Pneumococcal DiseasePhase 1NCT07019909
A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults
A Phase 1 study testing 20vPnC and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 3 sites in China.
Trial summary
This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 20vPnC and 13vPnC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 6 Jul 2025to 28 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment.
Who cannot join
- History of microbiologically-proven invasive disease caused by Streptococcus pneumoniae
- Previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, 310051
Kaihua County Center For Disease Prevention and Control
Kaihua, Zhejiang, 324300
Kaihua County Center For Disease Prevention and Control
Quzhou, Zhejiang, 324300
About this study
Official title: A Phase 1, Randomized, Double-Blind, Third-Party-Unblinded Trial to Evaluate the Safety and Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) and 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older in China
This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past
Read the detailed description
The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who:
- are 50 years of age and older
- did not receive any of vaccines used to treat infections caused by the bacteria called Streptococcus pneumonia in the past.
The participants will be grouped by three age groups:
- Adults between 50 to 59 years of age
- Adults between 60 to 64 years of age
- Adults who are 65 years of age or above
All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe.
The total duration of taking part in the study will be around 6 months, with 6 visits.
- Conditions
- Pneumococcal Disease
- Being tested
- 20vPnC, 13vPnC
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20vPnCBiological
20 valent pneumococcal conjugate vaccine
13vPnCBiological
13 valent pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| 20vPnC | Experimental | Single dose of 20-valent pneumococcal conjugate vaccine Receives: Biological: 20vPnC |
| 13vPnC | Experimental | Single dose of 13-valent pneumococcal conjugate vaccine Receives: Biological: 13vPnC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Prespecified local reactions (redness, swelling, and pain at the injection site)
Measured: Within 7 days after vaccination
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain)
Measured: Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Adverse events occurring within 1 month after vaccination
Measured: Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) throughout the study
SAEs occurring within 6 months after vaccination
Measured: Within 6 months after vaccination
Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
Measured: 3 to 5 days after vaccination
Secondary outcomes (2)
Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT)
Pneumococcal serotype-specific OPA GMTs
Measured: 1 month after vaccination
Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR)
Pneumococcal serotype-specific OPA GMFRs
Measured: 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 posted13 Jun 2025
- Study start6 Jul 2025
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 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
- NCT07019909
- Sponsor's protocol ID
- B7471039
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Third-Party-Unblinded Trial to Evaluate the Safety and Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) and 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older in China
- ClinicalTrials.gov ID
- NCT07019909
- Acronym / sponsor ID
- B7471039
- Conditions
- Pneumococcal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 13 Jun 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.
This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past
Detailed description
The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who:
- are 50 years of age and older
- did not receive any of vaccines used to treat infections caused by the bacteria called Streptococcus pneumonia in the past.
The participants will be grouped by three age groups:
- Adults between 50 to 59 years of age
- Adults between 60 to 64 years of age
- Adults who are 65 years of age or above
All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe.
The total duration of taking part in the study will be around 6 months, with 6 visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20vPnC | Experimental | Biological: 20vPnCSingle dose of 20-valent pneumococcal conjugate vaccine |
| 13vPnC | Experimental | Biological: 13vPnCSingle dose of 13-valent pneumococcal conjugate vaccine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment.
Key exclusion criteria (2 listed)
- History of microbiologically-proven invasive disease caused by Streptococcus pneumoniae
- Previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.
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 |
|---|---|---|
| 20vPnC20 valent pneumococcal conjugate vaccine | Biological | 20vPnC |
| 13vPnC13 valent pneumococcal conjugate vaccine | Biological | 13vPnC |
Primary outcome
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Time frame: Within 7 days after vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site)
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Time frame: Within 7 days after vaccination
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain)
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Time frame: Within 1 month after vaccination
Adverse events occurring within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Time frame: Within 6 months after vaccination
SAEs occurring within 6 months after vaccination
Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
Time frame: 3 to 5 days after vaccination
Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
2 secondary outcomes
Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT)
Time frame: 1 month after vaccination
Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR)
Time frame: Before vaccination to 1 month after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 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.
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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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
3 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 20vPnC and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 3 sites in China.
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 2 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: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 prompted local reactions within 7 days following investigational product administration (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 25 Feb 2026.