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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
611
Varicella virus vaccine live manufactured with a new seed process
Varicella virus vaccine live manufactured with the 2007 process
Measles, Mumps, and Rubella virus vaccine live
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
Antibody titers were measured with gpELISA.
Time frame: 6 weeks (43 days) after vaccination 1
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)
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
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
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
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
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