Trial Outcomes & Findings for Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (NCT NCT01863849)

NCT ID: NCT01863849

Last Updated: 2021-04-05

Results Overview

Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: 21-28 days after vaccination
• Results posted on: 2021-04-05

Participant Flow

Participant milestones

Measure	Age Group 1: Adults (18-59 Years) Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Vaccination with Fluval AB suspension for injection: Single intramuscular injection with Fluval AB suspension for injection in both age groups	Age Group 2: Elderly (> 60 Years) Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Vaccination with Fluval AB suspension for injection: Single intramuscular injection with Fluval AB suspension for injection in both age groups
Overall Study STARTED	60	60
Overall Study COMPLETED	59	60
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Age Group 1: Adults (18-59 Years) Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Vaccination with Fluval AB suspension for injection: Single intramuscular injection with Fluval AB suspension for injection in both age groups	Age Group 2: Elderly (> 60 Years) Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Vaccination with Fluval AB suspension for injection: Single intramuscular injection with Fluval AB suspension for injection in both age groups
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

Baseline characteristics by cohort

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Total n=119 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	59 Participants n=5 Participants	16 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants
Age, Continuous	46.1 years STANDARD_DEVIATION 9.69 • n=5 Participants	69.8 years STANDARD_DEVIATION 6.87 • n=7 Participants	58.1 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Region of Enrollment Hungary	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres

Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Change in Geometric Mean Titre Ratio, A/H1N1 Strain	3.13 Ratio of Day 0 and Day 21-28 titres Interval 2.63 to 3.72	3.17 Ratio of Day 0 and Day 21-28 titres Interval 2.65 to 3.8

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres

Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Change in Geometric Mean Titre Ratio, A/H3N2 Strain	3.58 Ratio of Day 0 and Day 21-28 titres Interval 2.92 to 4.38	3.86 Ratio of Day 0 and Day 21-28 titres Interval 3.19 to 4.68

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres

Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Change in Geometric Mean Titre Ratio, B Strain	3.58 Ratio of Day 0 and Day 21-28 titres Interval 2.96 to 4.32	4.29 Ratio of Day 0 and Day 21-28 titres Interval 3.45 to 5.33

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Percentage of subjects seroconverted or had a significant increase in titres

Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Seroconversion, A/H1N1 Strain	59.3 percentage of subjects seroconverted	66.7 percentage of subjects seroconverted

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28

Percentage of subjects seroconverted or had a significant increase in titres

Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Seroconversion, A/H3N2 Strain	69.5 percentage of subjects seroconverted	70.0 percentage of subjects seroconverted

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28

Percentage of subjects seroconverted or had a significant increase in titres

Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 %

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Seroconversion, B Strain	54.2 percentage of subjects seroconverted	65.0 percentage of subjects seroconverted

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Percentage of subjects seroprotected

Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Seroprotection, A/H1N1 Strain	94.9 percentage of subjects seroprotected	96.7 percentage of subjects seroprotected

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Percentage of subjects seroprotected

Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Seroprotection, A/H3N2 Strain	100.0 percentage of subjects seroprotected	100.0 percentage of subjects seroprotected

PRIMARY outcome

Timeframe: 21-28 days after vaccination

Population: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)

Percentage of subjects seroprotected

Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 %

Outcome measures

Measure	Age Group 1: Adults (18-59 Years) n=59 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (>60 Years) n=60 Participants Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
Seroprotection, B Strain	79.7 percentage of subjects seroprotected	78.3 percentage of subjects seroprotected

Adverse Events

Age Group 1: Adults (18-59 Years)

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Age Group 2: Elderly (> 60 Years)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Age Group 1: Adults (18-59 Years) n=59 participants at risk Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.	Age Group 2: Elderly (> 60 Years) n=60 participants at risk Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
General disorders vaccination site pain	32.2% 19/59 • Number of events 19 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	6.7% 4/60 • Number of events 4 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
General disorders vaccination site swelling	15.3% 9/59 • Number of events 9 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	8.3% 5/60 • Number of events 5 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
General disorders vaccination site erythema	22.0% 13/59 • Number of events 13 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	5.0% 3/60 • Number of events 3 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
General disorders vaccination site induration	18.6% 11/59 • Number of events 11 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	1.7% 1/60 • Number of events 1 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
Gastrointestinal disorders pyrexia	3.4% 2/59 • Number of events 2 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	0.00% 0/60 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
Nervous system disorders headache	11.9% 7/59 • Number of events 7 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	1.7% 1/60 • Number of events 1 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
General disorders malaise	3.4% 2/59 • Number of events 2 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	3.3% 2/60 • Number of events 2 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
General disorders hyperhidrosis	0.00% 0/59 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	1.7% 1/60 • Number of events 1 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
Musculoskeletal and connective tissue disorders myalgia	5.1% 3/59 • Number of events 3 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	1.7% 1/60 • Number of events 1 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/59 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	1.7% 1/60 • Number of events 1 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).
General disorders vaccination site haematoma	3.4% 2/59 • Number of events 2 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).	0.00% 0/60 • 21-28 days after vaccination Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions. All subjects were requested to complete a diary card to record local and systemic reactions started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that. All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).

Additional Information

Zsolt Németh

Fluart Innovative Vaccines Ltd

Phone: +3620

Email: info@fluart.hu

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor in the frames of the general confidentiality agreement is that the PI cannot release any information concerning the study without the prior consent of the sponsor. To further specification is provided.
• Publication restrictions are in place

Restriction type: OTHER