The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
308
CenExel
Hollywood, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Meridian Clinical Research
Sioux City, Iowa, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 176 (7 days follow-up post-vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28 days follow-up post-vaccination)
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
Time frame: Day 1 through end of study (EOS) (up to Day 1249)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 361
Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Time frame: Days 1 (Baseline), 29, 85, and 197
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Time frame: Days 1 (Baseline), 29, 85, and 197
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647
Time frame: Days 1 (Baseline), 29, 85, and 197
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine
Sterile lyophilized product
Meridian Clinical Research
Lincoln, Nebraska, United States
Benchmark Research
Austin, Texas, United States
Tekton Research, Inc
Austin, Texas, United States
DM Clinical Research- Texas Center for Drug Development
Houston, Texas, United States