Pneumococcal Disease
Conditions
Brief summary
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.
Interventions
BIOLOGICALV116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICALPlacebo
Saline in each 0.5 mL sterile solution
BIOLOGICALPCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
BIOLOGICALPPSV23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
BIOLOGICALPCV15 - Part B
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is infected with HIV * Is receiving combination anti-retroviral therapy (ART) for ≥6 weeks before study entry with no intended changes to combination ART therapy for 3 months after randomization. * Is vaccine-naïve
Exclusion criteria
* Has a history of opportunistic infections ≤12 months before the first vaccination * Has a history of noninfectious acquired immune deficiency syndrome-related illness * Has a history of active hepatitis * Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 2 (Day 1) * Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid * Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease * Has a coagulation disorder contraindicating intramuscular vaccinations. * Has a recent illness with fever * Has a known cancer malignancy that is progressing or has required active treatment \<3 years before enrollment * Had prior administration of PCV15 or PCV20. * Is expected to receive any pneumococcal vaccine during the study outside of the protocol * Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine * Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine * Has received any live virus vaccine ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine * Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Up to 5 days after each vaccination in Part A | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. |
| Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Up to 5 days after each vaccination in Part A | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. |
| Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A | Up to 194 days in Part A | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Up to 114 days | Serotype-specific OPA to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Up to 114 days | The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. |
| Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) | Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23. |
| Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) | The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23 |
| Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) | Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23 |
| Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23) | The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23 |
| Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Up to 5 days after vaccination in Part B | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B. |
| Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Up to 5 days after vaccination in Part B | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B |
| Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B | Up to 44 days after vaccination in Part B | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B |
Countries
Belgium, Chile, France, South Africa, Thailand, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Pre-assignment details
This study is conducted in two parts. Part A evaluated V116 and the comparator regimen of PCV15 followed by PPSV23. Part B evaluated PCV15 in participants who received V116 in Part A.
Participants by arm
| Arm | Count |
|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116. | 156 |
| PCV15 + PPSV23 (Part A) Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study. | 157 |
| Total | 313 |
Baseline characteristics
| Characteristic | PCV15 + PPSV23 (Part A) | Total | V116 + Placebo (Part A), PCV15 (Part B) |
|---|---|---|---|
| Age, Continuous | 46.7 Years STANDARD_DEVIATION 12.3 | 45.3 Years STANDARD_DEVIATION 12.5 | 44.0 Years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 76 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 112 Participants | 236 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 33 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 125 Participants | 62 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 79 Participants | 149 Participants | 70 Participants |
| Sex: Female, Male Female | 50 Participants | 92 Participants | 42 Participants |
| Sex: Female, Male Male | 107 Participants | 221 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 156 | 0 / 157 | 0 / 126 |
| other Total, other adverse events | 96 / 155 | 136 / 155 | 82 / 126 |
| serious Total, serious adverse events | 4 / 155 | 6 / 155 | 1 / 126 |
Outcome results
Primary
Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Time frame: Up to 5 days after each vaccination in Part A
Population: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Injection site erythema | 3.9 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Injection site pain | 50.3 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Injection site swelling | 7.1 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Injection site erythema | 11.0 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Injection site pain | 82.6 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A | Injection site swelling | 20.6 Percentage of Participants |
Primary
Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Time frame: Up to 5 days after each vaccination in Part A
Population: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Fatigue | 30.3 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Headache | 21.9 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Myalgia | 12.3 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Pyrexia | 1.9 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Pyrexia | 3.2 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Fatigue | 34.2 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Myalgia | 15.5 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A | Headache | 19.4 Percentage of Participants |
Primary
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed.
Time frame: Up to 194 days in Part A
Population: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A | 0.0 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A | 0.0 Percentage of Participants |
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype-specific OPA to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Time frame: Up to 114 days
Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 170.7 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 3896.0 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 3482.3 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 1847.5 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 5763.0 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 3693.0 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 3742.5 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 2585.4 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 8698.6 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 2178.9 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 7249.1 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 3622.4 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 14642.5 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 5859.0 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 5613.0 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 6703.0 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 5053.5 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 1593.8 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24B (Unique to V116) | 3725.6 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 5699.4 Titers |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 11306.2 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 5753.3 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 172.0 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24B (Unique to V116) | 567.9 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 3979.5 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 3979.8 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 3275.6 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 1674.9 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 2262.9 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 11864.5 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 5970.0 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 2977.7 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 3652.8 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 1970.5 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 1722.3 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 151.0 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 2292.4 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 2438.0 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 5886.3 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 530.8 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 2667.0 Titers |
| PCV15 + PPSV23 (Part A) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 1839.0 Titers |
Secondary
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23
Time frame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 42.3 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 70.8 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 70.1 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 66.4 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 75.2 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 76.6 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 66.4 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 67.9 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 83.9 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 43.8 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 67.2 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 76.6 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 67.9 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 83.9 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 82.5 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 73.7 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 82.5 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 72.3 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 70.1 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 83.2 Percentage of participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 75.9 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 57.1 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 50.4 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 0.0 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 68.2 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 78.9 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 57.9 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 29.3 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 73.7 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 63.2 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 67.7 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 0.8 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 68.4 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 21.8 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 54.1 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 37.6 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 60.2 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 61.7 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 73.7 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 6.8 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 58.6 Percentage of participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 9.0 Percentage of participants |
Secondary
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23
Time frame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 58.7 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 73.8 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 69.0 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 66.9 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 56.3 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 62.2 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 53.6 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 92.2 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 77.1 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 49.2 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 59.2 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 76.0 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 61.9 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 59.3 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 53.6 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 57.9 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 87.0 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 53.8 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 73.7 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 55.6 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 80.4 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 49.2 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 61.9 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 16.5 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 80.2 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 71.7 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 59.2 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 50.0 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 70.1 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 58.8 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 57.7 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 71.0 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 60.5 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 21.1 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 43.6 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 7.2 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 83.3 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 16.8 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 64.7 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 5.6 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 55.9 Percentage of Participants |
| PCV15 + PPSV23 (Part A) | Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 32.5 Percentage of Participants |
Secondary
Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B.
