of Participants With Vaccine-Related Serious Adverse Events | 0.3 Percentage of Participants |
95% CI: [-1.4, 1.3]
Secondary
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Time frame: 30 Days after Dose 3, up to a total of 11 months
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 6A (Shared) | 9124.96 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 14 (Shared) | 14175.13 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 3 (Shared) | 660.68 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 18C (Shared) | 3698.24 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 6B (Shared) | 8416.19 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 19A (Shared) | 2709.90 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 5 (Shared) | 1241.69 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 19F (Shared) | 2371.39 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 7F (Shared) | 22324.41 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 23F (Shared) | 11861.63 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 1 (Shared) | 211.51 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 22F (Unique to V114) | 5575.08 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 9V (Shared) | 2725.29 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 33F (Unique to V114) | 23888.79 Titer |
| V114 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 4 (Shared) | 3984.87 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 33F (Unique to V114) | 121.79 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 1 (Shared) | 322.44 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 3 (Shared) | 471.43 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 4 (Shared) | 4118.16 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 5 (Shared) | 1358.43 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 6A (Shared) | 11956.64 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 6B (Shared) | 10421.94 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 7F (Shared) | 27396.28 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 9V (Shared) | 3338.40 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 14 (Shared) | 12288.35 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 18C (Shared) | 3705.21 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 19A (Shared) | 3961.10 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 19F (Shared) | 2541.27 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 23F (Shared) | 18957.26 Titer |
| PCV13 | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | Serotype 22F (Unique to V114) | 9.95 Titer |
Comparison: Serotype 1: OPA GMT Ratio95% CI: [0.55, 0.78]
Comparison: Serotype 3: OPA GMT Ratio95% CI: [1.23, 1.59]
Comparison: Serotype 4: OPA GMT Ratio95% CI: [0.85, 1.1]
Comparison: Serotype 5: OPA GMT Ratio95% CI: [0.8, 1.04]
Comparison: Serotype 6A: OPA GMT Ratio95% CI: [0.65, 0.89]
Comparison: Serotype 6B: OPA GMT Ratio95% CI: [0.69, 0.95]
Comparison: Serotype 7F: OPA GMT Ratio95% CI: [0.7, 0.95]
Comparison: Serotype 9V: OPA GMT Ratio95% CI: [0.71, 0.94]
Comparison: Serotype 14: OPA GMT Ratio95% CI: [0.97, 1.38]
Comparison: Serotype 18C: OPA GMT Ratio95% CI: [0.9, 1.11]
Comparison: Serotype 19A: OPA GMT Ratio95% CI: [0.61, 0.77]
Comparison: Serotype 19F: OPA GMT Ratio95% CI: [0.84, 1.04]
Comparison: Serotype 23F: OPA GMT Ratio95% CI: [0.53, 0.74]
Comparison: Serotype 22F: OPA GMT Ratio95% CI: [474.05, 662.63]
Comparison: Serotype 33F: OPA GMT Ratio95% CI: [141.85, 271.21]
Secondary
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.
Time frame: 30 Days after Dose 4, up to a total of 14 months
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 19A (Shared) | 6.88 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 19F (Shared) | 6.53 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 1 (Shared) | 2.74 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 3 (Shared) | 2.18 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 4 (Shared) | 2.91 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 5 (Shared) | 4.43 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 6A (Shared) | 6.05 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 6B (Shared) | 8.03 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 7F (Shared) | 5.80 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 9V (Shared) | 4.27 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 14 (Shared) | 9.51 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 18C (Shared) | 5.21 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 23F (Shared) | 3.75 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 22F (Unique to V114) | 11.42 μg/mL |
| V114 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 33F (Unique to V114) | 6.14 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 19F (Shared) | 7.76 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 19A (Shared) | 8.37 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 7F (Shared) | 7.15 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 22F (Unique to V114) | 0.13 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 1 (Shared) | 5.19 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 9V (Shared) | 5.18 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 3 (Shared) | 1.28 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 23F (Shared) | 6.22 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 4 (Shared) | 3.18 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 14 (Shared) | 11.26 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 5 (Shared) | 6.65 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 33F (Unique to V114) | 0.14 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 6A (Shared) | 9.41 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 18C (Shared) | 5.21 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | Serotype 6B (Shared) | 10.88 μg/mL |
Comparison: Serotype 1: IgG GMC Ratio95% CI: [0.47, 0.59]
Comparison: Serotype 3: IgG GMC Ratio95% CI: [1.53, 1.9]
Comparison: Serotype 4: IgG GMC Ratio95% CI: [0.8, 1.05]
Comparison: Serotype 5: IgG GMC Ratio95% CI: [0.59, 0.75]
Comparison: Serotype 6A: IgG GMC Ratio95% CI: [0.56, 0.73]
Comparison: Serotype 6B: IgG GMC Ratio95% CI: [0.65, 0.84]
Comparison: Serotype 7F: IgG GMC Ratio95% CI: [0.71, 0.92]
Comparison: Serotype 9V: IgG GMC Ratio95% CI: [0.73, 0.94]
Comparison: Serotype 14: IgG GMC Ratio95% CI: [0.74, 0.96]
Comparison: Serotype 18C: IgG GMC Ratio95% CI: [0.87, 1.14]
Comparison: Serotype 19A: IgG GMC Ratio95% CI: [0.73, 0.92]
Comparison: Serotype 19F: IgG GMC Ratio95% CI: [0.75, 0.94]
Comparison: Serotype 23F: IgG GMC Ratio95% CI: [0.52, 0.7]
Comparison: Serotype 22F: IgG GMC Ratio95% CI: [77.61, 96.95]
Comparison: Serotype 33F: IgG GMC Ratio95% CI: [40.07, 51.54]
Secondary
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.
