Pneumococcal Vaccines
Conditions
Brief summary
The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older.
Interventions
BIOLOGICAL31 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
BIOLOGICAL20 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1
Sponsors
Vaxcyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged 50 to 64 years (inclusive) for Stage 1, or 50 years and older (inclusive) for Stage 2 at the time of randomization into the study. 2. Able and willing to complete the informed consent process. 3. Available for clinical follow-up through the last study visit at 6 months after the study vaccination. 4. In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the Investigator. 5. Willing to have blood samples collected, stored indefinitely, and used for research purposes. 6. Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process. 7. Women of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception 8. Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an electronic diary.
Exclusion criteria
1. Previous pneumococcal disease (either confirmed or self-reported). 2. Previous receipt of a licensed or investigational pneumococcal vaccine. 3. 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. 4. Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Month 1. 5. Physical examination indicating any clinically significant medical condition. 6. Body Temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled). 7. Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C. 8. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. 9. Female who is pregnant, breastfeeding, or planning to become pregnant during study participation. 10. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws. 11. 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. 12. 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. 13. Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study. 14. Received systemic corticosteroids (except for inhaled, topical, intra-articular) for ≥14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study. 15. Receiving immunosuppressive therapy. 16. 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Reporting Medically Attended Adverse Event | 6 months after vaccination | Percentage of participants with MAAEs. |
| Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | 7 days after vaccination | Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain. |
| Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 1 month after vaccination | Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 1 month after vaccination. |
| Percentage of Subjects Reporting Serious Adverse Event | 6 months after vaccination | Percentage of participants with SAEs. |
| Percentage of Subjects Reporting New Onset of Chronic Illness | 6 months after vaccination | Percentage of participants with NOCIs |
| Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | 7 days after vaccination | Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | 1 month after vaccination | Shifts from Normal at Baseline to Abnormal on Month 1 (30 days after vaccination) in Hematology, Clinical Chemistry and Urinalysis Parameters Occurring in Subjects Aged 50+ Years. |
| 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 1 month after vaccination | Antibody geometric mean titers as measured by OPA for the 31 pneumococcal serotypes in VAX-31. |
| 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 1 month after vaccination | Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31. |
| Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | 1 month after vaccination | Laboratory values that resulted in treatment and reporting as adverse events 1 month following vaccination. |
Countries
United States
Participant flow
Recruitment details
First subject was enrolled 08-Nov-2023 and last subject randomized/vaccinated was 10-Jan-2024. Study sites were medical clinics.
Pre-assignment details
1165 participants were screened. Of these, 150 failed screening, 98 did not meet eligibility criteria and 52 were excluded for other reasons. 13 participants were lost to follow-up and 11 withdrew from study.
Participants by arm
| Arm | Count |
|---|---|
| VAX-31 Low Dose Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1 | 255 |
| VAX-31 Mid Dose Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1 | 254 |
| VAX-31 High Dose Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-31 will be administered into the deltoid muscle at Day 1 | 253 |
| PCV20 Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 | 253 |
| Total | 1,015 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 1 | 1 |
Baseline characteristics
| Characteristic | VAX-31 Low Dose | Total | PCV20 | VAX-31 High Dose | VAX-31 Mid Dose |
|---|---|---|---|---|---|
| Age, Continuous | 58.0 years | 59.0 years | 60.0 years | 59.0 years | 58.0 years |
| Body Mass Index (kg/m^2) | 28.90 kg/m^2 | 29.27 kg/m^2 | 29.11 kg/m^2 | 28.82 kg/m^2 | 30.42 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 172 Participants | 43 Participants | 42 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 210 Participants | 836 Participants | 209 Participants | 209 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 1 Participants | 2 Participants | 2 Participants |
| Height (cm) | 167.6 cm | 167.9 cm | 167.6 cm | 168.0 cm | 169.1 cm |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 15 Participants | 3 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 226 Participants | 60 Participants | 51 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 188 Participants | 760 Participants | 185 Participants | 196 Participants | 191 Participants |
| Sex: Female, Male Female | 151 Participants | 609 Participants | 148 Participants | 150 Participants | 160 Participants |
| Sex: Female, Male Male | 104 Participants | 406 Participants | 105 Participants | 103 Participants | 94 Participants |
| Weight (kg) | 82.56 kg | 83.92 kg | 83.64 kg | 84.00 kg | 85.80 kg |
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 / 255 | 0 / 254 | 0 / 253 | 0 / 253 |
| other Total, other adverse events | 189 / 255 | 196 / 254 | 209 / 253 | 178 / 253 |
| serious Total, serious adverse events | 2 / 255 | 3 / 254 | 5 / 253 | 3 / 253 |
Outcome results
Primary
Percentage of Subjects Reporting Medically Attended Adverse Event
Percentage of participants with MAAEs.
