Trial Outcomes & Findings for Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age (NCT NCT01825200)

Last Updated: 2015-02-18

Results Overview

Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2640 participants

Primary outcome timeframe

30 Days

Results posted on

2015-02-18

Participant Flow

Subjects were recruited at outpatient medical clinics over a period of five weeks.

Participant milestones

Participant milestones
Measure	Flublok Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Overall Study STARTED	1319	1321
Overall Study COMPLETED	1314	1314
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Flublok Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Overall Study Lost to Follow-up	5	6
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flublok n=1314 Participants Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 Participants Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.	Total n=2627 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	64 years n=7 Participants	64 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	672 Participants n=5 Participants	665 Participants n=7 Participants	1337 Participants n=5 Participants
Age, Categorical >=65 years	642 Participants n=5 Participants	648 Participants n=7 Participants	1290 Participants n=5 Participants
Sex: Female, Male Female	730 Participants n=5 Participants	725 Participants n=7 Participants	1455 Participants n=5 Participants
Sex: Female, Male Male	584 Participants n=5 Participants	588 Participants n=7 Participants	1172 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	197 Participants n=5 Participants	212 Participants n=7 Participants	409 Participants n=5 Participants
Race (NIH/OMB) White	1098 Participants n=5 Participants	1083 Participants n=7 Participants	2181 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	105 Participants n=5 Participants	99 Participants n=7 Participants	204 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1209 Participants n=5 Participants	1214 Participants n=7 Participants	2423 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1314 participants n=5 Participants	1313 participants n=7 Participants	2627 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.

Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.

Outcome measures

Outcome measures
Measure	Flublok n=1314 Participants Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 Participants Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Number of Participants With Common Hypersensitivity Reactions as Measure of Safety	31 participants	21 participants

SECONDARY outcome

Timeframe: 30 Days

Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration

Outcome measures

Outcome measures
Measure	Flublok n=1314 Participants Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 Participants Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration Medically-Attended Unsolicited Adverse Events	53 participants	51 participants
Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration Serious Adverse Events (SAEs)	5 participants	10 participants

SECONDARY outcome

Timeframe: 7 Days

Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.

Outcome measures

Outcome measures
Measure	Flublok n=1314 Participants Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 Participants Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Number of Participants With Local and Systemic Events Reported as a Measure of Safety	432 participants	480 participants

SECONDARY outcome

Timeframe: 7 Days

Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration

Outcome measures

Outcome measures
Measure	Flublok n=1314 Participants Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 Participants Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety Day 0	5 participants	3 participants
Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety Days 0-7	25 participants	12 participants

Adverse Events

Flublok

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Afluria

Serious events: 10 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flublok n=1314 participants at risk Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 participants at risk Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Nervous system disorders Cerebellar Stroke Syndrome	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Infections and infestations Sepsis	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.15% 2/1313 • Number of events 2 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Cardiac disorders Myocardial Infarction	0.08% 1/1314 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.15% 2/1313 • Number of events 2 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Endocrine disorders Diabetic Ketoacidosis	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Injury, poisoning and procedural complications Alcoholic Hepatitis	0.08% 1/1314 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.08% 1/1314 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.00% 0/1313 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.08% 1/1314 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.00% 0/1313 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Injury, poisoning and procedural complications Leg Fracture	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Tumor	0.08% 1/1314 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.00% 0/1313 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Infections and infestations Pneumonia	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Cardiac disorders Hypertension	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Infections and infestations Appendicitis	0.00% 0/1314 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.08% 1/1313 • Number of events 1 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.

Other adverse events

Other adverse events
Measure	Flublok n=1314 participants at risk Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.	Afluria n=1313 participants at risk Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Nervous system disorders Headache	0.61% 8/1314 • Number of events 8 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.91% 12/1313 • Number of events 12 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.
Gastrointestinal disorders Diarrhea	0.91% 12/1314 • Number of events 12 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.	0.30% 4/1313 • Number of events 4 • 30 days following vaccine administration Adverse Events were reviewed by Investigators and by the Medical Monitor. Assessments of causality were conducted by both reviewers.

Additional Information

Lisa M. Dunkle, M.D., Chief Medical Officer

Protein Sciences Corporation

Phone: 203-599-6064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60