A Study of ProQuad™ in Healthy Children in Korea (V221-023)

Measles Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00839917
• Other study ID #: V221-023
• Secondary ID: 2009_538
• Status: Terminated
• Phase: Phase 3
• First received: February 6, 2009
• Last updated: October 1, 2015
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• Subject is in good health

• Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria:

• Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination

• Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity

• Subject has a history of seizure disorder

• Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks

• Subject has received an inactivated vaccine within the past 14 days

• Subject has received a live vaccine within the past 30 days

• Subject has received immune globulin within the past 5 months

• Subject has a recent history of fever (within the last 72 hours)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
Single administration of 0.5 mL subcutaneous injection
• M-M-R™ II and Varivax™
Single administration of 0.5 mL subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Measles-like Rash		Through 6 weeks postvaccination	Yes
Other	Percentage of Participants With Varicella-like Rash		Through 6 weeks postvaccination	Yes
Other	Percentage of Participants With Rubella-like Rash		Through 6 weeks postvaccination	Yes
Other	Percentage of Participants With Zoster-like Rash		Through 6 weeks postvaccination	Yes
Other	Percentage of Participants With Any Systemic Adverse Experience	An adverse experience is defined as any unfavorable and unintended change in the; structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences.	Through 6 weeks postvaccination	Yes
Other	Percentage of Participants With Injection-site Adverse Experiences	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.	Through 6 weeks postvaccination	Yes
Other	Percentage of Participants With Injection-site Adverse Experiences	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.	Through 5 days postvaccination	Yes
Other	Percentage of Participants With Fever (=101.0°F [38.3°C] Axillary or =103.0°F [39.4°C] Rectal)		Through 6 weeks postvaccination	Yes
Primary	Percentage of Participants With Measles Antibody Levels =255 mIU/mL	Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline	6 weeks postvaccination	No
Primary	Percentage of Participants With Mumps Antibody Levels =10 Mumps Antibody Units/mL	Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline	6 weeks postvaccination	No
Primary	Percentage of Participants With Rubella Antibody Levels =10 IU/mL	Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline	6 weeks postvaccination	No
Primary	Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels =5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL	Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline	6 weeks postvaccination	No
Secondary	Geometric Mean Titer of Measles Antibodies	Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline	6 weeks postvaccination	No
Secondary	Geometric Mean Titer of Mumps Antibodies	Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline	6 weeks postvaccination	No
Secondary	Geometric Mean Titer of Rubella Antibodies	Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline	6 weeks postvaccination	No
Secondary	Geometric Mean Titer of VZV (gpELISA) Antibodies	Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline	6 weeks postvaccination	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site