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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, 151-8589, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

There are no exclusion criteria for this study.

Treatment and study plan

20-valent pneumococcal conjugate vaccine

Biological

Injection in the muscle or subcutaneous , 1 dose 0.5mL

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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 -

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 1, 2024
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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