Trial Outcomes & Findings for Inactivated Influenza Via Jet Injection (NCT NCT02290691)

NCT ID: NCT02290691

Last Updated: 2017-11-30

Results Overview

The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 985 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2017-11-30

Participant Flow

Study participants were enrolled from 05 November 2014 to 15 January 2015 at six clinical centers in the United States.

A total of 984 participants who met all inclusion criteria and not of the exclusion criteria were enrolled and vaccinated in the study.

Participant milestones

Measure	Needle- Free Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle and Syringe Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Overall Study STARTED	496	488
Overall Study COMPLETED	488	479
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	Needle- Free Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle and Syringe Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Overall Study Noncompliance	0	1
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	7	7

Baseline Characteristics

Inactivated Influenza Via Jet Injection

Baseline characteristics by cohort

Measure	Needle- Free n=496 Participants Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle and Syringe n=488 Participants Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Total n=984 Participants Total of all reporting groups
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	496 Participants n=5 Participants	488 Participants n=7 Participants	984 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants	255 Participants n=7 Participants	496 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants	233 Participants n=7 Participants	488 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the immunogenicity population.

The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.

Outcome measures

Measure	Needle and Syringe n=465 Participants Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle- Free n=473 Participants Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) A/ H1N1 Day 0	3.80 Titers Standard Deviation 1.406	3.77 Titers Standard Deviation 1.441
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) A H1N1 Day 28	5.72 Titers Standard Deviation 1.109	5.70 Titers Standard Deviation 1.103
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) A/H3N2 Day 0	4.09 Titers Standard Deviation 1.549	4.09 Titers Standard Deviation 1.527
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) A/H3N2 Day 28	6.04 Titers Standard Deviation 1.104	5.99 Titers Standard Deviation 1.129
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) B1 Day 0	2.83 Titers Standard Deviation 1.128	2.94 Titers Standard Deviation 1.198
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) B1 Day 28	4.27 Titers Standard Deviation 1.102	4.25 Titers Standard Deviation 1.150
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) B2 Day 0	2.40 Titers Standard Deviation 0.904	2.52 Titers Standard Deviation 0.909
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) B2 Day 28	3.83 Titers Standard Deviation 0.978	3.78 Titers Standard Deviation 1.038

PRIMARY outcome

Timeframe: 28 Days

Population: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population.

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.

Outcome measures

Measure	Needle and Syringe n=465 Participants Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle- Free n=473 Participants Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer. A/H3N2	456 participants	468 participants
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer. B1	326 participants	365 participants
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer. A/H1N1	457 participants	461 participants
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer. B2	177 participants	167 participants

SECONDARY outcome

Timeframe: Day 0

The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: local pain, redness, induration/swelling, itching where the injection was given. The data will be reported as "immediate complaints" and presumed to be related to the test article. Any other symptom experienced at 30 minutes will be recorded as an adverse event.

Outcome measures

Measure	Needle and Syringe n=487 Participants Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle- Free n=496 Participants Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Percentage of Subjects With Immediate Complaints	13.6 percentage of participants	30.2 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

Population: Data included in the analysis were collected on a 7-Day Diary Card from the safety population and grade \>1.

vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site pain, injection site tenderness, injection site itching, injection site swelling, injection site redness, injection site bruising, fever, fatigue, headache, nausea, chills, muscle ache.

Outcome measures

Measure	Needle and Syringe n=488 Participants Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle- Free n=496 Participants Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Percentage of Subjects With Solicited Local or Systemic Adverse Events Muscle Ache	21.6 percentage of subjects	20.3 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Nausea	6.3 percentage of subjects	4.1 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Chills	6.3 percentage of subjects	4.9 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Vomiting	1.9 percentage of subjects	1.0 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Pain	33.7 percentage of subjects	48.6 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Tenderness	46.9 percentage of subjects	65.6 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Itching	6.9 percentage of subjects	24.3 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Redness	8.2 percentage of subjects	35.5 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Swelling	6.7 percentage of subjects	29.8 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Bruising	4.0 percentage of subjects	10.3 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Headache	16.0 percentage of subjects	14.8 percentage of subjects
Percentage of Subjects With Solicited Local or Systemic Adverse Events Fatigue	15.1 percentage of subjects	11.9 percentage of subjects

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Needle and Syringe n=488 Participants Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle- Free n=496 Participants Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Percentage of Subjects With Spontaneously Reported Adverse Events	26.5 percentage of subjects	24.4 percentage of subjects

Adverse Events

Needle- Free

Serious events: 1 serious events

Other events: 486 other events

Deaths: 0 deaths

Needle and Syringe

Serious events: 0 serious events

Other events: 475 other events

Deaths: 0 deaths

Serious adverse events

Measure	Needle- Free n=496 participants at risk Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle and Syringe n=488 participants at risk Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
Respiratory, thoracic and mediastinal disorders influenza and pneumonia	0.20% 1/496 • Number of events 1 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	0.00% 0/488 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
Injury, poisoning and procedural complications laceration	0.20% 1/496 • Number of events 1 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	0.00% 0/488 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events

Other adverse events

Measure	Needle- Free n=496 participants at risk Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine	Needle and Syringe n=488 participants at risk Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0. Influenza Vaccine: Influenza Vaccine
General disorders Pain	47.6% 236/496 • Number of events 236 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	32.8% 160/488 • Number of events 160 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Tenderness	64.3% 319/496 • Number of events 319 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	45.7% 223/488 • Number of events 223 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Itching	23.8% 118/496 • Number of events 118 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	6.8% 33/488 • Number of events 33 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Redness	34.9% 173/496 • Number of events 173 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	8.0% 39/488 • Number of events 39 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Swelling	29.2% 145/496 • Number of events 145 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	6.6% 32/488 • Number of events 32 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Bruising	10.1% 50/496 • Number of events 50 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	3.9% 19/488 • Number of events 19 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Fever	0.60% 3/496 • Number of events 3 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	1.8% 9/488 • Number of events 9 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Headache	14.5% 72/496 • Number of events 72 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	15.6% 76/488 • Number of events 76 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Fatigue	11.7% 58/496 • Number of events 58 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	14.8% 72/488 • Number of events 72 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Muscle Ache	20.0% 99/496 • Number of events 99 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	21.1% 103/488 • Number of events 103 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Chills	4.8% 24/496 • Number of events 24 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	6.1% 30/488 • Number of events 30 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Nausea	4.0% 20/496 • Number of events 20 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	6.1% 30/488 • Number of events 30 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events
General disorders Vomiting	1.0% 5/496 • Number of events 5 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events	1.8% 9/488 • Number of events 9 • Adverse events are reported based on participant recall of events over 28 days Spontaneously reported adverse events

Additional Information

Tara Miller, MS, Clinical Affairs Manager

PharmaJet, Inc

Phone: 888-900-4321

Email: tara.miller@pharmajet.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor may invite Study's Investigators to participate in the preparation of a multicenter article for a professional journal; terms will be at the discretion of the sponsor. Investigators may also wish to publish, present, or use for instruction and research the results of the Study collected at their individual research sites only after publication of pooled, multicenter results and under the following conditions. Materials will be provided to Sponsor for approval prior to submission.
• Publication restrictions are in place

Restriction type: OTHER