Time frame: 6 months after vaccination
Population: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Medically Attended Adverse Event | 17.6 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Medically Attended Adverse Event | 16.5 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Medically Attended Adverse Event | 13.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Medically Attended Adverse Event | 12.3 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 17.0 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 18.1 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 15.0 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 13.8 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 18.5 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 14.5 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 12.4 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 10.9 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 22.4 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 15.3 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 9.4 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Medically Attended Adverse Event | 11.9 percentage of participants |
Primary
Percentage of Subjects Reporting New Onset of Chronic Illness
Percentage of participants with NOCIs
Time frame: 6 months after vaccination
Population: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting New Onset of Chronic Illness | 0.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting New Onset of Chronic Illness | 2.4 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting New Onset of Chronic Illness | 2.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting New Onset of Chronic Illness | 2.0 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 0.0 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 1.4 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 2.1 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 0.9 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 1.9 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 3.6 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 1.8 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 2.9 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 3.4 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 3.4 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 1.9 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting New Onset of Chronic Illness | 1.5 percentage of participants |
Primary
Percentage of Subjects Reporting Serious Adverse Event
Percentage of participants with SAEs.
Time frame: 6 months after vaccination
Population: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Serious Adverse Event | 0.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Serious Adverse Event | 1.2 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Serious Adverse Event | 2.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Serious Adverse Event | 1.2 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Serious Adverse Event | 1.4 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Serious Adverse Event | 0.7 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Serious Adverse Event | 2.1 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Serious Adverse Event | 0.0 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Serious Adverse Event | 0.0 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Serious Adverse Event | 1.8 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Serious Adverse Event | 1.8 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Serious Adverse Event | 2.2 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Serious Adverse Event | 0.0 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Serious Adverse Event | 1.7 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Serious Adverse Event | 3.8 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Serious Adverse Event | 3.0 percentage of participants |
Primary
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) 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 subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine as received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 6.3 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 66.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 5.5 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 66.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 7.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 7.5 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 67.7 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 66.9 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 7.1 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 7.1 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 73.5 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 74.3 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 60.3 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 3.6 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 59.9 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 4.4 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 71.7 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 72.4 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 7.6 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 6.9 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 10.4 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 75.0 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 73.6 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 7.6 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 7.1 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 76.4 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 7.1 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 75.0 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 68.1 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 5.2 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 5.2 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 68.1 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 4.6 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 59.3 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 58.3 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 3.7 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 58.2 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 3.6 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 8.2 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 58.2 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 7.1 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 71.7 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 71.7 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 7.1 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 2.2 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 52.9 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 3.7 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 53.7 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 63.8 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 1.7 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 62.1 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 1.7 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 5.1 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 49.2 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 1.7 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 49.2 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 67.9 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 3.8 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 67.9 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 5.7 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Any solicited local AE; Overall, Any Grade | 44.8 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Erythema (redness) at injection site; Overall, Any Grade | 3.0 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Pain at injection site; Overall, Any Grade | 43.3 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group | Edema (swelling) at injection site; Overall, Any Grade | 0 percentage of participants |
