Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02062502
First received: February 12, 2014
Last updated: February 2, 2016
Last verified: February 2016
  Purpose
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 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™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.

Condition Intervention Phase
Varicella
Biological: VARIVAX™ New Seed Process
Biological: VARIVAX™ 2007 process
Biological: M-M-R II™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) 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:
  • Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL [ Time Frame: 6 weeks (43 days) after vaccination 1 ] [ Designated as safety issue: No ]
  • Geometric Mean Titer of VZV Antibodies [ Time Frame: 6 weeks (43 days) after vaccination 1 ] [ Designated as safety issue: No ]
    Antibody titers were measured with gpELISA.


Secondary Outcome Measures:
  • Percentage of Participants With Fever (>=102.2 °F Oral Equivalent) [ Time Frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1 [ Time Frame: Up to 42 days after Vaccination 1 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2 [ Time Frame: Up to 42 days after Vaccination 2 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1 [ Time Frame: Up to 5 days after Vaccination 1 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 [ Time Frame: Up to 5 days after Vaccination 2 ] [ Designated as safety issue: Yes ]

Enrollment: 611
Study Start Date: March 2014
Study Completion Date: October 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VARIVAX™ NSP + M-M-R II™
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91
Biological: VARIVAX™ New Seed Process
Varicella virus vaccine live manufactured with a new seed process
Biological: M-M-R II™
Measles, Mumps, and Rubella virus vaccine live
Active Comparator: VARIVAX™ 2007 Process + M-M-R II™
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91
Biological: VARIVAX™ 2007 process
Varicella virus vaccine live manufactured with the 2007 process
Biological: M-M-R II™
Measles, Mumps, and Rubella virus vaccine live

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months   (Child)
Genders Eligible for Study:   Both
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™
  • 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
  • Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062502

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: NCT02062502     History of Changes
Other Study ID Numbers: V210-063 
Study First Received: February 12, 2014
Results First Received: February 2, 2016
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016