A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

PHASE3CompletedINTERVENTIONAL
Enrollment

2,250

Participants

Timeline

Start Date

September 27, 2016

Primary Completion Date

March 9, 2017

Study Completion Date

August 11, 2017

Conditions
Influenza, Human
Interventions
BIOLOGICAL

Seqirus Quadrivalent Inactivated Influenza Vaccine

The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.

BIOLOGICAL

Comparator Quadrivalent Inactivated Influenza Vaccine

The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.

Trial Locations (39)

13901

Site 285, Binghamton

22902

Site 438, Charlottesville

27203

Site 429, Asheboro

29303

Site 439, Spartanburg

29407

Site 419, Charleston

33175

Site 418, Miami

33176

Site 426, Miami

35205

Site 434, Birmingham

36608

Site 442, Mobile

37620

Site 308, Bristol

37660

Site 444, Kingsport

40202

Site 443, Louisville

40291

Site 420, Louisville

Site 441, Louisville

45229

Site 446, Cincinnati

45419

Site 427, Dayton

67010

Site 390, Augusta

67114

Site 421, Newton

67205

Site 422, Wichita

70002

Site 393, Metairie

70006

Site 436, Metairie

76135

Site 282, Fort Worth

76904

Site 288, San Angelo

78705

Site 283, Austin

83642

Site 289, Meridian

84041

Site 395, Layton

84084

Site 440, West Jordan

84088

Site 433, West Jordan

Site 435, West Jordan

84109

Site 431, Salt Lake City

84121

Site 424, Salt Lake City

84124

Site 428, Salt Lake City

90241

Site 423, Downey

90723

Site 445, Paramount

91762

Site 397, Ontario

92103

Site 425, San Diego

92804

Site 430, Anaheim

Site 437, Anaheim

95822

Site 402, Sacramento

All Listed Sponsors
lead

Seqirus

INDUSTRY

NCT02914275 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. | Biotech Hunter | Biotech Hunter