Streptococcus PneumoniaePhase 1NCT07086677
A Study to Learn About How a New Pneumococcal Vaccine Works in Adults
A Phase 1 study testing PG4 vaccine in Buffer 1 with low dose PA-001, PG4 in Buffer 1 with low dose PA-002 and PG4 in Buffer 1 with high dose PA-001 in people with Streptococcus Pneumoniae, run by Pfizer at 20 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: an experimental PG4 vaccine a PG4 vaccine comparator a standard 20vPnC vaccine comparator placebo. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae
- What is being tested?
- PG4 vaccine in Buffer 1 with low dose PA-001, PG4 in Buffer 1 with low dose PA-002 and PG4 in Buffer 1 with high dose PA-001
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Jul 2025to 21 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study
Who cannot join
- Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526
Valley Regional Medical Center
Brownsville, Texas, 78526
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
Upstate Global Health Institute
East Syracuse, New York, 13057
Finlay Medical Research
Greenacres City, Florida, 33467
LabCorp
Houston, Texas, 77064
Orange County Research Center
Lake Forest, California, 92630
Johnson County Clinical Trials
Lenexa, Kansas, 66219
Indago Research & Health Center, Inc.
Miami Lakes, Florida, 33016
NYU Langone Health Vaccine Center
New York, New York, 10016
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Peninsula Research Associates
Rolling Hills Estates, California, 90274
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, 65807
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65807
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults.
Participants will receive either:
Read more
- an experimental PG4 vaccine
- a PG4 vaccine comparator
- a standard 20vPnC vaccine comparator
- placebo. A placebo does not have any medicine in it but looks just like the study medicine.
Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
- Conditions
- Streptococcus Pneumoniae
- Being tested
- PG4 vaccine in Buffer 1 with low dose PA-001, PG4 in Buffer 1 with low dose PA-002, PG4 in Buffer 1 with high dose PA-001, PG4 vaccine in Buffer 1 with high dose PA-002, PG4 vaccine in Buffer 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG4 vaccine in Buffer 1 with low dose PA-001Biological
Multivalent pneumococcal conjugate vaccine
PG4 in Buffer 1 with low dose PA-002Biological
Multivalent pneumococcal conjugate vaccine
PG4 in Buffer 1 with high dose PA-001Biological
Multivalent pneumococcal conjugate vaccine
PG4 vaccine in Buffer 1 with high dose PA-002Biological
Multivalent pneumococcal conjugate vaccine
PG4 vaccine in Buffer 2Biological
Multivalent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccineBiological
(20vPnC)
Saline injectionBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 1 | Experimental | Not described Receives: Biological: PG4 vaccine in Buffer 1 with low dose PA-001 |
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 | Experimental | Not described Receives: Biological: PG4 vaccine in Buffer 1 with low dose PA-001 |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 1 | Experimental | Not described Receives: Biological: PG4 in Buffer 1 with low dose PA-002 |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 | Experimental | Not described Receives: Biological: PG4 in Buffer 1 with low dose PA-002 |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 1 | Experimental | Not described Receives: Biological: PG4 in Buffer 1 with high dose PA-001 |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 | Experimental | Not described Receives: Biological: PG4 in Buffer 1 with high dose PA-001 |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 1 | Experimental | Not described Receives: Biological: PG4 vaccine in Buffer 1 with high dose PA-002 |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 | Experimental | Not described Receives: Biological: PG4 vaccine in Buffer 1 with high dose PA-002 |
| PG4 vaccine; dose schedule 1 | Active comparator | Not described Receives: Biological: PG4 vaccine in Buffer 2; Biological: Saline injection |
| PG4 vaccine; dose schedule 2 | Active comparator | Not described Receives: Biological: PG4 vaccine in Buffer 2; Biological: Saline injection |
| 20vPnC; dose schedule 1 | Active comparator | Not described Receives: Biological: 20-valent pneumococcal conjugate vaccine; Biological: Saline injection |
| 20vPnC; dose schedule 2 | Active comparator | Not described Receives: Biological: 20-valent pneumococcal conjugate vaccine; Biological: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting prespecified local reactions after each dose.
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Measured: Within 7 days after each study intervention.
Percentage of participants reporting prespecified systemic reactions after each dose.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Measured: Within 7 days after each study intervention.
Percentage of participants reporting adverse events.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Measured: From signing of the ICD to 1 month after last study intervention.
Percentage of participants reporting serious adverse events.
Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
Measured: From signing of the ICD to 6 months after the last study intervention.
Percentage of participants reporting serious adverse events.
Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
Measured: From signing of the ICD to 12 months after the last study intervention.
