Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

654

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2010

Conditions
Influenza
Interventions
BIOLOGICAL

MF59-eH1N1_f

3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

BIOLOGICAL

MF59-eH1N1_f

7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

BIOLOGICAL

MF59-eH1N1_f

15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

BIOLOGICAL

MF59-eH1N1_f

7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Trial Locations (29)

14000

Tlalpan

22902

Charlottesville

29303

Spartanburg

29406

Charleston

37087

Lebanon

40004

Bardstown

45406

Dayton

45424

Huber Heights

47150

New Albany

58104

Fargo

67114

Newton

67207

Wichita

72712

Bentonville

72903

Fort Smith

73103

Oklahoma City

75230

Dallas

77055

Houston

84088

West Jordan

84095

South Jordan

84604

Provo

84790

St. George

90015

Los Angeles

90503

Torrance

90806

Long Beach

91306

Canoga Park

93618

Dinuba

93637

Madera

93703

Fresno

01801

Woburn

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Novartis Vaccines

INDUSTRY