NCT06622109

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
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	20-valent Pneumococcal Conjugate Vaccine	Injection in the muscle or subcutaneous , 1 dose 0.5mL

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2024-10-01
• Last updated: 2026-03-12

Locations

1 site across 1 country: Japan