Trial Outcomes & Findings for A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population (NCT NCT01113580)
NCT ID: NCT01113580
Last Updated: 2017-11-21
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
2017-11-21
Participant Flow
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
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Adults
Healthy volunteers aged 18 to 59 years
|
Older Adults
Healthy volunteers aged 60 years or older
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population
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, Customized
< 18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
18 to 59 years
|
60 participants
n=5 Participants
|
0 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Age, Customized
>= 60 years
|
0 participants
n=5 Participants
|
60 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 21 days after vaccinationPopulation: 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
| Measure |
Adults
n=58 Participants
Healthy volunteers aged 18 to 59 years
|
Older Adults
n=60 Participants
Healthy volunteers aged 60 years or older
|
|---|---|---|
|
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
A/California/7/2009 (H1N1)-like strain
|
89.7 Percentage of participants
Interval 78.8 to 96.1
|
80.0 Percentage of participants
Interval 67.7 to 89.2
|
|
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
A/Perth/16/2009 (H3N2)-like strain
|
89.7 Percentage of participants
Interval 78.8 to 96.1
|
71.7 Percentage of participants
Interval 58.6 to 82.5
|
|
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
B/Brisbane/60/2008-like strain
|
63.8 Percentage of participants
Interval 50.1 to 76.0
|
28.3 Percentage of participants
Interval 17.5 to 41.4
|
PRIMARY outcome
Timeframe: Approximately 21 days after vaccinationPopulation: 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
| Measure |
Adults
n=58 Participants
Healthy volunteers aged 18 to 59 years
|
Older Adults
n=60 Participants
Healthy volunteers aged 60 years or older
|
|---|---|---|
|
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
A/California/7/2009 (H1N1)-like strain
|
20.48 Fold increase
Interval 14.714 to 28.512
|
12.90 Fold increase
Interval 8.218 to 20.239
|
|
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
A/Perth/16/2009 (H3N2)-like strain
|
24.70 Fold increase
Interval 16.967 to 35.958
|
11.53 Fold increase
Interval 7.313 to 18.191
|
|
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
B/Brisbane/60/2008-like strain
|
6.63 Fold increase
Interval 4.598 to 9.571
|
2.77 Fold increase
Interval 2.055 to 3.747
|
PRIMARY outcome
Timeframe: Approximately 21 days after vaccinationPopulation: 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
| Measure |
Adults
n=58 Participants
Healthy volunteers aged 18 to 59 years
|
Older Adults
n=60 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/California/7/2009 (H1N1)-like strain
|
91.4 Percentage of participants
Interval 81.0 to 97.1
|
90.0 Percentage of participants
Interval 79.5 to 96.2
|
|
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
A/Perth/16/2009 (H3N2)-like strain
|
98.3 Percentage of participants
Interval 90.8 to 100.0
|
96.7 Percentage of participants
Interval 88.5 to 99.6
|
|
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
B/Brisbane/60/2008-like strain
|
89.7 Percentage of participants
Interval 78.8 to 96.1
|
70.0 Percentage of participants
Interval 56.8 to 81.2
|
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 and provided follow-up safety data.
The number of participants reporting any solicited AEs.
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
|
|---|---|---|
|
Frequency of Any Solicited Adverse Events (AEs)
Any local solicited AE
|
32 participants
|
18 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any induration larger than 50 mm
|
2 participants
|
0 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any erythema
|
22 participants
|
9 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any ecchymosis
|
5 participants
|
4 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any pain
|
22 participants
|
10 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any general (systemic) solicited AE
|
4 participants
|
3 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any temperature above 38 degrees C for ≥ 24 hours
|
0 participants
|
3 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any chills
|
4 participants
|
2 participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any malaise
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: After vaccination until the end of the study; approximately 21 daysPopulation: The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.
Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities.
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
|
|---|---|---|
|
Frequency and Intensity of Any Unsolicited Adverse Events
Number of participants reporting moderate UAE
|
7 participants
|
2 participants
|
|
Frequency and Intensity of Any Unsolicited Adverse Events
Number of participants with at least one UAE
|
28 participants
|
22 participants
|
|
Frequency and Intensity of Any Unsolicited Adverse Events
Number of participants reporting mild UAE
|
22 participants
|
19 participants
|
|
Frequency and Intensity of Any Unsolicited Adverse Events
Number of participants reporting severe UAE
|
3 participants
|
2 participants
|
Adverse Events
Adults
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Older Adults
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
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
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
3/60 • Number of events 3 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
8.3%
5/60 • Number of events 5 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
Infections and infestations
Rhinitis
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
1.7%
1/60 • Number of events 1 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
Nervous system disorders
Headache
|
20.0%
12/60 • Number of events 12 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
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.
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.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
General disorders
Vaccination site erythema
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
1.7%
1/60 • Number of events 1 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
General disorders
Vaccination site induration
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
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.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
1.7%
1/60 • Number of events 1 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
Gastrointestinal disorders
Toothache
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
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.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
2/60 • Number of events 2 • Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
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.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
|
Additional Information
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