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Vaccine ; 24(47-48): 6875-85, 2006 Nov 17.
Article in English | MEDLINE | ID: mdl-17050042

ABSTRACT

A new manufacturing process, known as process upgrade varicella vaccine (PUVV) was developed for a refrigerated formulation of varicella vaccine and for an investigational zoster vaccine. Safety and tolerability of a two-dose regimen of high-titered (approximately 50,000 PFU) PUVV were compared to a lower-titer formulation (approximately 5400 PFU) of VARIVAX; in 1366 healthy subjects > or =13 years old. Only one vaccine-related clinical serious adverse experience (pruritus; no hospitalization) was reported, in the VARIVAX group. Injection-site adverse experiences following any dose were higher in the PUVV group, 70.0%, than in the VARIVAX group, 56.2%, but generally were mild. Immunogenicity were similar in both groups in seronegative subjects. PUVV was generally well tolerated, and elicited an immune response similar to that induced by the marketed formulation of VARIVAX.


Subject(s)
Chickenpox Vaccine/adverse effects , Chickenpox Vaccine/immunology , Chickenpox/immunology , Chickenpox/prevention & control , Herpes Zoster/immunology , Herpes Zoster/prevention & control , Adolescent , Antibodies, Viral/analysis , Antibodies, Viral/biosynthesis , Antibody Formation/immunology , Chickenpox Vaccine/administration & dosage , Double-Blind Method , Female , Humans , Immunity, Cellular/immunology , Interferon-gamma/biosynthesis , Male
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