Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations

Summary

This is a Phase II open-label study in approximately 240, and up to 400, healthy males and non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100 subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately 60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100 subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as 7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject will be approximately 7 months.

Timeline

Start

2014-06-11

Primary completion

2015-03-20

Completion

2015-03-20

Publications

• Munoz FM, Anderson EJ, Bernstein DI, Harrison CJ, Pahud B, Anderson E, Creech CB, Berry AA, Kotloff KL, Walter EB, Atmar RL, Bellamy AR, Chang S, Keitel WA. Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents. Vaccine. 2019 Aug 23;37(36):5161-5170. doi: 10.1016/j.vaccine.2019.07.085. Epub 2019 Jul 30.

Drugs

Indications