NCT04535037 - A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers | Biotech Hunter

Enrollment

500

Participants

Timeline

Start Date

May 26, 2021

Primary Completion Date

July 25, 2022

Study Completion Date

July 25, 2022

Conditions

Diphtheria

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib

3 doses (1 each at 2, 4 and 12 months of age) of DTPa-HBV-IPV/Hib vaccine administered by intramuscular injection into the right thigh

BIOLOGICAL

DTaP5-HBV-IPV-Hib

3 doses (1 each at 2, 4 and 12 months of age) of DTaP5-HBV-IPV-Hib vaccine administered by intramuscular injection into the right thigh

BIOLOGICAL

Pneumococcal 13-valent conjugate vaccine

3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13-valent conjugate vaccine administered by intramuscular injection into the left thigh

Trial Locations (20)

15706

GSK Investigational Site, Santiago de Compostela

16269

GSK Investigational Site, Leipzig

20122

GSK Investigational Site, Milan

25198

GSK Investigational Site, Lleida

28040

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28660

GSK Investigational Site, Boadilla Del Monte (Madrid)

28911

GSK Investigational Site, Leganés

29004

GSK Investigational Site, Málaga

38448

GSK Investigational Site, Wolfsburg

41013

GSK Investigational Site, Seville

41236

GSK Investigational Site, Mönchengladbach

49565

GSK Investigational Site, Bramsche

50354

GSK Investigational Site, Hürth

67227

GSK Investigational Site, Frankenthal

83026

GSK Investigational Site, Rosenheim

83471

GSK Investigational Site, Schönau am Königssee

99086

GSK Investigational Site, Erfurt

08916

GSK Investigational Site, Badalona