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Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults

A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05266456
Enrollment
835
Registered
2022-03-04
Start date
2022-02-22
Completion date
2023-01-10
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Vaccines

Brief summary

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

Detailed description

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to PCV20 in adults aged 50 to 64 years of age.

Interventions

BIOLOGICAL24 valent pneumococcal conjugate vaccine

0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1

0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Sponsors

Vaxcyte, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Triple (Participant, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female age 18 to 49 years (inclusive) for the Phase 1 group, or 50 to 64 years (inclusive) for the Phase 2 group at the time of enrollment into the study. * Able and willing to complete the informed consent process. * Available for clinical follow-up through the last study visit at 6 months after the study vaccination. * In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the investigator. * Screening laboratory values must be within the central laboratory normal limits prior to study enrollment. Minor abnormalities are considered acceptable if not clinically significant. * Willing to have blood samples collected, stored indefinitely, and used for research purposes. * Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process. * Negative pregnancy test (urine and serum) for women of childbearing potential.

Exclusion criteria

* Previous pneumococcal disease (either confirmed or by self-reporting). * Previous receipt of a licensed or investigational pneumococcal vaccine. * Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study. * Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Day 29. * Physical examination indicating any clinically significant medical condition. * Body Temperature \> 38.0°C (\> 100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled). * Seropositive to HIV, HCV, or HBsAg. * History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. * Female who is breast-feeding or planning to become pregnant during study participation. * Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. * Any other chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine. * Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent. * Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study. * Received systemic corticosteroids for ≥ 14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study. * Receiving immunosuppressive therapy. * History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group7 days after vaccinationSolicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group7 days after vaccinationSolicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain
Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group1 month after vaccinationPercentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)6 months after vaccinationPercentage of participants with SAEs and NOCIs

Secondary

MeasureTime frameDescription
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)1 month after vaccinationAntibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)1 month after vaccinationAntibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values1 month after vaccinationShifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in \>5% of Subjects Aged 50 to 64 Years

Countries

United States

Participant flow

Recruitment details

First subject was enrolled 22-Feb-2022 and last subject randomized/vaccinated was 01-Jul-22. Study sites were medical clinics.

Pre-assignment details

In Phase 1, 95 participants were screened; 21 did not meet inclusion/exclusion criteria, 4 withdrew consent, and 6 discontinued for other reason. Five of Phase 1 screen failures were rescreened and enrolled in Phase 2. An additional 1001 participants were screened (for a total of 1006); of these, 235 failed screening: 173 did not meet inclusion/exclusion criteria, 12 withdrew consent, and 50 failed for other reasons.

Participants by arm

ArmCount
VAX-24 Low Dose 18-49 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
16
VAX-24 Mid Dose 18-49 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
16
VAX-24 Mixed Dose 18-49 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
16
PCV20 18-49 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
16
VAX-24 Low Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
193
VAX-24 Mid Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
192
VAX-24 Mixed Dose 50-64 Yrs
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
192
PCV20 50-64 Yrs
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
194
Total835

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Phase 1, Adults 18-49 Years of AgeLost to Follow-up1100
Phase 1, Adults 18-49 Years of AgeWithdrawal by Subject0001
Phase 2, Adults 50-64 YearsLost to Follow-up6631
Phase 2, Adults 50-64 YearsUnavailable for follow up1001
Phase 2, Adults 50-64 YearsWithdrawal by Subject0020

