Pneumococcal Infections
Conditions
Keywords
Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F
Brief summary
This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There are no formal hypotheses.
Interventions
BIOLOGICALV114
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.
BIOLOGICALPrevnar 13™
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose.
BIOLOGICALPNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV ribonucleic acid (RNA) \<50,000 copies/mL * Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a \<13-valent PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™ vaccination ≥3 years before Visit 2 (Day 1) * Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before Visit 2 (Day 1) * Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last dose of the study vaccine.
Exclusion criteria
* History of World Health Organization (WHO) HIV classification of clinical Stage 4 disease within the past 12 months * History of invasive pneumococcal disease * Known hypersensitivity to any vaccine component * Known or suspected congenital immunodeficiency (other than HIV infection), functional or anatomic asplenia, or history of autoimmune disease * Bleeding disorder contraindicating intramuscular vaccinations * History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * Female participant: positive urine or serum pregnancy test * Expect to receive any pneumococcal vaccine during the study outside of the protocol * Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Received a blood transfusion or blood products within 6 months of enrollment * Participated in another clinical study of an investigational product within 2 months of enrollment * Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Through 14 Days after Vaccination 1 (Up to Day 14) | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling. |
| Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Through 14 Days after Vaccination 1 (Up to Day 14) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study | Through 6 Months after Vaccination 1 (Up to Day 194) | An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported. |
| Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Day 30 | The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Through 14 Days after Vaccination 2 (Up to Day 84) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling. |
| Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Week 12 | The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. |
| Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Through 14 Days after Vaccination 2 (Up to Day 84) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. |
| Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Day 30 | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. |
| Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Week 12 | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. |
Countries
South Africa, Thailand, Ukraine
Participant flow
Pre-assignment details
407 participants were randomized in a 1:1 ratio to receive either V114 or Prevnar 13™ on Day 1 and PNEUMOVAX™23 at Week 8.
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2). | 203 |
| Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2). | 204 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal By Parent/Guardian | 0 | 2 |
Baseline characteristics
| Characteristic | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Age, Continuous | 12.7 years STANDARD_DEVIATION 2.7 | 12.6 years STANDARD_DEVIATION 3 | 12.7 years STANDARD_DEVIATION 2.9 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 143 Participants | 142 Participants | 285 Participants |
| Age, Customized Adults (18-64 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 60 Participants | 62 Participants | 122 Participants |
| Age, Customized From 65-84 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 201 Participants | 203 Participants | 404 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 62 Participants | 66 Participants | 128 Participants |
| Race (NIH/OMB) Black or African American | 88 Participants | 78 Participants | 166 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 40 Participants | 49 Participants | 89 Participants |
| Sex: Female, Male Female | 96 Participants | 99 Participants | 195 Participants |
| Sex: Female, Male Male | 107 Participants | 105 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 204 | 0 / 203 | 0 / 202 |
| other Total, other adverse events | 158 / 203 | 138 / 204 | 152 / 203 | 154 / 202 |
| serious Total, serious adverse events | 1 / 203 | 1 / 204 | 2 / 203 | 2 / 202 |
Outcome results
Primary
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Time frame: Day 30
Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 23F (Shared) | 6.71 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 1 (Shared) | 2.17 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 3 (Shared) | 1.05 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 4 (Shared) | 2.59 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 5 (Shared) | 2.94 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6A (Shared) | 7.98 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6B (Shared) | 11.44 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 7F (Shared) | 4.84 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 9V (Shared) | 4.15 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 14 (Shared) | 20.38 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 18C (Shared) | 5.18 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19A (Shared) | 14.20 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19F (Shared) | 9.76 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 22F (Unique to V114) | 9.28 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 33F (Unique to V114) | 4.53 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 22F (Unique to V114) | 0.24 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 9V (Shared) | 4.78 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 1 (Shared) | 3.26 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19F (Shared) | 8.61 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 3 (Shared) | 0.84 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 14 (Shared) | 18.29 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 4 (Shared) | 4.27 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 23F (Shared) | 6.35 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 5 (Shared) | 2.78 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 18C (Shared) | 5.15 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6A (Shared) | 7.56 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 33F (Unique to V114) | 0.29 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6B (Shared) | 6.92 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19A (Shared) | 14.78 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 7F (Shared) | 5.00 μg/mL |
