Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397768
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-29
Brief Title:
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase III Randomized Single-blind Placebo-controlled Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus RSV Vaccine in Healthy Infants and Toddlers CORAL
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORAL
Brief Summary:
This study is a Phase III randomized single-blind placebo-controlled multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age Cohort 1 and approximately 12 months of age Cohort 2 The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler RSVt vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age Diphtheria and Tetanus Toxoids and Acellular Pertussis Inactivated Poliovirus Haemophilus b Conjugate and Hepatitis B Vaccine Vaxelis or Pentacel and Recombivax HB Prevnar 20 and RotaTeq and 12 months of age M-M-R II VARIVAX and Prevnar 20 or per local country recommendations compared to when administered non-concomitantly
Detailed Description:
The study duration is approximately 9 months for each participant
Cohort 1 Visits at 6 7 and 8 and 9 months of age for both groups with visit at 10 months of age for Group 2 only
Cohort 2 Visits at 12 13 14 and 15 months of age for both groups with visit at 16 months of age for Group 4 only
Routine pediatric vaccines authorized auxiliary medicinal products AxMP will be administered at 6 months in Cohort 1 and 12 months of age in Cohort 2 as per Advisory Committee on Immunization Practice ACIP or local country recommendations
Cohort 1 Visits at 6 7 and 8 and 9 months of age for both groups with visit at 10 months of age for Group 2 only
Cohort 2 Visits at 12 13 14 and 15 months of age for both groups with visit at 16 months of age for Group 4 only
Routine pediatric vaccines authorized auxiliary medicinal products AxMP will be administered at 6 months in Cohort 1 and 12 months of age in Cohort 2 as per Advisory Committee on Immunization Practice ACIP or local country recommendations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1290-7356 | REGISTRY | ICTRP | None |
| VAD00016 | OTHER | None | None |
| 2024-000262-15 | EUDRACT_NUMBER | None | None |