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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
213
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.
GSK Investigational Site
Rolling Hills Estates, California, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Omaha, Nebraska, United States
Number of participants reporting solicited administration site events within 7 days post-Dose 1
Time frame: From Day 1 to Day 7
Number of participants reporting solicited administration site events within 7 days post-Dose 2
Time frame: From Day 30 to Day 36
Number of participants reporting solicited systemic events within 7 days post-Dose 1
Time frame: From Day 1 to Day 7
Number of participants reporting solicited systemic events within 7 days post-Dose 2
Time frame: From Day 30 to Day 36
Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1
Time frame: From Day 1 to Day 29
Number of participants reporting unsolicited AEs within 29 days post-Dose 2
Time frame: From Day 30 to Day 58
Number of participants reporting serious adverse events (SAEs)
Time frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting medically attended adverse events (MAAEs)
Time frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting adverse event of special interest (AESI)
Time frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting fatal SAEs
Time frame: From Day 1 (Dose 1) up to Month 13 (study end)
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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.
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Camberwell, Victoria, Australia
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
Number of participants reporting related SAEs
Time frame: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related AESIs
Time frame: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants with clinically significant hematological and biochemical abnormalities at pre-Dose 1
Time frame: At Day 1
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
Time frame: At Day 8
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
Time frame: At Day 30
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2
Time frame: At Day 37
RSV- A neutralizing titers expressed as Geometric mean titers (GMTs)
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)
RSV- B neutralizing titers expressed as GMTs
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)
Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline
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)
Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline
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)
Number of participants with seroresponse in terms of neutralizing titer against RSV-A
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)
Number of participants with seroresponse in terms of neutralizing titer against RSV-B
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)