Trial · NCT01688921
Jet Injection for Influenza
NCT01688921, Phase 4, Completed, PharmaJet, Inc.; results first posted 2014-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Jet Injection for Influenza. Trials, record NCT01688921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01688921
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Jet Injection for Influenza
- NCT number
- NCT01688921
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- PharmaJet, Inc.
- Conditions
- Influenza, Human
- Interventions
- AFLURIA vaccine (2012-2013 formulation), Needle-Syringe, Stratis needle-free injection device
- First posted
- 2012-09-20
- Last updated
- 2017-11-01
- Results first posted
- 2014-10-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | 28 days | The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold. |
| Primary | Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | 28 days | The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold. |
| Primary | Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | 28 days | The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold. |
| Primary | Anti Influenza Type A/H1N1 Seroconversion | 28 days | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40. |
| Primary | Anti Influenza Type A/H3N2 Seroconversion | 28 days | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40. |
| Primary | Anti Influenza Type B Seroconversion | 28 days | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40. |
| Secondary | Number of Subjects With Complaints Within 30 Minutes Following Vaccination | Within 30 minutes post-vaccination | |
| Secondary | Number of Subjects With Vaccine Reactogenicity Events | Day 0, 1, 2, 3, 4, 5, and 6 | Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening. |
| Secondary | Number of Subjects With Spontaneously Reported Adverse Events | 28 days | Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events. |
| Secondary | Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again | 28 Days |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | 28 days | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | 28 days | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | 28 days | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Anti Influenza Type A/H1N1 Seroconversion | 28 days | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Percent of Participants | NUMBER |
| PRIMARY | Anti Influenza Type A/H3N2 Seroconversion | 28 days | Percent of Participants | NUMBER | |
| PRIMARY | Anti Influenza Type B Seroconversion | 28 days | The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population. | Percent of Participants | NUMBER |
| SECONDARY | Number of Subjects With Complaints Within 30 Minutes Following Vaccination | Within 30 minutes post-vaccination | The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). | participants | NUMBER |
| SECONDARY | Number of Subjects With Vaccine Reactogenicity Events | Day 0, 1, 2, 3, 4, 5, and 6 | The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card. | participants | NUMBER |
| SECONDARY | Number of Subjects With Spontaneously Reported Adverse Events | 28 days | The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). | participants with spontaneous AEs | NUMBER |
| SECONDARY | Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again | 28 Days | Safety population | Percent of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | PJ STRATIS | Day 0 | 4.43 | Standard Deviation 1.348 | Titers |
| Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | Needle-Syringe | Day 0 | 4.38 | Standard Deviation 1.352 | Titers |
| Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | PJ STRATIS | Day 28 | 5.64 | Standard Deviation 1.006 | Titers |
| Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | Needle-Syringe | Day 28 | 5.64 | Standard Deviation 0.997 | Titers |
| Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | PJ STRATIS | Day 0 | 4.22 | Standard Deviation 1.283 | Titers |
| Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | Needle-Syringe | Day 0 | 4.32 | Standard Deviation 1.290 | Titers |
| Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | PJ STRATIS | Day 28 | 5.51 | Standard Deviation 1.022 | Titers |
| Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | Needle-Syringe | Day 28 | 5.58 | Standard Deviation 0.987 | Titers |
| Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | PJ STRATIS | Day 0 | 2.60 | Standard Deviation 1.028 | Titers |
| Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT) | Needle-Syringe | Day 0 | 2.54 | Standard Deviation 1.003 | Titers |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | STRATIS | 627 | |
| Overall Study | STARTED | Needle-Syringe | 623 | |
| Overall Study | COMPLETED | STRATIS | 611 | |
| Overall Study | COMPLETED | Needle-Syringe | 608 | |
| Overall Study | NOT COMPLETED | STRATIS | 16 | |
| Overall Study | NOT COMPLETED | Needle-Syringe | 15 |
Source ClinicalTrials.gov
Adverse events34
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 | Pain | General disorders | STRATIS | 397 | 616 | |
| other | Pain | General disorders | Needle-Syringe | 299 | 606 | |
| other | Tenderness | General disorders | STRATIS | 551 | 616 | |
| other | Tenderness | General disorders | Needle-Syringe | 471 | 606 | |
| other | Itching | General disorders | STRATIS | 146 | 540 | |
| other | Itching | General disorders | Needle-Syringe | 49 | 527 | |
| other | Redness | General disorders | STRATIS | 366 | 609 | |
| other | Redness | General disorders | Needle-Syringe | 115 | 599 | |
| other | Swelling | General disorders | STRATIS | 392 | 605 | |
| other | Swelling | General disorders | Needle-Syringe | 118 | 599 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | STRATIS | ||
| Total, all-cause mortality | Needle-Syringe | ||
| Total, other adverse events | STRATIS | 586 | 624 |
| Total, other adverse events | Needle-Syringe | 516 | 623 |
| Total, serious adverse events | STRATIS | 1 | 624 |
| Total, serious adverse events | Needle-Syringe | 2 | 623 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24881803 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| STRATIS vs Needle-Syringe: serious adverse events |
Source 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/NCT01688921
GET https://conductscience.org/api/trials/v1/NCT01688921/results?page=2