Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults
NCT00921973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2014-09-23
Summary
The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years. The investigators will measure the immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given with VAX102 compared to TIV alone.
Conditions
Interventions
- BIOLOGICAL
-
VAX102
All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
- BIOLOGICAL
-
All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
Sponsors & Collaborators
-
VaxInnate Corporation
lead INDUSTRY
Principal Investigators
-
David N Taylor, MD · VaxInnate Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2009-07-31
- Completion
- 2009-09-30
Countries
- United States
Study Locations
More Related Trials
-
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
NCT02256488 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV
NCT02293317 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
NCT00328107 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
NCT01992094 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years
NCT04192500 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older
NCT00848848 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
NCT01991587 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
NCT00125944 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (VAX2012Q) in Adults 18-64 Years
NCT02434276 ·Status: UNKNOWN ·Phase: PHASE2
-
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
NCT00192127 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Evaluate the Safety of Bivalent Vaccine
NCT00325481 ·Status: COMPLETED ·Phase: PHASE3
-
Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)
NCT00903552 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
NCT00985673 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine
NCT01465035 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836
NCT06582277 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Safety and Immunogenicity Study in Healthy Adults of VAX125, a Recombinant HA-flagellin Influenza Vaccine
NCT00730457 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older
NCT02218697 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Safety and Immunogenicity of a Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years
NCT02247362 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
NCT01014806 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
NCT00819013 ·Status: COMPLETED ·Phase: PHASE1
-
A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
NCT00677820 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
NCT02148328 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
NCT00845429 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
NCT07291635 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
NCT02307851 ·Status: COMPLETED ·Phase: PHASE2