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

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?

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