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Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

NCT01657526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-05-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)

Administered intramuscularly (IM) in the deltoid region of non-dominant arm

BIOLOGICAL

GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)

2 doses administered IM in the deltoid region of non-dominant arm

BIOLOGICAL

Saline placebo

2 doses administered IM in the deltoid region of non-dominant arm

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-08
Primary Completion
2013-11-25
Completion
2013-11-25

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01657526 on ClinicalTrials.gov