Trial · NCT02290509
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
NCT02290509, Phase 3, Completed, Protein Sciences Corporation; results first posted 2016-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age. Trials, record NCT02290509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290509
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
- NCT number
- NCT02290509
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,350 participants, actual
- Lead sponsor
- Protein Sciences Corporation
- Conditions
- Influenza
- Interventions
- Flublok Quadrivalent, Inactivated Influenza Vaccine (IIV4)
- First posted
- 2014-11-14
- Last updated
- 2016-10-27
- Results first posted
- 2016-09-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Day 28 after final vaccination | Seroconversion is defined as: Either a pre vaccination titer \< 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination. |
| Primary | Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Day 0 and Day 28 after final vaccination | Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated. |
| Secondary | Number of Participants With Systemic and Injection Site Reactogenicity | Days 0-7 | |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) | Six months post-vaccination |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Day 28 after final vaccination | The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Systemic and Injection Site Reactogenicity | Days 0-7 | The Reactogenicity Population includes subjects who recorded any systemic reaction data and injection site reaction data following administration of study vaccine. This was two subjects less than the Safety Population. | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) | Six months post-vaccination | The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine. | participants | NUMBER |
| PRIMARY | Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Day 0 and Day 28 after final vaccination | The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response. | titer | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Flublok Quadrivalent Influenza Vaccine | A/H1N1/California | 66.7 | 95% Confidence Interval 63.6 to 69.6 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Inactivated Influenza Vaccine (IIV4) | A/H1N1/California | 63.5 | 95% Confidence Interval 58.0 to 68.7 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Flublok Quadrivalent Influenza Vaccine | A/H3N2/Texas | 72.1 | 95% Confidence Interval 69.2 to 74.9 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Inactivated Influenza Vaccine (IIV4) | A/H3N2/Texas | 57.0 | 95% Confidence Interval 51.4 to 62.4 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Flublok Quadrivalent Influenza Vaccine | B/Massachusetts | 59.6 | 95% Confidence Interval 56.5 to 62.8 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Inactivated Influenza Vaccine (IIV4) | B/Massachusetts | 60.4 | 95% Confidence Interval 54.8 to 65.7 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Flublok Quadrivalent Influenza Vaccine | B/Brisbane | 40.6 | 95% Confidence Interval 37.4 to 43.7 | percentage of participants |
| Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine | Inactivated Influenza Vaccine (IIV4) | B/Brisbane | 58.2 | 95% Confidence Interval 52.6 to 63.6 | percentage of participants |
| Number of Participants With Systemic and Injection Site Reactogenicity | Flublok Quadrivalent Influenza Vaccine | Subjects with one or more injection site reaction | 510 | participants | |
| Number of Participants With Systemic and Injection Site Reactogenicity | Inactivated Influenza Vaccine (IIV4) | Subjects with one or more injection site reaction | 172 | participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flublok Quadrivalent Influenza Vaccine | 1,011 | |
| Overall Study | STARTED | Inactivated Influenza Vaccine (IIV4) | 339 | |
| Overall Study | COMPLETED | Flublok Quadrivalent Influenza Vaccine | 962 | |
| Overall Study | COMPLETED | Inactivated Influenza Vaccine (IIV4) | 325 | |
| Overall Study | NOT COMPLETED | Flublok Quadrivalent Influenza Vaccine | 49 | |
| Overall Study | NOT COMPLETED | Inactivated Influenza Vaccine (IIV4) | 14 |
Source ClinicalTrials.gov
Adverse events36
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 | Nasophayngitis | Infections and infestations | Flublok Quadrivalent Influenza Vaccine | 13 | 998 | |
| other | Nasophayngitis | Infections and infestations | Inactivated Influenza Vaccine (IIV4) | 5 | 332 | |
| other | Upper respiratory tract infection | Infections and infestations | Flublok Quadrivalent Influenza Vaccine | 10 | 998 | |
| other | Upper respiratory tract infection | Infections and infestations | Inactivated Influenza Vaccine (IIV4) | 5 | 332 | |
| other | Sinusitis | Infections and infestations | Flublok Quadrivalent Influenza Vaccine | 6 | 998 | |
| other | Sinusitis | Infections and infestations | Inactivated Influenza Vaccine (IIV4) | 5 | 332 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Flublok Quadrivalent Influenza Vaccine | 14 | 998 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Inactivated Influenza Vaccine (IIV4) | 4 | 332 | |
| other | Headache | Nervous system disorders | Flublok Quadrivalent Influenza Vaccine | 20 | 998 | |
| other | Headache | Nervous system disorders | Inactivated Influenza Vaccine (IIV4) | 5 | 332 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flublok Quadrivalent Influenza Vaccine | ||
| Total, all-cause mortality | Inactivated Influenza Vaccine (IIV4) | ||
| Total, other adverse events | Flublok Quadrivalent Influenza Vaccine | 63 | 998 |
| Total, other adverse events | Inactivated Influenza Vaccine (IIV4) | 24 | 332 |
| Total, serious adverse events | Flublok Quadrivalent Influenza Vaccine | 10 | 998 |
| Total, serious adverse events | Inactivated Influenza Vaccine (IIV4) | 2 | 332 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28968871 | 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 |
|---|
| Flublok Quadrivalent Influenza Vaccine vs Inactivated Influenza Vaccine (IIV4): 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/NCT02290509
GET https://conductscience.org/api/trials/v1/NCT02290509/results?page=2