Effectiveness of the monovalent pandemic vaccine (page 7)
Clinical data with Celvapan® demonstrate that, after two doses in 408 adults and elderly the immunogenic response (measured by rises in antibodies) measured are comparable to those observed with seasonal influenza vaccines. Preliminary clinical data indicates that after the first dose of the vaccine in 101 children aged 9-17 years, 51 children aged 3-8 years an adequate immunogenic response is demonstrated .
The vaccine meets all three internationally accepted immunogenicity criteria for influenza vaccines, the data therefore indicate that an adequate immune response is achieved.
Co-administration (page 10)
There is no data available in the co-administration of Celvapan® with other vaccines.
Celvapan® is an inactivated vaccine and, from experience with influenza vaccine co-administration, it is not expected to have any safety or efficacy concerns. It should, however, be noted that adverse reactions may be intensified if Celvapan® is given with other vaccines.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
If other vaccines are needed to be given at the same time the vaccines should be injected into separate limbs and accurately recorded in the patient’s notes.
Patient information (page 31)
Doses
Two doses of Celvapan® are given three weeks apart. You will need to come back to the clinic for the second dose three weeks after your first dose.
Celvapan is recommended to be given separately from other vaccines.
If other vaccines are needed to be given at the same time as Celvapan the vaccines should be injected into separate limbs and accurately recorded.
Information for Parents and Guardians (page 33)
How many doses does my child need?
Two injections of Celvapan given three weeks apart are required. Your child will need to come back to the clinic three weeks after the first injection to get the second one.
There is no information available on having the Celvapan vaccine at the same time as other vaccines.
Celvapan® is an inactivated vaccine and, from experience with influenza vaccine co-administration, it is not expected to have any safety or efficacy concerns. It should, however, be noted that adverse reactions may be intensified if Celvapan® is given with other vaccines.
If other vaccines are needed to be given at the same time the vaccines should be injected into separate limbs and accurately recorded.