Primary
Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group 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, defined as all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 32.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 36.8 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 58.5 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 17.4 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 41.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 46.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 31.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 36.2 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 22.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 61.4 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.2 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 68.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 54.9 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 23.3 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.6 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 33.2 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 46.2 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 38.9 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 57.1 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 16.7 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 26.6 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 41.3 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 40.0 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.4 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 49.0 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 64.1 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 17.9 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 35.2 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 40.3 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.4 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 37.5 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 51.4 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 65.3 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 25.7 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 71.4 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 57.1 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 22.9 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 49.3 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 34.3 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 2.1 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 59.5 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 30.2 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.9 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 14.7 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 41.4 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 37.1 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 27.8 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 32.4 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 50.9 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 16.7 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.9 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 32.4 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 30.9 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 17.3 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.9 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 56.4 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 24.5 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 40.9 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 23.9 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 42.5 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 31.9 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 52.2 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 63.7 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.9 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 41.2 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 40.4 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 23.5 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.7 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 55.1 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 18.4 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 31.0 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 32.8 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.7 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 50.0 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 22.4 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 20.7 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 28.8 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 1.7 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 42.4 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 16.9 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 54.2 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 23.7 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 20.8 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 60.4 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.0 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 26.4 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 49.1 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 41.5 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Joint pain (any grade) | 17.9 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Muscle pain (any grade) | 40.3 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Headache (any grade) | 23.9 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Any solicited systemic AE (any grade) | 55.2 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fatigue (any grade) | 38.8 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group | Fever (any grade) | 0.0 percentage of participants |
Primary
Percentage of Subjects Reporting Unsolicited Adverse Event 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 1 month after vaccination.
Time frame: 1 month after vaccination
Population: Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 16.5 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 16.9 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 18.6 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 16.6 percentage of participants |
| VAX-31 Low Dose Age 50-59 Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 18.4 percentage of participants |
| VAX-31 Mid Dose Age 50-59 Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 16.7 percentage of participants |
| VAX-31 High Dose Age 50-59 Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 22.9 percentage of participants |
| PCV20 Age 50-59 Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 18.1 percentage of participants |
| VAX-31 Low Dose Age 60+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 13.9 percentage of participants |
| VAX-31 Mid Dose Age 60+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 17.3 percentage of participants |
| VAX-31 High Dose Age 60+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 13.3 percentage of participants |
| PCV20 Age 60+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 15.3 percentage of participants |
| VAX-31 Low Dose Age 65+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 17.2 percentage of participants |
| VAX-31 Mid Dose Age 65+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 18.6 percentage of participants |
| VAX-31 High Dose Age 65+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 13.2 percentage of participants |
| PCV20 Age 65+ Years | Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group | 14.9 percentage of participants |
Secondary
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31.
