Pneumococcal DiseasesPhase 3NCT07754539
A Study to Evaluate 20vPnC in Healthy Chinese Infants
A Phase 3 study testing 20vPnC and 13vPnC in people with Pneumococcal Diseases, run by Pfizer at 4 sites in China.
Trial summary
The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). Read more about this study
- Who is it for?
- Ages 42 to 98 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Diseases
- 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
- 1,250 participants
- Where
- 4 sitesChina
- Study dates
- 25 Jul 2026to 31 May 2031
- 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 42 to 98 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female infants born at ≥37 weeks of gestation and who are approximately 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered Day 1 of life) will be enrolled.
Who cannot join
- history of a severe adverse reaction associated with a vaccine and/or severe allergic reactions to any component of the study intervention.
- significant neurological disorder or history of seizure or significant stable or evolving disorders.
- major known congenital malformation or serious chronic disorder.
- history of microbiologically proven invasive disease caused by S. pneumoniae.
- known or suspected immunodeficiency or other conditions associated with immunosuppression.
- previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, 542800
- Recruiting
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530021
- Recruiting
Wuming District Center for Disease Control and Prevention
Nanning, Guangxi, 530199
- Recruiting
Zhongshan County Center for Disease Control and Prevention
Zhongshan Town, Guangxi, 542600
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) IN HEALTHY CHINESE INFANTS
The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants.
The study is seeking participants who:
Read more
- Are healthy infants
- Aged 42 to 98 days of age at the time of consent.
Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses.
The total time of the study will be about 16 to 19 months. A subset of infants will be asked to stay in the study for longer.
- Conditions
- Pneumococcal Diseases
- 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
20vPnC vaccine
13vPnCBiological
13vPnC vaccine
| Study group | Role | What they receive |
|---|---|---|
| 13vPnC group | Active comparator | Participants receive 13vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4) Receives: Biological: 13vPnC |
| 20vPnC group | Experimental | Participants receive 20vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4) Receives: Biological: 20vPnC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting prespecified local reactions
Measured: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting prespecified systemic events
Measured: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting Adverse Events (AEs) from the first study vaccination through 1 month following the third study vaccination.
Measured: From the first study vaccination to 1 month after the third study vaccination
Percentage of participants reporting AEs from the fourth study vaccination to 1 month following the fourth study vaccination.
Measured: From the fourth study vaccination to 1 month after the fourth study vaccination
Percentage of participants reporting serious adverse events (SAEs) through 6 months post last vaccination
Measured: From the first study vaccination to 6 months after the last study vaccination
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
Measured: At 1 month after Dose 3
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
Measured: At 1 month after Dose 3
Secondary outcomes (3)
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 4
Measured: At 1 month after Dose 4
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 4
Measured: At 1 month after Dose 4
To further describe the immune response of 20vPnC
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Measured: At prior to Dose 1, 1 months after Dose 3, prior to Dose 4 and 1 month after Dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start25 Jul 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseasesStudies 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, Care provider, Investigator
- Enrolment
- 1,250 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
- NCT07754539
- Sponsor's protocol ID
- B7471022
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 10 Aug 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 AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) IN HEALTHY CHINESE INFANTS
- ClinicalTrials.gov ID
- NCT07754539
- Acronym / sponsor ID
- B7471022
- Conditions
- Pneumococcal Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 10 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 evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants.
The study is seeking participants who:
- Are healthy infants
- Aged 42 to 98 days of age at the time of consent.
Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses.
The total time of the study will be about 16 to 19 months. A subset of infants will be asked to stay in the study for longer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13vPnC group | Active comparator | Biological: 13vPnCParticipants receive 13vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4) |
| 20vPnC group | Experimental | Biological: 20vPnCParticipants receive 20vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4) |
Who may qualify
- Ages
- 42 to 98 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy male or female infants born at ≥37 weeks of gestation and who are approximately 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered Day 1 of life) will be enrolled.
Key exclusion criteria (6 listed)
- history of a severe adverse reaction associated with a vaccine and/or severe allergic reactions to any component of the study intervention.
- significant neurological disorder or history of seizure or significant stable or evolving disorders.
- major known congenital malformation or serious chronic disorder.
- history of microbiologically proven invasive disease caused by S. pneumoniae.
- known or suspected immunodeficiency or other conditions associated with immunosuppression.
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 |
|---|---|---|
| 20vPnC20vPnC vaccine | Biological | 20vPnC group |
| 13vPnC13vPnC vaccine | Biological | 13vPnC group |
Primary outcome
Percentage of participants reporting prespecified local reactions
Time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting prespecified systemic events
Time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting Adverse Events (AEs) from the first study vaccination through 1 month following the third study vaccination.
Time frame: From the first study vaccination to 1 month after the third study vaccination
Percentage of participants reporting AEs from the fourth study vaccination to 1 month following the fourth study vaccination.
Time frame: From the fourth study vaccination to 1 month after the fourth study vaccination
Percentage of participants reporting serious adverse events (SAEs) through 6 months post last vaccination
Time frame: From the first study vaccination to 6 months after the last study vaccination
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
Time frame: At 1 month after Dose 3
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
Time frame: At 1 month after Dose 3
3 secondary outcomes
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 4
Time frame: At 1 month after Dose 4
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 4
Time frame: At 1 month after Dose 4
To further describe the immune response of 20vPnC
Time frame: At prior to Dose 1, 1 months after Dose 3, prior to Dose 4 and 1 month after Dose 4
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 10 Aug 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
4 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 20vPnC and 13vPnC in people with Pneumococcal Diseases, run by Pfizer at 4 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 6 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 reporting prespecified local reactions (time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4). The study lists 7 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 10 Aug 2026.