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Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)

NCT01536405•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Negative clinical history for measles, mumps, rubella, varicella, and zoster

Exclusion Criteria

•Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
•Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
•Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
•Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
•Received 1) systemic immunomodulatory steroids \[greater than the
•equivalent of 2 mg/kg total daily dose of prednisone\] within 3 months prior to
•entering the study, or 2) any dose of systemic immunomodulatory steroids within
•7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
•History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
•Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
+6 more criteria

Key Dates

Start Date

June 5, 2012

Primary Completion Date

July 2, 2013

Completion Date

January 27, 2014

Last Updated

October 31, 2018

Enrollment

1,412

ACTUAL participants

Conditions

MeaslesMumpsRubellaVaricella

Interventions

MMRV (AMP)

BIOLOGICAL

MMRV (2006 process)

BIOLOGICAL

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NCT07112846

ExanthemaDengue Fever+3 more

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COMPLETEDPHASE4

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NCT03460002

Measles VaccinationOral Polio Vaccine+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Inclusion Criteria

Exclusion Criteria

Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections

Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children

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