Time frame: 1 month after vaccination
Population: Immunogenicity Evaluable Population included all subjects 50+ years who received study vaccine, with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Month 1 within required time frames. Data were analyzed according to vaccine received.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23A | 3.05 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 20B | 16.33 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15A | 20.93 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 5 | 2.38 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15B | 12.34 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19F | 5.94 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 16F | 3.03 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 17F | 9.54 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19A | 8.08 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 18C | 7.15 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6A | 2.97 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 31 | 6.84 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6B | 3.26 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 35B | 25.39 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7C | 11.96 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 3 | 0.47 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23F | 4.58 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7F | 5.81 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 8 | 6.13 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23B | 23.14 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9N | 6.52 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9V | 3.77 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 4 | 1.22 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 1 | 5.56 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 10A | 6.67 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 11A | 4.78 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 2 | 12.64 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 22F | 3.45 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 12F | 1.52 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 33F | 13.10 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 14 | 7.41 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 12F | 1.96 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 14 | 10.33 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7F | 6.59 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15A | 26.40 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 3 | 0.53 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19F | 6.94 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23B | 25.41 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15B | 4.06 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 5 | 2.82 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 10A | 7.55 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 8 | 7.44 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 16F | 4.06 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 2 | 14.78 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19A | 11.00 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 35B | 31.05 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 17F | 11.05 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 31 | 10.46 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 4 | 1.56 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 22F | 4.05 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 18C | 8.34 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9N | 6.60 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6A | 3.15 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 1 | 5.55 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 33F | 14.21 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23A | 3.23 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6B | 3.88 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 20B | 20.44 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23F | 5.51 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9V | 4.31 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7C | 14.02 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 11A | 5.70 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 14 | 11.58 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 1 | 6.40 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 2 | 15.04 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 3 | 0.61 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 4 | 1.73 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 5 | 2.80 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6A | 4.28 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6B | 5.01 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7C | 13.71 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7F | 7.10 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 8 | 9.69 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9N | 7.92 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9V | 3.78 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 10A | 8.21 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 11A | 5.37 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 12F | 1.70 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15A | 25.91 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15B | 18.25 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 16F | 3.82 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 17F | 12.67 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 18C | 8.31 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19A | 11.83 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19F | 8.91 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 20B | 20.24 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 22F | 4.60 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23A | 4.01 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23B | 28.61 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23F | 6.45 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 31 | 11.92 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 33F | 15.88 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 35B | 36.39 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 12F | 1.38 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 4 | 1.50 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 20B | 3.91 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 11A | 3.75 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 10A | 10.82 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 3 | 0.60 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 22F | 4.37 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9V | 2.63 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 9N | 1.00 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 35B | 3.05 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23A | 0.52 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 8 | 6.99 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7F | 5.14 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 33F | 12.24 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23B | 11.27 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 7C | 0.56 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6B | 3.08 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 2 | 0.93 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 23F | 4.60 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 6A | 3.14 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 5 | 2.47 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 18C | 6.62 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 17F | 0.56 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 16F | 0.95 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 1 | 4.32 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19A | 8.53 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15B | 13.17 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 15A | 4.22 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 31 | 0.44 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 19F | 4.37 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration | 14 | 9.15 mcg/mL |
Secondary
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
Antibody geometric mean titers as measured by OPA for the 31 pneumococcal serotypes in VAX-31.
Time frame: 1 month after vaccination
