Trial Outcomes & Findings for Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above (NCT NCT01885117)

Results Overview

Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

125 participants

Primary outcome timeframe

Day 1 (baseline) and Day 22 (postvaccination)

Results posted on

2014-03-12

Participant Flow

Subjects were enrolled from one center in Germany.

Participant milestones

Participant milestones
Measure	TIVf (18 to ≤ 60 Years) Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere	TIVf (≥ 61 Years) Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
Overall Study STARTED	61	64
Overall Study COMPLETED	61	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIVf (18 to ≤ 60 Years) n=61 Participants Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere	TIVf (≥ 61 Years) n=64 Participants Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere	Total n=125 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 11.2 • n=5 Participants	68.2 years STANDARD_DEVIATION 4.7 • n=7 Participants	54.1 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (baseline) and Day 22 (postvaccination)

Population: Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.

Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.