Pneumococcal Infections
Conditions
Brief summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (\>=42 days to \<=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG \>=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.
Interventions
BIOLOGICALV114 Lot 1
Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
BIOLOGICALV114 Lot 2
Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
BIOLOGICALPrevnar 13™
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml 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
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Infant approximately 2 months of age (42 days to 90 days), inclusive * In good health
Exclusion criteria
* Prior administration of any pneumococcal vaccine * Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine * Known or suspected impairment of immunological function * History of congenital or acquired immunodeficiency (eg, splenomegaly) * Mother has documented human immunodeficiency virus (HIV) infection * Mother has documented hepatitis B surface antigen-positive test result * Known or history of functional or anatomic asplenia * History of failure to thrive * History of a coagulation disorder * History of autoimmune disease * Known neurologic or cognitive behavioral disorder * Expects to require systemic corticosteroids within 30 days after each vaccination during the trial * Prior administration of a blood transfusion or blood products, including immunoglobulin * Participated in another clinical trial of an investigational product * History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Systemic Adverse Event | Up to 14 days post any vaccination | Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed. |
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | Up to 1 month post Vaccination 4 (up to 14 months) | The percentage of participants who discontinued the study because of an AE (as defined above) was assessed. |
| Percentage of Participants With a Solicited Injection-site Adverse Event | Up to 14 days post any vaccination | Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed. |
| Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | 1 month post vaccination 3 (Month 5) | Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype. |
| Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | 1 month post Vaccination 3 (Month 5) | Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed. |
| Percentage of Participants Who Experience at Least 1 Adverse Event | Up to 1 month post Vaccination 4 (up to 14 months) | An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | 1 month post vaccination 4 (Month 11-14) | Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay. |
| Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Before Vaccination 4 (Month 10 to 13) | Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay. |
Countries
Canada, Denmark, Finland, Israel, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V114 Lot 1 Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) | 351 |
| V114 Lot 2 Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) | 350 |
| Prevnar 13™ Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) | 350 |
| Total | 1,051 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 9 | 12 | 12 |
| Overall Study | Lost to Follow-up | 7 | 8 | 4 |
| Overall Study | Physician Decision | 1 | 6 | 0 |
| Overall Study | Protocol Violation | 2 | 1 | 5 |
| Overall Study | Withdrawal by Subject | 22 | 17 | 21 |
Baseline characteristics
| Characteristic | V114 Lot 2 | Total | V114 Lot 1 | Prevnar 13™ |
|---|---|---|---|---|
| Age, Customized Infants and toddlers (28 days-23 months) | 350 Participants | 1051 Participants | 351 Participants | 350 Participants |
| Ethnicity Hispanic Or Latino | 36 Participants | 138 Participants | 49 Participants | 53 Participants |
| Ethnicity Not Hispanic Or Latino | 313 Participants | 907 Participants | 300 Participants | 294 Participants |
| Ethnicity Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity Unknown | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 6 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 91 Participants | 34 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 25 Participants | 65 Participants | 18 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 296 Participants | 875 Participants | 290 Participants | 289 Participants |
| Sex: Female, Male Female | 186 Participants | 523 Participants | 164 Participants | 173 Participants |
| Sex: Female, Male Male | 164 Participants | 528 Participants | 187 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 350 | 0 / 347 | 0 / 347 |
| other Total, other adverse events | 333 / 350 | 337 / 347 | 330 / 347 |
| serious Total, serious adverse events | 18 / 350 | 19 / 347 | 15 / 347 |
Outcome results
Primary
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.
Time frame: 1 month post Vaccination 3 (Month 5)
Population: Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 6B | 1.95 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 4 | 1.30 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 19A | 1.63 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 7F | 2.43 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 3 | 1.04 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 18C | 1.24 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 9V | 1.40 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 23F | 1.22 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 14 | 5.08 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 5 | 1.37 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 33F | 1.58 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 1 | 1.19 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 6A | 1.42 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 22F | 4.80 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 19F | 2.26 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 19F | 2.33 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 1 | 1.37 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 3 | 1.02 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 4 | 1.27 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 5 | 1.45 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 6A | 1.48 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 6B | 1.71 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 7F | 2.42 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 9V | 1.70 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 14 | 4.78 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 18C | 1.65 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 19A | 1.64 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 23F | 1.47 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 22F | 4.18 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 33F | 1.51 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 6B | 1.89 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 22F | 0.05 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 19A | 1.99 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 6A | 2.62 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 5 | 1.75 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 19F | 2.57 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 4 | 1.26 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 1 | 1.65 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 23F | 1.25 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 9V | 1.59 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 3 | 0.53 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 14 | 5.79 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 7F | 2.98 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 33F | 0.05 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Type 18C | 1.67 µg/mL |
Comparison: Type 195% CI: [0.64, 0.81]
Comparison: Type 395% CI: [1.75, 2.23]
Comparison: Type 495% CI: [0.92, 1.16]
Comparison: Type 595% CI: [0.68, 0.89]
Comparison: Type 6A95% CI: [0.47, 0.63]
Comparison: Type 6B95% CI: [0.84, 1.26]
Comparison: Type 7F95% CI: [0.73, 0.92]
Comparison: Type 9V95% CI: [0.77, 1]
Comparison: Type 1495% CI: [0.75, 1.03]
Comparison: Type 18C95% CI: [0.66, 0.84]
Comparison: Type 19A95% CI: [0.73, 0.92]
Comparison: Type 19F95% CI: [0.79, 0.98]
Comparison: Type 23F95% CI: [0.84, 1.13]
Comparison: Type 22F95% CI: [80.84, 104.81]
Comparison: Type 33F95% CI: [28.5, 41.54]
Comparison: Type 195% CI: [0.74, 0.94]
Comparison: Type 395% CI: [1.71, 2.18]
Comparison: Type 495% CI: [0.9, 1.14]
Comparison: Type 595% CI: [0.72, 0.94]
Comparison: Type 6A95% CI: [0.49, 0.66]
Comparison: Type 6B95% CI: [0.74, 1.1]
Comparison: Type 7F95% CI: [0.72, 0.91]
Comparison: Type 9V95% CI: [0.94, 1.22]
Comparison: Type 1495% CI: [0.71, 0.97]
Comparison: Type 18C95% CI: [0.88, 1.12]
Comparison: Type 19A95% CI: [0.73, 0.92]
Comparison: Type 19F95% CI: [0.81, 1.01]
Comparison: Type 23F95% CI: [1.01, 1.37]
Comparison: Type 22F95% CI: [70.3, 91.24]
Comparison: Type 33F95% CI: [27.25, 39.78]
Primary
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Time frame: 1 month post vaccination 3 (Month 5)
Population: Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 19F | 100.0 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 14 | 99.3 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 6B | 90.6 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 4 | 98.2 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 9V | 97.1 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 7F | 99.6 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 1 | 96.8 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 3 | 96.0 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 19A | 98.9 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 5 | 96.0 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 23F | 92.4 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 18C | 96.8 Percentage of Participants |
| V114 Lot 1 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 6A | 90.6 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 7F | 99.3 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 1 | 97.8 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 3 | 94.1 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 4 | 97.1 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 5 | 96.0 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 6A | 95.6 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 6B | 92.3 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 9V | 97.8 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 14 | 97.4 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 18C | 98.2 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 19A | 98.5 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 19F | 98.9 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 23F | 94.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 14 | 97.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 5 | 96.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 19F | 99.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 18C | 95.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 4 | 95.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 1 | 96.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 19A | 98.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 7F | 99.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 6B | 91.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 3 | 71.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 9V | 95.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 6A | 96.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Type 23F | 90.7 Percentage of Participants |