Population: Immunogenicity Evaluable Population included all subjects 50+ years who received study vaccine, with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Month 1 within required time frames. Data were analyzed according to vaccine received.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6B | 3114.80 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 20B | 9756.59 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15A | 8705.55 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 33F | 10686.74 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15B | 2891.81 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 5 | 453.32 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19F | 1754.37 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 16F | 7931.81 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 17F | 2146.39 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 2 | 1984.89 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19A | 4199.53 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 18C | 1928.40 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6A | 3017.66 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 31 | 7199.08 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7C | 5333.37 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 35B | 9264.48 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23F | 1829.26 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7F | 4889.66 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 3 | 247.34 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 8 | 1614.83 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23B | 1919.13 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9N | 6245.38 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 1 | 412.94 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9V | 4709.89 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23A | 2778.60 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 10A | 2718.18 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 4 | 1909.83 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 11A | 1130.91 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 22F | 7196.50 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 12F | 1199.57 mcg/mL |
| VAX-31 Low Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 14 | 3574.38 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 20B | 10664.95 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 14 | 4000.68 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7F | 5647.05 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15A | 9982.41 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 10A | 4553.86 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19F | 1817.82 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23B | 1855.53 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15B | 3548.99 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 12F | 1389.71 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 8 | 1943.14 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 3 | 301.19 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 16F | 9980.42 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 5 | 553.68 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19A | 4726.99 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 22F | 8843.18 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 17F | 2112.12 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 35B | 9913.10 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9N | 7075.75 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 11A | 1101.72 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 18C | 2302.99 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 31 | 7821.34 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23A | 2929.12 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6A | 3649.18 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 2 | 2158.32 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 4 | 1923.46 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6B | 3430.49 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 1 | 474.22 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23F | 2128.26 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9V | 5572.21 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7C | 5642.80 mcg/mL |
| VAX-31 Mid Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 33F | 12553.75 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 14 | 4657.38 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 1 | 509.76 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 2 | 2376.00 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 3 | 369.12 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 4 | 2204.29 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 5 | 643.83 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6A | 5476.69 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6B | 4778.40 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7C | 6230.76 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7F | 6584.45 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 8 | 2329.26 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9N | 7924.85 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9V | 5353.40 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 10A | 4715.10 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 11A | 1147.21 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 12F | 1658.63 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15A | 10153.26 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15B | 3877.44 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 16F | 11055.25 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 17F | 2160.76 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 18C | 2640.00 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19A | 5032.82 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19F | 2185.14 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 20B | 9988.69 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 22F | 8633.65 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23A | 3253.49 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23B | 2010.19 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23F | 2491.49 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 31 | 8605.44 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 33F | 12763.17 mcg/mL |
| VAX-31 High Dose Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 35B | 10659.18 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 12F | 1382.15 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 4 | 1909.84 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 20B | 427.17 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 11A | 946.05 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 10A | 4849.53 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 3 | 351.45 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 22F | 9989.08 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9V | 3700.19 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 9N | 1484.59 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 35B | 2845.55 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23A | 175.01 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 8 | 2077.75 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7F | 4990.65 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 33F | 10332.19 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23B | 248.33 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 7C | 656.15 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6B | 4032.19 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 2 | 160.47 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 23F | 1433.09 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 6A | 5039.25 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 5 | 518.71 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 18C | 1845.17 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 17F | 405.86 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 16F | 2130.17 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 1 | 410.32 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19A | 4271.98 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15B | 2568.68 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 15A | 2696.64 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 31 | 623.66 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 19F | 1321.85 mcg/mL |
| PCV20 Overall (Age 50+) | 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer | 14 | 4306.60 mcg/mL |
Secondary
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Shifts from Normal at Baseline to Abnormal on Month 1 (30 days after vaccination) in Hematology, Clinical Chemistry and Urinalysis Parameters Occurring in Subjects Aged 50+ Years.
Time frame: 1 month after vaccination
Population: Safety population, defined as all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Glucose (mmol/L) | 18.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Gamma glutamyl transferase (U/L) | 1.6 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bicarbonate (mmol/L) | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Nitrite | 0.4 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Creatinine (umol/L) | 9.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Chloride (mmol/L) | 3.1 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Direct bilirubin (umol/L) | 0.8 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine glucose | 0.8 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Cholesterol (mmol/L) | 5.1 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Calcium (mmol/L) | 6.7 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bilirubin (umol/L) | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine bilirubin | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Platelets (10^9/L) | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Hemoglobin (g/L) | 2.8 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocyte esterase | 6.5 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Ketones | 1.6 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocytes (10^9/L) | 6.3 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Eosinophils (10^9/L) | 1.6 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urea nitrogen (mmol/L) | 7.5 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urate (umol/L) | 7.1 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Albumin (g/L) | 0.