Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622109
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - Investigation in Infants Starting Vaccination at the Age of 2 Months Inclusive to 7 Months Exclusive -
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: