Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

February 1, 2014

Primary Completion Date

March 18, 2016

Study Completion Date

March 18, 2016

Conditions
Neisseria MeningitidisHaemophilus Influenzae Type b
Interventions
BIOLOGICAL

Hib-MenCY-TT (MenHibrix®)

4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.

BIOLOGICAL

Pediarix®

3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group.

BIOLOGICAL

Rotarix®

2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group.

BIOLOGICAL

Prevnar 13®

4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group.

BIOLOGICAL

PedvaxHIB®

3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group.

BIOLOGICAL

Havrix®

2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group.

Trial Locations (26)

16148

GSK Investigational Site, Hermitage

27609

GSK Investigational Site, Raleigh

29406

GSK Investigational Site, Charleston

35205

GSK Investigational Site, Birmingham

44121

GSK Investigational Site, Cleveland

45406

GSK Investigational Site, Dayton

49120

GSK Investigational Site, Niles

49127

GSK Investigational Site, Stevensville

72401

GSK Investigational Site, Jonesboro

72703

GSK Investigational Site, Fayetteville

84041

GSK Investigational Site, Layton

84057

GSK Investigational Site, Orem

84067

GSK Investigational Site, Roy

84075

GSK Investigational Site, Syracuse

84124

GSK Investigational Site, Murray

90723

GSK Investigational Site, Paramount

92648

GSK Investigational Site, Huntington Beach

93726

GSK Investigational Site, Fresno

94588

GSK Investigational Site, Pleasanton

94596

GSK Investigational Site, Walnut Creek

95051

GSK Investigational Site, Santa Clara

95119

GSK Investigational Site, San Jose

95661

GSK Investigational Site, Roseville

95823

GSK Investigational Site, Sacramento

02721

GSK Investigational Site, Fall River

01801

GSK Investigational Site, Woburn

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01978093 - Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age | Biotech Hunter | Biotech Hunter