Investigational RSV vaccine 1
BiologicalInvestigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.
NCT Number: NCT06573281
The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Camberwell, Victoria, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medical conditions
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
Other exclusion criteria
Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 6 administered intramuscularly on Day 1.
Placebo administered intramuscularly on Day 1 and Day 30 and for RSV_Group F placebo administered only on Day 30.
Time frame: From Day 1 to Day 7
Time frame: From Day 30 to Day 36
Time frame: From Day 1 to Day 7
Time frame: From Day 30 to Day 36
Time frame: From Day 1 to Day 29
Time frame: From Day 30 to Day 58
Time frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Time frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Time frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Time frame: From Day 1 (Dose 1) up to Month 13 (study end)
Time frame: From Day 1 (Dose 1) up to Month 13 (study end)
Time frame: From Day 1 (Dose 1) up to Month 13 (study end)
Time frame: At Day 1
Time frame: At Day 8
Time frame: At Day 30
Time frame: At Day 37
Time frame: At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2)
Time frame: At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2)
Time frame: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Time frame: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Time frame: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer.
Time frame: Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)
Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer.
GlaxoSmithKline
Industry
A Phase 1, First-Time-in-Human (FTiH), Observer-blind, Randomized, Controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of Various Doses of an mRNA-based Respiratory Syncytial Virus (RSV) Investigational Vaccine in Healthy Participants 18-45 Years of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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