Comparison: Type 9Vp-value: <0.00195% CI: [-1.1, 5.2]Miettinen and Nurminen
Comparison: Type 14p-value: <0.00195% CI: [-2.8, 3.1]Miettinen and Nurminen
Comparison: Type 18Cp-value: <0.00195% CI: [-0.3, 5.9]Miettinen and Nurminen
Comparison: Type 5p-value: <0.00195% CI: [-4.1, 2.7]Miettinen and Nurminen
Comparison: Type 6Ap-value: <0.00195% CI: [-4.2, 2.8]Miettinen and Nurminen
Comparison: Type 6Bp-value: <0.00195% CI: [-3.7, 5.6]Miettinen and Nurminen
Comparison: Type 7Fp-value: <0.00195% CI: [-1.7, 2.4]Miettinen and Nurminen
Comparison: Type 1p-value: <0.00195% CI: [-3.3, 3]Miettinen and Nurminen
Comparison: Type 3p-value: <0.00195% CI: [18.7, 30]Miettinen and Nurminen
Comparison: Type 4p-value: <0.00195% CI: [0, 6.4]Miettinen and Nurminen
Comparison: Type 5p-value: <0.00195% CI: [-3.9, 2.8]Miettinen and Nurminen
Comparison: Type 6Ap-value: <0.00195% CI: [-10, -1.6]Miettinen and Nurminen
Comparison: Type 6Bp-value: <0.00195% CI: [-5.7, 4]Miettinen and Nurminen
Comparison: Type 7Fp-value: <0.00195% CI: [-1.1, 2.7]Miettinen and Nurminen
Comparison: Type 9Vp-value: <0.00195% CI: [-1.9, 4.6]Miettinen and Nurminen
Comparison: Type 14p-value: <0.00195% CI: [-0.2, 4.7]Miettinen and Nurminen
Comparison: Type 18Cp-value: <0.00195% CI: [-2.1, 4.7]Miettinen and Nurminen
Comparison: Type 19Ap-value: <0.00195% CI: [-1.9, 2.6]Miettinen and Nurminen
Comparison: Type 19Fp-value: <0.00195% CI: [-1, 1.9]Miettinen and Nurminen
Comparison: Type 23Fp-value: <0.00195% CI: [-2.9, 6.5]Miettinen and Nurminen
Comparison: Type 1p-value: <0.00195% CI: [-2, 3.9]Miettinen and Nurminen
Comparison: Type 3p-value: <0.00195% CI: [16.5, 28.3]Miettinen and Nurminen
Comparison: Type 4p-value: <0.00195% CI: [-1.4, 5.4]Miettinen and Nurminen
Comparison: Type 19Ap-value: <0.00195% CI: [-2.5, 2.2]Miettinen and Nurminen
Comparison: Type 19Fp-value: <0.00195% CI: [-2.9, 0.9]Miettinen and Nurminen
Comparison: Type 23Fp-value: <0.00195% CI: [-0.1, 8.7]Miettinen and Nurminen
Primary
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
Time frame: Up to 1 month post Vaccination 4 (up to 14 months)
Population: All participants that received at least 1 vaccination and had data available for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Lot 1 | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | 0.3 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | 0.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | 0.0 Percentage of Participants |
Comparison: Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.95% CI: [-0.8, 1.6]
Comparison: Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.95% CI: [-0.8, 1.6]
Primary
Percentage of Participants Who Experience at Least 1 Adverse Event
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.
Time frame: Up to 1 month post Vaccination 4 (up to 14 months)
Population: All participants that received at least 1 vaccination and had data available for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Lot 1 | Percentage of Participants Who Experience at Least 1 Adverse Event | 95.7 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants Who Experience at Least 1 Adverse Event | 97.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants Who Experience at Least 1 Adverse Event | 95.7 Percentage of Participants |
Comparison: Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.95% CI: [-3.1, 3.2]
Comparison: Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.95% CI: [-0.7, 5]
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.
Time frame: Up to 14 days post any vaccination
Population: All participants that received at least 1 vaccination and had data available for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event | 76.6 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event | 76.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | 70.3 Percentage of Participants |
95% CI: [-0.3, 12.8]
95% CI: [-0.2, 12.9]
Primary
Percentage of Participants With a Solicited Systemic Adverse Event
Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.
Time frame: Up to 14 days post any vaccination
Population: All participants that received at least 1 vaccination and had data available for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event | 90.3 Percentage of Participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event | 92.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | 89.6 Percentage of Participants |
p-value: 0.77295% CI: [-3.9, 5.2]Miettinen and Nurminen
p-value: 0.23595% CI: [-1.7, 7]Miettinen and Nurminen
Secondary
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Time frame: 1 month post vaccination 4 (Month 11-14)
Population: Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 3 | 1.12 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 18C | 2.75 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 6B | 7.38 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 1 | 1.75 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 14 | 7.29 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 7F | 4.25 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 23F | 2.52 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 9V | 2.43 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 4 | 1.66 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 33F | 5.02 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 19F | 5.29 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 5 | 3.43 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 22F | 8.60 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 19A | 5.80 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 6A | 4.97 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 23F | 3.12 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 1 | 2.00 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 3 | 1.16 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 4 | 1.53 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 5 | 3.24 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 6A | 4.60 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 6B | 5.74 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 7F | 4.47 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 9V | 2.71 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 14 | 7.01 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 18C | 3.15 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 19A | 5.35 