Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432042
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2007-02-05
Brief Title:
Immunogenicity and Safety Study of Proquad and Infanrix Hexa When Administered Concomitantly V221-035
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 Concomitant Versus Separate Administration of a Combined Measles Mumps Rubella and Varicella Live Vaccine ProQuad and a Booster Dose of Infanrix Hexa in Healthy Children 12 to 23 Months of Age
Status:
COMPLETED
Status Verified Date:
2018-02
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 demonstrate that ProQuad can be administered concomitantly with a booster dose of Infanrix hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles mumps rubella varicella hepatitis B and Haemophilus influenzae type b or to the 3 pertussis antibody titres measured at 42 days following vaccination
Secondary Objectives
To describe the antibody titres and the antibody response rates to measles mumps rubella varicella diphtheria tetanus pertussis hepatitis B poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix hexa primary series schedule and all data are pooled
To evaluate the safety profile of ProQuad when administered concomitantly with a booster dose of Infanrix hexa by an Infanrix hexa primary series schedule and all data are pooled
To demonstrate that ProQuad can be administered concomitantly with a booster dose of Infanrix hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles mumps rubella varicella hepatitis B and Haemophilus influenzae type b or to the 3 pertussis antibody titres measured at 42 days following vaccination
Secondary Objectives
To describe the antibody titres and the antibody response rates to measles mumps rubella varicella diphtheria tetanus pertussis hepatitis B poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix hexa primary series schedule and all data are pooled
To evaluate the safety profile of ProQuad when administered concomitantly with a booster dose of Infanrix hexa by an Infanrix hexa primary series schedule and all data are pooled
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-004129-27 | EUDRACT_NUMBER | Sanofi Pasteur MSD Protocol Number | None |
| X06-MMRV-302 | OTHER | None | None |