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

PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - Investigation in Infants Starting Vaccination at the Age of 2 Month, Inclusive, to 7 Months, Exclusive -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06622109

Enrollment

1100

Registered

2024-10-01

Start date

2024-11-25

Completion date

2026-12-15

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Disease

Brief 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.

Interventions

BIOLOGICAL20-valent Pneumococcal Conjugate Vaccine

Injection in the muscle or subcutaneous , 1 dose 0.5mL

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 6 Months

Healthy volunteers

Inclusion criteria

1. Infants aged 2 months, inclusive, to 7 months, exclusive 2. Those without a history of pneumococcal vaccination including PREVENAR 20 3. Those who are expected to receive 4 doses 4. 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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Reporting Adverse Reactions(ADRs)	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)	From the first day of 1st vaccination up to 28 days after 4th vaccination.

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026