Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

PHASE3CompletedINTERVENTIONAL
Enrollment

4,209

Participants

Timeline

Start Date

January 6, 2005

Primary Completion Date

November 1, 2006

Study Completion Date

December 4, 2006

Conditions
TetanusAcellular PertussisDiphtheria
Interventions
BIOLOGICAL

SB213503 lot 1

SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

SB213503 lot 2

SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

SB213503 lot 3

SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

Infanrix

Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

IPOL

IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.

BIOLOGICAL

M-M-R II

M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.

Trial Locations (24)

23111

GSK Investigational Site, Mechanicsville

43214

GSK Investigational Site, Columbus

72205

GSK Investigational Site, Little Rock

93726

GSK Investigational Site, Fresno

94015

GSK Investigational Site, Daly City

94063

GSK Investigational Site, Redwood City

94115

GSK Investigational Site, San Francisco

94509

GSK Investigational Site, Antioch

94533

GSK Investigational Site, Fairfield

94538

GSK Investigational Site, Fremont

94545

GSK Investigational Site, Hayward

94583

GSK Investigational Site, San Ramon

94588

GSK Investigational Site, Pleasanton

94589

GSK Investigational Site, Vallejo

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

94801

GSK Investigational Site, Richmond

95051

GSK Investigational Site, Santa Clara

95119

GSK Investigational Site, San Jose

95403

GSK Investigational Site, Santa Rosa

95661

GSK Investigational Site, Roseville

95688

GSK Investigational Site, Vacaville

95823

GSK Investigational Site, Sacramento

95825

GSK Investigational Site, Sacramento

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY