Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Sponsor
Protein Sciences Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02285998
Collaborator
(none)
9,003
38
2
7
236.9
34
Study Details
Study Description
Brief Summary
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population. Real-time Polymerase Chain Reaction (rtPCR) will be used to confirm influenza infection and to type the strains involved, as molecular methodologies have been demonstrated to be more sensitive than other more traditional methodologies, e.g. culture. For rtPCR-positive clinical samples, reserved aliquots will be processed for culture, so that antigenic similarity to the HA present in study vaccines can be tested.
In various clinical studies the investigators demonstrated that the immune response against the influenza A viruses is improved as a result of the higher hemagglutinin content. Furthermore, influenza virus disease and hospitalization associated with influenza-related illness in older adults (> 50 years) was considerably reduced (90%) following vaccination with TIV, even though the circulating influenza A strain was antigenically dissimilar to that in the vaccine. However, more recently Skowronski et al. reported that the low influenza vaccine effectiveness in 2012-2013 was not associated with antigenic drift but was instead related to mutations in the egg-adapted H3N2 vaccine strain. Flublok manufactured using recombinant technology does not contain the mutations responsible for the reported lower effectiveness and may thus offer improved protection when mutations such as those described are induced in the process of adapting the influenza virus to growth in eggs.
Study Design
Study Type:
Interventional
Actual Enrollment
:
9003 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) in Healthy, Medically Stable Adults ≥50 Years of Age
Study Start Date
:
Oct 1, 2014
Actual Primary Completion Date
:
May 1, 2015
Actual Study Completion Date
:
May 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Flublok Quadrivalent Influenza Vaccine Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL |
Biological: Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine
|
| Active Comparator: Inactivated Influenza Vaccine Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. |
Biological: Inactivated Influenza Vaccine
Intramuscular injection of vaccine
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With rtPCR-confirmed Influenza-Like Illness [14 days post vaccination through and up to 32 weeks post vaccination]
rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination
Secondary Outcome Measures
- Number of Participants With Culture-confirmed Influenza-Like Illness [14 days post vaccination through and up to 32 weeks post vaccination]
Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines. Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms: Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)
- Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness [14 days post vaccination through and up to 32 weeks post vaccination]
Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines. CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat.
- Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness [14 days post vaccination through and up to 32 weeks post vaccination]
rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.
- Percentage of Participants With Seroconversion [Days 0 through 28]
Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.
- Number of Participants With Local Injection Site Reactogenicity [Days 0 through 7]
Solicited events of injection site reactogenicity reported during Day 0-7.
- Number of Participants With Unsolicited Adverse Events [Days 0 through 28]
Unsolicited adverse events reported in the 28 days following vaccine administration.
- Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) [Day 0 through and up to 32 weeks post vaccination]
Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination). A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment.
- Measure of Post-vaccination HAI GMTs [Days 0 through 28]
GMT titers for all four antigens in a preselected subset of subjects.
- Number of Participants With Systemic Reactogenicity [Days 0 through 7]
Solicited events of systemic reactogenicity reported during Day 0-7.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Ambulatory adults aged 50 and older.
-
Medically stable, as determined by medical history and targeted physical examination. "Medically stable" is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study.
-
Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
-
Able to understand and comply with planned study procedures.
-
Provides written informed consent prior to initiation of any study procedure.
Exclusion Criteria:
-
Known contraindication to either study vaccine (see product package inserts)
-
Receipt of any other influenza vaccine within 180 days prior to enrollment in this study.
