NCT01855945

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.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 3 Years – 92 Years
• Healthy volunteers: Accepted

Summary

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

Interventions

Type	Name	Description
BIOLOGICAL	Swine Influenza	Comparison of different dosages of vaccines

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-05-17
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

11 sites across 1 country: United States