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 19F | 4.94 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 33F | 4.39 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 22F | 7.54 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 23F | 3.38 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 18C | 2.94 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 5 | 4.72 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 1 | 2.47 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 19A | 6.53 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 4 | 1.88 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 33F | 0.06 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 19F | 5.47 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 7F | 6.29 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 3 | 0.78 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 9V | 3.53 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 6B | 6.91 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 22F | 0.06 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 14 | 8.28 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Type 6A | 6.94 µg/mL |
Comparison: Type 195% CI: [0.62, 0.81]
Comparison: Type 395% CI: [1.27, 1.63]
Comparison: Type 495% CI: [0.76, 1.02]
Comparison: Type 595% CI: [0.63, 0.84]
Comparison: Type 6A95% CI: [0.62, 0.82]
Comparison: Type 6B95% CI: [0.93, 1.22]
Comparison: Type 7F95% CI: [0.59, 0.77]
Comparison: Type 9V95% CI: [0.6, 0.79]
Comparison: Type 1495% CI: [0.76, 1.02]
Comparison: Type 18C95% CI: [0.81, 1.08]
Comparison: Type 19A95% CI: [0.78, 1.01]
Comparison: Type 19F95% CI: [0.85, 1.1]
Comparison: Type 23F95% CI: [0.64, 0.87]
Comparison: Type 22F95% CI: [130.23, 172.06]
Comparison: Type 33F95% CI: [79.93, 102.12]
Comparison: Type 195% CI: [0.71, 0.93]
Comparison: Type 395% CI: [1.31, 1.68]
Comparison: Type 495% CI: [0.7, 0.94]
Comparison: Type 595% CI: [0.6, 0.79]
Comparison: Type 6A95% CI: [0.58, 0.76]
Comparison: Type 6B95% CI: [0.72, 0.95]
Comparison: Type 7F95% CI: [0.62, 0.81]
Comparison: Type 9V95% CI: [0.67, 0.88]
Comparison: Type 1495% CI: [0.73, 0.98]
Comparison: Type 18C95% CI: [0.93, 1.24]
Comparison: Type 19A95% CI: [0.72, 0.93]
Comparison: Type 19F95% CI: [0.79, 1.03]
Comparison: Type 23F95% CI: [0.79, 1.08]
Comparison: Type 22F95% CI: [114.05, 151]
Comparison: Type 33F95% CI: [69.82, 89.36]
Secondary
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Time frame: Before Vaccination 4 (Month 10 to 13)
Population: Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 6B | 0.61 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 4 | 0.26 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 19A | 0.40 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 7F | 0.77 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 3 | 0.25 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 18C | 0.28 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 9V | 0.40 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 23F | 0.29 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 14 | 1.34 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 5 | 0.74 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 33F | 1.01 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 1 | 0.32 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 6A | 0.33 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 22F | 1.30 µg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 19F | 0.43 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 19F | 0.47 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 1 | 0.35 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 3 | 0.26 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 4 | 0.26 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 5 | 0.74 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 6A | 0.38 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 6B | 0.56 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 7F | 0.81 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 9V | 0.41 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 14 | 1.24 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 18C | 0.41 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 19A | 0.41 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 23F | 0.37 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 22F | 1.23 µg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 33F | 0.95 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 6B | 0.50 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 22F | 0.05 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 19A | 0.50 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 6A | 0.58 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 5 | 0.86 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 19F | 0.57 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 4 | 0.27 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 1 | 0.46 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 23F | 0.32 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 9V | 0.48 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 3 | 0.12 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 14 | 2.03 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 7F | 1.05 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 33F | 0.04 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Type 18C | 0.34 µg/mL |
Comparison: Type 195% CI: [0.62, 0.76]
Comparison: Type 395% CI: [1.75, 2.28]
Comparison: Type 495% CI: [0.86, 1.07]
Comparison: Type 595% CI: [0.78, 0.96]
Comparison: Type 6A95% CI: [0.5, 0.65]
Comparison: Type 6B95% CI: [1.06, 1.39]
Comparison: Type 7F95% CI: [0.67, 0.82]
Comparison: Type 9V95% CI: [0.74, 0.95]
Comparison: Type 1495% CI: [0.58, 0.76]
Comparison: Type 18C95% CI: [0.72, 0.9]
Comparison: Type 19A95% CI: [0.69, 0.91]
Comparison: Type 19F95% CI: [0.65, 0.85]
Comparison: Type 33F95% CI: [22.61, 28.92]
Comparison: Type 195% CI: [0.69, 0.85]
Comparison: Type 23F95% CI: [0.79, 1.07]
Comparison: type 22F95% CI: [24.64, 31.4]
Comparison: Type 395% CI: [1.84, 2.39]
Comparison: Type 495% CI: [0.85, 1.05]
Comparison: Type 595% CI: [0.77, 0.95]
Comparison: Type 6A95% CI: [0.57, 0.74]
Comparison: Type 6B95% CI: [0.97, 1.28]
Comparison: Type 7F95% CI: [0.7, 0.86]
Comparison: Type 9V95% CI: [0.76, 0.97]
Comparison: Type 1495% CI: [0.53, 0.7]
Comparison: Type 18C95% CI: [1.07, 1.34]
Comparison: Type 19A95% CI: [0.71, 0.94]
Comparison: Type 19F95% CI: [0.73, 0.94]
Comparison: Type 23F95% CI: [0.99, 1.35]
Comparison: Type 22F95% CI: [23.31, 29.68]
Comparison: Type 33F95% CI: [21.32, 27.25]