-
Underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Coastal Clinical Research | Mobile | Alabama | United States | 36608 |
| 2 | Clinical Research Consortium Arizona | Tempe | Arizona | United States | 85283 |
| 3 | Baptist Health Center for Clinical Research | Little Rock | Arkansas | United States | 72205 |
| 4 | Northern California Clinical Research Center | Redding | California | United States | 96001 |
| 5 | Benchmark Research - Sacramento | Sacramento | California | United States | 95816 |
| 6 | Benchmark Research - San Francisco | San Francisco | California | United States | 94102 |
| 7 | Lynn Institute of the Rockies | Colorado Springs | Colorado | United States | 80907 |
| 8 | Clinical Research Consulting | Milford | Connecticut | United States | 06460 |
| 9 | Clinical Research of South Florida | Coral Gables | Florida | United States | 33134 |
| 10 | Avail Clinical Research | DeLand | Florida | United States | 32720 |
| 11 | Westside Center for Clinical Research | Jacksonville | Florida | United States | 32205 |
| 12 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 13 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 14 | Meridian Research | Savannah | Georgia | United States | 31406 |
| 15 | ACR - Boise | Meridian | Idaho | United States | 83642 |
| 16 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
| 17 | Central Kentucky Research Associates | Lexington | Kentucky | United States | 40509 |
| 18 | Benchmarch Research - New Orleans | Metairie | Louisiana | United States | 70006 |
| 19 | ActivMed Practices & Research | Methuen | Massachusetts | United States | 01844 |
| 20 | Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
| 21 | Meridian Research | Bellevue | Nebraska | United States | 68005 |
| 22 | Meridian Research | Norfolk | Nebraska | United States | 68701 |
| 23 | Meridian Clinical Research | Omaha | Nebraska | United States | 68164 |
| 24 | Clinical Research Consortium-Nevada | Las Vegas | Nevada | United States | 89119 |
| 25 | ActivMed Practices & Research | Newington | New Hampshire | United States | 03801 |
| 26 | Regional Clinical Research, Inc. | Endwell | New York | United States | 13760 |
| 27 | Rochester Clinical Research | Rochester | New York | United States | 14609 |
| 28 | Wake Research | Raleigh | North Carolina | United States | 27612 |
| 29 | Rapid Medical Research, Inc. | Cleveland | Ohio | United States | 44122 |
| 30 | Lynn Institute of Norman | Norman | Oklahoma | United States | 73069 |
| 31 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 32 | Meridian Research | Dakota Dunes | South Dakota | United States | 57049 |
| 33 | Clinical Research Associates | Nashville | Tennessee | United States | 37203 |
| 34 | Benchmark Reseach | Austin | Texas | United States | 78705 |
| 35 | Benchmark Research - Fort Worth | Fort Worth | Texas | United States | 76135 |
| 36 | Benchmark Research - San Angelo | San Angelo | Texas | United States | 76904 |
| 37 | Jean Brown Research | Salt Lake City | Utah | United States | 84124 |
| 38 | Clinical Research Associates of Tidewater | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Protein Sciences Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT02285998
Other Study ID Numbers:
- PSC12
First Posted:
Nov 7, 2014
Last Update Posted:
Oct 27, 2017
Last Verified:
Sep 1, 2017
Keywords provided by Protein Sciences Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Excludes 40 subjects who received randomization numbers, but who either withdrew prior to vaccination (n=15) or for whom the vaccine received could not be verified (n=25; 12 assigned to Flublok quadrivalent and 13 assigned to IIV4). |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Period Title: Overall Study | ||
