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Evaluation of Immunogenicity and Safety of VARIVAX™ Passage Extension 34 (PE34) Process in Children (V210-A03)

This study is currently recruiting participants.
Verified November 2017 by Merck Sharp & Dohme Corp.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03239873
First Posted: August 4, 2017
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX™ 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ PE34 Process are non-inferior to those induced by VARIVAX™ 2016 commercial process, and that antibody response rate induced by VARIVAX™ PE34 Process is acceptable.

Condition Intervention Phase
Varicella Biological: VARIVAX™ PE34 Process Biological: VARIVAX™ 2016 Commercial Process Biological: M-M-R II™ Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Varicella Zoster Virus (VZV) Antibody Response Rate [ Time Frame: 6 weeks (43 days) after Vaccination 1 ]
    The percentage of participants with VZV antibody levels >=5 glycoprotein enzyme-linked immunosorbent Assay (gpELISA) units/mL will be assessed.

  • Varicella Zoster Virus (VZV) Geometric Mean Titer [ Time Frame: 6 weeks (43 days) after Vaccination 1 ]
    The geometric mean titer of VZV antibodies will be assessed.


Secondary Outcome Measures:
  • Elevated Temperature [ Time Frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) ]
    The percentage of participants with fever (>=102.2 °F oral equivalent) will be assessed.

  • Measles-like, Rubella-like, Varicella-like Rashes, and Mumps-like Symptoms after Vaccination 1 [ Time Frame: Up to 42 days after Vaccination 1 ]
    The percentage of participants with measles-like rashes, rubella-like rashes, varicella-like rashes, and mumps-like symptoms will be assessed.

  • Measles-like, Rubella-like, Varicella-like Rashes, and Mumps-like Symptoms after Vaccination 2 [ Time Frame: Up to 42 days after Vaccination 2 ]
    The percentage of participants with measles-like rashes, rubella-like rashes, varicella-like rashes, and mumps-like symptoms will be assessed.

  • Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness after Vaccination 1 [ Time Frame: Up to 5 days after Vaccination 1 ]
    The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness will be assessed.

  • Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness after Vaccination 2 [ Time Frame: Up to 5 days after Vaccination 2 ]
    The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness will be assessed.

  • Adverse Events [ Time Frame: Up to 42 days after any vaccination ]
    The percentage of participants with one or more adverse events will be assessed.

  • Serious Adverse Events [ Time Frame: Up to 180 days after vaccination 2 (up to 285 days) ]
    The percentage of participants with one or more serious adverse events will be assessed.

  • Varicella Zoster Virus (VZV) Antibody Seroconversion Rate [ Time Frame: 6 weeks (43 days) after Vaccination 1 ]
    The percentage of participants with VZV antibody levels >=1.25 gpELISA units/mL will be assessed.

  • Varicella Zoster Virus (VZV) Antibody Geometric Mean Fold Rise from Baseline [ Time Frame: Baseline and 6 weeks (43 days) after Vaccination 1 ]
    The geometric mean fold rise from Baseline in VZV antibody titer will be assessed.

  • Varicella Zoster Virus (VZV) Antibody Geometric Mean Fold Rise from Baseline >=4-fold [ Time Frame: Baseline and 6 weeks (43 days) after Vaccination 1 ]
    The percentage of participants with geometric mean fold rise from Baseline in VZV antibody titer >=4-fold will be assessed.

  • Vaccine-related Adverse Events [ Time Frame: Up to 42 days after any vaccination ]
    The percentage of participants with one or more vaccine-related adverse events will be assessed.

  • Vaccine-related Serious Adverse Events [ Time Frame: Up to 180 days after vaccination 2 (up to 285 days) ]
    The percentage of participants with one or more vaccine-related serious adverse events will be assessed.

  • Study Discontinuations due to an Adverse Event [ Time Frame: Up to 42 days after any vaccination ]
    The percentage of participants discontinued from the study due to an adverse event will be assessed.

  • Unsolicited Injection-site Adverse Events [ Time Frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) ]
    The percentage of participants with one or more unsolicited injection-site adverse events will be assessed.

  • Unsolicited Injection-site Reactions [ Time Frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) ]
    The percentage of participants with unsolicited (Vaccine Report Card) injection-site reactions will be assessed.


Estimated Enrollment: 600
Actual Study Start Date: October 17, 2017
Estimated Study Completion Date: April 19, 2019
Estimated Primary Completion Date: October 9, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VARIVAX™ PE34 Process + M-M-R II™
VARIVAX™ Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II™ vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
Biological: VARIVAX™ PE34 Process
Varicella virus vaccine live manufactured with a new passage extension process (PE34)
Biological: M-M-R II™
Measles, Mumps, and Rubella virus vaccine live
Active Comparator: VARIVAX™ 2016 Commercial Process + M-M-R II™
VARIVAX™ 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II™ vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
Biological: VARIVAX™ 2016 Commercial Process
Varicella virus vaccine live manufactured with the 2016 commercial process
Biological: M-M-R II™
Measles, Mumps, and Rubella virus vaccine live

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
  • Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
  • Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
  • History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™
  • Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
  • Received salicylates within 14 days prior to study vaccination
  • Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
  • Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
  • History of seizure disorder, including febrile seizure
  • Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
  • History of thrombocytopenia
  • Born to a human immunodeficiency virus (HIV)-infected mother
  • Has a diagnosis of active untreated tuberculosis
  • Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239873


Contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

  Show 31 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03239873     History of Changes
Other Study ID Numbers: V210-A03
First Submitted: August 1, 2017
First Posted: August 4, 2017
Last Update Posted: November 16, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs