Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432523
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2007-02-07
Brief Title:
Immunogenicity and Safety of Concomitant Administration of MMR rHA and VARIVAX by Intramuscular Versus Subcutaneous Route V205C-011
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
An Open Randomised Comparative Multicentre Study of the Immunogenicity and Safety of M-M-RII Manufactured With Recombinant Human Albumin rHA and VARIVAX When Administered Concomitantly by Intramuscular IM Route or Subcutaneous SC Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age
Status:
COMPLETED
Status Verified Date:
2021-10
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:
None
Brief Summary:
Primary objective
To compare if when given concomitantly with VARIVAX by the same route at 12-18 months of age using separate injection sites a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles mumps and rubella at 42 days following the vaccination
ANDOR
To compare if when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites a single dose of VARIVAX administered by IM route is as immunogenic as a single dose of VARIVAX administered by SC route in terms of response rate to varicella at 42 days following the vaccination
Secondary objectives
To summarise the antibody titres to measles mumps rubella and varicella at 42 days following the vaccination in children immunised with M-M-RII and VARIVAX administered concomitantly at two separate injection sites by the same route IM or SC
To evaluate the safety profiles of M-M-RII and VARIVAX administered concomitantly at two separate injection sites by the same route IM or SC
To compare if when given concomitantly with VARIVAX by the same route at 12-18 months of age using separate injection sites a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles mumps and rubella at 42 days following the vaccination
ANDOR
To compare if when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites a single dose of VARIVAX administered by IM route is as immunogenic as a single dose of VARIVAX administered by SC route in terms of response rate to varicella at 42 days following the vaccination
Secondary objectives
To summarise the antibody titres to measles mumps rubella and varicella at 42 days following the vaccination in children immunised with M-M-RII and VARIVAX administered concomitantly at two separate injection sites by the same route IM or SC
To evaluate the safety profiles of M-M-RII and VARIVAX administered concomitantly at two separate injection sites by the same route IM or SC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| X04-MMRr-301 | OTHER | MCMVaccBV SPMSD Secondary ID | None |