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urobilinogen | 0.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Triglycerides (mmol/L) | 6.7 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Sodium (mmol/L) | 3.9 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alkaline phosphatase (U/L) | 2.4 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine protein | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Protein (g/L) | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Phosphate (mmol/L) | 5.9 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alanine aminotransferase (U/L) | 2.4 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine hemoglobin | 1.2 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Lactate dehydrogenase (U/L) | 0.4 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Potassium (mmol/L) | 3.5 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Aspartate aminotransferase (U/L) | 2.0 percentage of participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Neutrophils (10^9/L) | 5.1 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocytes (10^9/L) | 4.7 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Eosinophils (10^9/L) | 1.2 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Hemoglobin (g/L) | 1.2 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Neutrophils (10^9/L) | 4.7 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Platelets (10^9/L) | 2.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Albumin (g/L) | 0.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alkaline phosphatase (U/L) | 1.6 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alanine aminotransferase (U/L) | 4.3 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Aspartate aminotransferase (U/L) | 2.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bicarbonate (mmol/L) | 2.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Direct bilirubin (umol/L) | 0.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bilirubin (umol/L) | 0.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Calcium (mmol/L) | 5.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Cholesterol (mmol/L) | 6.7 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Chloride (mmol/L) | 3.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Creatinine (umol/L) | 5.5 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Gamma glutamyl transferase (U/L) | 2.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Glucose (mmol/L) | 21.3 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Potassium (mmol/L) | 2.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Lactate dehydrogenase (U/L) | 0.4 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Phosphate (mmol/L) | 3.2 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Protein (g/L) | 1.6 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Sodium (mmol/L) | 3.1 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Triglycerides (mmol/L) | 9.1 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urate (umol/L) | 7.9 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urea nitrogen (mmol/L) | 5.1 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Ketones | 0.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocyte esterase | 7.1 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine bilirubin | 2.4 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine glucose | 0.8 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine hemoglobin | 2.4 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine protein | 2.0 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Nitrite | 1.2 percentage of participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urobilinogen | 0.4 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alkaline phosphatase (U/L) | 1.6 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Glucose (mmol/L) | 21.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Potassium (mmol/L) | 2.8 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alanine aminotransferase (U/L) | 2.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Eosinophils (10^9/L) | 1.6 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Lactate dehydrogenase (U/L) | 0.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine hemoglobin | 2.4 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Phosphate (mmol/L) | 5.2 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Aspartate aminotransferase (U/L) | 0.4 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Protein (g/L) | 1.2 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Hemoglobin (g/L) | 4.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Sodium (mmol/L) | 4.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Albumin (g/L) | 0.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Triglycerides (mmol/L) | 7.5 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine protein | 2.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urate (umol/L) | 6.3 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocytes (10^9/L) | 4.7 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urea nitrogen (mmol/L) | 7.5 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Ketones | 0.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Platelets (10^9/L) | 1.2 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urobilinogen | 0.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocyte esterase | 7.8 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Nitrite | 2.8 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bilirubin (umol/L) | 0.4 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine bilirubin | 2.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Calcium (mmol/L) | 7.1 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Direct bilirubin (umol/L) | 0.4 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Cholesterol (mmol/L) | 4.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Neutrophils (10^9/L) | 5.1 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Chloride (mmol/L) | 6.3 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bicarbonate (mmol/L) | 2.0 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Creatinine (umol/L) | 9.5 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine glucose | 1.3 percentage of participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Gamma glutamyl transferase (U/L) | 1.2 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Calcium (mmol/L) | 5.9 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine glucose | 0.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urea nitrogen (mmol/L) | 8.7 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Glucose (mmol/L) | 24.1 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alanine aminotransferase (U/L) | 2.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Hemoglobin (g/L) | 1.2 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Platelets (10^9/L) | 0.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Potassium (mmol/L) | 2.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Eosinophils (10^9/L) | 0.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Aspartate aminotransferase (U/L) | 2.4 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Ketones | 1.2 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Lactate dehydrogenase (U/L) | 0.4 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Alkaline phosphatase (U/L) | 0.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine bilirubin | 1.6 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Nitrite | 0.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Phosphate (mmol/L) | 4.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Cholesterol (mmol/L) | 5.5 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine hemoglobin | 2.5 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocyte esterase | 8.3 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Protein (g/L) | 2.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Albumin (g/L) | 0.4 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Neutrophils (10^9/L) | 2.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bicarbonate (mmol/L) | 3.2 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Sodium (mmol/L) | 2.8 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Gamma glutamyl transferase (U/L) | 2.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urobilinogen | 0.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Bilirubin (umol/L) | 0.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Triglycerides (mmol/L) | 8.7 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Leukocytes (10^9/L) | 4.3 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Direct bilirubin (umol/L) | 0.0 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Creatinine (umol/L) | 10.3 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urate (umol/L) | 6.7 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Chloride (mmol/L) | 2.4 percentage of participants |
| PCV20 Overall (Age 50+) | Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis) | Urine protein | 3.7 percentage of participants |
Secondary
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
Laboratory values that resulted in treatment and reporting as adverse events 1 month following vaccination.
