Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-26

Study Completion Date

2008-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella \[Oka/Merck\] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.

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

Measles Mumps Rubella +1 more

COMPLETED PHASE3

ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

NCT00975507

Measles Mumps Rubella +1 more

COMPLETED PHASE3

ProQuad Dose Selection Study (V221-011)(COMPLETED)

NCT00986232

Measles Mumps Rubella +1 more

COMPLETED PHASE2

A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

NCT00985166

Measles Mumps Rubella +1 more

COMPLETED PHASE3

Immune Responses to Two Dose Varivax +/- MMR-II

NCT00258726

Measles Mumps Rubella +1 more

TERMINATED PHASE1/PHASE2

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.

Hepatitis A Measles Mumps Rubella Chickenpox

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Arm 1: vaccine

Group Type ACTIVE_COMPARATOR

VAQTA®

Intervention Type BIOLOGICAL

0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.

2

Arm 2: Active comparator

Group Type ACTIVE_COMPARATOR

VAQTA®

Intervention Type BIOLOGICAL

0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.

ProQuad

Intervention Type BIOLOGICAL

0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VAQTA®

0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.

Intervention Type BIOLOGICAL

ProQuad

0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

V251

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 hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster
* No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM)

Exclusion Criteria

* Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination
* History of allergy to any vaccine component
* History of seizure disorder
* Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy
* Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections
* Recent (\<72 hours) febrile illness (\>100.3 degrees F \[\>37.9 degrees C\] oral equivalent) prior to study vaccination.

Minimum Eligible Age

12 Months

Maximum Eligible Age

17 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes