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

Active, not recruiting

• Conditions: Pneumococcal Disease
• Interventions: Biological: 20-valent Pneumococcal Conjugate Vaccine

• Registration Number: NCT06622109
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-28
• Study First Submitted QC: 2024-09-28
• Study First Posted: 2024-10-01
• Study Start: 2024-11-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2027-03-24
• Study Completion: 2027-03-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1100

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 exclusion criteria for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
20-valent Pneumococcal Conjugate Vaccine	20-valent Pneumococcal Conjugate Vaccine	Infants aged 2 months, inclusive to 7 months, exclusive who have been vaccinated with PREVENAR 20 for the first time.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan