Pneumococcal DiseasePhase 3NCT07794748
A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
A Phase 3 study testing PG4 Multivalent Vaccine and 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 37 sites in United States.
Trial summary
The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine. This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- PG4 Multivalent Vaccine and 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,670 participants
- Where
- 37 sitesUnited States
- Study dates
- 8 Sep 2026to 7 Jun 2027
- Phase
- Phase 3
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.
Who cannot join
- Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
United States37 sites, 37 recruiting
- Recruiting
Achieve Clinical Research, LLC d/b/a Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216
- Recruiting
Clinical Research Professionals
Chesterfield, Missouri, 63005
- Recruiting
Cincinnati Children's Hospital Medical Center Investigational Drug Services
Cincinnati, Ohio, 45206
- Recruiting
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45206
- Recruiting
CTI Clinical Research Center
Cincinnati, Ohio, 45212
- Recruiting
Suncoast Research Associates
Doral, Florida, 33172
- Recruiting
Javara Inc.
Fayetteville, Georgia, 30214
- Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
- Recruiting
Henry Ford St. John Hospital - Thomas Mackey Center for Infectious Disease Research
Grosse Pointe Woods, Michigan, 48236
- Recruiting
Research Centers of America
Hollywood, Florida, 33024
- Recruiting
East-West Medical Research Institute
Honolulu, Hawaii, 96814
- Recruiting
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
- Recruiting
Orange County Research Center
Lake Forest, California, 92630
- Recruiting
DM Clinical Research
Melrose Park, Illinois, 60160
- Recruiting
SMS Clinical Research LLC
Mesquite, Texas, 75149
- Recruiting
Entrust Clinical Research
Miami, Florida, 33176
- Recruiting
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
- Recruiting
Indago Research and Health Center, Inc.
Miami Lakes, Florida, 33016
- Recruiting
Clinical Research Consulting
Milford, Connecticut, 06460
- Recruiting
Clinical Trials of South Carolina
Moncks Corner, South Carolina, 29461
- Recruiting
TMA Headlands LLC (d/b/a Trial Management Associates)
Myrtle Beach, South Carolina, 29572
- Recruiting
Coastal Carolina Research Center, LLC
North Charleston, South Carolina, 29405
- Recruiting
Innovation Medical Research, LLC
Palmetto Bay, Florida, 33157
- Recruiting
DM Clinical Research
Philadelphia, Pennsylvania, 19107
- Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
- Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
- Recruiting
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
- Recruiting
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
- Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802
- Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, 65807
- Recruiting
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
- Recruiting
Clinical Research Atlanta
Stockbridge, Georgia, 30281
- Recruiting
DM Clinical Research - Sugar Land
Sugar Land, Texas, 77478
- Recruiting
DM Clinical Research
Tomball, Texas, 77375
- Recruiting
Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California, 94598
- Recruiting
Palm Beach Research Center
West Palm Beach, Florida, 33409
- Recruiting
Accellacare - Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine.
This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines.
Read more
The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC.
Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC.
Each participant will take part in the study for approximately 6 months.