Percentage of participants with abnormal hematology and chemistry laboratory values.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
Measured: Within 2 weeks after each study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start22 Jul 2025
- Primary completion21 Oct 2027 (estimated)
- Study completion21 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus PneumoniaeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086677
- Sponsor's protocol ID
- C4931020
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
- ClinicalTrials.gov ID
- NCT07086677
- Acronym / sponsor ID
- C4931020
- Conditions
- Streptococcus Pneumoniae
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 380 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 21 Oct 2027 (estimated)
- Study completion
- 21 Oct 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults.
Participants will receive either:
- an experimental PG4 vaccine
- a PG4 vaccine comparator
- a standard 20vPnC vaccine comparator
- placebo. A placebo does not have any medicine in it but looks just like the study medicine.
Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 1 | Experimental | Biological: PG4 vaccine in Buffer 1 with low dose PA-001 |
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 | Experimental | Biological: PG4 vaccine in Buffer 1 with low dose PA-001 |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 1 | Experimental | Biological: PG4 in Buffer 1 with low dose PA-002 |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 | Experimental | Biological: PG4 in Buffer 1 with low dose PA-002 |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 1 | Experimental | Biological: PG4 in Buffer 1 with high dose PA-001 |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 | Experimental | Biological: PG4 in Buffer 1 with high dose PA-001 |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 1 | Experimental | Biological: PG4 vaccine in Buffer 1 with high dose PA-002 |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 | Experimental | Biological: PG4 vaccine in Buffer 1 with high dose PA-002 |
| PG4 vaccine; dose schedule 1 | Active comparator | Biological: PG4 vaccine in Buffer 2, Biological: Saline injection |
| PG4 vaccine; dose schedule 2 | Active comparator | Biological: PG4 vaccine in Buffer 2, Biological: Saline injection |
| 20vPnC; dose schedule 1 | Active comparator | Biological: 20-valent pneumococcal conjugate vaccine, Biological: Saline injection |
| 20vPnC; dose schedule 2 | Active comparator | Biological: 20-valent pneumococcal conjugate vaccine, Biological: Saline injection |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study
Key exclusion criteria (1 listed)
- Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG4 vaccine in Buffer 1 with low dose PA-001Multivalent pneumococcal conjugate vaccine | Biological | PG4 vaccine with low dose adjuvant PA-001; dose schedule 1, PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 |
| PG4 in Buffer 1 with low dose PA-002Multivalent pneumococcal conjugate vaccine | Biological | PG4 vaccine with low dose adjuvant PA-002; dose schedule 1, PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 |
| PG4 in Buffer 1 with high dose PA-001Multivalent pneumococcal conjugate vaccine | Biological | PG4 vaccine with high dose adjuvant PA-001; dose schedule 1, PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 |
| PG4 vaccine in Buffer 1 with high dose PA-002Multivalent pneumococcal conjugate vaccine | Biological | PG4 vaccine with high dose adjuvant PA-002; dose schedule 1, PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 |
| PG4 vaccine in Buffer 2Multivalent pneumococcal conjugate vaccine | Biological | PG4 vaccine; dose schedule 1, PG4 vaccine; dose schedule 2 |
| 20-valent pneumococcal conjugate vaccine(20vPnC) | Biological | 20vPnC; dose schedule 1, 20vPnC; dose schedule 2 |
| Saline injectionPlacebo | Biological | 20vPnC; dose schedule 1, 20vPnC; dose schedule 2, PG4 vaccine; dose schedule 1, PG4 vaccine; dose schedule 2 |
Primary outcome
Percentage of participants reporting prespecified local reactions after each dose.
Time frame: Within 7 days after each study intervention.
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting prespecified systemic reactions after each dose.
Time frame: Within 7 days after each study intervention.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Percentage of participants reporting adverse events.
Time frame: From signing of the ICD to 1 month after last study intervention.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Percentage of participants reporting serious adverse events.
Time frame: From signing of the ICD to 6 months after the last study intervention.
Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
Percentage of participants reporting serious adverse events.
Time frame: From signing of the ICD to 12 months after the last study intervention.
Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
Percentage of participants with abnormal hematology and chemistry laboratory values.
Time frame: Within 2 weeks after each study intervention.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Streptococcus Pneumoniae
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
RecruitingObservational study
Bacteriological Evaluation of Children With Otorrhea
Otorrhea
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PG4 vaccine in Buffer 1 with low dose PA-001, PG4 in Buffer 1 with low dose PA-002 and PG4 in Buffer 1 with high dose PA-001 in people with Streptococcus Pneumoniae, run by Pfizer at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting prespecified local reactions after each dose. (time frame: Within 7 days after each study intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.