Pneumococcal Infections
Conditions
Brief summary
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
Interventions
BIOLOGICALV114
V114 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™
Prevnar 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
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of sickle cell disease in their medical record * Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply: 1\) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine * Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.
Exclusion criteria
* History of Invasive Pneumococcal Disease (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1) * Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine * Known or suspected impairment of immunological function * History of congenital or acquired immunodeficiency * Documented human immunodeficiency virus (HIV) infection * History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus) * Known coagulation disorder contraindicating intramuscular vaccination * History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1) * Received any PCV or pneumococcal polysaccharide vaccine \<3 years before Visit 1 (Day 1) * Five (5) years of age and has received \<3 doses of PCV * Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Note: hydroxyurea is permitted * Received immunoglobulin within 6 months before receipt of study vaccine * Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included * Recent history (within the last year) of more than 3 inpatient hospitalizations * At the time of signing informed consent/assent, is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator * History or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study in the opinion of the Investigator * Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event | Up to 14 days post-vaccination | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling. |
| Percentage of Participants With a Solicited Systemic Adverse Event | Up to 14 days post-vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts). |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | Up to 6 months post-vaccination | A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized. |
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Day 30 | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Day 1 (Baseline) and Day 30 | IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination). |
| GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Day 1 (Baseline) and Day 30 | Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination). |
| Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Day 30 | Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA). |
Countries
Brazil, Colombia, Dominican Republic, Greece, Italy, Panama, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 mL IM injection of V114 on Day 1. | 70 |
| Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1. | 34 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal By Parent/Guardian | 2 | 0 |
Baseline characteristics
| Characteristic | V114 | Total | Prevnar 13™ |
|---|---|---|---|
| Age, Continuous | 10.8 years STANDARD_DEVIATION 3.5 | 10.8 years STANDARD_DEVIATION 3.4 | 10.8 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 68 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 36 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 12 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 63 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 17 Participants | 4 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 | 10 Participants | 12 Participants | 2 Participants |
| Sex: Female, Male Female | 33 Participants | 47 Participants | 14 Participants |
| Sex: Female, Male Male | 37 Participants | 57 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 34 |
| other Total, other adverse events | 52 / 69 | 27 / 34 |
| serious Total, serious adverse events | 13 / 69 | 8 / 34 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 6A | 23.29 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 14 | 16.03 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 3 | 1.09 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 18C | 6.11 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 6B | 38.38 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 19A | 19.86 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 5 | 4.44 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 19F | 13.88 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 7F | 5.81 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 23F | 5.38 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 4 | 1.58 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 22F | 7.30 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 9V | 4.46 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 33F | 4.46 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 1 | 2.12 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 33F | 0.97 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 1 | 2.76 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 3 | 1.07 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 4 | 2.90 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 5 | 6.56 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 6A | 15.97 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 6B | 22.94 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 7F | 4.65 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 9V | 5.36 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 14 | 20.53 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 18C | 4.20 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 19A | 21.65 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 19F | 12.80 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 23F | 6.88 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 | Serotype 22F | 0.49 μg/mL |
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Time frame: Up to 14 days post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site erythema | 4.3 Percentage of participants | 95% Confidence Interval 0.9 |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site induration | 8.7 Percentage of participants | 95% Confidence Interval 3.3 |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site pain | 60.9 Percentage of participants | 95% Confidence Interval 48.4 |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site swelling | 27.5 Percentage of participants | 95% Confidence Interval 17.5 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site swelling | 35.3 Percentage of participants | 95% Confidence Interval 19.7 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site erythema | 5.9 Percentage of participants | 95% Confidence Interval 0.7 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site pain | 67.6 Percentage of participants | 95% Confidence Interval 49.5 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site induration | 8.8 Percentage of participants | 95% Confidence Interval 1.9 |
Primary
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Time frame: Up to 14 days post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Headache | 24.6 Percentage of participants | 95% Confidence Interval 15.1 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Fatigue | 13.0 Percentage of participants | 95% Confidence Interval 6.1 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Myalgia | 23.2 Percentage of participants | 95% Confidence Interval 13.9 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Urticaria | 0.0 Percentage of participants | 95% Confidence Interval 0 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Arthralgia | 2.9 Percentage of participants | 95% Confidence Interval 0.4 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Urticaria | 2.9 Percentage of participants | 95% Confidence Interval 0.1 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Arthralgia | 8.8 Percentage of participants | 95% Confidence Interval 1.9 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Fatigue | 20.6 Percentage of participants | 95% Confidence Interval 8.7 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Headache | 17.6 Percentage of participants | 95% Confidence Interval 6.8 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Myalgia | 11.8 Percentage of participants | 95% Confidence Interval 3.3 |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Time frame: Up to 6 months post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of participants | 95% Confidence Interval 0 |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Secondary
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Time frame: Day 1 (Baseline) and Day 30
Population: All randomized participants without protocol deviations that could have substantially impacted the results of these immunogenicity analyses and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 6A | 54.7 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 14 | 10.8 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 3 | 4.8 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 18C | 10.8 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 6B | 37.2 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 19A | 8.2 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 5 | 5.3 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 19F | 8.3 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 7F | 11.6 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 23F | 9.3 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 4 | 6.0 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 22F | 15.0 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 9V | 7.4 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 33F | 9.0 Ratio |
| V114 | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 1 | 6.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 33F | 1.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 1 | 6.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 3 | 4.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 4 | 9.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 5 | 6.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 6A | 40.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 6B | 25.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 7F | 9.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 9V | 8.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 14 | 7.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 18C | 7.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 19A | 8.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 19F | 7.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 23F | 13.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30 | Serotype 22F | 1.1 Ratio |
Secondary
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 6A | 27305.7 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 14 | 6597.6 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 3 | 264.8 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 18C | 9684.6 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 6B | 31560.4 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 19A | 14067.7 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 5 | 1383.9 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 19F | 4931.8 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 7F | 19411.5 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 23F | 17190.9 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 4 | 4670.8 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 22F | 7257.5 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 9V | 4561.8 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 33F | 24013.6 1/dil |
| V114 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 1 | 484.0 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 33F | 4824.8 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 1 | 504.0 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 3 | 234.3 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 4 | 7015.5 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 5 | 1198.2 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 6A | 20277.1 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 6B | 18531.0 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 7F | 16928.1 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 9V | 3941.7 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 14 | 8112.2 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 18C | 5685.1 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 19A | 9224.9 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 19F | 3313.3 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 23F | 19197.1 1/dil |
| Prevnar 13™ | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 | Serotype 22F | 1013.2 1/dil |
Secondary
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Time frame: Day 1 (Baseline) and Day 30
Population: All randomized participants without protocol deviations that could have substantially affected the results of these immunogenicity analyses and who had sufficient data to perform the analyses
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 6A | 20.7 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 14 | 6.9 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 3 | 4.9 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 18C | 14.0 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 6B | 21.7 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 19A | 9.0 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 5 | 23.7 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 19F | 6.4 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 7F | 5.4 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 23F | 10.4 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 4 | 10.2 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 22F | 6.5 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 9V | 4.4 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 33F | 3.8 Ratio |
| V114 | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 1 | 24.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 33F | 0.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 1 | 13.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 3 | 3.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 4 | 18.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 5 | 13.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 6A | 11.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 6B | 13.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 7F | 5.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 9V | 6.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 14 | 4.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 18C | 4.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 19A | 7.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 19F | 6.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 23F | 18.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30 | Serotype 22F | 0.9 Ratio |