| STARTED | 4474 | 4489 |
| COMPLETED | 4228 | 4236 |
| NOT COMPLETED | 246 | 253 |
Baseline Characteristics
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine | Total |
|---|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine | Total of all reporting groups |
| Overall Participants | 4328 | 4344 | 8672 |
| Age, Customized (participants) [Number] | |||
| 50-64 years |
2569
59.4%
|
2617
60.2%
|
5186
59.8%
|
| 65-74 years |
1234
28.5%
|
1254
28.9%
|
2488
28.7%
|
| 75 years and older |
525
12.1%
|
473
10.9%
|
998
11.5%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2532
58.5%
|
2537
58.4%
|
5069
58.5%
|
| Male |
1796
41.5%
|
1807
41.6%
|
3603
41.5%
|
Outcome Measures
| Title | Number of Participants With rtPCR-confirmed Influenza-Like Illness |
|---|---|
| Description | rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination |
| Time Frame | 14 days post vaccination through and up to 32 weeks post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4303 | 4301 |
| Number [participants] |
96
2.2%
|
138
3.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Flublok Quadrivalent Influenza Vaccine, Inactivated Influenza Vaccine |
|---|---|---|
| Comments | The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was > -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be > +9%. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Vaccine Efficacy (rVE) |
| Estimated Value | 30 | |
| Confidence Interval |
(2-Sided) 95% 10 to 47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Culture-confirmed Influenza-Like Illness |
|---|---|
| Description | Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines. Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms: Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache) |
| Time Frame | 14 days post vaccination through and up to 32 weeks post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4303 | 4301 |
| Number [participants] |
58
1.3%
|
101
2.3%
|
| Title | Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness |
|---|---|
| Description | Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines. CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat. |
| Time Frame | 14 days post vaccination through and up to 32 weeks post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4303 | 4301 |
| Number [participants] |
38
0.9%
|
64
1.5%
|
| Title | Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness |
|---|---|
| Description | rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain. |
| Time Frame | 14 days post vaccination through and up to 32 weeks post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4303 | 4301 |
| Number [participants] |
54
1.2%
|
83
1.9%
|
| Title | Percentage of Participants With Seroconversion |
|---|---|
| Description | Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects. |
| Time Frame | Days 0 through 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 314 | 300 |
| A/California |
44.9
1%
|
49.0
1.1%
|
| A/Texas |
54.5
1.3%
|
43.3
1%
|
| B/Massachusetts |
38.9
0.9%
|
38.3
0.9%
|
| B/Brisbane |
21.0
0.5%
|
34.3
0.8%
|
| Title | Number of Participants With Local Injection Site Reactogenicity |
|---|---|
| Description | Solicited events of injection site reactogenicity reported during Day 0-7. |
| Time Frame | Days 0 through 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited local reactogenicity events include subjects who recorded any injection site reaction data. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4307 | 4319 |
| Number [participants] |
1621
37.5%
|
1745
40.2%
|
| Title | Number of Participants With Unsolicited Adverse Events |
