Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

Phase 3 Completed 454 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Timeline

Start: 2011-03-04
Primary completion: 2012-02-24
Completion: 2012-02-24

Publications

Background Kim KH, Kim CS, Kim HM, Kim JD, Ma SH, Kim DH, Hwang PH, Han JW, Lee TJ, Kim JH, Karkada N, Mesaros N, Sohn WY, Kim JH. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. Epub 2018 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	Vaccine	—	Intramuscular
Comparator	Infanrix IPV	Vaccine	—	Intramuscular
Subject	Infanrix™-IPV+Hib	Vaccine	—	Intramuscular
Background	Rotarix	Vaccine	—	Oral
Background	Synflorix	Vaccine	—	Intramuscular

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

Summary

Timeline

Publications

Drugs

Indications