Safety, Tolerability, and Immunogenicity Study of a 31-Va... | NCT06151288

NCT06151288

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	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.	Biological: 31 valent pneumococcal conjugate vaccine
Group 2	Experimental	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.	Biological: 31 valent pneumococcal conjugate vaccine
Group 3	Experimental	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.	Biological: 31 valent pneumococcal conjugate vaccine
Group 4	Active Comparator	Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.	Biological: 20 valent pneumococcal conjugate vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
31 valent pneumococcal conjugate vaccine	Biological	0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	7 days after vaccination
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.	7 days after vaccination
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.	1 month after vaccination
Percentage of Subjects Reporting Serious Adverse Event	Percentage of participants with SAEs.	6 months after vaccination
Percentage of Subjects Reporting New Onset of Chronic Illness	Percentage of participants with NOCIs	6 months after vaccination
Percentage of Subjects Reporting Medically Attended Adverse Event	Percentage of participants with MAAEs.	6 months after vaccination

Secondary Outcomes

Measure	Description	Time Frame
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.	1 month after vaccination
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Able and willing to complete the informed consent process.
Available for clinical follow-up through the last study visit at 6 months after the study vaccination.
In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the Investigator.
Willing to have blood samples collected, stored indefinitely, and used for research purposes.
Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.
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
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:

Previous pneumococcal disease (either confirmed or self-reported).
Previous receipt of a licensed or investigational pneumococcal vaccine.
Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Month 1.
Physical examination indicating any clinically significant medical condition.
Body Temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C.
History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
Female who is pregnant, breastfeeding, or planning to become pregnant during study participation.
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.
Any other chronic or clinically significant medical condition that, in the opinion of the Investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
Received systemic corticosteroids (except for inhaled, topical, intra-articular) for

≥14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
Receiving immunosuppressive therapy.
History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

Contacts/Locations Module

Name	Affiliation	Role
Clinical Development	Vaxcyte, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
AMR Mobile		Mobile	Alabama	36608	United States
AMR Phoenix

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41864214	Derived	Wassil J, Fairman J, Fierro CA, Clark J, Bennett S, Johnson D, Jiang Q, Migone TS, Paschenko A, Simon JK, Lamola S, Sisti M. Safety, tolerability, and immunogenicity of a 31-valent pneumococcal conjugate vaccine (VAX-31) in healthy adults aged 50 years and older from the USA: a phase 1/2, double-blinded, active-controlled, parallel-group, dose-finding randomised clinical trial. Lancet Infect Dis. 2026 Mar 18:S1473-3099(26)00059-9. doi: 10.1016/S1473-3099(26)00059-9. Online ahead of print.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 8, 2023	Jul 8, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	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
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00058.0(50.0 to 84.0) BG00158.0(50.0 to 86.0) BG00259.0(50.0 to 79.0) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000151 BG001160 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00043 BG00144 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0013 BG002

Height (cm)

Median

Inter-Quartile Range

Title

Denominators

Categories

Title	Measurements
	BG000167.6(160.3 to 175.3) BG001169.1(162.6 to 175.3) BG002

Weight (kg)

Median

Inter-Quartile Range

Title

Denominators

Categories

Title	Measurements
	BG00082.56(71.10 to 94.30) BG00185.80(72.00 to 102.15) BG002

Body Mass Index (kg/m^2)

Median

Inter-Quartile Range

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00028.90(25.98 to 33.47) BG00130.42(25.58 to 34.42) BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Number

percentage of participants

7 days after vaccination

ID	Title	Description
OG000	VAX-31 Low Dose Overall (Age 50+)	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
OG001	VAX-31 Mid Dose Overall (Age 50+)	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
OG002	VAX-31 High Dose Overall (Age 50+)	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
OG003	PCV20 Overall (Age 50+)	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
OG004	VAX-31 Low Dose Age 50-59 Years	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
OG005	VAX-31 Mid Dose Age 50-59 Years	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
OG006	VAX-31 High Dose Age 50-59 Years	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
OG007	PCV20 Age 50-59 Years	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
OG008	VAX-31 Low Dose Age 60+ Years	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
OG009	VAX-31 Mid Dose Age 60+ Years	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
OG010	VAX-31 High Dose Age 60+ Years	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
OG011	PCV20 Age 60+ Years	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
OG012	VAX-31 Low Dose Age 65+ Years	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
OG013	VAX-31 Mid Dose Age 65+ Years	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
OG014	VAX-31 High Dose Age 65+ Years	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
OG015	PCV20 Age 65+ Years	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

Units	Counts
Participants	OG000253 OG001254 OG002253 OG003

Title

Denominators

Categories

Any solicited local AE; Overall, Any Grade

Title	Measurements
	OG00066.8 OG00167.7 OG00274.3 OG003

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.

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.

Posted

Number

percentage of participants

7 days after vaccination

ID	Title	Description
OG000	VAX-31 Low Dose Overall (Age 50+)	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
OG001	VAX-31 Mid Dose Overall (Age 50+)	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
OG002	VAX-31 High Dose Overall (Age 50+)

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.

Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.

Posted

Number

percentage of participants

1 month after vaccination

ID	Title	Description
OG000	VAX-31 Low Dose Overall (Age 50+)	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
OG001	VAX-31 Mid Dose Overall (Age 50+)	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
OG002	VAX-31 High Dose Overall (Age 50+)

Primary

Percentage of Subjects Reporting Serious Adverse Event

Percentage of participants with SAEs.

Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.

Posted

Number

percentage of participants

6 months after vaccination

ID	Title	Description
OG000	VAX-31 Low Dose Overall (Age 50+)	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
OG001	VAX-31 Mid Dose Overall (Age 50+)	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
OG002	VAX-31 High Dose Overall (Age 50+)	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

Primary

Percentage of Subjects Reporting New Onset of Chronic Illness

Percentage of participants with NOCIs

Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.

Posted

Number

percentage of participants

6 months after vaccination

ID	Title	Description
OG000	VAX-31 Low Dose Age 50+ Years	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
OG001	VAX-31 Mid Dose Age 50+ Years	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
OG002	VAX-31 High Dose Age 50+ Years	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

Primary

Percentage of Subjects Reporting Medically Attended Adverse Event

Percentage of participants with MAAEs.

Safety population, defined as all subjects who received study vaccine. Subject safety data were analyzed according to the vaccine they received.

Posted

Number

percentage of participants

6 months after vaccination

ID	Title	Description
OG000	VAX-31 Low Dose Overall (Age 50+)	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
OG001	VAX-31 Mid Dose Overall (Age 50+)	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
OG002	VAX-31 High Dose Overall (Age 50+)	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

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.

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.

Posted

Count of Participants

Participants

1 month after vaccination

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

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.

Posted

Number

percentage of participants

1 month after vaccination

ID	Title	Description
OG000	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
OG001	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
OG002

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.

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.

Posted

Geometric Mean

95% Confidence Interval

mcg/mL

1 month after vaccination

ID	Title	Description
OG000	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
OG001	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
OG002	VAX-31 High Dose

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.

Posted

Geometric Mean

95% Confidence Interval

mcg/mL

1 month after vaccination

ID	Title	Description
OG000	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
OG001	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
OG002

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VAX-31 Low Dose Overall (Age 50+)	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	2	255	189	255
EG001	VAX-31 Mid Dose Overall (Age 50+)	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	3	254	196	254
EG002	VAX-31 High Dose Overall (Age 50+)	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	5	253	209	253
EG003	PCV20 Overall (Age 50+)	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	3	253	178	253

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Gait disturbance	General disorders	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0020 events0 affected253 at risk EG0031 events1 affected253 at risk
Hip fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0020 events0 affected253 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected254 at risk EG0020 events0 affected253 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0020 events0 affected253 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0021 events1 affected253 at risk EG003
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0022 events2 affected253 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected254 at risk EG0020 events0 affected253 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0021 events1 affected253 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected254 at risk EG0020 events0 affected253 at risk EG003
Ischaemic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0010 events0 affected254 at risk EG0020 events0 affected253 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0010 events0 affected254 at risk EG0021 events1 affected253 at risk EG003
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected255 at risk EG0011 events1 affected254 at risk EG0020 events0 affected253 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pain at injection site	Skin and subcutaneous tissue disorders	Systematic Assessment	EG000167 events167 affected255 at risk EG001170 events170 affected254 at risk EG002186 events186 affected253 at risk EG003151 events151 affected252 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00016 events16 affected255 at risk EG00119 events19 affected254 at risk EG00218 events18 affected253 at risk EG003
Edema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00014 events14 affected255 at risk EG00120 events20 affected254 at risk EG00218 events18 affected253 at risk EG003
Fever	General disorders	Systematic Assessment	EG0003 events3 affected255 at risk EG0013 events3 affected254 at risk EG0024 events4 affected253 at risk EG003
Headache	General disorders	Systematic Assessment	EG00081 events81 affected255 at risk EG00181 events81 affected254 at risk EG00284 events84 affected253 at risk EG003
Tiredness	General disorders	Systematic Assessment	EG00093 events93 affected255 at risk EG00192 events92 affected254 at risk EG002117 events117 affected253 at risk EG003
Muscle pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG000106 events106 affected255 at risk EG001119 events119 affected254 at risk EG002139 events139 affected253 at risk EG003
Joint pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00044 events44 affected255 at risk EG00156 events56 affected254 at risk EG00259 events59 affected253 at risk EG003
Injection site pruritis	General disorders	Non-systematic Assessment	EG0001 events1 affected255 at risk EG0014 events4 affected254 at risk EG0022 events2 affected253 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected255 at risk EG0010 events0 affected254 at risk EG0021 events1 affected253 at risk EG003

