Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

NCT02096263 ↗

Phase 3 Completed 585 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Timeline

Start: 2014-04-16
Primary completion: 2015-02-06
Completion: 2015-11-13

Publications

Background Klein NP, Abu-Elyazeed R, Cheuvart B, Janssens W, Mesaros N. Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States. Hum Vaccin Immunother. 2019;15(4):809-821. doi: 10.1080/21645515.2018.1549449. Epub 2019 Jan 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ActHIB	Vaccine	—	Intramuscular
Comparator	Engerix-B	Vaccine	—	Intramuscular
Subject	HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	Vaccine	—	Intramuscular
Subject	Infanrix	Vaccine	—	Intramuscular
Subject	Infanrix hexa	Vaccine	—	Intramuscular
Comparator	Pediarix	Vaccine	—	Intramuscular
Comparator	Pentacel	Vaccine	—	Intramuscular
Background	Prevnar 13	Vaccine	—	Intramuscular
Background	Rotarix	Vaccine	—	Oral

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Summary

Timeline

Publications

Drugs

Indications