Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico

• Published in: Vaccine Vol. 29; no. 44; pp. 7826 - 7834
• Main Authors: López-Macías, Constantino, Ferat-Osorio, Eduardo, Tenorio-Calvo, Alejandra, Isibasi, Armando, Talavera, Juan, Arteaga-Ruiz, Oscar, Arriaga-Pizano, Lourdes, Hickman, Somia P., Allende, María, Lenhard, Kathy, Pincus, Steven, Connolly, Kevin, Raghunandan, Ramadevi, Smith, Gale, Glenn, Gregory
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 13.10.2011; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; adults; Aged; Allergy and Immunology; Animals; Antibodies, Viral - blood; antigens; Applied microbiology; Avian flu; Baculoviridae - genetics; Biological and medical sciences; Cell Line; clinical trials; Cloning; dose response; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Genetic engineering; H1N1; HAI; hemagglutination; Hemagglutination Inhibition Tests; hemagglutinins; Humans; Immunogenicity; influenza; Influenza A Virus, H1N1 Subtype - genetics; Influenza A Virus, H1N1 Subtype - immunology; Influenza vaccine; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Influenza virus; Male; Manufacturing; Mexico; Microbiology; Middle Aged; Miscellaneous; Orthomyxoviridae; pain; pandemic; Pandemic influenza; Pandemics; Placebos - administration & dosage; seroconversion; Spodoptera; Spodoptera frugiperda; Swine flu; Technological change; vaccination; Vaccination - methods; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Vaccines, Virosome - administration & dosage; Vaccines, Virosome - adverse effects; Vaccines, Virosome - immunology; Virology; Virus-like particle; virus-like particle vaccines; virus-like particles; VLP; Young Adult; Mexico; Central America; America; United States > US; HAI; Virus-like particle; VLP; Pandemic influenza; Influenza vaccine; H1N1; Virus like particle; Orthomyxoviridae; Vaccine; Infection; Virus; Influenzavirus A; Immunogenicity; Influenza A virus; Viral disease; Influenza; Influenzavirus A(H1N1)

► The safety and immunogenicity of one or two doses of a recombinant A (H1N1) 2009 influenza VLP vaccine was evaluated in a two-stage, Phase 2, randomized, double-blind, placebo-controlled study conducted during the H1N1 2009 pandemic in Mexico. ► The H1N1 2009 VLP vaccine was safe and well-tolerate...