Some limitations of this clinical study include the lack of a group, such as 3.3 mcg or 4.4 mcg, for all serotypes, aimed at understanding whether the dose response of polysaccharide can overcome carrier suppression. The relatively low ethnic diversity of participants is also a limitation, which will be addressed in larger phase 3 clinical trials.

Certain Agreements

BG00459.0(50.0 to 86.0)

BG003167.6(160.8 to 175.3)

BG004167.9(162.5 to 175.3)

BG00383.64(72.12 to 97.52)

BG00483.92(71.90 to 98.80)

BG00329.11(25.91 to 34.14)

BG00429.27(25.78 to 33.91)

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

Title	Measurements
	OG0001984.89(1687.63 to 2334.51) OG0012158.32(1830.96 to 2544.21) OG0022376.00(2016.93 to 2798.99) OG003160.47(136.23 to 189.01)

Title	Measurements
	OG000247.34(215.11 to 284.39) OG001301.19(261.87 to 346.41) OG002369.12(320.89 to 424.61) OG003351.45(305.59 to 404.18)

Title	Measurements
	OG0001909.83(1697.83 to 2148.29) OG0011923.46(1708.37 to 2165.64) OG0022204.29(1957.32 to 2482.43) OG0031909.84(1696.64 to 2149.82)

Title	Measurements
	OG000453.32(366.56 to 560.62) OG001553.68(446.96 to 685.89) OG002643.83(519.50 to 797.91) OG003518.71(418.91 to 642.29)

Title	Measurements
	OG0003017.66(2421.39 to 3760.77) OG0013649.18(2920.00 to 4560.43) OG0025476.69(4383.39 to 6842.69) OG0035039.25(4034.70 to 6293.90)

Title	Measurements
	OG0003114.80(2534.60 to 3827.81) OG0013430.49(2784.90 to 4225.76) OG0024778.40(3874.70 to 5892.86) OG0034032.19(3277.67 to 4960.39)

Title	Measurements
	OG0005333.37(4722.15 to 6023.70) OG0015642.80(4991.20 to 6379.48) OG0026230.76(5507.58 to 7048.89) OG003656.15(578.74 to 743.90)

Title	Measurements
	OG0004889.66(4224.12 to 5660.06) OG0015647.05(4857.85 to 6540.22) OG0026584.45(5686.59 to 7624.08) OG0034990.65(4311.96 to 5776.16)

Title	Measurements
	OG0001614.83(1399.07 to 1863.87) OG0011943.14(1680.15 to 2247.28) OG0022329.26(2010.27 to 2698.88) OG0032077.75(1798.13 to 2400.84)

Title	Measurements
	OG0006245.38(5374.40 to 7257.52) OG0017075.75(6082.90 to 8230.66) OG0027924.85(6808.85 to 9223.76) OG0031484.59(1274.23 to 1729.67)

Title	Measurements
	OG0004709.89(4015.67 to 5524.13) OG0015572.21(4748.00 to 6539.50) OG0025353.40(4560.06 to 6284.77) OG0033700.19(3153.92 to 4341.07)

Title	Measurements
	OG0002718.18(2272.32 to 3251.53) OG0014553.86(3800.58 to 5456.44) OG0024715.10(3936.02 to 5648.37) OG0034849.53(4052.41 to 5803.44)

Title	Measurements
	OG0001130.91(1061.75 to 1204.58) OG0011101.72(1033.84 to 1174.07) OG0021147.21(1076.37 to 1222.72) OG003946.05(887.55 to 1008.41)

Title	Measurements
	OG0001199.57(968.68 to 1485.49) OG0011389.71(1119.73 to 1724.78) OG0021658.63(1335.19 to 2060.42) OG0031382.15(1115.80 to 1712.08)

Title	Measurements
	OG0003574.38(3048.13 to 4191.50) OG0014000.68(3404.71 to 4700.99) OG0024657.38(3965.48 to 5469.99) OG0034306.60(3670.73 to 5052.62)

