Trial Outcomes & Findings for A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers (NCT NCT01863433)

Results Overview

As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

Approximately 21 days after vaccination

Results posted on

2018-06-28

Participant Flow

The study was open label, non-randomized with single group assignment in healthy volunteers aged 18 to 60 years.

Participant milestones

Participant milestones
Measure	Trivalent Influenza Vaccine Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
Overall Study STARTED	120
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Trivalent Influenza Vaccine Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
Overall Study Protocol Violation	1

Baseline Characteristics

A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trivalent Influenza Vaccine n=120 Participants Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
Age, Customized	31.8 years STANDARD_DEVIATION 10.12 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 21 days after vaccination

Population: The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.

As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=119 Participants Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. H1N1 strain	79 percentage of participants Interval 70.6 to 85.9
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. H3N2 strain	79 percentage of participants Interval 70.6 to 85.9
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. B strain	64.7 percentage of participants Interval 55.4 to 73.2

PRIMARY outcome

Timeframe: Approximately 21 days after vaccination

Population: The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.

GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=119 Participants Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. H1N1 strain	15.01 fold increase Standard Deviation 4.27
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. H3N2 strain	13.18 fold increase Standard Deviation 4.494
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. B strain	5.86 fold increase Standard Deviation 3.461

PRIMARY outcome

Timeframe: Approximately 21 days after vaccination

Population: The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.

For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=119 Participants Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. H1N1 strain	97.5 percentage of participants Interval 92.8 to 99.5
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. H3N2 strain	99.2 percentage of participants Interval 95.4 to 100.0
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. B strain	95.0 percentage of participants Interval 89.3 to 98.1

SECONDARY outcome

Timeframe: During the 4 days after vaccination (Day 0 plus 3 days)

Population: The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.

The percentage of participants reporting any solicited AEs.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=120 Participants Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
Type and Frequency of Any Solicited Adverse Events (AEs) Pain	51.7 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Any solicited local AE	52.5 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Induration > 50 mm	0.8 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Erythema	10 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Ecchymosis	8.3 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Any solicited systemic AE	19.2 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Temperature > 38°C for ≥ 24 hours	0 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Chills	10.8 percentage of participants
Type and Frequency of Any Solicited Adverse Events (AEs) Malaise	17.5 percentage of participants

SECONDARY outcome

Timeframe: After vaccination until the end of the study; approximately 21 days.

Population: The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.

The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=120 Participants Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
Type and Frequency of Any Unsolicited AEs	44.2 percentage of participants

Adverse Events

Trivalent Influenza Vaccine

Serious events: 0 serious events

Other events: 81 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trivalent Influenza Vaccine n=120 participants at risk Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
Gastrointestinal disorders Chills	10.8% 13/120 • Number of events 13 • For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days). The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
General disorders Injection site pain	51.7% 62/120 • Number of events 64 • For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days). The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
General disorders Malaise	17.5% 21/120 • Number of events 21 • For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days). The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
General disorders Injection site erythema	10.0% 12/120 • Number of events 12 • For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days). The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
General disorders Injection site haemorrhage	8.3% 10/120 • Number of events 10 • For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days). The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
Nervous system disorders Headache	26.7% 32/120 • Number of events 41 • For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days). The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.

Additional Information

Clinical Trial Disclosure Manager

Seqirus

Phone: 1-855-358-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER