NCT00996307

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 654 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MF59-eH1N1_f	3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
BIOLOGICAL	MF59-eH1N1_f	7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
BIOLOGICAL	MF59-eH1N1_f	15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
BIOLOGICAL	MF59-eH1N1_f	7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2009-10-16
• Last updated: 2017-05-30
• Results posted: 2011-05-25

Locations

29 sites across 2 countries: United States, Mexico