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A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults

NCT02564237 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-01-19

No results posted yet for this study

Summary

This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.

Conditions

  • Healthy

Interventions

BIOLOGICAL

StreptAnova™ (Group A streptococcal (GAS) vaccine)

StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine

BIOLOGICAL

Hepatitis B vaccine

Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.

BIOLOGICAL

Hepatitis A vaccine

Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.

BIOLOGICAL

Human Papillomavirus vaccine

Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.

Sponsors & Collaborators

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Shelly McNeil, MD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-03-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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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 NCT02564237 on ClinicalTrials.gov