Pneumococcal DiseasePhase 3NCT05512819
A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
A Phase 3 study testing 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 11 sites in 2 countries.
Trial summary
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study Have a bodyweight of at least 3 kg Participants will… Read more about this study
- Who is it for?
- Ages 42 to 84 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 16 Sep 2022to 20 Sep 2025
- Phase
- Phase 3
- 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 42 to 84 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
- Weight of 3.0 kg or greater at the time of randomization
Who cannot join
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine.
- Major known congenital malformation or serious chronic disorder
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
India6 sites
Jawahar Lal Nehru Medical College
Ajmer, Rajasthan, 305001
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, 560060
Institute of Child Health
Kolkata, West Bengal, 700017
Maulana Azad Medical College and Associated with Lok Nayak Hospital
New Delhi, National Capital Territory of Delhi, 110002
Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
Pune, Maharashtra, 411043
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
Taiwan5 sites
Hsinchu Mackay Memorial Hospital
Hsinchu, Hsinchu, 30071
Taichung Veterans General Hospital
Taichung, 407219
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital
Taipei, 10449
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN IN A SERIES OF 3 INFANT DOSES AND 1 TODDLER DOSE IN INFANTS IN INDIA AND TAIWAN
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers.
This study is enrolling participants who are:
Read more
- Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study
- Have a bodyweight of at least 3 kg
Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age.
Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.
- Conditions
- Pneumococcal Disease
- Being tested
- 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-valent pneumococcal conjugate vaccineBiological
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccineBiological
13-valent pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine (20vPnC) Receives: Biological: 20-valent pneumococcal conjugate vaccine |
| 13-valent pneumococcal conjugate vaccine | Active comparator | Pneumococcal conjugate vaccine (13vPnC) Receives: Biological: 13-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country
Prompted local reactions after each dose
Measured: Day 7
Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country
Prompted systemic reactions after each dose
Measured: Day 7
Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country
Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group
Measured: Dose 1 to 1 month after Dose 3
Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country
Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group
Measured: Dose 4 to 1 month after Dose 4
Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country
SAEs occurring up to 1 month after Dose 4 in each group
Measured: Dose 1 to 1 month after Dose 4
GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group
IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only
Measured: 1 month after Dose 4
Secondary outcomes (4)
Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country
IgG GMCs for the 20vPnC serotypes 1 month after Dose 3
Measured: 1 month after Dose 3
Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country
IgG concentrations for 20vPnC serotypes 1 month after Dose 3
Measured: 1 month after Dose 3
GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group
IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only
Measured: 1 month after Dose 4
Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country
IgG concentrations for 20vPnC serotypes 1 month after Dose 4
Measured: 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 posted23 Aug 2022
- Study start16 Sep 2022
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 541 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
- NCT05512819
- Sponsor's protocol ID
- B7471024
- Other IDs
- NCT05512819
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2022
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. 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 A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN IN A SERIES OF 3 INFANT DOSES AND 1 TODDLER DOSE IN INFANTS IN INDIA AND TAIWAN
- ClinicalTrials.gov ID
- NCT05512819
- Acronym / sponsor ID
- B7471024
- Conditions
- Pneumococcal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 23 Aug 2022 (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 understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers.
This study is enrolling participants who are:
- Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study
- Have a bodyweight of at least 3 kg
Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age.
Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Experimental | Biological: 20-valent pneumococcal conjugate vaccinePneumococcal conjugate vaccine (20vPnC) |
| 13-valent pneumococcal conjugate vaccine | Active comparator | Biological: 13-valent pneumococcal conjugate vaccinePneumococcal conjugate vaccine (13vPnC) |
Who may qualify
- Ages
- 42 to 84 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
- Weight of 3.0 kg or greater at the time of randomization
Key exclusion criteria (4 listed)
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine.
- Major known congenital malformation or serious chronic disorder
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
- 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 |
|---|---|---|
| 20-valent pneumococcal conjugate vaccine20-valent pneumococcal conjugate vaccine | Biological | 20-valent pneumococcal conjugate vaccine |
| 13-valent pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine | Biological | 13-valent pneumococcal conjugate vaccine |
Primary outcome
Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country
Time frame: Day 7
Prompted local reactions after each dose
Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country
Time frame: Day 7
Prompted systemic reactions after each dose
Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country
Time frame: Dose 1 to 1 month after Dose 3
Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group
Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country
Time frame: Dose 4 to 1 month after Dose 4
Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group
Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country
Time frame: Dose 1 to 1 month after Dose 4
SAEs occurring up to 1 month after Dose 4 in each group
GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group
Time frame: 1 month after Dose 4
IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only
4 secondary outcomes
Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country
Time frame: 1 month after Dose 3
Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country
Time frame: 1 month after Dose 3
GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group
Time frame: 1 month after Dose 4
Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country
Time frame: 1 month after Dose 4
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 15 Dec 2025.
- 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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 11 sites in 2 countries.
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 3 inclusion and 4 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India, Taiwan. 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?
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 in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country (time frame: Day 7). 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?
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 15 Dec 2025.