Time frame: 30 days after Dose 3, up to a total of 11 months
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | Serotype 22F (Unique to V114) | 6.59 μg/mL |
| V114 | GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | Serotype 33F (Unique to V114) | 1.85 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | Serotype 22F (Unique to V114) | 0.06 μg/mL |
| PCV13 | GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | Serotype 33F (Unique to V114) | 0.06 μg/mL |
Comparison: Serotype 22F: IgG GMC Ratio95% CI: [96.18, 120.03]
Comparison: Serotype 33F: IgG GMC Ratio95% CI: [27.72, 38.05]
Secondary
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Time frame: 30 Days after Dose 4, up to a total of 14 months
Population: The first 50% of all participants with sufficient serum volume after dose 3 to evaluate OPA responses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 6A (Shared) | 12553.06 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 14 (Shared) | 8486.72 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 3 (Shared) | 1444.00 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 18C (Shared) | 7027.62 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 6B (Shared) | 9218.64 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 19A (Shared) | 8441.43 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 5 (Shared) | 1853.08 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 19F (Shared) | 4716.70 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 7F (Shared) | 15451.96 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 23F (Shared) | 11319.82 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 4 (Shared) | 4531.52 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 22F (Unique to V114) | 5561.71 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 9V (Shared) | 3259.24 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 33F (Unique to V114) | 19899.34 Titer |
| V114 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 1 (Shared) | 453.42 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 33F (Unique to V114) | 1183.52 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 1 (Shared) | 854.50 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 3 (Shared) | 893.97 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 4 (Shared) | 6264.94 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 5 (Shared) | 2151.95 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 6A (Shared) | 17476.24 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 6B (Shared) | 14041.53 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 7F (Shared) | 18039.04 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 9V (Shared) | 5050.89 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 14 (Shared) | 5719.04 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 18C (Shared) | 5903.86 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 19A (Shared) | 10834.58 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 19F (Shared) | 3829.62 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 23F (Shared) | 30686.58 Titer |
| PCV13 | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | Serotype 22F (Unique to V114) | 35.68 Titer |
Comparison: Serotype 1: OPA GMT Ratio95% CI: [0.38, 0.75]
Comparison: Serotype 3: OPA GMT Ratio95% CI: [1.28, 2.03]
Comparison: Serotype 4: OPA GMT Ratio95% CI: [0.57, 0.93]
Comparison: Serotype 5: OPA GMT Ratio95% CI: [0.66, 1.13]
Comparison: Serotype 6A: OPA GMT Ratio95% CI: [0.57, 0.91]
Comparison: Serotype 6B: OPA GMT Ratio95% CI: [0.52, 0.83]
Comparison: Serotype 7F: OPA GMT Ratio95% CI: [0.68, 1.07]
Comparison: Serotype 9V: OPA GMT Ratio95% CI: [0.5, 0.84]
Comparison: Serotype 14: OPA GMT Ratio95% CI: [1.16, 1.9]
Comparison: Serotype 18C: OPA GMT Ratio95% CI: [0.95, 1.48]
Comparison: Serotype 19A: OPA GMT Ratio95% CI: [0.6, 1.01]
Comparison: Serotype 19F: OPA GMT Ratio95% CI: [1, 1.52]
Comparison: Serotype 23F: OPA GMT Ratio95% CI: [0.28, 0.49]
Comparison: Serotype 22F: OPA GMT Ratio95% CI: [101.84, 238.59]
Comparison: Serotype 33F: OPA GMT Ratio95% CI: [11.74, 24.08]
Secondary
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Time frame: 30 Days after Dose 4, up to a total of 14 months
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 6A (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 14 (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 3 (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 18C (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 6B (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 19A (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 5 (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 19F (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 7F (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 23F (Shared) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 4 (Shared) | 99.7 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 22F (Unique to V114) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 9V (Shared) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 33F (Unique to V114) | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 1 (Shared) | 99.7 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 33F (Unique to V114) | 11.5 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 1 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 3 (Shared) | 96.7 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 4 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 5 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 6A (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 6B (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 7F (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 9V (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 14 (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 18C (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 19A (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 19F (Shared) | 100.0 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 23F (Shared) | 99.4 Percentage of Participants |
| PCV13 | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | Serotype 22F (Unique to V114) | 5.2 Percentage of Participants |
Comparison: Serotype 6A: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 1: Participants With IgG ≥0.35 μg/mL95% CI: [-1.7, 0.8]
Comparison: Serotype 3: Participants With IgG ≥0.35 μg/mL95% CI: [1.8, 5.8]
Comparison: Serotype 4: Participants With IgG ≥0.35 μg/mL95% CI: [-1.7, 0.8]
Comparison: Serotype 5: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 6B: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 7F: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 9V: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 14: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 18C: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 19A: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 19F: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.1]
Comparison: Serotype 23F: Participants With IgG ≥0.35 μg/mL95% CI: [-1.1, 1.9]
Comparison: Serotype 22F: Participants With IgG ≥0.35 μg/mL95% CI: [91.8, 96.7]
Comparison: Serotype 33F: Participants With IgG ≥0.35 μg/mL95% CI: [84.5, 91.6]