Baseline characteristics

CharacteristicVAX-24 Low Dose 18-49 YrsVAX-24 Mid Dose 18-49 YrsVAX-24 Mixed Dose 18-49 YrsPCV20 18-49 YrsVAX-24 Low Dose 50-64 YrsVAX-24 Mid Dose 50-64 YrsVAX-24 Mixed Dose 50-64 YrsPCV20 50-64 YrsTotal
Age, Continuous39.5 Years34.0 Years39.0 Years37.0 Years57.0 Years57.0 Years57.0 Years57.0 Years57.0 Years
Body Mass Index (kg/m^2) Median, Q1 - Q326.99 kg/m^231.09 kg/m^229.16 kg/m^226.91 kg/m^229.87 kg/m^230.65 kg/m^229.34 kg/m^229.06 kg/m^229.49 kg/m^2
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants5 Participants2 Participants3 Participants22 Participants18 Participants22 Participants17 Participants93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants10 Participants14 Participants13 Participants171 Participants172 Participants168 Participants177 Participants737 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants0 Participants2 Participants2 Participants0 Participants5 Participants
Height (cm)176.1 cm170.1 cm167.1 cm170.8 cm168.3 cm167.6 cm167.6 cm167.6 cm167.6 cm
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants2 Participants3 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants2 Participants1 Participants0 Participants2 Participants3 Participants8 Participants
Race (NIH/OMB)
Black or African American
5 Participants7 Participants4 Participants10 Participants40 Participants32 Participants29 Participants29 Participants156 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants0 Participants2 Participants1 Participants4 Participants3 Participants11 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants3 Participants2 Participants1 Participants3 Participants10 Participants
Race (NIH/OMB)
White
10 Participants8 Participants12 Participants4 Participants145 Participants157 Participants156 Participants154 Participants646 Participants
Region of Enrollment
United States
16 participants16 participants16 participants16 participants193 participants192 participants192 participants194 participants835 participants
Sex: Female, Male
Female
7 Participants7 Participants8 Participants8 Participants110 Participants121 Participants134 Participants127 Participants522 Participants
Sex: Female, Male
Male
9 Participants9 Participants8 Participants8 Participants83 Participants71 Participants58 Participants67 Participants313 Participants
Weight (kg)80.85 kg92.10 kg90.50 kg78.07 kg87.82 kg86.72 kg83.10 kg82.83 kg84.81 kg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 160 / 160 / 160 / 1930 / 1910 / 1910 / 1960 / 2090 / 2070 / 2070 / 212
other
Total, other adverse events
9 / 1613 / 1614 / 1616 / 16161 / 193155 / 191164 / 191163 / 196170 / 209168 / 207178 / 207179 / 212
serious
Total, serious adverse events
0 / 160 / 160 / 160 / 162 / 1933 / 1911 / 1914 / 1962 / 2093 / 2071 / 2074 / 212

Outcome results

Primary

Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)

Percentage of participants with SAEs and NOCIs

Time frame: 6 months after vaccination

Population: Safety population, including all subjects in the exposed population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

ArmMeasureGroupValue (NUMBER)
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE0 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI0 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI0 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE0 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI0 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE0 percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE0 percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI0 percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE1.0 percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI1.6 percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI1.6 percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE1.6 percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE0.5 percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI3.1 percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI2.6 percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE2.0 percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI1.4 percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE1.0 percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI1.4 percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE1.4 percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE0.5 percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI2.9 percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one SAE1.9 percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)Subjects with at least one NOCI2.4 percentage of participants
Primary

Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group

Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group

Time frame: 7 days after vaccination

Population: Safety population, defined as all patients exposed to study vaccine. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

ArmMeasureGroupValue (NUMBER)
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade6.3 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade56.3 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade18.8 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade56.3 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade75.0 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade81.3 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade6.3 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade12.5 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade81.3 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade81.3 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade18.8 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade25.0 percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade93.8 percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade18.8 percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade81.3 percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade25.0 percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade71.0 percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade8.8 percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade6.7 percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade73.6 percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade71.7 percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade71.2 percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade7.9 percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade7.9 percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade8.9 percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade77.5 percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade77.0 percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade7.9 percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade69.9 percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade71.9 percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade10.7 percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade8.7 percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade6.7 percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade9.6 percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade69.9 percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade72.2 percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade72.5 percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade7.7 percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade71.5 percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade8.2 percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade77.3 percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade9.7 percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade77.8 percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade9.2 percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupAny solicited local AE; Overall, Any Grade73.6 percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupErythema (redness) at injection site; Overall, Any Grade9.9 percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupPain at injection site; Overall, Any Grade70.8 percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age GroupEdema (swelling) at injection site; Overall, Any Grade11.3 percentage of participants
Primary

Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group

Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain

Time frame: 7 days after vaccination

Population: Safety population, which included all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

ArmMeasureGroupValue (NUMBER)
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache31.3 Percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event50.0 Percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain25.0 Percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain37.5 Percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)6.3 Percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue37.5 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain12.5 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain37.5 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event62.5 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue31.3 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)6.3 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache37.5 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue37.5 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain18.8 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)0.0 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event56.3 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain12.5 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache25.0 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event75.0 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain43.8 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)12.5 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain56.3 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue50.0 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache37.5 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)1.0 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain24.9 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event69.4 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue42.5 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain57.0 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache30.6 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain56.0 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event69.6 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)0.5 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue40.8 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache28.8 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain16.2 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event71.2 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)2.1 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain60.2 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache30.4 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue40.8 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain27.7 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain53.1 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue39.8 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain24.0 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)1.0 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache30.1 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event64.8 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event67.9 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain55.5 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain24.9 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache30.6 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue42.1 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)1.4 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue40.1 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache29.5 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)1.0 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain54.6 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event69.1 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain15.9 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event70.0 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue40.6 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)1.9 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache30.0 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain26.6 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain57.0 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFatigue40.6 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupMuscle Pain53.3 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupAny solicited systemic adverse event65.6 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupFever (oral temperature >= 100.4ºF)1.9 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupHeadache30.7 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age GroupJoint Pain25.5 Percentage of participants
Primary

Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group

Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.

Time frame: 1 month after vaccination

Population: Safety population, including all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

ArmMeasureValue (NUMBER)
VAX-24 Low Dose 18-49 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group12.5 Percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group12.5 Percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group6.3 Percentage of participants
PCV20 18-49 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group6.3 Percentage of participants
VAX-24 Low Dose 50-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group15.5 Percentage of participants
VAX-24 Mid Dose 50-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group11.5 Percentage of participants
VAX-24 Mixed Dose 50-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group13.1 Percentage of participants
PCV20 50-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group16.8 Percentage of participants
VAX24 Low Dose 18-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group15.3 Percentage of participants
VAX-24 Mid Dose 18-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group11.6 Percentage of participants
VAX-24 Mixed Dose 18-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group12.6 Percentage of participants
PCV20 18-64 YrsPercentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group16.0 Percentage of participants
Secondary

Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values

Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in \>5% of Subjects Aged 50 to 64 Years

Time frame: 1 month after vaccination

Population: Prespecified analysis population included all subjects age 50-64 in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.

ArmMeasureGroupValue (NUMBER)
VAX-24 Low Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesGlucose: High7.2 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCholesterol: High7.2 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesUric Acid: High8.1 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesTriglycerides: High9.1 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCreatinine: High11.5 percentage of participants
VAX-24 Low Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesBicarbonate: Low14.4 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCholesterol: High7.7 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesBicarbonate: Low18.4 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesTriglycerides: High8.2 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesGlucose: High3.9 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCreatinine: High11.1 percentage of participants
VAX-24 Mid Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesUric Acid: High7.2 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesBicarbonate: Low15.0 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCholesterol: High8.7 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesGlucose: High5.3 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCreatinine: High10.6 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesUric Acid: High2.9 percentage of participants
VAX-24 Mixed Dose 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesTriglycerides: High9.7 percentage of participants
PCV20 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesUric Acid: High5.7 percentage of participants
PCV20 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesBicarbonate: Low11.8 percentage of participants
PCV20 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCholesterol: High8.5 percentage of participants
PCV20 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesTriglycerides: High10.8 percentage of participants
PCV20 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesCreatinine: High8.5 percentage of participants
PCV20 18-49 YrsPercentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory ValuesGlucose: High7.1 percentage of participants
Secondary

VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)

Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24

Time frame: 1 month after vaccination

Population: Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)20B19.53 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)10A6.73 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9V3.93 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6B2.83 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)213.31 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9N7.98 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)88.94 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)7F4.97 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)22F4.13 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19F4.98 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19A7.35 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)30.41 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)12.85 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)18C6.66 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)17F9.57 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)41.79 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)33F12.20 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)15B10.67 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)148.62 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)52.13 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)23F4.60 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)12F1.73 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)11A5.62 mcg/mL
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6A3.92 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)1410.47 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)14.65 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)216.37 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)30.53 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)42.52 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)52.42 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6A4.66 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6B3.78 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)7F6.29 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)88.79 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9N10.78 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9V5.12 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)10A7.90 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)11A5.76 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)12F2.13 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)15B14.09 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)17F10.51 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)18C8.50 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19A9.21 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19F8.92 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)20B24.90 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)22F5.45 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)23F5.90 mcg/mL
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)33F17.58 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)33F11.82 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)18C10.35 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)20B19.40 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)1410.47 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)23F5.27 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19A11.50 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)51.78 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)218.73 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)41.83 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)7F8.82 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)22F3.81 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)15B11.59 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19F9.96 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)88.94 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)12F1.91 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6B4.43 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)11A4.87 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9N7.91 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)14.01 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)17F9.89 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)10A6.58 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9V7.15 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)30.79 mcg/mL
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6A4.38 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19A8.84 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)10A9.38 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)53.70 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)33F9.73 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)11A3.72 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)12F1.15 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)42.02 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)148.17 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)22F7.32 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)15B14.81 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)30.48 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)17F0.46 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)18C6.67 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)21.02 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)20B4.06 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)23F5.18 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)7F4.74 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6B2.44 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)87.30 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)19F4.34 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9N2.52 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)6A4.62 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)14.39 mcg/mL
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)9V2.94 mcg/mL
Secondary

VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)

Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24

Time frame: 1 month after vaccination

Population: Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)20B8205.88 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6B3506.32 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)5491.01 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)41229.24 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)10A4156.84 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)7F3318.45 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)1190.08 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9V2596.46 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6A3252.03 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)82344.26 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)22F6243.38 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9N8217.87 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)3319.33 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19F1928.24 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)15B2384.28 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)18C2735.58 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)23F1000.62 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)17F2317.55 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)143398.89 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19A4351.67 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)33F11672.18 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)21371.45 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)12F1550.61 Titer
VAX-24 Low Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)11A1117.61 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)12F2307.24 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19A5653.21 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19F2347.67 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)20B8545.04 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)22F7164.92 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6A3604.41 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)23F1368.00 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)33F17099.25 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)21698.18 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6B4646.32 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)7F4359.57 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)1317.62 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)82483.57 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9N9753.78 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)3407.13 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9V3028.18 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)10A5800.54 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)11A1076.79 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)41717.83 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)144282.68 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)15B3242.54 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)17F2301.19 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)18C3435.80 Titer
VAX-24 Mid Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)5546.38 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)1228.09 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)18C4103.02 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)11A1064.03 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6B4867.77 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)33F11856.15 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6A3218.37 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)12F1549.29 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)17F2290.15 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)23F857.41 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)5366.50 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)144107.89 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)41326.49 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)22F4843.18 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)82668.87 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19A6211.37 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9N9066.94 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)15B2535.37 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)7F5962.25 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)20B7809.21 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9V3757.52 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)3497.72 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)21822.43 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19F2453.82 Titer
VAX-24 Mixed Dose 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)10A5366.49 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)33F11030.39 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)1358.18 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)262.40 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)3343.29 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)41414.77 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)5691.28 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6A3932.31 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)6B3783.96 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)7F3975.12 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)82267.98 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9N1636.07 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)9V1733.44 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)10A5533.20 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)11A1038.01 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)12F1914.42 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)143634.47 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)15B3137.65 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)17F666.74 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)18C1963.65 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19A4813.63 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)19F1419.27 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)20B140.23 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)22F7631.74 Titer
PCV20 18-49 YrsVAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)23F962.52 Titer

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026