Trial · NCT04120194
Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
NCT04120194, Phase 3, Completed, Novavax; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Pivotal Trial of NanoFlu™ in Older Adults. Trials, record NCT04120194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04120194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
- NCT number
- NCT04120194
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,654 participants, actual
- Lead sponsor
- Novavax
- Conditions
- Influenza, Human
- Interventions
- NanoFlu, Fluzone Quadrivalent
- First posted
- 2019-10-09
- Last updated
- 2023-05-06
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | Day 28 | Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28 |
| Primary | Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants | Day 0 - Day 28 | Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28 |
| Primary | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Day 0 - Day 6 | Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive). |
| Primary | Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) | Day 0 - Day 364 | Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection. |
| Primary | Number of Subjects With MAAEs, SAEs, SNMCs | Day 0 - Day 27 | Number of subjects with MAEs, SAEs, and SNMCs - including AESIs. |
| Secondary | HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT) | Day 0 - Day 28 | Homologous influenza strains and 1 antigenically drifted strain expressed as GMT |
| Secondary | HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 - 364 | Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR. |
| Secondary | Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain | Day 28 - Day 364 | Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR). |
| Secondary | Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR | Day 28 | Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | Day 28 | Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol. | Geometric Mean Fold Ratio | GEOMETRIC_MEAN |
| PRIMARY | Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants | Day 0 - Day 28 | Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol. | percentage of participants | NUMBER |
| PRIMARY | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Day 0 - Day 6 | Safety Population, including all study subjects who provided consent, were randomized, and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received). | participants | NUMBER |
| PRIMARY | Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) | Day 0 - Day 364 | Safety Population, including all study subjects who provided consent, were randomized, and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received). | participants | NUMBER |
| PRIMARY | Number of Subjects With MAAEs, SAEs, SNMCs | Day 0 - Day 27 | Safety Population, including all study subjects who provided consent, were randomized and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received). | participants | NUMBER |
| SECONDARY | HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT) | Day 0 - Day 28 | Per-Protocol (PP) Population including all subjects provided consent, were randomized and received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined by the sponsor prior to database lock and unblinding. | titers | GEOMETRIC_MEAN |
| SECONDARY | HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 - 364 | Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol. | Geometric Mean Fold Rise | GEOMETRIC_MEAN |
| SECONDARY | Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain | Day 28 - Day 364 | Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol. | percentage of participants | NUMBER |
| SECONDARY | Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR | Day 28 | Per-Protocol (PP) Population including all subjects provided consent, were randomized and received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined by the sponsor prior to database lock and unblinding. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | NanoFlu | A/Brisbane/02/2018 (H1N1) | 1.9 | 95% Confidence Interval 1.8 to 2.0 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | Fluzone Quadrivalent | A/Brisbane/02/2018 (H1N1) | 1.7 | 95% Confidence Interval 1. to 1.8 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | NanoFlu | A/Kansas/14/2017 (H3N2) | 2.7 | 95% Confidence Interval 2.6 to 2.9 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | Fluzone Quadrivalent | A/Kansas/14/2017 (H3N2) | 2.3 | 95% Confidence Interval 2.2 to 2.4 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | NanoFlu | B/Maryland/15/2016 (Victoria lineage) | 1.6 | 95% Confidence Interval 1.5 to 1.6 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | Fluzone Quadrivalent | B/Maryland/15/2016 (Victoria lineage) | 1.5 | 95% Confidence Interval 1.5 to 1.6 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | NanoFlu | B/Phuket/3073/2013 (Yamagata lineage) | 2.4 | 95% Confidence Interval 2.3 to 2.5 | Geometric Mean Fold Ratio |
| HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) | Fluzone Quadrivalent | B/Phuket/3073/2013 (Yamagata lineage) | 2.0 | 95% Confidence Interval 1.9 to 2.1 | Geometric Mean Fold Ratio |
| Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants | NanoFlu | A/Brisbane/02/2018 (H1N1) pdm09 | 22.0 | 95% Confidence Interval 19.8 to 24.4 | percentage of participants |
| Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants | Fluzone Quadrivalent | A/Brisbane/02/2018 (H1N1) pdm09 | 17.0 | 95% Confidence Interval 15.0 to 19.2 | percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NanoFlu | 1,332 | |
| Overall Study | STARTED | Fluzone Quadrivalent | 1,322 | |
| Overall Study | Safety Population | NanoFlu | 1,333 | |
| Overall Study | Safety Population | Fluzone Quadrivalent | 1,319 | |
| Overall Study | COMPLETED | NanoFlu | 1,312 | |
| Overall Study | COMPLETED | Fluzone Quadrivalent | 1,302 | |
| Overall Study | NOT COMPLETED | NanoFlu | 20 | |
| Overall Study | NOT COMPLETED | Fluzone Quadrivalent | 20 |
Source ClinicalTrials.gov
Adverse events314
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | NanoFlu | 0 | 1,333 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Fluzone Quadrivalent | 2 | 1,319 | 2 |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | NanoFlu | 1 | 1,333 | 1 |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | Fluzone Quadrivalent | 1 | 1,319 | 1 |
| serious | Leukocytosis | Blood and lymphatic system disorders | NanoFlu | 0 | 1,333 | 0 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Fluzone Quadrivalent | 1 | 1,319 | 1 |
| serious | Acute coronary syndrome | Cardiac disorders | NanoFlu | 0 | 1,333 | 0 |
| serious | Acute coronary syndrome | Cardiac disorders | Fluzone Quadrivalent | 1 | 1,319 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | NanoFlu | 0 | 1,333 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Fluzone Quadrivalent | 2 | 1,319 | 2 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NanoFlu | 8 | 1,333 |
| Total, all-cause mortality | Fluzone Quadrivalent | 8 | 1,319 |
| Total, other adverse events | NanoFlu | 0 | 1,333 |
| Total, other adverse events | Fluzone Quadrivalent | 0 | 1,319 |
| Total, serious adverse events | NanoFlu | 136 | 1,333 |
| Total, serious adverse events | Fluzone Quadrivalent | 125 | 1,319 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34563277 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NanoFlu vs Fluzone Quadrivalent: deaths from any cause | Trial comparisons |
| NanoFlu vs Fluzone Quadrivalent: 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/NCT04120194
GET https://conductscience.org/api/trials/v1/NCT04120194/results?page=2