Trial Outcomes & Findings for A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers (NCT NCT00888381)

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 is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10; significant increase 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

Participant milestones

Participant milestones
Measure	Adults Healthy volunteers aged 18 to 59 years	Older Adults Healthy volunteers aged 60 years or older
Overall Study STARTED	60	60
Overall Study COMPLETED	60	59
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Adults Healthy volunteers aged 18 to 59 years	Older Adults Healthy volunteers aged 60 years or older
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=60 Participants Healthy volunteers aged 60 years or older	Total n=120 Participants Total of all reporting groups
Age, Continuous	35.3 years STANDARD_DEVIATION 12.31 • n=93 Participants	66.2 years STANDARD_DEVIATION 5.92 • n=4 Participants	50.7 years STANDARD_DEVIATION 18.24 • n=27 Participants
Sex: Female, Male Female	27 Participants n=93 Participants	29 Participants n=4 Participants	56 Participants n=27 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	31 Participants n=4 Participants	64 Participants n=27 Participants

PRIMARY outcome

Timeframe: Approximately 21 days after vaccination

Population: The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).

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 is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10; significant increase 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	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=58 Participants Healthy volunteers aged 60 years or older
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. A/Brisbane/59/2007 (H1N1) - like strain	91.7 percentage of participants Interval 81.6 to 97.2	53.4 percentage of participants Interval 39.9 to 66.7
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. A/Brisbane/10/2007 (H3N2) - like strain	93.3 percentage of participants Interval 83.8 to 98.2	63.8 percentage of participants Interval 50.1 to 76.0
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. B/Brisbane/60/2008 - like strain	76.7 percentage of participants Interval 64.0 to 86.6	46.6 percentage of participants Interval 33.3 to 60.1

PRIMARY outcome

Timeframe: Approximately 21 days after vaccination

Population: The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).

GMFI 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	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=58 Participants Healthy volunteers aged 60 years or older
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. A/Brisbane/59/2007 (H1N1) - like strain	27.86 percentage of participants Interval 19.339 to 40.129	5.02 percentage of participants Interval 3.575 to 7.048
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. A/Brisbane/10/2007( H3N2) - like strain	30.32 percentage of participants Interval 21.003 to 43.772	9.80 percentage of participants Interval 6.105 to 15.738
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. B/Brisbane/60/2008 - like strain	12.85 percentage of participants Interval 9.333 to 17.683	6.13 percentage of participants Interval 4.121 to 9.107

PRIMARY outcome

Timeframe: Approximately 21 days after vaccination

Population: The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).

Outcome measures

Outcome measures
Measure	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=58 Participants Healthy volunteers aged 60 years or older
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. A/Brisbane/59/2007 (H1N1) - like strain	100.0 percentage of participants Interval 94.0 to 100.0	91.4 percentage of participants Interval 81.0 to 97.1
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. A/Brisbane/10/2007( H3N2) - like strain	100.0 percentage of participants Interval 94.0 to 100.0	94.8 percentage of participants Interval 85.6 to 98.9
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. B/Brisbane/60/2008 - like strain	85.0 percentage of participants Interval 73.4 to 92.9	60.3 percentage of participants Interval 46.6 to 73.0

SECONDARY outcome

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

Population: The Safety Population comprised all participants who received study vaccine.

The number of participants reporting any solicited local reactions.

Outcome measures

Outcome measures
Measure	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=60 Participants Healthy volunteers aged 60 years or older
The Frequency of Any Solicited Local Reactions. Any solicited local reaction	32 participants	22 participants
The Frequency of Any Solicited Local Reactions. Any induration larger than 50 mm	1 participants	2 participants
The Frequency of Any Solicited Local Reactions. Any erythema	22 participants	12 participants
The Frequency of Any Solicited Local Reactions. Any pain	26 participants	14 participants
The Frequency of Any Solicited Local Reactions. Any ecchymosis	5 participants	4 participants

SECONDARY outcome

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

Population: The Safety Population comprised all participants who received study vaccine.

The number of participants reporting any solicited systemic symptoms.

Outcome measures

Outcome measures
Measure	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=60 Participants Healthy volunteers aged 60 years or older
The Frequency of Any Solicited Systemic Symptoms. Any solicited systemic symptom	7 participants	5 participants
The Frequency of Any Solicited Systemic Symptoms. Any temperature above 38°C for 24 hours or longer	1 participants	0 participants
The Frequency of Any Solicited Systemic Symptoms. Any chills	6 participants	2 participants
The Frequency of Any Solicited Systemic Symptoms. Any malaise	5 participants	5 participants

SECONDARY outcome

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

Population: The Safety Population comprised all participants who received study vaccine.

The number of participants reporting any unsolicited adverse events. Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities.

Outcome measures

Outcome measures
Measure	Adults n=60 Participants Healthy volunteers aged 18 to 59 years	Older Adults n=60 Participants Healthy volunteers aged 60 years or older
The Incidence of Any Unsolicited Adverse Events (AEs). Number of participants with at least one UAE	25 participants	21 participants
The Incidence of Any Unsolicited Adverse Events (AEs). Number of participants reporting mild UAE	20 participants	21 participants
The Incidence of Any Unsolicited Adverse Events (AEs). Number of participants reporting moderate UAE	12 participants	3 participants
The Incidence of Any Unsolicited Adverse Events (AEs). Number of participants reporting severe UAE	0 participants	0 participants

Adverse Events

Adults

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Older Adults

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adults n=60 participants at risk Healthy volunteers aged 18 to 59 years	Older Adults n=60 participants at risk Healthy volunteers aged 60 years or older
General disorders Injection site mass	3.3% 2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.	5.0% 3/60 • Number of events 4 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
General disorders Injection site erythema	3.3% 2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.	5.0% 3/60 • Number of events 3 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
General disorders Influenza like illness	5.0% 3/60 • Number of events 3 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.	0.00% 0/60 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
Nervous system disorders Headache	13.3% 8/60 • Number of events 10 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.	6.7% 4/60 • Number of events 5 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
Infections and infestations Nasopharyngitis	3.3% 2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.	6.7% 4/60 • Number of events 4 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 3/60 • Number of events 3 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.	0.00% 0/60 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events. The Safety Population comprised all participants who received study vaccine. Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.

Additional Information

Clinical Study 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