Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

PHASE3CompletedINTERVENTIONAL
Enrollment

10,644

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

October 31, 2015

Study Completion Date

August 31, 2016

Conditions
Influenza Virus
Interventions
BIOLOGICAL

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

BIOLOGICAL

Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Trial Locations (167)

220

343, Novartis Investigational Site, Banqiao District

333

342, Novartis Investigational Site, Taoyuan District

1000

302, Novartis Investigational Site, Manila

1001

301, Novartis Investigational Site, Manila

1781

306, Novartis Investigational Site, Alabang

303, Novartis Investigational Site, City of Muntinlupa

304, Novartis Investigational Site, City of Muntinlupa

305, Novartis Investigational Site, City of Muntinlupa

4114

300, Novartis Investigational Site, Dasmariñas

7020

175, Novartis Investigational Site, México

10041

340, Novartis Investigational Site, Taipei

10330

323, Novartis Investigational Site, Pathum Wan

10341

346, Novartis Investigational Site, Datong

10400

327, Novartis Investigational Site, Ratchathewi

320, Novartis Investigational Site, Bangkok

324, Novartis Investigational Site, Bangkok

10449

341, Novartis Investigational Site, Taipei

10700

321, Novartis Investigational Site, Bangkoknoi

322, Novartis Investigational Site, Bangkoknoi

11201

414, Novartis Investigational Site, Brooklyn

12120

325, Novartis Investigational Site, Pathum Thani

13057

264, Novartis Investigational Site, Syracuse

13901

255, Novartis Investigational Site, Binghamton

14000

178, Novartis Investigational Site, México

15683

270, Novartis Investigational Site, Scottdale

15701

075, Novartis Investigational Site, Santiago de Compostela

16132

023, Novartis Investigational Site, Genova

16505

292, Novartis Investigational Site, Erie

18009

074, Novartis Investigational Site, Granada

20122

020, Novartis Investigational Site, Milan

20157

026, Novartis Investigational Site, Milan

20910

405, Novartis Investigational Site, Silver Spring

21401

262, Novartis Investigational site, Annapolis

21702

263, Novartis Investigational Site, Frederick

22015

251, Novartis Investigational Site, Burke

22180

296, Novartis Investigational Site, Vienna

27262

291, Novartis Investigational vaccine, Spartanburg

27518

266, Novartis Investigational Site, Cary

28041

076, Novartis Investigational Site, Madrid

28046

077, Novartis Investigational Site, Madrid

28100

021, Novartis Investigational Site, Novara

28607

409, Novartis Investigational Site, Boone

28721

403, Novartis Investigational Site, Clyde

29011

79, Novartis Investigational Site, Málaga

29407

272, Novartis Investigational Site, Charleston

29461

232, Novartis Investigational Site, Moncks Corner

29621

220, Novartis Investigational Site, Anderson

29812

406, novartis Investigational Site, Barnwell

30322

401, Novartis iNvestiagtional Site, Atlanta

32801

297, Novartis Investigational Site, Orlando

32806

297, Novartis Investigational vaccine, Orlando

32935

224, Novartis Investigational Site, Melbourne

33013

416, Novartis Investigational Site, Hialeah

33015

417, Novartis Investigational Site, Miami

33054

234, Novartis Investigational Site, Opa-locka

33106

287, Novartis Investigational Site, Hialeah

33144

404, Novartis Investigational Site, Miami

33172

285, Novartis Investigational Site, Miami

33412

277,Novartis Investigational Site, Miami

33432

229, Novartis Investigational Site, Boca Raton

34000

176, Novartis Investigational Site, Durango

34239

412, Novartis Investigational Site, Homestead

410, Novartis Investigational Site, Sarasota

35128

022, Novartis Investigational Site, Padua

37203

283, Novartis Investigational Site, Nashville

40004

269, Novartis Investigational Site, Bardstown

40202

226, Novartis Investigational Site, Louisville

40217

248, Novartis Investigational Site, Louisville

40291

207, Novartis Investigational Site, Louisville

290, Novartis Investigational Site, Louisville

40447

344, Novartis Investigational Site, Taichung

40705

345, Novartis Investigational Site, Taichung

44122

254, Novartis Investigational Site, Cleveland

44311

240, Novartis Investigational Site, Akron

45406

245, Novartis Investigational Site, Dayton

45409

281, Novartis Investigational Site, Dayton

281, Novartis Investigational vaccines, Dayton

46026

078, Novartis Investigational Site, Valencia

50139

030, Novartis Investigational Site, Florence

51215

044, Novartis Investigational Site, Wroclaw

55108

278, Novartis Investigational Site, Saint Paul

56126

024, Novartis Investigational Site, Pisa

