ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
NCT ID: NCT00975507
Last Updated: 2015-10-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
480 participants
INTERVENTIONAL
1998-03-31
1999-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
NCT00985153
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
NCT00985166
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
NCT00839917
ProQuad Dose Selection Study (V221-011)(COMPLETED)
NCT00986232
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
NCT00984295
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
ProQuad™ (V221) + Placebo Followed by ProQuad™
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
Comparator: Placebo
a single 0.5 mL subcutaneous placebo injection at Day 0
2
M-M-R™ II + VARIVAX™
Comparator: Varivax
a single 0.5 mL subcutaneous injection of Varivax at Day 0
Comparator: M-M-R II
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
Comparator: Placebo
a single 0.5 mL subcutaneous placebo injection at Day 0
Comparator: Varivax
a single 0.5 mL subcutaneous injection of Varivax at Day 0
Comparator: M-M-R II
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Negative clinical history of varicella, shingles, measles, mumps, and rubella
Exclusion Criteria
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Immune globulin or any blood product administered in the past 3 months
12 Months
23 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009_660
Identifier Type: -
Identifier Source: secondary_id
V221-009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.