Phase I Multi-center, Observer-Blind, Randomized, Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated Novel Swine Origin A/H3N2v Monovalent Subunit Influenza Virus Vaccine (H3N2c) in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to < 65 Years and Elderly ≥ 65 Years and Older
Abstract
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.
Conditions: Prophylaxis of A/H3N2v Influenza.
Primary outcome: Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.; Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.; Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.; Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.; Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.; Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.; Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine..
Enrollment: 627 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 627 participants or records.
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