The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
375
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Diex Recherche Quebec
Québec, Quebec, Canada
RECRUITINGDiex Recherche Victoraville
Victoriaville, Quebec, Canada
RECRUITINGNumber of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
Time frame: Up to End of Study (EOS) (Day 181)
Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)
Time frame: Day 29
Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level
Time frame: Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MAC Clinical Research
Manchester, Greater Manchester, United Kingdom
NOT_YET_RECRUITINGSouthampton General Hospital, NHS
Southampton, Hampshire, United Kingdom
NOT_YET_RECRUITINGNorfolk and Norwich University Hospital, NHS
Norwich, Norfolk, United Kingdom
NOT_YET_RECRUITINGUniversity Hospital Birmingham, NHS
Birmingham, West Midlands, United Kingdom
NOT_YET_RECRUITINGRoyal Free Hospital, NHS
London, United Kingdom
NOT_YET_RECRUITINGGuys and St. Thomas Hospital, NHS
London, United Kingdom
NOT_YET_RECRUITINGSt. George University Hospital, NHS
London, United Kingdom
NOT_YET_RECRUITINGRoyal Victoria Infirmary, NHS
Newcastle, United Kingdom
NOT_YET_RECRUITING