NCT02100436 - Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations | Biotech Hunter

Enrollment

270

Participants

Timeline

Start Date

June 11, 2014

Primary Completion Date

March 20, 2015

Study Completion Date

March 20, 2015

Conditions

Influenza

Interventions

BIOLOGICAL

Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203

A unadjuvanted subvirion monovalent inactivated split influenza virus vaccine (H3N2v MIV) produced in eggs. Subjects are enrolled in 3 cohorts stratified by age. 6-35 month old subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart, or 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. 3-8 year old subjects and 9-17 year old subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart.

Trial Locations (8)

30322-1014

Emory Children's Center - Pediatric Infectious Diseases, Atlanta

21201-1509

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore, Baltimore

64108-4619

Children's Mercy Hospital and Clinics - Infectious Diseases, Kansas City

63104-1015

Saint Louis University - Center for Vaccine Development, St Louis

27704-2120

Duke Health Center at Roxboro, Durham

45229-3039

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

37232-2573

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center, Nashville

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH