Trial · NCT05044195
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: had both Day 1 and Day 22 immunogenicity assessment; correctly received the vaccine (ie, received the vaccine to which the subjects were randomized and at the scheduled time points); had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; were not excluded due to other reasons defined prior to unblinding or analysis. Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| PRIMARY | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 22 | PPS Immunogenicity | percentage of participants | NUMBER |
| PRIMARY | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data at any time point. Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 181 | FAS Immunogenicity. Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity. Note: Unadjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity | Fold Increase | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity | percentage of participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity | percentage of participants | NUMBER |
| SECONDARY | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Day 1 through Day 7 | Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data including temperature measurements or use of analgesics/antipyretics | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Day 1 through Day 22 | Unsolicited Safety Set, defined as all subjects in the All Exposed Set with any unsolicited AE data. Note: Subjects are categorized according to the maximum symptom severity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs) | Day 1 through Day 271 | Unsolicited Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis) | Day 22 | FAS Immunogenicity. Subgroup analysis by age (50 to 59 years; 60 to 64 years). Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis) | Day 22 | FAS Immunogenicity. Subgroup analysis by influenza vaccination history (Received at least one influenza vaccination within the previous 3 influenza seasons: yes; no). Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis) | Day 22 | FAS Immunogenicity. Subgroup analysis by comorbidity risk score (\<50; ≥50). Note: Adjusted GMTs are presented. | 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.
For software
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