Clinical trial NCT02062502: Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 611
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
timeFrame: 6 weeks (43 days) after vaccination 1
measure: Geometric Mean Titer of VZV Antibodies
timeFrame: 6 weeks (43 days) after vaccination 1
Secondary outcomes:
measure: Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
timeFrame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
measure: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
timeFrame: Up to 42 days after Vaccination 1
measure: Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
timeFrame: Up to 42 days after Vaccination 2
measure: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
timeFrame: Up to 5 days after Vaccination 1
measure: Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
timeFrame: Up to 5 days after Vaccination 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11.