Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-Label, Baseline- Controlled Study in Two Age Groups: Adult Subjects = 18 and = 60 Years and Elderly Subjects = 61 Years of Age. - Influvac Annual Update 2012/2013 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001032-57-DE

Enrollment

130

Registered

2012-03-29

Start date

2012-06-26

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of Influenza MedDRA version: 14.1 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Influvac® 2012/2013 Product Name: Influvac® 2012/2013 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Influenza vaccine (surface antigen,inactivated) Other descriptive n

A/Victoria/361/2011 (H3N2)-like virus

B/Wisconsin/1/2010-like virus Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 15 µg per strain-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2.Men and women aged = 18 and = 60 years or = 61 years of age at the day of study vaccination. 3.Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65

Exclusion criteria

Exclusion criteria: 1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. A serious adverse reaction after a previous (influenza) vaccination. 3. Presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. 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. 5. Having any condition which suppresses the immune system and autoimmune disorders.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine the immunogenicity of the trivalent influenza subunit vaccine Influvac® for the northern hemisphere season 2012/2013, three weeks after vaccination according to the CHMP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96) in two age groups: - Adult subjects aged =18 and = 60 years. - Elderly subjects = 61 years of age. Safety Objective: To collect evidence on the safety (unsolicited adverse events) and tolerability (reactogenicity and overall inconvenience) of Influvac®.;Secondary Objective: None;Primary end point(s): The primary endpoint will be the pre- and post-vaccination serum antihemagglutinin antibody titers and the derived parameters defined in the CHMP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96) for influenza vaccines. ;Timepoint(s) of evaluation of this end point: 3 weeks after vaccination	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine the immunogenicity of the trivalent influenza subunit vaccine Influvac® for the northern hemisphere season 2012/2013, three weeks after vaccination according to the CHMP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96) in two age groups: - Adult subjects aged =18 and = 60 years. - Elderly subjects = 61 years of age. Safety Objective: To collect evidence on the safety (unsolicited adverse events) and tolerability (reactogenicity and overall inconvenience) of Influvac®.;Secondary Objective: None;Primary end point(s): The primary endpoint will be the pre- and post-vaccination serum antihemagglutinin antibody titers and the derived parameters defined in the CHMP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96) for influenza vaccines. ;Timepoint(s) of evaluation of this end point: 3 weeks after vaccination

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: -	—

Countries

Belgium, Germany

Contacts

Public ContactGijs Slappendel

Abbott Biologicals B.V.

gijs.slappendel@abbott.com+31 (0) 294 47 7167

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026