Safety, tolerability, and immunogenicity of a two-dose regimen of high-titer varicella vaccine in subjectsor =13 years of age
| Autor: | Rocio Gonzalez, Pietro Dentico, Katia Schlienger, Jon E. Stek, Andrew S. Robertson, Christina Y. Chan, Jeffrey G. Smith, Ira Chalikonda, Rupert Vessey, Clemente Diaz, Jeffrey L. Silber, William Wang, Florian Schödel, Holly Matthews, Jerald C. Sadoff, Rafael G Mendez, Michael J. Caulfield, Luigi Roberto Biasio, Ivan S. F. Chan, Julie L Barben, Anna L. Harmon, Sandro Cinquetti |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Varicella vaccine Adolescent medicine.disease_cause Antibodies Viral Herpes Zoster law.invention Chickenpox Vaccine Interferon-gamma Chickenpox Randomized controlled trial Double-Blind Method law Medicine Humans Immunity Cellular General Veterinary General Immunology and Microbiology business.industry Immunogenicity Public Health Environmental and Occupational Health Varicella zoster virus Clinical trial Regimen Infectious Diseases Tolerability Immunology Antibody Formation Molecular Medicine Zoster vaccine Female business medicine.drug |
| Zdroj: | Vaccine. 24(47-48) |
| ISSN: | 0264-410X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect