Trial · NCT01162122
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
NCT01162122, Phase 3, Completed, Novartis Vaccines; results first posted 2014-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects. Trials, record NCT01162122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01162122
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
- NCT number
- NCT01162122
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,109 participants, actual
- Lead sponsor
- Novartis Vaccines
- Conditions
- Influenza
- Interventions
- MF59 adjuvanted trivalent subunit influenza vaccine (aTIV), Non-adjuvanted trivalent subunit influenza vaccine (TIV)
- First posted
- 2010-07-14
- Last updated
- 2014-06-26
- Results first posted
- 2014-06-12
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | Day 22 post vaccination | Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain. |
| Primary | Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS | Day 22 post vaccination | The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains. |
| Primary | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS | Day 22 post vaccination | The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
| Primary | Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS) | Day 22 post vaccination | The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains. |
| Primary | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS | Day 22 post vaccination | The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
| Primary | Percentage of Subjects With HI Titers ≥40 Against Homologous Strains | Day 22 post vaccination | The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. |
| Primary | Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains | Day 22 post vaccination | The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10. |
| Primary | Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains | Day 22 post vaccination | The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. |
| Primary | Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains | Day 22 post vaccination | The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV. |
| Primary | Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains | Day 22 post vaccination | The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | Day 22 post vaccination | Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS | Day 22 post vaccination | Analysis was done on PPS. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Percentage of subjects | NUMBER |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS) | Day 22 post vaccination | Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22 | Titers | GEOMETRIC_MEAN |
| PRIMARY | Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS | Day 22 post vaccination | Analysis was done on FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With HI Titers ≥40 Against Homologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains | Day 22 post vaccination | Analysis was done on the FAS. | Percentage of subjects | NUMBER |
| PRIMARY | Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains | Day 22 post vaccination | Analysis was done on the FAS | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS | Day 22 post vaccination | Analysis was done on PPS. | Percentage of subjects | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group283
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 1 | H1N1 strain (N=1072,1078,1075) | 209 | 95% Confidence Interval 189 to 231 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 2 | H1N1 strain (N=1072,1078,1075) | 187 | 95% Confidence Interval 170 to 207 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 3 | H1N1 strain (N=1072,1078,1075) | 199 | 95% Confidence Interval 180 to 220 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 1 | H3N2 strain (N=1072,1078,1075) | 548 | 95% Confidence Interval 502 to 598 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 2 | H3N2 strain (N=1072,1078,1075) | 542 | 95% Confidence Interval 498 to 591 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 3 | H3N2 strain (N=1072,1078,1075) | 556 | 95% Confidence Interval 510 to 606 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 1 | B strain | 56 | 95% Confidence Interval 51 to 61 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 2 | B strain | 56 | 95% Confidence Interval 51 to 61 | Titers |
| Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV | aTIV_Lot 3 | B strain | 58 | 95% Confidence Interval 53 to 64 | Titers |
| Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS | aTIV (Pooled) | H1N1 strain (N=3225,3257) | 198 | 95% Confidence Interval 185 to 211 | Titers |
1 to 10 of 283Source ClinicalTrials.gov
See all 283 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | aTIV (Pooled) | 3,552 | |
| Overall Study | STARTED | Licensed TIV | 3,552 | |
| Overall Study | Vaccinated | aTIV (Pooled) | 3,541 | |
| Overall Study | Vaccinated | Licensed TIV | 3,541 | |
| Overall Study | COMPLETED | aTIV (Pooled) | 3,361 | |
| Overall Study | COMPLETED | Licensed TIV | 3,356 | |
| Overall Study | NOT COMPLETED | aTIV (Pooled) | 191 | |
| Overall Study | NOT COMPLETED | Licensed TIV | 196 |
Source ClinicalTrials.gov
Adverse events588
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | aTIV (Pooled) | 258 | 3,545 | |
| other | Chills | General disorders | Licensed TIV | 176 | 3,537 | |
| other | Fatigue | General disorders | aTIV (Pooled) | 480 | 3,545 | |
| other | Fatigue | General disorders | Licensed TIV | 379 | 3,537 | |
| other | Injection site erythema | General disorders | aTIV (Pooled) | 292 | 3,545 | |
| other | Injection site erythema | General disorders | Licensed TIV | 255 | 3,537 | |
| other | Injection site pain | General disorders | aTIV (Pooled) | 1,172 | 3,545 | |
| other | Injection site pain | General disorders | Licensed TIV | 643 | 3,537 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | aTIV (Pooled) | 315 | 3,545 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Licensed TIV | 293 | 3,537 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | aTIV (Pooled) | ||
| Total, all-cause mortality | Licensed TIV | ||
| Total, other adverse events | aTIV (Pooled) | 1,678 | 3,545 |
| Total, other adverse events | Licensed TIV | 1,257 | 3,537 |
| Total, serious adverse events | aTIV (Pooled) | 264 | 3,545 |
| Total, serious adverse events | Licensed TIV | 243 | 3,537 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25045825 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| aTIV (Pooled) vs Licensed TIV: Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups | Trial comparisons |
| aTIV (Pooled) vs Licensed TIV: Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups | Trial comparisons |
| aTIV (Pooled) vs Licensed TIV: serious adverse events | Trial comparisons |
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/NCT01162122
GET https://conductscience.org/api/trials/v1/NCT01162122/registered?page=2