NCT01356342

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Adimmune Corporation · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Accepted

Summary

This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through \< 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through \< 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through \< 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	AdimFlu-S 2010-2011, inactivated	The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL 6 months\~\<3 years;0.25 mL per injection2 injections at 4 weeks apart 3\~\<9 years;0.5 mL per injection2 injections at 4 weeks apart 9\~\<18 years;0.5 mL per injection1 injections

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2011-05-19
• Last updated: 2012-12-28