Pneumococcal DiseasePhase 1NCT07023081

A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant

A Phase 1 study testing 20vPnC and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC) among adults, children, and infants, as well as the immunogenicity of 20vPnC among infants and children under 2 years of age in China. Read more about this study

Who is it for?: Ages 42 days to 49 yearsHealthy 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: 200 participants
Where: 2 sitesChina
Study dates: 15 Jun 2025to 10 Jun 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 42 days to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Male or female participants:
Adults ≥18 to <50 years of age
Children ≥2 to <6 years of age
Children ≥12 months to <2 years of age
Infants ≥7 to <12 months of age
Infants ≥42 to ≤98 days of age
Healthy participants determined by clinical assessment and clinical judgment, to be eligible for the study.

Who cannot join

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention, or any diphtheria toxoid-containing vaccine.
History of microbiologically proven invasive disease caused by S pneumoniae.
Congenital, functional, or surgical asplenia.
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s).
Please refer to the study contact for further eligibility details.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Wuming District Center for Disease Control and Prevention
Chengxiang, Nanning, 530199
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530021

Other trials in China

About this study

Official title: A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHINESE ADULTS, CHILDREN, AND INFANTS

This study is seeking healthy participants of 6 groups:

Group 1: Adults ≥18 to <50 years of age
Group 2: Children ≥2 to <6 years of age
Group 3: Children ≥12 months to <2 years of age
Group 4: Infants ≥7 to <12 months of age
Group 5: Infants ≥42 to ≤98 days of age
Group 6: Infants ≥42 to ≤98 days of age

All participants in Group 1 to 5, in this study will receive 20vPnC as per the age-specific dosing schedules:

Group 1: participants will receive 1 dose of 20vPnC.
Group 2: participants will receive 1 dose of 20vPnC.
Group 3: participants will receive 2 doses of 20vPnC. Dose 2 will be given 56 to 70 days after Dose 1.
Group 4: participants will receive 3 doses of 20vPnC. Dose 2 will be given 28 to 56 days after Dose 1, and Dose 3 will be given at 365 to <455 days of age and at least 56 days after Dose 2.
Group 5: participants will receive 4 doses of 20vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.

Participants in Group 6 will be randomized in a 1:1 ratio to received either 20vPnC or 13vPnC:

Group 6: participants will receive 4 doses of 20vPnC or 13vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.

The study will look at the experiences of people receiving the study vaccine. The study will also look at the immune response of some people receiving the study vaccine. This will help decide if the study vaccine is safe.

The total duration of taking part in the study from each group is:

Participants in Group 1 and Group 2 will take part for about 6 months, with 6 visits.
Participants in Group 3 will take part for about 8 months, with 9 visits.
Participants in Group 4 will take part for about 12 months, with 8 visits.
Participants in Group 5 and 6 will take part for about 16 to 19 months, with 11 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
20vPnC vaccine
13vPnCBiological
13vPnC vaccine

Study groups in NCT07023081
Study group	Role	What they receive
Cohort 1	Experimental	Participants will receive 1 dose of 20vPnC Vaccine. Receives: Biological: 20vPnC
Cohort 2	Experimental	Participants will receive 1 dose of 20vPnC Vaccine. Receives: Biological: 20vPnC
Cohort 3	Experimental	Participants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2). Receives: Biological: 20vPnC
Cohort 4	Experimental	Participants will receive 3 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 28 to 56 days after Vaccination 1 (Vaccination 2), and at 365 to <455 days of age and at least 56 days after Vaccination 2 (Vaccination 3). Receives: Biological: 20vPnC
Cohort 5	Experimental	Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4). Receives: Biological: 20vPnC
Cohort 6 (20vPnC)	Experimental	Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4). Receives: Biological: 20vPnC
Cohort 6 (13vPnC)	Active comparator	Participants will receive 4 doses of 13vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4). Receives: Biological: 13vPnC

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of participants reporting prespecified local reactions within 7 days following each study intervention
Prespecified local reactions following each study intervention
Measured: Within 7 days of each study intervention
Percentage of participants reporting prespecified systemic events within 7 days following each study intervention
Prespecified systemic events following each study intervention
Measured: Within 7 days of each study intervention
Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration
AEs occurring through 1 month following the last study intervention administration for participants of adults ≥18 to <50 years of age at the time of consent, and children and infants ≥7 months to <6 years of age at the time of consent.
Measured: 1 month after the last vaccination
Percentage of participants reporting AEs from the first study intervention through 1 month following the third study intervention.
AEs occurring from the first study intervention through 1 month following the third study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Measured: From the first study intervention to 1 month after the third study intervention
Percentage of participants reporting AEs from the fourth study intervention to 1 month following the fourth study intervention.
AEs occurring from the fourth study intervention to 1 month following the fourth study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Measured: From the fourth study intervention to 1 month after the fourth study intervention
Percentage of participants reporting serious adverse events (SAEs) throughout the study
SAEs through 6 months following last study intervention
Measured: From the first study intervention to 6 months after the last study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202510 Jun 2027