Title	Measurements
	OG0008705.55(7402.46 to 10238.03) OG0019982.41(8488.71 to 11738.94) OG00210153.26(8613.07 to 11968.86) OG0032696.64(2290.66 to 3174.58)

Title	Measurements
	OG0002891.81(2423.77 to 3450.24) OG0013548.99(2969.28 to 4241.87) OG0023877.44(3243.71 to 4634.98) OG0032568.68(2149.28 to 3069.93)

Title	Measurements
	OG0007931.81(6996.40 to 8992.27) OG0019980.42(8794.73 to 11325.96) OG00211055.25(9739.33 to 12548.96) OG0032130.17(1876.88 to 2417.65)

Title	Measurements
	OG0002146.39(1904.03 to 2419.61) OG0012112.12(1871.11 to 2384.19) OG0022160.76(1913.48 to 2439.99) OG003405.86(358.82 to 459.08)

Title	Measurements
	OG0001928.40(1599.06 to 2325.57) OG0012302.99(1910.36 to 2776.31) OG0022640.00(2190.27 to 3182.06) OG0031845.17(1531.20 to 2223.52)

Title	Measurements
	OG0004199.53(3606.89 to 4889.55) OG0014726.99(4055.05 to 5510.27) OG0025032.82(4316.05 to 5868.63) OG0034271.98(3666.77 to 4977.07)

Title	Measurements
	OG0001754.37(1541.08 to 1997.18) OG0011817.82(1595.18 to 2071.52) OG0022185.14(1917.00 to 2490.78) OG0031321.85(1160.51 to 1505.61)

Title	Measurements
	OG0009756.59(8193.85 to 11617.39) OG00110664.95(8936.58 to 12727.60) OG0029988.69(8381.50 to 11904.07) OG003427.17(358.03 to 509.66)

Title	Measurements
	OG0007196.50(6125.39 to 8454.92) OG0018843.18(7517.43 to 10402.73) OG0028633.65(7333.92 to 10163.72) OG0039989.08(8496.59 to 11743.74)

Title	Measurements
	OG0002778.60(2235.23 to 3454.05) OG0012929.12(2354.16 to 3644.51) OG0023253.49(2612.93 to 4051.07) OG003175.01(139.54 to 219.49)

Title	Measurements
	OG0001919.13(1555.79 to 2367.32) OG0011855.53(1501.21 to 2293.47) OG0022010.19(1625.78 to 2485.48) OG003248.33(200.25 to 307.96)

Title	Measurements
	OG0001829.26(1475.00 to 2268.62) OG0012128.26(1714.84 to 2641.34) OG0022491.49(2007.55 to 3092.09) OG0031433.09(1156.18 to 1776.33)

Title	Measurements
	OG0007199.08(5973.44 to 8676.19) OG0017821.34(6480.26 to 9439.94) OG0028605.44(7127.04 to 10390.50) OG003623.66(515.16 to 755.00)

Title	Measurements
	OG00010686.74(9102.59 to 12546.58) OG00112553.75(10684.65 to 14749.82) OG00212763.17(10869.89 to 14986.22) OG00310332.19(8815.38 to 12109.97)

Title	Measurements
	OG0009264.48(8193.76 to 10475.12) OG0019913.10(8758.88 to 11219.41) OG00210659.18(9415.66 to 12066.95) OG0032845.55(2511.80 to 3223.64)

Title	Measurements
	OG00012.64(10.60 to 15.08) OG00114.78(12.37 to 17.66) OG00215.04(12.59 to 17.97) OG0030.93(0.78 to 1.11)

Title	Measurements
	OG0000.47(0.40 to 0.55) OG0010.53(0.45 to 0.61) OG0020.61(0.52 to 0.71) OG0030.60(0.52 to 0.70)

Title	Measurements
	OG0001.22(1.02 to 1.46) OG0011.56(1.30 to 1.86) OG0021.73(1.44 to 2.06) OG0031.50(1.26 to 1.79)

Title	Measurements
	OG0002.38(2.01 to 2.83) OG0012.82(2.38 to 3.35) OG0022.80(2.36 to 3.33) OG0032.47(2.08 to 2.93)

Title	Measurements
	OG0002.97(2.42 to 3.66) OG0013.15(2.56 to 3.89) OG0024.28(3.48 to 5.27) OG0033.14(2.55 to 3.87)

Title	Measurements
	OG0003.26(2.58 to 4.13) OG0013.88(3.06 to 4.92) OG0025.01(3.95 to 6.35) OG0033.08(2.43 to 3.91)

Title	Measurements
	OG00011.96(9.47 to 15.09) OG00114.02(11.09 to 17.73) OG00213.71(10.83 to 17.36) OG0030.56(0.44 to 0.71)

