Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	From Month 0 to Month 6	Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (\>) 2 episodes) reported.
Primary	Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	From Month 0 to Month 6	Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.
Primary	Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	From Month 0 to Month 6	ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.
Primary	Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	From Month 0 to Month 6	Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.
Primary	Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	From Month 0 to Month 6	As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).
Primary	Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	From Month 0 to Month 6	ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.
Primary	Number of Subjects With Influenza-related Complications	From Month 0 to Month 6	ILI complications refer to episodes of pneumonia, ischemic heart disease \[HD\] (unstable angina or myocardial infarction), congestive heart failure \[HF\], acute cerebrovascular disease \[ACD\] (stroke or transient ischemic attack \[IA\]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).
Primary	Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	From Month 0 to Month 6	Death due to lab confirmed influenza infection was recorded during the influeza period only.
Primary	Number of Subjects With Fatal Outcomes	From Month 0 to Month 6	Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza
Primary	Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	From Month 0 to Month 6	RSV infection was determined by the RT-PCR assay.
Primary	Number of Subjects With Serious Adverse Events (SAEs)	From Month 0 to Month 6	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Primary	Number of Seroconverted Subjects for Each Influenza Strain	At Day 21	A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.
Primary	Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease	At Day 21	The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Primary	Number of Seroprotected Subjects Against the 3 Influenza Strains	At Day 0 (PRE)	A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Primary	Number of Seroprotected Subjects Against the 3 Influenza Strains	At Day 21	A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Primary	Number of Seropositive Subjects for Each Influenza Strain	At Day 0 (PRE)	A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.
Primary	Number of Seropositive Subjects for Each Influenza Strain	At Day 21	A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.
Primary	Serum HI Antibody Titers for Each Influenza Strain	At Day 0 (PRE)	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).
Primary	Serum HI Antibody Titers for Each Influenza Strain	At Day 21	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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