Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 2/7/2015 |
Start Date: | March 2014 |
End Date: | October 2015 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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
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.
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.
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.
We found this trial at
38
sites
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