Trial Outcomes & Findings for A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers (NCT NCT01857297)
NCT ID: NCT01857297
Last Updated: 2018-06-27
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
2018-06-27
Participant Flow
The study was non-randomized with a parallel assignment comprising of 2 groups of healthy volunteers: adults (aged 18 - 59 years) and older adults (aged 60 years or older).
None relevant
Participant milestones
| Measure |
Adults (18 to 59 Years)
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Adults (18 to 59 Years)
n=60 Participants
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 Participants
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Years
|
34.5 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 6.02 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 19.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 21 days after vaccinationPopulation: The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer 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
| Measure |
Adults (18 to 59 Years)
n=59 Participants
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 Participants
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
|---|---|---|
|
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
H1N1 strain
|
72.9 percentage of participants
Interval 59.7 to 83.6
|
63.3 percentage of participants
Interval 49.9 to 75.4
|
|
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
H3N2 strain
|
78.0 percentage of participants
Interval 65.3 to 87.7
|
55.0 percentage of participants
Interval 41.6 to 67.9
|
|
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
B strain
|
54.2 percentage of participants
Interval 40.8 to 67.3
|
30.0 percentage of participants
Interval 18.8 to 43.2
|
PRIMARY outcome
Timeframe: Approximately 21 days after vaccinationPopulation: The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer 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
| Measure |
Adults (18 to 59 Years)
n=59 Participants
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 Participants
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
|---|---|---|
|
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
H1N1 strain
|
12.90 fold increase
Standard Deviation 4.764
|
6.11 fold increase
Standard Deviation 3.675
|
|
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
H3N2 strain
|
17.85 fold increase
Standard Deviation 5.237
|
5.77 fold increase
Standard Deviation 4.549
|
|
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
B strain
|
5.30 fold increase
Standard Deviation 3.522
|
2.81 fold increase
Standard Deviation 2.858
|
PRIMARY outcome
Timeframe: Approximately 21 days after vaccinationPopulation: The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer 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
| Measure |
Adults (18 to 59 Years)
n=59 Participants
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 Participants
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL 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
|
98.3 percentage of participants
Interval 90.9 to 100.0
|
95.0 percentage of participants
Interval 86.1 to 99.0
|
|
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
H3N2 strain
|
100 percentage of participants
Interval 93.9 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
|
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
B strain
|
86.4 percentage of participants
Interval 75.0 to 94.0
|
51.7 percentage of participants
Interval 38.4 to 64.8
|
SECONDARY outcome
Timeframe: During the 4 days after vaccination (Day 0 plus 3 days)Population: The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.
The percentage of participants reporting any solicited AEs.
Outcome measures
| Measure |
Adults (18 to 59 Years)
n=60 Participants
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 Participants
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
|---|---|---|
|
Frequency of Any Solicited Adverse Events (AEs)
Ecchymosis
|
3.3 percentage of participants
|
0 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any solicited local AE
|
61.7 percentage of participants
|
13.3 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Induration > 50 mm
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Erythema
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Pain
|
58.3 percentage of participants
|
13.3 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Any solicited systemic AE
|
25 percentage of participants
|
10 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Temperature > 38°C for ≥ 24 hours
|
0 percentage of participants
|
1.7 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Chills
|
10 percentage of participants
|
6.7 percentage of participants
|
|
Frequency of Any Solicited Adverse Events (AEs)
Malaise
|
23.3 percentage of participants
|
6.7 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 the Influenza Vaccine and provided follow-up safety data.
The percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.
Outcome measures
| Measure |
Adults (18 to 59 Years)
n=60 Participants
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 Participants
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
|---|---|---|
|
Frequency of Any Unsolicited AEs
|
46.7 percentage of participants
|
36.7 percentage of participants
|
Adverse Events
Adults (18 to 59 Years)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Older Adults (60 Years or Older)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adults (18 to 59 Years)
n=60 participants at risk
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
Older Adults (60 Years or Older)
n=60 participants at risk
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
|
|---|---|---|
|
General disorders
Injection site pain
|
58.3%
35/60 • Number of events 35 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
13.3%
8/60 • Number of events 8 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
|
General disorders
Malaise
|
23.3%
14/60 • Number of events 15 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
6.7%
4/60 • Number of events 5 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
|
General disorders
Chills
|
10.0%
6/60 • Number of events 7 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
6.7%
4/60 • Number of events 5 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
|
Nervous system disorders
Headache
|
25.0%
15/60 • Number of events 17 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
10.0%
6/60 • Number of events 6 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
6/60 • Number of events 7 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
1.7%
1/60 • Number of events 1 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
|
General disorders
Pyrexia
|
6.7%
4/60 • Number of events 4 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
0.00%
0/60 • 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 CSL Influenza Vaccine and provided follow-up safety data.
|
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