Sanofi PSK05 Clinical Study
Austin Regional Clinic physicians constantly work to improve the care given to all our patients. We are dedicated to offering unique options for our patients and helping them reach their ideal health goals. Part of this dedication involves making clinical research available. Clinical research makes it possible to discover the benefits, risks, and safety of commercially available and investigational medications.
Research standards are very strict to help make studies as safe as possible. Teams of government and research experts have already reviewed each study we conduct to minimize any study risks. Austin Regional Clinic has decided to be involved in this research study because we believe it can potentially benefit our patients.
About the PSK05 clinical study
A phase III, randomized, modified double-blind, active-controlled, parallel-group, two-arm study to investigate the safety of a four-dose regimen of a 21-valent pneumococcal conjugate vaccine in healthy infants and toddlers.
By participating in this study, you would be contributing to the development of groundbreaking technology with the potential to benefit many people in the future. ARC is one of the many study centers in the United States participating in this research study.
What to expect
We are currently seeking candidates for a clinical research study. During the study, patients can expect:
- The study duration per participant will be up to 19 months.
- The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately two, four, six, and 12 to 15 months of age.
- For participants enrolled in the US, routine pediatric vaccines will be permitted anytime during the study, including at study visits.
- For participants enrolled in non-US countries, the hexavalent routine pediatric vaccine VaxelisTM, will be co-administered with either PCV21 or 20vPCV at two, four, and six months of age. Depending on local recommendations, the following routine pediatric vaccines may be co-administered with either PCV21 or 20vPCV to participants enrolled in non-US countries:
- RotaTeqTM or RotarixTM at two, four, and six months of age or at two and four months of age, respectively
- M-M-R IITM or PriorixTM, VarivaxTM, VaqtaTM or HavrixTM at 12 to 15 months of age
- Participants must not receive any BCG vaccine within four weeks before first study vaccine administration and throughout the study.
- Other routine pediatric vaccines recommended as per local recommendation will be permitted during the study period. These vaccines should be US Food and Drug Administration (FDA) approved if administered during the study visits. Other non-US FDA approved pediatric vaccines can be administered as per local recommendations provided, they are administered at least four weeks before or after the study vaccines administration.
- There will be six study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
Eligibility criteria
All participants must be:
- Aged 42 to 89 days on the day of inclusion
Location
Request to participate
Please contact our ARC Clinical Research team to request to participate by calling 737-247-7240.