Pneumococcal DiseaseNCT06622109
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
An observational study of Pneumococcal Disease, run by Pfizer at 1 site in Japan.
Trial summary
The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan. This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time. Read more about this study
- Who is it for?
- Ages 2 to 6 months
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 20-valent Pneumococcal Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,100 participants
- Where
- 1 siteJapan
- Study dates
- 25 Nov 2024to 4 Dec 2026
- Phase
- Observational
- 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 2 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants aged 2 months, inclusive, to 7 months, exclusive who PREVENAR 20 for the first time.
Who may be able to join
- Infants aged 2 months, inclusive, to 7 months, exclusive
- Those without a history of pneumococcal vaccination including PREVENAR 20
- Those who are expected to receive 4 doses
- Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes.
- Exclusion Criteria:There are no exclusion criteria for this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - INVESTIGATION IN INFANTS STARTING VACCINATION AT THE AGE OF 2 MONTH, INCLUSIVE, TO 7 MONTHS, EXCLUSIVE -
The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.
This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.
Read more
Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.
Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.
The side effects observed in the participants will be recorded and looked into.
- Conditions
- Pneumococcal Disease
- Being tested
- 20-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
Injection in the muscle or subcutaneous , 1 dose 0.5mL
| Study group | Role | What they receive |
|---|---|---|
| 20-valent Pneumococcal Conjugate Vaccine | Infants aged 2 months, inclusive to 7 months, exclusive who have been vaccinated with PREVENAR 20 for the first time. Receives: Biological: 20-valent Pneumococcal Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Adverse Reactions(ADRs)
Measured: From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th).
Percentage of Participants Reporting Serious Adverse Reactions (SADRs)
Measured: From the first day of 1st vaccination up to 28 days after 4th vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start25 Nov 2024
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Dec 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 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
- NCT06622109
- Sponsor's protocol ID
- B7471035
- Other IDs
- NCT06622109
- Status last verified
- Nov 2026
- First submitted
- 28 Sep 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - INVESTIGATION IN INFANTS STARTING VACCINATION AT THE AGE OF 2 MONTH, INCLUSIVE, TO 7 MONTHS, EXCLUSIVE -
- ClinicalTrials.gov ID
- NCT06622109
- Acronym / sponsor ID
- B7471035
- Conditions
- Pneumococcal Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 4 Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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 learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.
This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.
Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.
Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.
The side effects observed in the participants will be recorded and looked into.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20-valent Pneumococcal Conjugate Vaccine | – | Biological: 20-valent Pneumococcal Conjugate VaccineInfants aged 2 months, inclusive to 7 months, exclusive who have been vaccinated with PREVENAR 20 for the first time. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants aged 2 months, inclusive, to 7 months, exclusive who PREVENAR 20 for the first time.
Key inclusion criteria (5 listed)
- Infants aged 2 months, inclusive, to 7 months, exclusive
- Those without a history of pneumococcal vaccination including PREVENAR 20
- Those who are expected to receive 4 doses
- Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes.
- Exclusion Criteria:There are no exclusion criteria for this study.
Key exclusion criteria (0 listed)
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 VaccineInjection in the muscle or subcutaneous , 1 dose 0.5mL | Biological | 20-valent Pneumococcal Conjugate Vaccine |
Primary outcome
Percentage of Participants Reporting Adverse Reactions(ADRs)
Time frame: From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th).
Percentage of Participants Reporting Serious Adverse Reactions (SADRs)
Time frame: From the first day of 1st vaccination up to 28 days after 4th vaccination.
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 5 Nov 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Disease, run by Pfizer at 1 site in Japan.
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 5 inclusion and 0 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
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 Adverse Reactions(ADRs) (time frame: From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th).). The study lists 2 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 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.