mRNA NA vaccine
BiologicalPharmaceutical form: Suspension for injection Route of administration: Intramuscular
NCT Number: NCT05426174
This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
AES - DRS - Optimal Research_Site 8400007, Huntsville, Alabama, United States
This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other names: Fluzone HD
Time frame: Within 30 minutes after vaccination
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: From Day 1 to Day 8
Time frame: From Day 1 to Day 29
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
Time frame: From Day 1 to Day 366
Serious adverse events are collected throughout the study
Time frame: From Day 1 to Day 366
Adverse events of special interest are collected throughout the study
Time frame: From Day 1 to Day 8
Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen
Time frame: Day 1 and 29
Antibody are expressed as GMTs at baseline and post-baseline
Time frame: Day 1 and Day 29
Antibody titers are expressed as GMTs at baseline and post-baseline
Time frame: From Day 1 to Day 29
Expressed as percentage post-baseline
Time frame: Day 1 and Day 29
Expressed as percentage at baseline and post-baseline
Sanofi Pasteur, a Sanofi Company
Industry
Phase I, Randomized, Modified Double-blind, Parallel-group, Active-controlled, Multi-arm, Dose-escalation Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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