NCT02858440View on ClinicalTrials.gov

A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia

PHASE3CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

September 13, 2016

Primary Completion Date

October 24, 2017

Study Completion Date

November 13, 2018

Conditions
DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenzae Type b
Interventions
BIOLOGICAL

Infanrix-IPV/Hib

Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.

Trial Locations (5)

183038

GSK Investigational Site, Murmansk

191025

GSK Investigational Site, Saint Petersburg

620131

GSK Investigational Site, Yekaterinburg

656056

GSK Investigational Site, Barnaul

634 050

GSK Investigational Site, Tomsk

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia | Biotech Hunter | Biotech Hunter