At a glance
ClinicalIndex Comparison Record- ✓Age 18–45 years (younger adults) or 60–80 years (older adults); sentinel older adults limited to ≤70 years
- ✓Healthy or medically stable with normal safety laboratory assessments and clinical examination
- ✓Body mass index ≥18 and ≤32 kg/m²
- ✓Females of childbearing potential must have negative pregnancy test on vaccination day and use adequate contraception for 28 days prior and ≥1 month after vaccination
- ✕Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality
- ✕Any clinically significant hematological, coagulation, or urine analysis laboratory abnormality
- ✕Current or past malignancy unless completely resolved without sequelae for >5 years
- ✕Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Randomized, Dose Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an mRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults
In Brief
A Phase 1 clinical trial evaluating GSK4382276A Dose level 1, GSK4382276A Dose level 2, and 10 other interventions for Influenza, Human. Completed, enrolled 324 participants across 7 sites in 3 countries.
Detailed Summary
The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).
Study Details
Timeline
Interventions
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1