Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age
NCT07516418 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 570
Last updated 2026-05-08
Summary
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years.
The total duration of study participation for each participant varies by stage and treatment arm.
Stage 1:
* For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant.
* For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant.
Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.
Conditions
- Respiratory Syncytial Virus (RSV)
- Influenza A(H5N1)
Interventions
- BIOLOGICAL
-
H5 Flu Investigational Medical Product (IMP) 1
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 2
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 3
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
RSV IMP 4
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
RSV IMP 5
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
RSV IMP 6
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 7
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 8
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 9
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 10
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 11
Suspension for injection. Route of administration: Intramuscular (IM) injection
- BIOLOGICAL
-
H5 Flu IMP 12
Suspension for injection. Route of administration: Intramuscular (IM) injection
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2027-04-04
- Completion
- 2027-04-04
Countries
- Australia
Study Locations
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