|---|---|
| Description | Unsolicited adverse events reported in the 28 days following vaccine administration. |
| Time Frame | Days 0 through 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4328 | 4344 |
| Number [participants] |
1345
31.1%
|
1355
31.2%
|
| Title | Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) |
|---|---|
| Description | Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination). A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment. |
| Time Frame | Day 0 through and up to 32 weeks post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4328 | 4344 |
| SAEs |
145
3.4%
|
132
3%
|
| MAEs |
774
17.9%
|
785
18.1%
|
| Title | Measure of Post-vaccination HAI GMTs |
|---|---|
| Description | GMT titers for all four antigens in a preselected subset of subjects. |
| Time Frame | Days 0 through 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 314 | 300 |
| Day 0 - A/California |
45
|
49
|
| Day 28 - A/California |
194
|
224
|
| Day 0 - A/Texas |
88
|
100
|
| Day 28 - A/Texas |
530
|
366
|
| Day 0 - B/Massachusetts |
17
|
18
|
| Day 28 - B/Massachusetts |
56
|
58
|
| Day 0 - B/Brisbane |
14
|
15
|
| Day 28 - B/Brisbane |
30
|
44
|
| Title | Number of Participants With Systemic Reactogenicity |
|---|---|
| Description | Solicited events of systemic reactogenicity reported during Day 0-7. |
| Time Frame | Days 0 through 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data. |
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine |
|---|---|---|
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine |
| Measure Participants | 4306 | 4318 |
| Number [participants] |
1077
24.9%
|
1106
25.5%
|
Adverse Events
| Time Frame | From time vaccination until the end of the influenza season (~6 months). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine | ||
| Arm/Group Description | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine | ||
All Cause Mortality |
||||
| Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 145/4328 (3.4%) | 132/4344 (3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/4328 (0%) | 0/4344 (0%) | ||
| Leukocytosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Microcytic anaemia | 1/4328 (0%) | 0/4344 (0%) | ||
| Thrombocytosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 6/4328 (0.1%) | 3/4344 (0.1%) | ||
| Myocardial infarction | 4/4328 (0.1%) | 3/4344 (0.1%) | ||
| Angina pectoris | 2/4328 (0%) | 2/4344 (0%) | ||
| Cardiac failure congestive | 2/4328 (0%) | 2/4344 (0%) | ||
| Angina unstable | 2/4328 (0%) | 1/4344 (0%) | ||
| Coronary artery disease | 2/4328 (0%) | 1/4344 (0%) | ||
| Cardiac arrest | 1/4328 (0%) | 1/4344 (0%) | ||
| Cardiac failure | 0/4328 (0%) | 2/4344 (0%) | ||
| Acute myocardial infarction | 1/4328 (0%) | 0/4344 (0%) | ||
| Arrhythmia | 1/4328 (0%) | 0/4344 (0%) | ||
| Atrial flutter | 1/4328 (0%) | 0/4344 (0%) | ||
| Cardiac tamponade | 0/4328 (0%) | 1/4344 (0%) | ||
| Cardio-respiratory arrest | 0/4328 (0%) | 1/4344 (0%) | ||
| Cardiogenic shock | 1/4328 (0%) | 0/4344 (0%) | ||
| Cardiovascular disorder | 0/4328 (0%) | 1/4344 (0%) | ||
| Coronary artery insufficiency | 1/4328 (0%) | 0/4344 (0%) | ||
| Coronary artery stenosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Coronary artery thrombosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Ischaemic cardiomyopathy | 1/4328 (0%) | 0/4344 (0%) | ||
| Sick sinus syndrome | 0/4328 (0%) | 1/4344 (0%) | ||
| Supraventricular tachycardia | 1/4328 (0%) | 0/4344 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 0/4328 (0%) | 1/4344 (0%) | ||
| Gastrointestinal disorders | ||||
| Gastrointestinal haemorrhage | 4/4328 (0.1%) | 1/4344 (0%) | ||
