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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-25

Study Completion Date

2027-01-15

Brief Summary

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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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Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

20-valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

Injection in the muscle or subcutaneous , 1 dose 0.5mL

Interventions

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20-valent Pneumococcal Conjugate Vaccine

Injection in the muscle or subcutaneous , 1 dose 0.5mL

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No