NCT01640327

A Phase 3, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Fluvirin®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects

Completed Phase 3 Results posted Last updated 28 October 2015

What this trial tests

Phase 3 trial testing Trivalent influenza virus vaccine (TIVf) in Human in 126 participants. Completed in 1 August 2012.

Timeline

1 July 2012

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	126
Start date	1 July 2012
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	1 location across Germany

Drugs / interventions tested

• Trivalent influenza virus vaccine (TIVf) — full drug profile →

Conditions studied

• Human — all drugs for Human →
• Influenza — all drugs for Influenza →

Sponsor

Novartis Vaccines — full company profile →

Who can join

18 and older, any sex, with Human or 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 Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVf
  Time frame: Day 22
  Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI antigen assay. As per the European (CHMP) criteria seroconversion or significant increase in titer was defined as the percentage of subjects with a
• Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVf
  Time frame: Day 22
  Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), 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 HI antibody titer was \>2.5 (≥18 years to ≤60 years) or \>2.0 (≥61 years).
• Percentage of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVf
  Time frame: Day 1 and 22
  Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVf vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is \>70% (≥18 years to ≤60) or \>60% (≥61 years).

Sponsor's own description

This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining marketing approval of the vaccine formulation intended for use prior to the next influenza season in the Northern Hemisphere.

The antibody response to each influenza vaccine antigen, was measured by hemagglutination inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM) injection of the vaccine was evaluated in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).

Publications & conference data

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