01% find more Tween-20 (v/v) and 1.5% (v/v) glycerol, pH 7.2) to a final aluminum concentration of 4 mg/mL with a fill volume of 300 μL, was kept refrigerated (2–8 °C). Diluent vials were filled with 300 μL and stored at −20 °C. Immediately prior to injection the vaccine (250 μL) was mixed with equal volumes of alhydrogel or diluent in an empty, 2 mL sterile vial provided, and 500 μL were injected in the deltoid muscle using a masked syringe with a 25G, 16 mm needle. This was a double-blinded, 1:1 randomized Phase 1 healthy volunteer study conducted at two sites in Singapore.

The study was designed to assess the safety, tolerability and immunogenicity of the vaccine in healthy adults with no or low pre-existing immunity NVP-AUY922 manufacturer to A/California/07/2009 (H1N1). Subjects received two intramuscular

injections, of 100 μg vaccine (42 μg HA) per dose, 21 days apart, either non-adjuvanted or adjuvanted with 2% alhydrogel, in a total volume of 500 μL per injection. A total of 84 subjects were randomized to the two treatment arms. Study personnel and participants were blinded to the treatment allocation, except for the independent statistician from the Singapore Clinical Research Institute (SCRI), generating the randomization list and the unblinded clinical research coordinator, mixing the vaccine with alhydrogel or diluent prior to injection. Study approval was obtained from the Singapore Health Sciences Authority (HSA)

and the Centralized Institutional Review Board (CIRB Ref: 2012/906/E) and the study was performed in agreement with MYO10 the International Conference on Harmonisation guidelines on Good Clinical Practices, laws and regulatory requirements in Singapore and monitored by SCRI. A written informed consent was obtained from each subject prior to screening. Subjects were first enrolled on May 16, 2013 with the last visit on August 2, 2013. Participants, between 21 and 64 years of age, with satisfactory baseline medical assessment and laboratory values within the normal ranges were eligible. Exclusion criteria were presence of acute infection during 14 days preceding the first vaccination, a temperature ≥38 °C at the date of the first vaccination, and the receipt of immunoglobulins or blood products within 9 months prior to enrolment or during the study. Additional exclusion criteria were receipt of seasonal influenza vaccine in the past 2 years, or any licensed vaccine within 30 days prior to the first injection or HAI titers >1:40 at screening. Concomitant medications (except other vaccines) were not restricted. Women of childbearing potential had to have a negative pregnancy test at each visit.