Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 19 of 19

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
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	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Influenza-related Complications	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Fatal Outcomes	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Serious Adverse Events (SAEs)	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Seroconverted Subjects for Each Influenza Strain	At Day 21	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease	At Day 21	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Titer	GEOMETRIC_MEAN
PRIMARY	Number of Seroprotected Subjects Against the 3 Influenza Strains	At Day 0 (PRE)	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Seroprotected Subjects Against the 3 Influenza Strains	At Day 21	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Seropositive Subjects for Each Influenza Strain	At Day 0 (PRE)	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Seropositive Subjects for Each Influenza Strain	At Day 21	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Serum HI Antibody Titers for Each Influenza Strain	At Day 0 (PRE)	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Titer	GEOMETRIC_MEAN
PRIMARY	Serum HI Antibody Titers for Each Influenza Strain	At Day 21	The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.	Titer	GEOMETRIC_MEAN

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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GET https://conductscience.org/api/trials/v1/NCT00377611/outcomes

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