NCT01885117

A Phase III, Open Label, Single Arm, Multi Center Study to Evaluate Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus (Fluvirin®) in Healthy Adults

Completed Phase 3 Results posted Last updated 10 February 2014

What this trial tests

Phase 3 trial testing TIVf in Human Influenza in 125 participants. Completed in 1 September 2013.

Timeline

1 August 2013

Primary endpoint
1 September 2013

1 September 2013

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	125
Start date	1 August 2013
Primary completion	1 September 2013
Estimated completion	1 September 2013
Sites	1 location across Germany

Drugs / interventions tested

• TIVf — full drug profile →

Conditions studied

• Human Influenza — all drugs for Human Influenza →

Sponsor

Novartis Vaccines — full company profile →

Who can join

18 and older, any sex, with Human Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
  Time frame: Day 1 (baseline) and Day 22 (postvaccination)
  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 \>6
• Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
  Time frame: Day 22 (postvaccination) /Day 1 (Baseline)
  Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defin
• Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf
  Time frame: Day 22 (postvaccination)/ Day 1 (baseline)
  The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subje
• Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
  Time frame: Day 1 (baseline) and Day 22 (postvaccination)
  Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, 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 HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥
• Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf
  Time frame: Day 22 (postvaccination)/ Day 1 (baseline)
  Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer
• Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf
  Time frame: Day 22/ Day 1
  The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers 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 GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 f

Sponsor's own description

The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization.

The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine.

The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.