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

Pfizer

Status

Active, not recruiting

Conditions

Pneumococcal Disease

Treatments

Biological: 20-valent Pneumococcal Conjugate Vaccine

Study type

Observational

Funder types

Industry

Identifiers

NCT06622109

NCT06622109 (Registry Identifier)

B7471035

Details and patient eligibility

About

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.

Enrollment

1,100 patients

Sex

All

Ages

2 to 6 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.