Time frame: Up to 5 days after vaccination in Part B
Population: All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Injection site erythema | 3.2 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Injection site pain | 61.9 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Injection site swelling | 6.3 Percentage of Participants |
Secondary
Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B
Time frame: Up to 5 days after vaccination in Part B
Population: All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Fatigue | 22.2 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Headache | 14.3 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Myalgia | 11.1 Percentage of Participants |
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B | Pyrexia | 0.8 Percentage of Participants |
Secondary
Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
Time frame: Up to 44 days after vaccination in Part B
Population: All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B | 0.0 Percentage of Participants |
Secondary
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23
Time frame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 3.7 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 11.4 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 9.1 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 8.1 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 10.4 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 12.2 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 6.6 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 9.7 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 13.8 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 3.8 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 7.3 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 13.7 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 8.1 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (unique to V116) | 16.1 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (unique to V116) | 16.6 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (unique to V116) | 8.8 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (unique to V116) | 15.8 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (unique to V116) | 10.0 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (unique to V116) | 10.9 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (unique to V116) | 11.6 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (unique to V116) | 11.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 5.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 4.0 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (unique to V116) | 1.0 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 9.2 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 10.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 5.7 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (unique to V116) | 2.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 10.0 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 5.9 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 7.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (unique to V116) | 1.1 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 8.2 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (unique to V116) | 2.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 4.5 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (unique to V116) | 3.6 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 6.7 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (unique to V116) | 6.1 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 7.5 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (unique to V116) | 1.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 4.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (unique to V116) | 1.4 Ratio |
Secondary
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Time frame: Up to 114 days
Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 0.50 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 3.79 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 2.95 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 7.05 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 5.02 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 7.15 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 4.40 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 1.10 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 10.34 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 5.96 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 7.08 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 3.70 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 7.55 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 5.67 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 6.92 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 1.55 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23F (Unique to V116) | 2.54 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 3.27 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 1.80 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 2.20 μg/mL |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 10.26 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 4.94 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 0.58 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 0.17 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 2.80 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F (Shared) | 2.99 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 1.81 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23F (Unique to V116) | 0.41 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 8.10 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 5.56 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 3.36 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 0.90 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 3.73 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 1.02 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 2.64 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 0.99 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 0.71 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 2.68 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 4.43 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 0.25 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 5.99 μg/mL |
| PCV15 + PPSV23 (Part A) | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 0.21 μg/mL |
Secondary
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23.
Time frame: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 5.5 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 14.3 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 12.3 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 11.9 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 6.7 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 9.4 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 9.2 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 57.3 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 15.1 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 5.0 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 7.1 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F(Shared) | 19.2 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 7.5 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 5.7 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 27.8 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 6.3 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 9.0 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 52.0 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 5.8 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 19.9 Ratio |
| V116 + Placebo (Part A), PCV15 (Part B) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 5.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 20A (Shared) | 4.7 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 3 (Shared) | 5.3 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 24F (Unique to V116) | 1.0 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 6A (Shared) | 15.3 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 22F(Shared) | 19.3 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 7F (Shared) | 7.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23A (Unique to V116) | 2.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 8 (Shared) | 15.0 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 33F (Shared) | 6.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 9N (Shared) | 5.9 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 35B (Unique to V116) | 1.3 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 10A (Shared) | 7.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15A (Unique to V116) | 1.4 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 11A (Shared) | 3.8 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 23B (Unique to V116) | 7.2 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 12F (Shared) | 46.7 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 15C (Unique to V116) | 16.3 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 17F (Shared) | 8.5 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 31 (Unique to V116) | 1.5 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 19A (Shared) | 5.6 Ratio |
| PCV15 + PPSV23 (Part A) | Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116 | Serotype 16F (Unique to V116) | 1.7 Ratio |