Trial · NCT05501561
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
NCT05501561, Phase 2, Completed, Seqirus
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age. Trials, record NCT05501561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05501561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
- NCT number
- NCT05501561
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,056 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1, Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1, Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1, Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1
- First posted
- 2022-08-15
- Last updated
- 2026-06-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29 | Day 1 and Day 29 | GMTs on Day 1 (prior to vaccination) and Day 29 as determined by HI assay against each of the 4 vaccine strains. No hypothesis testing was performed for the primary immunogenicity objectives. |
| Primary | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay) | Day 1 to Day 29 | Geometric mean of the fold increase in serum HI titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains. |
| Primary | Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29 | Day 1 and Day 29 | Percentages of subjects with HI titers ≥1:40 at Day 1 and Day 29 for each of the 4 vaccine strains. |
| Primary | Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay) | Day 1 to Day 29 | Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies. |
| Primary | Immunogenicity Endpoint: GMT Ratio (HI Assay) | Day 29 | The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group). |
| Primary | Solicited Local or Systemic AEs | Day 1 through Day 7 | Number and percentage of subjects with solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (electronic Diary \[eDiary\]). No hypothesis testing was performed for the primary safety objectives. |
| Primary | Severe Solicited Local or Systemic AEs | Day 1 through Day 7 | Number and percentage of subjects with severe solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (eDiary). |
| Primary | Unsolicited AEs | Day 1 to Day 29 | Number and percentage of subjects with unsolicited AEs for 28 days following vaccination |
| Primary | Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs) | Day 1 to Day 181 | Number and percentage of subjects with SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs |
| Secondary | Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29 | Day 1 and Day 29 | GMTs on Day 1 (prior to vaccination) and Day 29 as determined by MN assay against each of the 4 vaccine strains. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41855648 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05501561
GET https://conductscience.org/api/trials/v1/NCT05501561/registered