| Literature DB >> 17050042 |
Clemente Diaz1, Pietro Dentico, Rocio Gonzalez, Rafael G Mendez, Sandro Cinquetti, Julie L Barben, Anna Harmon, Ira Chalikonda, Jeffrey G Smith, Jon E Stek, Andrew Robertson, Michael J Caulfield, Luigi R Biasio, Jeffrey L Silber, Christina Y Chan, Rupert Vessey, Jerald Sadoff, Ivan S F Chan, Holly Matthews, William Wang, Katia Schlienger, Florian P Schödel.
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.Entities:
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Year: 2006 PMID： 17050042 DOI： 10.1016/j.vaccine.2006.06.030
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641