First posted15 Jun 2025
Study start15 Jun 2025
Primary completion10 Jun 2027 (estimated)
Study completion10 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07023081
Sponsor's protocol ID: B7471021
Status last verified: Oct 2026
First submitted: 8 Jun 2025
Last updated: 23 Oct 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pneumococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHINESE ADULTS, CHILDREN, AND INFANTS
ClinicalTrials.gov ID: NCT07023081
Acronym / sponsor ID: B7471021
Conditions: Pneumococcal Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 200 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Jun 2025 (actual)
Primary completion: 10 Jun 2027 (estimated)
Study completion: 10 Jun 2027 (estimated)
First posted: 15 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 study is seeking healthy participants of 6 groups:

Group 1: Adults ≥18 to <50 years of age
Group 2: Children ≥2 to <6 years of age
Group 3: Children ≥12 months to <2 years of age
Group 4: Infants ≥7 to <12 months of age
Group 5: Infants ≥42 to ≤98 days of age
Group 6: Infants ≥42 to ≤98 days of age

All participants in Group 1 to 5, in this study will receive 20vPnC as per the age-specific dosing schedules:

Group 1: participants will receive 1 dose of 20vPnC.
Group 2: participants will receive 1 dose of 20vPnC.
Group 3: participants will receive 2 doses of 20vPnC. Dose 2 will be given 56 to 70 days after Dose 1.
Group 4: participants will receive 3 doses of 20vPnC. Dose 2 will be given 28 to 56 days after Dose 1, and Dose 3 will be given at 365 to <455 days of age and at least 56 days after Dose 2.
Group 5: participants will receive 4 doses of 20vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.

Participants in Group 6 will be randomized in a 1:1 ratio to received either 20vPnC or 13vPnC:

Group 6: participants will receive 4 doses of 20vPnC or 13vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.

The total duration of taking part in the study from each group is:

Participants in Group 1 and Group 2 will take part for about 6 months, with 6 visits.
Participants in Group 3 will take part for about 8 months, with 9 visits.
Participants in Group 4 will take part for about 12 months, with 8 visits.
Participants in Group 5 and 6 will take part for about 16 to 19 months, with 11 visits.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Cohort 1	Experimental	Biological: 20vPnCParticipants will receive 1 dose of 20vPnC Vaccine.
Cohort 2	Experimental	Biological: 20vPnCParticipants will receive 1 dose of 20vPnC Vaccine.
Cohort 3	Experimental	Biological: 20vPnCParticipants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2).
Cohort 4	Experimental	Biological: 20vPnCParticipants will receive 3 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 28 to 56 days after Vaccination 1 (Vaccination 2), and at 365 to <455 days of age and at least 56 days after Vaccination 2 (Vaccination 3).
Cohort 5	Experimental	Biological: 20vPnCParticipants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4).
Cohort 6 (20vPnC)	Experimental	Biological: 20vPnCParticipants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4).
Cohort 6 (13vPnC)	Active comparator	Biological: 13vPnCParticipants will receive 4 doses of 13vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4).

Who may qualify

Ages: 42 days to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Male or female participants:
Healthy participants determined by clinical assessment and clinical judgment, to be eligible for the study.

Key exclusion criteria (6 listed)

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention, or any diphtheria toxoid-containing vaccine.
History of microbiologically proven invasive disease caused by S pneumoniae.
Congenital, functional, or surgical asplenia.
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s).

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	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 (20vPnC)
13vPnC13vPnC vaccine	Biological	Cohort 6 (13vPnC)

Primary outcome

Percentage of participants reporting prespecified local reactions within 7 days following each study intervention
Time frame: Within 7 days of each study intervention
Prespecified local reactions following each study intervention
Percentage of participants reporting prespecified systemic events within 7 days following each study intervention
Time frame: Within 7 days of each study intervention
Prespecified systemic events following each study intervention
Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration
Time frame: 1 month after the last vaccination
AEs occurring through 1 month following the last study intervention administration for participants of adults ≥18 to <50 years of age at the time of consent, and children and infants ≥7 months to <6 years of age at the time of consent.
Percentage of participants reporting AEs from the first study intervention through 1 month following the third study intervention.
Time frame: From the first study intervention to 1 month after the third study intervention
AEs occurring from the first study intervention through 1 month following the third study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Percentage of participants reporting AEs from the fourth study intervention to 1 month following the fourth study intervention.
Time frame: From the fourth study intervention to 1 month after the fourth study intervention
AEs occurring from the fourth study intervention to 1 month following the fourth study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Time frame: From the first study intervention to 6 months after the last study intervention
SAEs through 6 months following last 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 23 Oct 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

2 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 2 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 7 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: under way, not looking for participants, as of the sponsor's last update on 23 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 2 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?

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 within 7 days following each study intervention (time frame: Within 7 days of 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?

On the ClinicalTrials.gov record for NCT07023081.

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 23 Oct 2026.