Completed PHASE3 INTERVENTIONAL 3-arm NCT02096263

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

Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Sponsor: GlaxoSmithKline

Conditions Acellular Pertussis Diphtheria Haemophilus Influenzae Type b Hepatitis B Poliomyelitis Tetanus

Interventions ActHIB Engerix-B Hiberix Infanrix Infanrix hexa Pediarix Pentacel Prevnar13 Rotarix

Updated 12 times since 2017 Last updated: Nov 15, 2019 Started: Apr 16, 2014 Primary completion: Feb 6, 2015 Completion: Nov 13, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Acellular Pertussis and Diphtheria, this trial is completed. The trial is conducted by GlaxoSmithKline and has accumulated 12 data snapshots since 2014. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

12 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Dec 2019 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 7 earlier versions

Oct 2018 — Dec 2019 [monthly]

Completed PHASE3
Aug 2018 — Oct 2018 [monthly]

Completed PHASE3
Jun 2018 — Aug 2018 [monthly]

Completed PHASE3
Sep 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Unknown Status → Completed
Aug 2017 — Sep 2017 [monthly]

Unknown Status PHASE3

Status: Active Not Recruiting → Unknown Status
Feb 2017 — Aug 2017 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Apr 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Altamonte Springs, United States , Anaheim, United States , Augusta, United States , Charlottesville, United States , Colorado Springs, United States , Columbia, United States , Daly City, United States , Dayton, United States , Ellensburg, United States , Erie, United States and 31 more locations