A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
Phase of Trial: Phase II/III
Latest Information Update: 18 Apr 2016
At a glance
- Drugs Influenza A virus vaccine-H1N1 (Primary)
- Indications Influenza A virus H1N1 subtype
- Focus Adverse reactions; Pharmacodynamics; Registrational
- Sponsors Novartis Vaccines
- 14 Oct 2015 Treatment arms increased from 2 to 8, added a dosage of 15 micro-gram A/H1N1-SOIV.
- 26 Jan 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 17 Nov 2009 Interim results reported in a Novartis media release.