Trial intelligence / Profile preview

Safety of Poliorix and Infanrix Co-administration in Russian Infants

NCT01094171Phase 4

Key facts

Status: Completed
Start: Dec 2010
Primary completion: Oct 2012
Countries: 1
Sponsor: GSK
Modality: Vaccines & Immunotherapeutics

Drugs: Poliorix
Conditions: poliomyelitis

Overview

Phase 4, open-label, single-arm trial of Poliorix in poliomyelitis, sponsored by GSK. Primary endpoints: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at 4 days, Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms at 4 days and 2 more. Started Dec 2010; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Poliorix Group
Subjects receive 3 primary doses of Poliorix and Infanrix vaccines at 3, 4.5, and 6 months of age.

Who it enrols

Healthy male or female infants aged 3 months without contraindications for vaccination against diphtheria, tetanus, pertussis, and poliomyelitis.

Endpoints

Primary

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms4 days
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms4 days
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)31 days
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)4 months

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