The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,504
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Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 43 (21 days after each injection)
Number of Participants with AEs Leading to Discontinuation From Study
Time frame: Day 1 to Day 205 (end of study [EoS])
Number of Participants with Medically-Attended AEs (MAAEs)
Time frame: Day 1 to Day 205 (EoS)
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 205 (EoS)
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 205 (EoS)
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
Time frame: Days 22, 29, and 43
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
Time frame: Baseline (Day 1), Days 22, 29, and 43
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
Seroconversion is defined as a Day 22, 29, or 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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CenExel RCA
Hollywood, Florida, United States
Velocity Clinical Research
Savannah, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
DM Clinical Research
Southfield, Michigan, United States
Velocity Clinical Research
Lincoln, Nebraska, United States
Velocity Clinical Research Providence
East Greenwich, Rhode Island, United States
DM Clinical Research
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, United States
Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
...and 17 more locations
Time frame: Baseline (Day 1) to Days 22, 29, and 43
Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
Time frame: Days 22, 29, and 43
GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
Time frame: Days 22, 29, and 43
GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
Time frame: Baseline (Day 1), Days 22, 29, and 43
Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is \<LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.
Time frame: Baseline (Day 1) to Days 22, 29, and 43