Time frame: 1 month after vaccination
Population: Safety population, including all subjects who received study vaccine and provided safety assessment data. Subject safety data were analyzed according to the vaccine they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Neutrophils | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (low) | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Ketones | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Eosinophils | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine hemoglobin | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (high) | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (low) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine glucose | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Triglycerides (high) | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (low) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (low) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Sodium (low) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (high) | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urea nitrogen | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urate | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (high) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urobilinogen | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Protein | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Hemoglobin (low) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alanine aminotransferase (high) | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine protein | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Phosphate | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Lactate dehydrogenase | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Aspartate aminotransferase (high) | 1 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine bilirubin | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Chloride | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Calcium | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Cholesterol (high) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (high) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Direct bilirubin | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bilirubin | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Creatinine (high) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Nitrite | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bicarbonate | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Albumin | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Gamma glutamyl transferase (high) | 0 Participants |
| VAX-31 Low Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocyte esterase | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Phosphate | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Hemoglobin (low) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (low) | 1 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (low) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alanine aminotransferase (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Aspartate aminotransferase (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Cholesterol (high) | 1 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Creatinine (high) | 1 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Gamma glutamyl transferase (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (low) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (low) | 1 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Sodium (low) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Triglycerides (high) | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine glucose | 1 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine hemoglobin | 2 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Eosinophils | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Neutrophils | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Albumin | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bicarbonate | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bilirubin | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Direct bilirubin | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Calcium | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Chloride | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Lactate dehydrogenase | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Protein | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urate | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urea nitrogen | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Ketones | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocyte esterase | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine bilirubin | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine protein | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Nitrite | 0 Participants |
| VAX-31 Mid Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urobilinogen | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Phosphate | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Neutrophils | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (high) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Cholesterol (high) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Protein | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Albumin | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Direct bilirubin | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urate | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Creatinine (high) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (low) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urobilinogen | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urea nitrogen | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (low) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Calcium | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Hemoglobin (low) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (high) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Aspartate aminotransferase (high) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (low) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Nitrite | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Sodium (low) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bicarbonate | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Chloride | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Ketones | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Triglycerides (high) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocyte esterase | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (high) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Gamma glutamyl transferase (high) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine glucose | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine protein | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Lactate dehydrogenase | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (high) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine hemoglobin | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine bilirubin | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (low) | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alanine aminotransferase (high) | 1 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Eosinophils | 0 Participants |
| VAX-31 High Dose Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bilirubin | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urate | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Neutrophils | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocyte esterase | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alkaline phosphatase | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Creatinine (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (low) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Albumin | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bicarbonate | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Cholesterol (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Bilirubin | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine bilirubin | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Direct bilirubin | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Aspartate aminotransferase (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Calcium | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urobilinogen | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Chloride | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Alanine aminotransferase (high) | 1 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Lactate dehydrogenase | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Phosphate | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine protein | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Protein | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Leukocytes (low) | 1 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Hemoglobin (low) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Gamma glutamyl transferase (high) | 1 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urea nitrogen | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (low) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Platelets (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Potassium (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Sodium (low) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (high) | 1 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Triglycerides (high) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Ketones | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine glucose | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Glucose (low) | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Urine hemoglobin | 2 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Nitrite | 0 Participants |
| PCV20 Overall (Age 50+) | Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values | Eosinophils | 0 Participants |