Title	Measurements
	OG0005.81(4.97 to 6.80) OG0016.59(5.63 to 7.72) OG0027.10(6.06 to 8.32) OG0035.14(4.39 to 6.01)

Title	Measurements
	OG0006.13(5.24 to 7.16) OG0017.44(6.36 to 8.70) OG0029.69(8.27 to 11.34) OG0036.99(5.97 to 8.17)

Title	Measurements
	OG0006.52(5.49 to 7.73) OG0016.60(5.56 to 7.84) OG0027.92(6.67 to 9.41) OG0031.00(0.84 to 1.19)

Title	Measurements
	OG0003.77(3.12 to 4.55) OG0014.31(3.57 to 5.20) OG0023.78(3.12 to 4.57) OG0032.63(2.18 to 3.17)

Title	Measurements
	OG0006.67(5.27 to 8.43) OG0017.55(5.96 to 9.56) OG0028.21(6.47 to 10.40) OG00310.82(8.55 to 13.69)

Title	Measurements
	OG0004.78(4.00 to 5.71) OG0015.70(4.76 to 6.82) OG0025.37(4.49 to 6.42) OG0033.75(3.13 to 4.48)

Title	Measurements
	OG0001.52(1.24 to 1.86) OG0011.96(1.60 to 2.40) OG0021.70(1.39 to 2.08) OG0031.38(1.13 to 1.68)

Title	Measurements
	OG0007.41(6.02 to 9.12) OG00110.33(8.38 to 12.74) OG00211.58(9.38 to 14.28) OG0039.15(7.42 to 11.27)

Title	Measurements
	OG00020.93(17.27 to 25.38) OG00126.40(21.75 to 32.06) OG00225.91(21.32 to 31.50) OG0034.22(3.48 to 5.12)

Title	Measurements
	OG00012.34(10.04 to 15.16) OG0014.06(3.45 to 4.79) OG00218.25(14.82 to 22.46) OG00313.17(10.71 to 16.19)

Title	Measurements
	OG0003.03(2.57 to 3.57) OG0014.06(3.45 to 4.79) OG0023.82(3.24 to 4.51) OG0030.95(0.81 to 1.12)

Title	Measurements
	OG0009.54(8.08 to 11.27) OG00111.05(9.35 to 13.06) OG00212.67(10.72 to 14.99) OG0030.56(0.47 to 0.66)

Title	Measurements
	OG0007.15(5.91 to 8.67) OG0018.34(6.87 to 10.11) OG0028.31(6.85 to 10.09) OG0036.62(5.46 to 8.03)

Title	Measurements
	OG0008.08(6.64 to 9.83) OG00111.00(9.03 to 13.39) OG00211.83(9.71 to 14.41) OG0038.53(7.01 to 10.38)

Title	Measurements
	OG0005.94(4.82 to 7.34) OG0016.94(5.62 to 8.58) OG0028.91(7.20 to 11.02) OG0034.37(3.54 to 5.40)

Title	Measurements
	OG00016.33(13.89 to 19.19) OG00120.44(17.37 to 24.05) OG00220.24(17.20 to 23.83) OG0033.91(3.33 to 4.60)

Title	Measurements
	OG0003.45(2.93 to 4.06) OG0014.05(3.43 to 4.77) OG0024.60(3.90 to 5.43) OG0034.37(3.71 to 5.16)

Title	Measurements
	OG0003.05(2.43 to 3.84) OG0013.23(2.57 to 4.07) OG0024.01(3.18 to 5.05) OG0030.52(0.42 to 0.66)

Title	Measurements
	OG00023.14(19.65 to 27.27) OG00125.41(21.54 to 29.97) OG00228.61(24.25 to 33.76) OG00311.27(9.56 to 13.29)

Title	Measurements
	OG0004.58(3.79 to 5.53) OG0015.51(4.56 to 6.66) OG0026.45(5.33 to 7.80) OG0034.60(3.81 to 5.56)

Title	Measurements
	OG0006.84(5.64 to 8.31) OG00110.46(8.61 to 12.72) OG00211.92(9.80 to 14.50) OG0030.44(0.36 to 0.53)

Title	Measurements
	OG00013.10(11.12 to 15.43) OG00114.21(12.05 to 16.76) OG00215.88(13.46 to 18.73) OG00312.24(10.39 to 14.43)

Title	Measurements
	OG00025.39(21.52 to 29.96) OG00131.05(26.28 to 36.68) OG00236.39(30.77 to 43.03) OG0033.05(2.58 to 3.60)