A Study of ProQuad™ in Healthy Children in Korea (V221-023)
This study has been terminated.
(Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot)
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00839917
First received: February 6, 2009
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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™.
| Condition | Intervention | Phase |
|---|---|---|
|
Measles Mumps Rubella Varicella |
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™) Biological: M-M-R™ II and Varivax™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
- Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
- Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
- Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline
Secondary Outcome Measures:
- Geometric Mean Titer of Measles Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
- Geometric Mean Titer of Mumps Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
- Geometric Mean Titer of Rubella Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
- Geometric Mean Titer of VZV (gpELISA) Antibodies [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline
Other Outcome Measures:
- Percentage of Participants With Measles-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
- Percentage of Participants With Varicella-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
- Percentage of Participants With Rubella-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
- Percentage of Participants With Zoster-like Rash [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
- Percentage of Participants With Any Systemic Adverse Experience [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]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.
- Percentage of Participants With Injection-site Adverse Experiences [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]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 occurrs at the injection site only.
- Percentage of Participants With Injection-site Adverse Experiences [ Time Frame: Through 5 days postvaccination ] [ Designated as safety issue: Yes ]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 occurrs at the injection site only.
- Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal) [ Time Frame: Through 6 weeks postvaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ProQuad™ |
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
Single administration of 0.5 mL subcutaneous injection
Other Name: V221
|
| Active Comparator: M-M-R™ II and Varivax™ |
Biological: M-M-R™ II and Varivax™
Single administration of 0.5 mL subcutaneous injection
|
Eligibility| Ages Eligible for Study: | 12 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00839917 History of Changes |
| Other Study ID Numbers: | V221-023, 2009_538 |
| Study First Received: | February 6, 2009 |
| Results First Received: | September 7, 2012 |
| Last Updated: | November 8, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Merck:
|
Measles Mumps Rubella Varicella |
Additional relevant MeSH terms:
|
Chickenpox Herpes Zoster Measles Mumps Parotitis Rubella Herpesviridae Infections DNA Virus Infections Virus Diseases Morbillivirus Infections Paramyxoviridae Infections |
Mononegavirales Infections RNA Virus Infections Rubulavirus Infections Parotid Diseases Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Sialadenitis Rubivirus Infections Togaviridae Infections |
ClinicalTrials.gov processed this record on June 18, 2013