A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

2,278

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

January 31, 2016

Study Completion Date

June 30, 2016

Conditions
Influenza, Human
Interventions
BIOLOGICAL

Seqirus QIV

"Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."

BIOLOGICAL

Comparator QIV

"The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."

Trial Locations (32)

13901

Site 285, Binghamton

27511

Site 387, Cary

32934

Site 293, Melbourne

33012

Site 388, Hialeah

35802

Site 296, Huntsville

40004

Site 386, Bardstown

43123

Site 384, Grove City

44122

Site 383, Cleveland

45246

Site 385, Cincinnati

45414

Site 399, Dayton

61614

Site 294, Peoria

63141

Site 287, St Louis

67010

Site 390, Augusta

67114

Site 396, Newton

67207

Site 317, Wichita

67219

Site 400, Park City

68005

Site 316, Bellevue

68114

Site 382, Omaha

70002

Site 393, Metairie

76135

Site 282, Fort Worth

76904

Site 288, San Angelo

78229

Site 394, San Antonio

78705

Site 283, Austin

83642

Site 289, Boise

84041

Site 395, Layton

84124

Site 300, Salt Lake City

91762

Site 397, Ontario

93637

Site 401, Madera

95127

Site 398, San Jose

95822

Site 402, Sacramento

96001

Site 392, Redding

97030

Site 389, Gresham

All Listed Sponsors
lead

Seqirus

INDUSTRY

NCT02545543 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age | Biotech Hunter | Biotech Hunter