Who is sponsoring NCT01631071?

NCT01631071 is sponsored by Crucell Holland BV.

What drugs are being tested in NCT01631071?

Interventions: Virosomal influenza vaccine.

What is the status of NCT01631071?

NCT01631071 is currently COMPLETED.

Last reviewed 2013-12-19 · How we verify

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

NCT01631071 NA COMPLETED Results posted

The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Details

Lead sponsor	Crucell Holland BV
Phase	NA
Status	COMPLETED
Enrolment	110
Start date	2012-07
Completion	2012-08

Conditions

Influenza

Interventions

Virosomal influenza vaccine

Primary outcomes

Seroprotection — Day 22 +/- 2 days
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Seroconversion — Day 22 +/- 2 days
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Geometric Mean Titer — Day 22 +/- 2 days
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

Countries

Switzerland