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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 611
- Primary Endpoint
- Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 12 Months to 23 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: VARIVAX™ New Seed Process (Biological)
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
Intervention: M-M-R II™ (Biological)
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
Intervention: VARIVAX™ 2007 process (Biological)
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
Intervention: M-M-R II™ (Biological)
Outcomes
Primary Outcomes
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
Geometric Mean Titer of VZV Antibodies
Time Frame: 6 weeks (43 days) after vaccination 1
Antibody titers were measured with gpELISA.
Secondary Outcomes
- Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1(Up to 5 days after Vaccination 1)
- Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2(Up to 5 days after Vaccination 2)
- Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)(Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days))
- Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2(Up to 42 days after Vaccination 2)
- Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1(Up to 42 days after Vaccination 1)