| Small intestinal obstruction | 2/4328 (0%) | 1/4344 (0%) | ||
| Upper gastrointestinal haemorrhage | 1/4328 (0%) | 2/4344 (0%) | ||
| Diverticulum intestinal haemorrhagic | 1/4328 (0%) | 1/4344 (0%) | ||
| Dysphagia | 2/4328 (0%) | 0/4344 (0%) | ||
| Intestinal obstruction | 1/4328 (0%) | 1/4344 (0%) | ||
| Pancreatitis | 2/4328 (0%) | 0/4344 (0%) | ||
| Abdominal pain | 1/4328 (0%) | 0/4344 (0%) | ||
| Colitis ischaemic | 0/4328 (0%) | 1/4344 (0%) | ||
| Cyclic vomiting syndrome | 1/4328 (0%) | 0/4344 (0%) | ||
| Diverticulum | 1/4328 (0%) | 0/4344 (0%) | ||
| Food poisoning | 1/4328 (0%) | 0/4344 (0%) | ||
| Gastric ulcer | 1/4328 (0%) | 0/4344 (0%) | ||
| Haemorrhoids | 1/4328 (0%) | 0/4344 (0%) | ||
| Hiatus hernia | 0/4328 (0%) | 1/4344 (0%) | ||
| Ileus | 1/4328 (0%) | 0/4344 (0%) | ||
| Inguinal hernia | 1/4328 (0%) | 0/4344 (0%) | ||
| Intestinal perforation | 1/4328 (0%) | 0/4344 (0%) | ||
| Volvulus | 0/4328 (0%) | 1/4344 (0%) | ||
| General disorders | ||||
| Chest pain | 7/4328 (0.2%) | 6/4344 (0.1%) | ||
| Death | 2/4328 (0%) | 1/4344 (0%) | ||
| Non-cardiac chest pain | 3/4328 (0.1%) | 0/4344 (0%) | ||
| Asthenia | 0/4328 (0%) | 1/4344 (0%) | ||
| Drug withdrawal syndrome | 0/4328 (0%) | 1/4344 (0%) | ||
| Hernia obstructive | 0/4328 (0%) | 1/4344 (0%) | ||
| Oedema peripheral | 1/4328 (0%) | 0/4344 (0%) | ||
| Pain | 1/4328 (0%) | 0/4344 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/4328 (0%) | 1/4344 (0%) | ||
| Cholecystitis | 0/4328 (0%) | 1/4344 (0%) | ||
| Hepatic cirrhosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Hepatic haemorrhage | 0/4328 (0%) | 1/4344 (0%) | ||
| Hepatitis alcoholic | 0/4328 (0%) | 1/4344 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 6/4328 (0.1%) | 6/4344 (0.1%) | ||
| Bronchitis | 2/4328 (0%) | 3/4344 (0.1%) | ||
| Diverticulitis | 2/4328 (0%) | 2/4344 (0%) | ||
| Influenza | 1/4328 (0%) | 3/4344 (0.1%) | ||
| Urinary tract infection | 2/4328 (0%) | 2/4344 (0%) | ||
| Cellulitis | 0/4328 (0%) | 3/4344 (0.1%) | ||
| Appendicitis | 1/4328 (0%) | 1/4344 (0%) | ||
| Lung Infection | 1/4328 (0%) | 1/4344 (0%) | ||
| Osteomyelitis | 1/4328 (0%) | 1/4344 (0%) | ||
| Pyelonephritis | 1/4328 (0%) | 1/4344 (0%) | ||
| Abscess intestinal | 1/4328 (0%) | 0/4344 (0%) | ||
| Device related infection | 1/4328 (0%) | 0/4344 (0%) | ||
| Endocarditis staphylococcal | 1/4328 (0%) | 0/4344 (0%) | ||
| Erysipelas | 0/4328 (0%) | 1/4344 (0%) | ||
| Eye abscess | 1/4328 (0%) | 0/4344 (0%) | ||
| Gangrene | 0/4328 (0%) | 1/4344 (0%) | ||
| Osteomyelitis acute | 0/4328 (0%) | 1/4344 (0%) | ||
| Osteomyelitis chronic | 0/4328 (0%) | 1/4344 (0%) | ||
| Otitis media | 0/4328 (0%) | 1/4344 (0%) | ||
| Pneumonia bacterial | 1/4328 (0%) | 0/4344 (0%) | ||
| Salmonellosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Urinary tract infection fungal | 0/4328 (0%) | 1/4344 (0%) | ||
| Urosepsis | 0/4328 (0%) | 1/4344 (0%) | ||
| Viral upper respiratory tract infection | 0/4328 (0%) | 1/4344 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Craniocerebral injury | 1/4328 (0%) | 1/4344 (0%) | ||
| Toxicity to various agents | 0/4328 (0%) | 2/4344 (0%) | ||
| Upper limb fracture | 1/4328 (0%) | 1/4344 (0%) | ||
| Cervical vertebral fracture | 1/4328 (0%) | 0/4344 (0%) | ||
| Head injury | 1/4328 (0%) | 0/4344 (0%) | ||
| Hip fracture | 1/4328 (0%) | 0/4344 (0%) | ||
| Lower limb fracture | 0/4328 (0%) | 1/4344 (0%) | ||
| Overdose | 1/4328 (0%) | 0/4344 (0%) | ||
| Procedural pain | 0/4328 (0%) | 1/4344 (0%) | ||
| Road traffic accident | 1/4328 (0%) | 0/4344 (0%) | ||
| Spinal compression fracture | 1/4328 (0%) | 0/4344 (0%) | ||
