Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

3,604

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

July 31, 2008

Conditions
Influenza
Interventions
BIOLOGICAL

Cell culture-derived influenza subunit vaccine (cTIV)

One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.

BIOLOGICAL

Egg derived influenza subunit vaccine (eTIV)

One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.

BIOLOGICAL

Cell culture-derived influenza subunit vaccine (cTIV)

Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.

BIOLOGICAL

Egg derived influenza subunit vaccine (eTIV)

Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.

Trial Locations (60)

1042

Site 57: Házi Gyermekorvosi Rendelő, Budapest

1089

Site 53: Heim Pál Gyermekkórház, Budapest

1097

Site 52: Ferencvárosi Gyermekorvos Kft., Budapest

1136

Site 56: Házi Gyermekorvosi Rendelő, Budapest

1173

Site 54: Házi Gyermekorvosi Rendelő, Budapest

3534

Site 51: 5053. számú Gyermekorvosi Rendelő, Miskolc

4481

Site 55: Revamed kft., Nyíregyháza

9700

Site 59: Vas Megyei Markusovszky Lajos, Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Szombathely

10207

Site 31, Vilnius

11200

Site 33, Vilnius

13760

Site 05, Endwell

15140

Site 67: Lahden rokotetutkimusklinikka, Lahti

16132

Site 47: Dipartimento Scienze della Salute, Sezione di Igiene e Medicina Preventiva, Univesità di Genova, Genova

20520

Site 69: Turun rokotetutkimusklinikka, Turku

22105

Site 06, Burke

28100

Site 41: Ospedale Maggiore della Carità-Clinica Pediatrica, Novara

28120

Site 68: Porin rokotetutkimusklinikka, Pori

33100

Site 66: Tampereen rokotetutkimusklinikka, Tampere

40004

Site 02, Bardstown

44100

Site 42: Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Ferrara

48259

Site 35, Kaunas

48600

Site 77: Kotkan rokotetutkimusklinikka, Kotka

63104

Site 01, St Louis

67100

Site 79: Kokkola Vaccine Research Clinic, Rantakatu 7

68134

Site 11, Omaha

70006

Site 14, Metairie

70211

Site 78: Kuopio Vaccine Research Clinic, Microkatu 1,Osa/Section A, 3rd Floor Pl1188

72703

Site 09, Fayetteville

76135

Site 16, Fort Worth

76904

Site 13, San Angelo

78205

Site 12, San Antonio

84010

Site 08, Bountiful

84109

Site 07, Salt Lake City

84121

Site 03, Salt Lake City

90100

Site 75: Oulun rokotetutkimusklinikka, Oulu

90241

Site 10, Downey

97100

Site 45: AUSL 7, Ragusa

99202

Site 15, Spokane

115100

Site 25, Campulung Muscel

200642

Site 21, Craiova

08817

Site 04, Edison

Unknown

Site 27:Institute of Public Health, Zagreb

Site 29: Institute of Public Health, Zagreb

Site 40:Spec. Pediatric Dispensary, Zagreb

Site 49: Spec. Pediatric Dispensary, Zagreb

Site 50: Spec. Pediatric Dispensary, Zagreb

Site 86: Spec. Pediatric Dispensary, Zagreb

Site 44:Spec. Pediatric Dispensary, Đakovo

Site 43: Spec. Pediatric Dispensary, Sisak

Site 83, Ljudevita Gaja 2, Djakovo

02100

Site 70: Espoon rokotetutkimusklinikka, Heikintori

00100

Site 71: Etelä-Helsingin rokotetutkimusklinikka, Helsinki

00930

Site 72: Itä-Helsingin rokotetutkimusklinikka, Helsinki

04400

Site 76: Järvenpään rokotetutkimusklinikka, Järvenpää

01300

Site 73: Itä-Vantaan rokotetutkimusklinikka, Vantaa

01600

Site 74: Länsi-Vantaan rokotetutkimusklinikka, Vantaa

06070

Site 46: USL 2 Perugia, Distretto del perugino, Centro di Salute n. 4 (Madonna Alta) e n. 6 (Ellera di Corciano del distretto del perugino), Perugia

01117

Site 36, Vilnius

02169

Site 32, Vilnius

04318

Site 34, Vilnius

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY

NCT00645411 - Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents | Biotech Hunter | Biotech Hunter