Influenza
Conditions
Keywords
Influenza, Vaccine, Committee for Medicinal Products for Human Use (CHMP) criteria
Brief summary
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).
Interventions
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Sponsors
Abbott
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to give informed consent and able to adhere to all protocol required study procedures. * Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. * Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator
Exclusion criteria
* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. * A serious adverse reaction after a previous (influenza) vaccination. * Presence of any significant condition that may prohibit inclusion as determined by the investigator. * Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period. * A history of Guillain-Barré syndrome or active neurological disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 weeks post vaccination | Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults. |
Secondary
| Measure | Time frame |
|---|---|
| Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | up to 3 weeks post vaccination |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Influvac Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Influvac |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age, Continuous adult (18-60 year old) | 41.2 years |
| Age, Continuous elderly adult (>=61 year old) | 71.5 years |
| Gender Female | 58 Participants |
| Gender Male | 62 Participants |
| Region of Enrollment Australia | 120 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
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.
Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.
Time frame: 3 weeks post vaccination
Population: Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
Primary
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 in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.
Time frame: 3 weeks post vaccination
Population: Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
| Influvac | 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 |
Secondary
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Time frame: up to 3 weeks post vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Redness (18-60 years of age) | 6 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Swelling (18-60 years of age) | 5 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Itching (18-60 years of age) | 4 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Warmth (18-60 years of age) | 5 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Tenderness (18-60 years of age) | 22 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Pain (18-60 years of age) | 7 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Impairment of movement of arm (18-60 years of age) | 4 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Induration (hardening) (18-60 year of age) | 4 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Ecchymosis (blue spots) (18-60 year of age) | 0 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Fever >=38c (18-60 year of age) | 0 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Increased sweating (18-60 year of age) | 4 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Headache (18-60 year of age) | 10 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Malaise (18-60 year of age) | 5 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Fatigue (18-60 year of age) | 10 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Shivering (18-60 year of age) | 2 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Redness (>=61 year of age) | 0 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Swelling (>=61 year of age) | 1 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Itching (>=61 year of age) | 0 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Warmth (>=61 year of age) | 5 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Tenderness (>=61 year of age) | 7 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Pain (>=61 year of age) | 0 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Impairment of movement arm (>=61 year of age) | 0 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Induration (hardening) (>=61 year of age) | 1 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Ecchymosis (blue spots) (>=61 year of age) | 1 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Fever >-38c (>=61 year of age) | 1 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Increased sweating (>=61 year of age) | 2 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Headache (>=61 year of age) | 8 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Malaise(>=61 year of age) | 6 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Fatigue (>=61 year of age) | 9 participants |
| Influvac | Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. | Shivering | 2 participants |