- Conditions
- Pneumococcal Disease
- Being tested
- PG4 Multivalent Vaccine, 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG4 Multivalent VaccineBiological
Also called PG4 lot 1
Multivalent Pneumococcal Vaccine
PG4 Multivalent VaccineBiological
Also called PG4 Lot 2
Multivalent Pneumococcal Vaccine
PG4 Multivalent VaccineBiological
Also called PG4 Lot 3
Multivalent Pneumococcal Vaccine
20 Valent Pneumococcal Conjugate Vaccine (20vPnC)Biological
Also called Prevnar 20
20 Valent Pneumococcal Conjugate Vaccine
| Study group | Role | What they receive |
|---|---|---|
| PG4 Vaccine Lot 3 | Experimental | Multivalent Pneumococcal Vaccine Receives: Biological: PG4 Multivalent Vaccine |
| PG4 Vaccine Lot 2 | Experimental | Multivalent Pneumococcal Vaccine Receives: Biological: PG4 Multivalent Vaccine |
| PG4 Vaccine Lot 1 | Experimental | Multivalent Pneumococcal Vaccine Receives: Biological: PG4 Multivalent Vaccine |
| 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) | Active comparator | 20 Valent Pneumococcal Conjugate Vaccine Receives: Biological: 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination
Prompted local reactions after each dose
Measured: Within 7 days after Vaccination
Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination
Prompted systemic events after each dose
Measured: Within 7 days after Vaccination
Percentage of Participants with Adverse Events (AEs)
AEs occurring from Dose 1 to 1 month after the vaccination
Measured: From Vaccination to 1 month after Vaccination
Percentage of Participants with Serious Adverse Events (SAEs)
SAEs occurring from Dose 1 to 6 months after the vaccination
Measured: From Vaccination to 6 months after Vaccination
OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots
OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination
Measured: 1 month after Vaccination
Secondary outcomes (4)
OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes
OPA GMTs at 1 month after vaccination
Measured: 1 month after Vaccination
OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes
GMFRs in OPA titers from before to 1 month after vaccination
Measured: From before vaccination to 1 month after vaccination
Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers
Percentages of participants with a ≥4-fold rise in OPA titers from before to 1 month after vaccination
Measured: From Vaccination to 6 months after Vaccination
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ)
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ) from before vaccination to 1 month after vaccination
Measured: From before vaccination to 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start8 Sep 2026
- Primary completion7 Jun 2027 (estimated)
- Study completion7 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4,670 participants (estimated)
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
- NCT07794748
- Sponsor's protocol ID
- C4931012
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
- ClinicalTrials.gov ID
- NCT07794748
- Acronym / sponsor ID
- C4931012
- Conditions
- Pneumococcal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,670 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 7 Jun 2027 (estimated)
- Study completion
- 7 Jun 2027 (estimated)
- First posted
- 31 Aug 2026 (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 provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine.
This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines.
The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC.
Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC.
Each participant will take part in the study for approximately 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PG4 Vaccine Lot 3 | Experimental | Biological: PG4 Multivalent VaccineMultivalent Pneumococcal Vaccine |
| PG4 Vaccine Lot 2 | Experimental | Biological: PG4 Multivalent VaccineMultivalent Pneumococcal Vaccine |
| PG4 Vaccine Lot 1 | Experimental | Biological: PG4 Multivalent VaccineMultivalent Pneumococcal Vaccine |
| 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) | Active comparator | Biological: 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)20 Valent Pneumococcal Conjugate Vaccine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.
Key exclusion criteria (1 listed)
- Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.
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 Multivalent VaccineAlso: PG4 lot 1Multivalent Pneumococcal Vaccine | Biological | PG4 Vaccine Lot 1 |
| PG4 Multivalent VaccineAlso: PG4 Lot 2Multivalent Pneumococcal Vaccine | Biological | PG4 Vaccine Lot 2 |
| PG4 Multivalent VaccineAlso: PG4 Lot 3Multivalent Pneumococcal Vaccine | Biological | PG4 Vaccine Lot 3 |
| 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)Also: Prevnar 2020 Valent Pneumococcal Conjugate Vaccine | Biological | 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) |
Primary outcome
Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination
Time frame: Within 7 days after Vaccination
Prompted local reactions after each dose
Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination
Time frame: Within 7 days after Vaccination
Prompted systemic events after each dose
Percentage of Participants with Adverse Events (AEs)
Time frame: From Vaccination to 1 month after Vaccination
AEs occurring from Dose 1 to 1 month after the vaccination
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: From Vaccination to 6 months after Vaccination
SAEs occurring from Dose 1 to 6 months after the vaccination
OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots
Time frame: 1 month after Vaccination
OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination
4 secondary outcomes
OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes
Time frame: 1 month after Vaccination
OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes
Time frame: From before vaccination to 1 month after vaccination
Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers
Time frame: From Vaccination to 6 months after Vaccination
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ)
Time frame: From before vaccination to 1 month after vaccination
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 14 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Pfizer CT.gov Call Center study director
Pfizer
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PG4 Multivalent Vaccine and 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 37 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 1 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination (time frame: Within 7 days after Vaccination). The study lists 5 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 14 Oct 2026.