58070

173, Novartis Investigational Site, Morelia

60115

299, Novartis Investigational Site, DeKalb

61602

268, Novartis Investigational Site, Peoria

67010

209, Novartis Investigational Site, Augusta

67114

210, Novartis Investigational Site, Newton

67205

211, Novartis Investigational Site, Wichita

67219

274 Novartis Investigational Site, Park City

68005

221, Novartis Investigational Site, Bellevue

68025

219, Novartis Investigational Site, Fremont

68114

402, Novartis Investigational Site, Omaha

68131

288, Novartis Investigational Site, Omaha

68134

228, Novartis Investigational Site, Omaha

70006

225, Novartis Investigational Site, Metairie

233, Novartis Investigational Site, Metairie

71037

265, Novartis Investigational Site, Haughton

71201

418, Novartis Investigational SIte, Monroe

71259

408, Novartis Investigational Site, Mangham

72432

267, Novartis Investigational Site, Harrisburg

74127

256, Novartis Investigational Site, Tulsa

76107

247, Novartis Investigational Site, Fort Worth

76135

217, Novartis Investigational Site, Fort Worth

76904

214, Novartis Investigational Site, San Angelo

77375

260, Novartis Investigational Site, Tomball

78229

400, Novartis investigational Site, San Antonio

78705

208, Novartis Investigational Site, Austin

80131

025, Novartis Investigational Site, Napoli

80902

243, Novartis Investigational Site, Colorado Springs

249, Novartis Investigational Site, Denver

84041

295, Novartis Investigational Site, Layton

84075

282, Novartis Investigational Site, Syracuse

84088

201, Novartis Investigational Site, West Jordan

271, Novartis Investigational Site, West Jordan

84109

236, Novartis Investigational Site, Salt Lake City

84121

212, Novartis Investigational Site, Salt Lake City

84124

246, Novartis Investigational Site, Salt Lake City

84401

294, Novartis Investigational Site, West Haven

84660

279, Novartis Investigational Site, Spanish Fork

85224

222, Novartis Investigational Site, Chandler

89014

244, Novartis Investigational Site, Henderson

89106

286, Novartis Investigational site, Las Vegas

90110

326, Novartis Investigational Site, Hat Yai

90220

006, Novartis Investigational Site, Oulu

90241

407, Novartis Investigational Site, Downey

90723

202, Novartis Investigational Site, Paramount

91347

048, Novartis Investigational Site, Lodz

91706

213, Novartis Investigational Site, Baldwin Park

91762

411, Novartis Investigational Site, Ontario

91774

238, Novartis Investigational Site, La Puente

92103

250, Novartis Investigational Site, San Diego

92801

259, Novartis Investigational Site, Anaheim

92804

280, Novartis Investigational Site, Anaheim

94102

293, Novartis Investigational Site, San Francisco

P3E 1H5

184, Novartis Investigational Site, Greater Sudbury

L3Y 5G8

180, Novartis Investigational Site, Newmarket

M9V 4B4

182,Novartis Investigational Site, Toronto

G1E 7G9

183, Novartis Investigational Site, Québec

Unknown

186, Novartis Investigational Site, Québec

FI-02230

001, Novartis Investigational Site, Espoo

FIN-00100

003, Novartis Investigational Site, Helsinki

FIN-00930

002, Novartis Investigational Site, Helsinki

FIN-04400

004, Novartis Investigational Site, Järvenpää

FI-67100

005, Novartis Investigational Site, Kokkola

FI-28100

007, Novartis Investigational Site, Pori

FI-60100

008, Novartis Investigational Site, Seinäjoki

FIN-33100

009, Novartis Investigational Site, Tampere

FIN-20520

010, Novartis Investigational Site, Turku

FIN-01300

011, Novartis Investigational Site, Vantaa

07100

028, Novartis Investigational Site, Sassari

04530

170, Novartis Investigational Site, México

06760

177, Novartis Investigational Site, México

39-200

040, Novartis Investigational Site, Dębica

40-018

042, Novartis Investigational Site, Katowice

21-100

049, Novartis Investigational Site, Lubartów

55-120

051, Novartis Investigational Site, Oborniki Śląskie

86-031

046, Novartis Investigational Site, Osielsko

41-103

043, Novartis Investigational Site, Siemianowice Śląskie

33-100

047, Novartis Investigational Site, Tarnów

01809

041, Novartis Investigational Site, Warsaw

04-730

050, Novartis Investigational Site, Warsaw

43-225

045, Novartis Investigational Site, Wola

21-010

052, Novartis Investigational Site, Łęczna

00716

257, Novartis Investigational Site, Ponce

00909

415, Novartis Investigational vaccine, San Juan

00921

415, Novartis Investigational Site, San Juan

08208

80, Novartis Investigational Site, Sabadell

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Seqirus

INDUSTRY

NCT01964989 - Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children. | Biotech Hunter | Biotech Hunter