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Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

NCT02639351 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-06-28

Study results available
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Summary

Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R

Intramuscular (IM) vaccination of 1 dose of 0.5 mL

BIOLOGICAL

Investigational MenC-CRM adjuavnted with 25 ug of LHD153R

IM vaccination of 1 dose of 0.5 mL

BIOLOGICAL

Investigational MenC-CRM adjuavnted with 50 ug of LHD153R

IM vaccination of 1 dose of 0.5 mL

BIOLOGICAL

Investigational MenC-CRM adjuavnted with 100 ug of LHD153R

IM vaccination of 1 dose of 0.5 mL

BIOLOGICAL

Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)

IM vaccination of 1 dose of 0.5 mL

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT02639351 on ClinicalTrials.gov