Trial Outcomes & Findings for Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season (NCT NCT02381418)
NCT ID: NCT02381418
Last Updated: 2016-12-22
Results Overview
Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
3 weeks post vaccination
Results posted on
2016-12-22
Participant Flow
Participant milestones
| Measure |
Influvac
Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
Baseline characteristics by cohort
| Measure |
Influvac
n=120 Participants
Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
|
Age, Continuous
adult (18-60 year old)
|
41.2 years
n=5 Participants
|
|
Age, Continuous
elderly adult (>=61 year old)
|
71.5 years
n=5 Participants
|
|
Gender
Female
|
58 Participants
n=5 Participants
|
|
Gender
Male
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks post vaccinationPopulation: Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.
Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.
Outcome measures
| Measure |
Influvac
n=118 Participants
Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
|
|---|---|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage adults with seroprotection for A/H3N2
|
96.6 percentage of subjects
Interval 88.3 to 99.6
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage adults with seroprotection for A/H1N1
|
96.6 percentage of subjects
Interval 88.3 to 99.6
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage adults with seroprotection for B
|
93.2 percentage of subjects
Interval 83.5 to 98.1
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage elderly with seroprotection for A/H3N2
|
98.3 percentage of subjects
Interval 90.9 to 100.0
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage elderly with seroprotection for A/H1N1
|
88.1 percentage of subjects
Interval 77.1 to 95.1
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage elderly with seroprotection for B
|
64.4 percentage of subjects
Interval 50.9 to 76.4
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage adults with seroconversion for A/H3N2
|
83.1 percentage of subjects
Interval 71.0 to 91.6
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage adults with seroconversion for A/H1N1
|
50.8 percentage of subjects
Interval 37.5 to 64.1
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage adults with seroconversion for B
|
52.5 percentage of subjects
Interval 39.1 to 65.7
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage elderly with seroconversion for A/H3N2
|
76.3 percentage of subjects
Interval 63.4 to 86.4
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage elderly with seroconversion for A/H1N1
|
32.2 percentage of subjects
Interval 20.6 to 45.6
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Percentage elderly with seroconversion for B
|
35.6 percentage of subjects
Interval 23.6 to 49.1
|
PRIMARY outcome
Timeframe: 3 weeks post vaccinationPopulation: Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.
Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.
Outcome measures
| Measure |
Influvac
n=118 Participants
Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
|
|---|---|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Mean fold increase A/H3N2 titer in adults
|
19.2 fold change
Interval 12.4 to 29.7
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Mean fold increase A/H1N1 titer in adults
|
8.6 fold change
Interval 5.0 to 15.0
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Mean fold increase B titer in adults
|
5.7 fold change
Interval 3.9 to 8.3
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Mean fold increase A/H3N2 titer in elderly
|
12.2 fold change
Interval 8.3 to 17.8
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Mean fold increase A/H1N1 titer in elderly
|
3.1 fold change
Interval 2.3 to 4.2
|
|
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
Mean fold increase B titer in elderly
|
2.7 fold change
Interval 1.9 to 3.8
|
SECONDARY outcome
Timeframe: up to 3 weeks post vaccinationOutcome measures
| Measure |
Influvac
n=120 Participants
Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
|
|---|---|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Shivering (18-60 year of age)
|
2 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Redness (>=61 year of age)
|
0 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Redness (18-60 years of age)
|
6 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Swelling (18-60 years of age)
|
5 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Itching (18-60 years of age)
|
4 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Warmth (18-60 years of age)
|
5 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Tenderness (18-60 years of age)
|
22 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Pain (18-60 years of age)
|
7 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Impairment of movement of arm (18-60 years of age)
|
4 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Induration (hardening) (18-60 year of age)
|
4 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Ecchymosis (blue spots) (18-60 year of age)
|
0 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Fever >=38c (18-60 year of age)
|
0 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Increased sweating (18-60 year of age)
|
4 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Headache (18-60 year of age)
|
10 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Malaise (18-60 year of age)
|
5 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Fatigue (18-60 year of age)
|
10 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Swelling (>=61 year of age)
|
1 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Itching (>=61 year of age)
|
0 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Warmth (>=61 year of age)
|
5 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Tenderness (>=61 year of age)
|
7 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Pain (>=61 year of age)
|
0 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Impairment of movement arm (>=61 year of age)
|
0 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Induration (hardening) (>=61 year of age)
|
1 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Ecchymosis (blue spots) (>=61 year of age)
|
1 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Fever >-38c (>=61 year of age)
|
1 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Increased sweating (>=61 year of age)
|
2 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Headache (>=61 year of age)
|
8 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Malaise(>=61 year of age)
|
6 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Fatigue (>=61 year of age)
|
9 participants
|
|
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Shivering
|
2 participants
|
Adverse Events
Influvac
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Influvac
n=120 participants at risk
Trivalent influenza subunit vaccine Influvac. "3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
|
|---|---|
|
General disorders
vaccine site pain
|
5.8%
7/120 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
2.5%
3/120 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
3.3%
4/120 • Number of events 4
|
|
General disorders
application site pruritus
|
1.7%
2/120 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.7%
2/120 • Number of events 2
|
|
General disorders
fatigue
|
2.5%
3/120 • Number of events 3
|
|
General disorders
malaise
|
2.5%
3/120 • Number of events 3
|
|
General disorders
vaccination site warmth
|
2.5%
3/120 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
nasopharyngitis
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
respiratory disorder
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.83%
1/120 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
headache
|
1.7%
2/120 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
respiratory tract infection
|
0.83%
1/120 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER