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MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly

NCT01623232 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-09-26

No results posted yet for this study

Summary

This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.

Conditions

  • Influenza Vaccines
  • Aged

Interventions

BIOLOGICAL

MAS-1 adjuvant and influenza HA antigen

Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested. 1. Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS). 2. Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS. 3. Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.

BIOLOGICAL

standard dose, inactivated trivalent influenza vaccine (TIV)

Vaccine will be administered IM in the deltoid muscle. HA antigen of each of three viral strains as nonadjuvanted standard dose TIV will be tested. 4\. Treatment Group 4:0.5 mL dose of licensed, unadjuvanted, standard dose influenza virus vaccine with 15 micrograms HA of each of 3 viral strains.

Sponsors & Collaborators

Principal Investigators

  • Geoffrey J. Gorse, MD · St. Louis VA Medical Center John Cochran Division, St. Louis, MO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-11-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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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 NCT01623232 on ClinicalTrials.gov