| Stab wound | 1/4328 (0%) | 0/4344 (0%) | ||
| Tendon rupture | 0/4328 (0%) | 1/4344 (0%) | ||
| Tibia fracture | 0/4328 (0%) | 1/4344 (0%) | ||
| Wound complication | 0/4328 (0%) | 1/4344 (0%) | ||
| Investigations | ||||
| Haematocrit decreased | 0/4328 (0%) | 1/4344 (0%) | ||
| International normalised ratio increased | 1/4328 (0%) | 0/4344 (0%) | ||
| Troponin increased | 1/4328 (0%) | 0/4344 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hyponatraemia | 2/4328 (0%) | 1/4344 (0%) | ||
| Dehydration | 2/4328 (0%) | 0/4344 (0%) | ||
| Diabetes mellitus inadequate control | 1/4328 (0%) | 1/4344 (0%) | ||
| Diabetic ketoacidosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Failure to thrive | 0/4328 (0%) | 1/4344 (0%) | ||
| Gout | 0/4328 (0%) | 1/4344 (0%) | ||
| Hyperglycaemia | 1/4328 (0%) | 0/4344 (0%) | ||
| Hypoglycaemia | 0/4328 (0%) | 1/4344 (0%) | ||
| Lactic acidosis | 0/4328 (0%) | 1/4344 (0%) | ||
| Obesity | 0/4328 (0%) | 1/4344 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 8/4328 (0.2%) | 7/4344 (0.2%) | ||
| Intervertebral disc protrusion | 1/4328 (0%) | 4/4344 (0.1%) | ||
| Arthralgia | 2/4328 (0%) | 0/4344 (0%) | ||
| Back pain | 2/4328 (0%) | 0/4344 (0%) | ||
| Intervertebral disc degeneration | 1/4328 (0%) | 1/4344 (0%) | ||
| Musculoskeletal pain | 1/4328 (0%) | 1/4344 (0%) | ||
| Neck pain | 2/4328 (0%) | 0/4344 (0%) | ||
| Spinal column stenosis | 1/4328 (0%) | 1/4344 (0%) | ||
| Arthritis | 0/4328 (0%) | 1/4344 (0%) | ||
| Intervertebral disc compression | 1/4328 (0%) | 0/4344 (0%) | ||
| Lumbar spinal stenosis | 0/4328 (0%) | 1/4344 (0%) | ||
| Muscular weakness | 0/4328 (0%) | 1/4344 (0%) | ||
| Pain in extremity | 1/4328 (0%) | 0/4344 (0%) | ||
| Rhabdomyolysis | 1/4328 (0%) | 0/4344 (0%) | ||
| Rotator cuff syndrome | 1/4328 (0%) | 0/4344 (0%) | ||
| Tenosynovitis stenosans | 0/4328 (0%) | 1/4344 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 1/4328 (0%) | 4/4344 (0.1%) | ||
| Prostate cancer | 2/4328 (0%) | 2/4344 (0%) | ||
| Bladder cancer | 1/4328 (0%) | 1/4344 (0%) | ||
| Hepatic cancer | 0/4328 (0%) | 2/4344 (0%) | ||
| Squamous cell carcinoma of lung | 0/4328 (0%) | 2/4344 (0%) | ||
| Abdominal wall neoplasm | 1/4328 (0%) | 0/4344 (0%) | ||
| B-cell lymphoma | 0/4328 (0%) | 1/4344 (0%) | ||
| Bladder neoplasm | 0/4328 (0%) | 1/4344 (0%) | ||
| Colorectal cancer | 0/4328 (0%) | 1/4344 (0%) | ||
| Colorectal cancer recurrent | 1/4328 (0%) | 0/4344 (0%) | ||
| Invasive ductal breast carcinoma | 1/4328 (0%) | 0/4344 (0%) | ||
| Metastases to liver | 0/4328 (0%) | 1/4344 (0%) | ||
| Oesophageal carcinoma | 1/4328 (0%) | 0/4344 (0%) | ||
| Pancreatic carcinoma metastatic | 1/4328 (0%) | 0/4344 (0%) | ||
| Renal cancer | 0/4328 (0%) | 1/4344 (0%) | ||
| Rhabdomyoma | 0/4328 (0%) | 1/4344 (0%) | ||
| Testis cancer | 1/4328 (0%) | 0/4344 (0%) | ||
| Thyroid cancer | 0/4328 (0%) | 1/4344 (0%) | ||
| Thyroid neoplasm | 0/4328 (0%) | 1/4344 (0%) | ||
| Transitional cell carcinoma | 0/4328 (0%) | 1/4344 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 5/4328 (0.1%) | 6/4344 (0.1%) | ||
| Transient ischaemic attack | 3/4328 (0.1%) | 2/4344 (0%) | ||
| Syncope | 1/4328 (0%) | 3/4344 (0.1%) | ||
| Convulsion | 1/4328 (0%) | 1/4344 (0%) | ||
| Embolic stroke | 2/4328 (0%) | 0/4344 (0%) | ||
| Cerebral haemorrhage | 1/4328 (0%) | 0/4344 (0%) | ||
| Encephalopathy | 0/4328 (0%) | 1/4344 (0%) | ||
| Haemorrhagic stroke | 0/4328 (0%) | 1/4344 (0%) | ||
| Lacunar infarction | 1/4328 (0%) | 0/4344 (0%) | ||
| Loss of consciousness | 1/4328 (0%) | 0/4344 (0%) | ||
| Lumbar radiculopathy | 0/4328 (0%) | 1/4344 (0%) | ||
| Myelomalacia | 1/4328 (0%) | 0/4344 (0%) | ||
| Sinus headache | 1/4328 (0%) | 0/4344 (0%) | ||
| Subarachnoid haemorrhage | 1/4328 (0%) | 0/4344 (0%) | ||
| Thalamic infarction | 1/4328 (0%) | 0/4344 (0%) | ||
| Psychiatric disorders | ||||
| Suicidal ideation | 0/4328 (0%) | 2/4344 (0%) | ||
| Anxiety | 0/4328 (0%) | 1/4344 (0%) | ||
| Renal and urinary disorders | ||||
| Renal failure acute | 3/4328 (0.1%) | 1/4344 (0%) | ||
| Urinary retention | 2/4328 (0%) | 0/4344 (0%) | ||
| Bladder outlet obstruction | 1/4328 (0%) | 0/4344 (0%) | ||
| Calculus ureteric | 1/4328 (0%) | 0/4344 (0%) | ||
| Renal necrosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/4328 (0%) | 0/4344 (0%) | ||
| Cystocele | 0/4328 (0%) | 1/4344 (0%) | ||
| Menorrhagia | 0/4328 (0%) | 1/4344 (0%) | ||
| Uterine disorder | 0/4328 (0%) | 1/4344 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 5/4328 (0.1%) | 5/4344 (0.1%) | ||
| Pulmonary embolism | 3/4328 (0.1%) | 1/4344 (0%) | ||
| Acute respiratory failure | 2/4328 (0%) | 0/4344 (0%) | ||
| Respiratory failure | 1/4328 (0%) | 1/4344 (0%) | ||
| Aspiration | 0/4328 (0%) | 1/4344 (0%) | ||
| Epistaxis | 0/4328 (0%) | 1/4344 (0%) | ||
| Pleural effusion | 0/4328 (0%) | 1/4344 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 0/4328 (0%) | 1/4344 (0%) | ||
| Surgical and medical procedures | ||||
| Knee arthroplasty | 2/4328 (0%) | 0/4344 (0%) | ||
| Abdominal hernia repair | 1/4328 (0%) | 0/4344 (0%) | ||
| Alcohol detoxification | 0/4328 (0%) | 1/4344 (0%) | ||
| Drug detoxification | 0/4328 (0%) | 1/4344 (0%) | ||
| Gastric bypass | 1/4328 (0%) | 0/4344 (0%) | ||
| Hernia repair | 1/4328 (0%) | 0/4344 (0%) | ||
| Hip arthroplasty | 0/4328 (0%) | 1/4344 (0%) | ||
| Inguinal hernia repair | 0/4328 (0%) | 1/4344 (0%) | ||
| Intestinal resection | 1/4328 (0%) | 0/4344 (0%) | ||
| Joint surgery | 1/4328 (0%) | 0/4344 (0%) | ||
| Rotator cuff repair | 1/4328 (0%) | 0/4344 (0%) | ||
| Vascular disorders | ||||
| Hypertensive crisis | 1/4328 (0%) | 1/4344 (0%) | ||
| Aortic aneurysm | 1/4328 (0%) | 0/4344 (0%) | ||
| Aortic aneurysm rupture | 0/4328 (0%) | 1/4344 (0%) | ||
| Aortic dissection | 0/4328 (0%) | 1/4344 (0%) | ||
| Arteriosclerosis | 1/4328 (0%) | 0/4344 (0%) | ||
| Circulatory collapse | 0/4328 (0%) | 1/4344 (0%) | ||
| Haemorrhage | 1/4328 (0%) | 0/4344 (0%) | ||
| Hypotension | 0/4328 (0%) | 1/4344 (0%) | ||
| Peripheral arterial occlusive disease | 0/4328 (0%) | 1/4344 (0%) | ||
| Thrombosis | 1/4328 (0%) | 0/4344 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Flublok Quadrivalent Influenza Vaccine | Inactivated Influenza Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1122/4328 (25.9%) | 1206/4344 (27.8%) | ||
| General disorders | ||||
| Influenza like illness | 186/4328 (4.3%) | 199/4344 (4.6%) | ||
| Fatigue | 106/4328 (2.4%) | 100/4344 (2.3%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 129/4328 (3%) | 156/4344 (3.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 95/4328 (2.2%) | 79/4344 (1.8%) | ||
| Nervous system disorders | ||||
| Headache | 143/4328 (3.3%) | 145/4344 (3.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 226/4328 (5.2%) | 253/4344 (5.8%) | ||
| Oropharyngeal pain | 178/4328 (4.1%) | 177/4344 (4.1%) | ||
| Productive cough | 59/4328 (1.4%) | 97/4344 (2.2%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lisa M. Dunkle, M.D., Chief Medical Officer |
|---|---|
| Organization | Protein Sciences Corporation |
| Phone | 203-599-6064 ext 153 |
| ldunkle@proteinsciences.com |
Responsible Party:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT02285998
Other Study ID Numbers:
- PSC12
First Posted:
Nov 7, 2014
Last Update Posted:
Oct 27, 2017
Last Verified:
Sep 1, 2017