Primary
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Time frame: Through 14 Days after Vaccination 1 (Up to Day 14)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site redness/erythema | 9.4 Percentage of Participants | 95% Confidence Interval 5.7 |
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site hard lump/induration | 10.3 Percentage of Participants | 95% Confidence Interval 6.5 |
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site tenderness/pain | 55.2 Percentage of Participants | 95% Confidence Interval 48.1 |
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site swelling | 28.6 Percentage of Participants | 95% Confidence Interval 22.5 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site swelling | 21.6 Percentage of Participants | 95% Confidence Interval 16.1 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site redness/erythema | 5.9 Percentage of Participants | 95% Confidence Interval 3.1 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site tenderness/pain | 53.9 Percentage of Participants | 95% Confidence Interval 46.8 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ | Injection site hard lump/induration | 6.4 Percentage of Participants | 95% Confidence Interval 3.4 |
Primary
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Time frame: Through 14 Days after Vaccination 1 (Up to Day 14)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Tiredness/fatigue | 7.9 Percentage of Participants | 95% Confidence Interval 4.6 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Muscle pain/myalgia | 34.0 Percentage of Participants | 95% Confidence Interval 27.5 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Headache | 14.8 Percentage of Participants | 95% Confidence Interval 10.2 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Hives or welts/urticaria | 0.5 Percentage of Participants | 95% Confidence Interval 0 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Joint pain/arthralgia | 9.4 Percentage of Participants | 95% Confidence Interval 5.7 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Hives or welts/urticaria | 1.5 Percentage of Participants | 95% Confidence Interval 0.3 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Joint pain/arthralgia | 10.3 Percentage of Participants | 95% Confidence Interval 6.5 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Tiredness/fatigue | 8.3 Percentage of Participants | 95% Confidence Interval 4.9 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Headache | 10.8 Percentage of Participants | 95% Confidence Interval 6.9 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ | Muscle pain/myalgia | 25.5 Percentage of Participants | 95% Confidence Interval 19.7 |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported.
Time frame: Through 6 Months after Vaccination 1 (Up to Day 194)
Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not analyzed for Vaccination 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study | Vaccination 1 | 0.0 Percentage of Participants |
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study | Vaccination 2 | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study | Vaccination 1 | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study | Vaccination 2 | 0.0 Percentage of Participants |
Secondary
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Time frame: Week 12
Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6A (Shared) | 4.67 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 14 (Shared) | 18.88 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 3 (Shared) | 1.10 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 18C (Shared) | 3.75 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6B (Shared) | 7.12 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19A (Shared) | 11.23 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 5 (Shared) | 3.01 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19F (Shared) | 8.56 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 7F (Shared) | 4.10 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 23F (Shared) | 4.40 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 4 (Shared) | 2.36 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 22F (Unique to V114) | 8.18 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 9V (Shared) | 3.69 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 33F (Unique to V114) | 3.76 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 1 (Shared) | 2.58 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 33F (Unique to V114) | 6.18 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 1 (Shared) | 3.33 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 3 (Shared) | 1.08 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 4 (Shared) | 3.61 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 5 (Shared) | 3.24 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6A (Shared) | 4.91 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6B (Shared) | 4.96 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 7F (Shared) | 4.27 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 9V (Shared) | 4.52 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 14 (Shared) | 19.89 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 18C (Shared) | 4.11 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19A (Shared) | 12.19 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19F (Shared) | 7.98 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 23F (Shared) | 4.83 μg/mL |
| Prevnar 13™ | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 22F (Unique to V114) | 10.32 μg/mL |
Secondary
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Time frame: Week 12
Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6A (Shared) | 10208.7 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 14 (Shared) | 17207.5 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 3 (Shared) | 327.2 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 18C (Shared) | 3635.1 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6B (Shared) | 13774.8 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19A (Shared) | 7613.7 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 5 (Shared) | 985.6 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19F (Shared) | 3694.8 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 7F (Shared) | 17415.9 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 23F (Shared) | 10216.7 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 4 (Shared) | 5445.7 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 22F (Unique to V114) | 8756.1 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 9V (Shared) | 5135.9 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 33F (Unique to V114) | 34173.6 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 1 (Shared) | 326.4 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 33F (Unique to V114) | 30651.0 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 1 (Shared) | 337.0 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 3 (Shared) | 384.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 4 (Shared) | 7526.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 5 (Shared) | 939.5 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6A (Shared) | 10699.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 6B (Shared) | 12745.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 7F (Shared) | 19140.5 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 9V (Shared) | 6152.2 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 14 (Shared) | 16461.2 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 18C (Shared) | 3369.0 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19A (Shared) | 8838.0 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 19F (Shared) | 3904.4 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 23F (Shared) | 10086.0 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | Serotype 22F (Unique to V114) | 6958.0 Titers (1/dil) |
Secondary
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Time frame: Day 30
Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6A (Shared) | 14274.6 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 14 (Shared) | 18444.3 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 3 (Shared) | 330.0 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 18C (Shared) | 4556.2 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6B (Shared) | 17636.5 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19A (Shared) | 8176.4 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 5 (Shared) | 847.6 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19F (Shared) | 3711.8 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 7F (Shared) | 17574.4 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 23F (Shared) | 11693.1 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 4 (Shared) | 6078.3 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 22F (Unique to V114) | 10791.3 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 9V (Shared) | 4800.0 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 33F (Unique to V114) | 36357.0 Titers (1/dil) |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 1 (Shared) | 353.4 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 33F (Unique to V114) | 5520.6 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 1 (Shared) | 398.3 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 3 (Shared) | 301.5 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 4 (Shared) | 9172.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 5 (Shared) | 642.1 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6A (Shared) | 11915.4 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 6B (Shared) | 15052.9 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 7F (Shared) | 18519.3 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 9V (Shared) | 5879.7 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 14 (Shared) | 17920.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 18C (Shared) | 3543.0 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19A (Shared) | 8690.2 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 19F (Shared) | 3277.6 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 23F (Shared) | 11933.8 Titers (1/dil) |
| Prevnar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | Serotype 22F (Unique to V114) | 503.1 Titers (1/dil) |
Secondary
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Time frame: Through 14 Days after Vaccination 2 (Up to Day 84)
Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site redness/erythema | 10.3 Percentage of Participants | 95% Confidence Interval 6.5 |
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site hard lump/induration | 18.2 Percentage of Participants | 95% Confidence Interval 13.2 |
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site tenderness/pain | 51.7 Percentage of Participants | 95% Confidence Interval 44.6 |
| V114 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site swelling | 47.3 Percentage of Participants | 95% Confidence Interval 40.3 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site swelling | 34.7 Percentage of Participants | 95% Confidence Interval 28.1 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site redness/erythema | 12.4 Percentage of Participants | 95% Confidence Interval 8.2 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site tenderness/pain | 55.0 Percentage of Participants | 95% Confidence Interval 47.8 |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site hard lump/induration | 13.4 Percentage of Participants | 95% Confidence Interval 9 |
Secondary
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Time frame: Through 14 Days after Vaccination 2 (Up to Day 84)
Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Tiredness/fatigue | 12.3 Percentage of Participants | 95% Confidence Interval 8.1 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Muscle pain/myalgia | 43.3 Percentage of Participants | 95% Confidence Interval 36.4 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Headache | 10.3 Percentage of Participants | 95% Confidence Interval 6.5 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Hives or welts/urticaria | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Joint pain/arthralgia | 12.8 Percentage of Participants | 95% Confidence Interval 8.5 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Hives or welts/urticaria | 0.5 Percentage of Participants | 95% Confidence Interval 0 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Joint pain/arthralgia | 8.4 Percentage of Participants | 95% Confidence Interval 5 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Tiredness/fatigue | 11.4 Percentage of Participants | 95% Confidence Interval 7.4 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Headache | 9.4 Percentage of Participants | 95% Confidence Interval 5.8 |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Muscle pain/myalgia | 39.1 Percentage of Participants | 95% Confidence Interval 32.3 |