Trial Outcomes & Findings for Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects (NCT NCT01651104)

Last Updated: 2014-04-21

Results Overview

Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Day 22

Results posted on

2014-04-21

Participant Flow

Subjects were enrolled at one study center in Belgium.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	≥65 Y Subjects ≥65 years of age who received one aTIV vaccination
Overall Study STARTED	63
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	≥65 Y n=63 Participants Subjects ≥65 years of age who received one aTIV vaccination
Age, Continuous	70.5 Years STANDARD_DEVIATION 3.9 • n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	35 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 22

Population: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Outcome measures

Outcome measures
Measure	≥65 Y n=63 Participants Subjects ≥65 years of age who received one aTIV vaccination
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H1N1	59 Percentages of subjects Interval 46.0 to 71.0
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H3N2	65 Percentages of subjects Interval 52.0 to 77.0
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV B	81 Percentages of subjects Interval 69.0 to 90.0

PRIMARY outcome

Timeframe: Day 22

Population: Analysis was done on the PP set.

Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is \>2.0 (≥65 years).

Outcome measures

Outcome measures
Measure	≥65 Y n=63 Participants Subjects ≥65 years of age who received one aTIV vaccination
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H1N1	2.46 Ratio Interval 1.93 to 3.12
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H3N2	2.68 Ratio Interval 2.15 to 3.35
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV B	4.44 Ratio Interval 3.53 to 5.58

PRIMARY outcome

Timeframe: Day 1 and 22

Population: Analysis was done on the PP set.

Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22). This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years).

Outcome measures

Outcome measures
Measure	≥65 Y n=63 Participants Subjects ≥65 years of age who received one aTIV vaccination
Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H1N1 (Day 1)	56 Percentages of subjects Interval 42.0 to 68.0
Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H1N1 (Day 22)	97 Percentages of subjects Interval 89.0 to 100.0
Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H3N2 (Day 1)	49 Percentages of subjects Interval 36.0 to 62.0
Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV A/H3N2 (Day 22)	94 Percentages of subjects Interval 85.0 to 98.0
Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV B (Day 1)	19 Percentages of subjects Interval 10.0 to 31.0
Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV B (Day 22)	87 Percentages of subjects Interval 77.0 to 94.0

SECONDARY outcome

Timeframe: From day 1 through day 4 postvaccination

Population: Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.

Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.

Outcome measures

Outcome measures
Measure	≥65 Y n=63 Participants Subjects ≥65 years of age who received one aTIV vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Injection site ecchymosis	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Injection site erythema	7 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Injection site induration	6 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Injection site swelling	4 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Injection site pain	22 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Chills/shivering	0 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Malaise	3 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Myalgia	2 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Arthralgia	2 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Headache	4 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Sweating (N=62)	2 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Fatigue (N=62)	6 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination) Fever (≥38°C)	0 Number of subjects

Adverse Events

≥65 Y

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	≥65 Y n=63 participants at risk Subjects ≥65 years of age who received one aTIV vaccination
General disorders Injection site pain	34.9% 22/63 • Number of events 22 • From day 1 through day 22. Serious adverse events (SAEs) were collected from day 1 through day 22.
General disorders Injection site erythema	11.1% 7/63 • Number of events 7 • From day 1 through day 22. Serious adverse events (SAEs) were collected from day 1 through day 22.
General disorders Injection site induration	9.5% 6/63 • Number of events 6 • From day 1 through day 22. Serious adverse events (SAEs) were collected from day 1 through day 22.
General disorders Fatigue	9.5% 6/63 • Number of events 6 • From day 1 through day 22. Serious adverse events (SAEs) were collected from day 1 through day 22.
General disorders Injection site swelling	6.3% 4/63 • Number of events 4 • From day 1 through day 22. Serious adverse events (SAEs) were collected from day 1 through day 22.
Nervous system disorders Headache	6.3% 4/63 • Number of events 4 • From day 1 through day 22. Serious adverse events (SAEs) were collected from day 1 through day 22.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place