The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Study duration per participant: 12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort. Treatment Duration: Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination. Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination. Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
646
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos, California, United States
Matrix Clinical Research Site Number : 8400011
Los Angeles, California, United States
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California, United States
Suncoast Research Associates, LLC Site Number : 8400002
Miami, Florida, United States
AMR Chicago, Oakbrook Terrace Site Number : 8400019
Oakbrook Terrace, Illinois, United States
Velocity Clinical Research, Sioux City Site Number : 8400012
Sioux City, Iowa, United States
AMR Lexington Site Number : 8400008
Lexington, Kentucky, United States
AMR Kansas City Site Number : 8400014
Kansas City, Missouri, United States
AMR Knoxville Site Number : 8400010
Knoxville, Tennessee, United States
DM Clinical Research - Tomball Site Number : 8400004
Tomball, Texas, United States
...and 3 more locations
Presence of unsolicited systemic immediate adverse events (AEs)
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Time frame: Within 30 minutes after primary vaccination
Presence of solicited injection site or systemic reactions
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Time frame: Within 7 days after primary vaccination
Presence of unsolicited AEs
Number of participants experiencing unsolicited AEs
Time frame: Within 28 days after vaccination
Presence of medically attended adverse events (MAAEs)
Number of participants experiencing MAAEs
Time frame: Up to 6 months after primary injection
Presence of serious adverse events (SAEs)
Number of participants experiencing SAEs
Time frame: Up to 6 months after primary injection
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs
Time frame: Up to 6 months after primary injection
Presence of related SAEs
Number of participants experiencing related SAEs
Time frame: Throughout study (approximately 24 months)
Presence of related AESIs
Number of participants experiencing related AESIs
Time frame: Throughout study (approximately 24 months)
Presence of fatal SAEs
Number of participants experiencing fatal SAEs
Time frame: Throughout study (approximately 24 months)
Presence of out-of-range biological test results
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
Time frame: Within 7 days after vaccination
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)
Time frame: Day 1 and Day 29
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)
Time frame: Day 1 and Day 29
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination
Time frame: Day 1 and Day 29
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination
Time frame: Day 1 and Day 29
hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)
hMPV serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination
Time frame: Day 1 and Day 29
RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
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hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12