Active — Not RecruitingNot Applicable

A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months

Japan1,100 participantsStarted 2024-11-25

Plain-language 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. 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.

Who can participate

Age range

2 Months – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Reporting Adverse Reactions(ADRs)

Timeframe: 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)

Timeframe: From the first day of 1st vaccination up to 28 days after 4th vaccination.

Trial details

NCT IDNCT06622109

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-15

View on ClinicalTrials.gov More Pneumococcal Disease trials