To demonstrate that QIV-HD induces an immune response that is superior to the responses induced by QIV-SD for all 4 virus strains 28 days post-vaccination in subjects 60 to 64 years of age and in subjects 65 years of age and older.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hemagglutination inhibition antibody titers obtained on D28 for each age group
and for subjects in each vaccine group.
Secondary outcome
- Hemagglutination inhibition antibody titers obtained on D0 and D28 for each
age group and for subjects in each vaccine group.
- Individual hemagglutination inhibition antibody titers ratio D28/D0
- Subjects with titers * 40 [1/dilution (dil)] at D28 for each age group and
for subjects in each vaccine group.
- Seroconversion for each age group and for subjects in each vaccine group.
- Occurence, nature, intensity and relationship to vaccination of any
unsolicited systemic AEs reported in the 30 minutes after vaccination.
- Occurence, time to onset, number of days of occurrence, intensity and action
taken of solicited injection site reactions and systemic reactions occurring up
to 7 days after vaccination.
- Occurrence, nature, time to onset, duartion, intensity and relationship to
vaccination of unsolicited AEs up to 28 days after vaccination.
- Occurrence, nature, time to onset, seriousness criteria, relationship to
vaccination and outcome of SAEs and AESIs throughout the study.
Background summary
Traditional trivalent and quadrivalent inactivated influenza vaccines (TIV and
QIV) administered by the intramuscular route contain a standard dose of 15 µg
HA of each of the virus strains, with a total of 45 µg and 60 µg of HA antigen
per dose, respectively. However, the effectiveness of the influenza vaccine in
preventing or attenuating illness depends in part on the age, underlying
conditions, and immune competence of the vaccine recipient and on the
similarity between the virus strains present in the vaccine and the strains
circulating in the community. The immune response to standard-dose (SD)
influenza vaccines is sub-optimal in adults 65 years of age and older compared
to healthy young adults. A strategy to improve protection against influenza in
adults 65 years of age and older is to increase the antigen dose. Therefore,
Sanofi Pasteur has developed a high-dose quadrivalent influenza vaccine
(QIV-HD) containing 60 µg of HA of each of 4 virus strains (A/H1N1, A/H3N2, and
1 B strain from each of the Victoria and the Yamagata lineages).
Study objective
To demonstrate that QIV-HD induces an immune response that is superior to the
responses induced by QIV-SD for all 4 virus strains 28 days post-vaccination in
subjects 60 to 64 years of age and in subjects 65 years of age and older.
Study design
Phase III, randomized, modified double-blind, active-controlled, multi-center
study.
Intervention
Patients will be given one intramuscular injection in the upper arm on D0 via
prefilled syringe, in the form of either:
- One injection of high-dose influenza vaccine (QIV-HD), consisting of 60µg
hemagglutinin of each of the four selected strains. The injection is 0.7ml, or;
- One injection of standard-dose influenza vaccine (QIV-SD), consisting of 15µg
hemagglutinin of each of the four selected strains. The injection is 0.5ml.
Study burden and risks
Risks and burdens related to blood collection, study procedures and possible
adverse events of study medication.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
- Sixty years of age and older on the day of inclusion;
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
- Participant is pregnant, or lactating, or of childbearing potential and not
using an effective method of contraception or abstinence from at least 4 weeks
prior to vaccination until at least 4 weeks after vaccination. To be considered
of non-childbearing potential, a female must be post-menopausal for at least 1
year, or surgically sterile;
- Participation at the time of study enrollment (or in the 4 weeks [28 days]
preceding the trial vaccination) or planned participation during the present
trial period in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure;
- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial
vaccination or planned receipt of any vaccine prior to V02;
- Previous vaccination against influenza (in the previous 6 months) with either
the trial vaccine or another vaccine;
- Receipt of immune globulins, blood or blood-derived products in the past 3
months;
- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation
therapy, within the preceding 6 months; or long-term systemic corticosteroid
therapy (prednisone or equivalent for more than 2 consecutive weeks within the
past 3 months);
- Known systemic hypersensitivity to any of the vaccine components, or history
of a life-threatening reaction to the vaccines used in the trial or to a
vaccine containing any of the same substances;
- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM)
vaccination based on Investigator*s judgement
- Alcohol or substance abuse that, in the opinion of the Investigator might
interfere with the trial conduct or completion
- Chronic illness that, in the opinion of the Investigator, is at a stage where
it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to Investigator
judgment) or febrile illness (temperature * 38.0°C) on the day of vaccination.
A prospective participant should not be included in the study until the
condition has resolved or the febrile event has subsided
- Identified as an Investigator or employee of the Investigator or study center
with direct involvement in the proposed study, or identified as an immediate
family member (ie, parent, spouse, natural or adopted child) of the
Investigator or employee with direct involvement in the proposed study
- Personal or family history of Guillain Barré syndrome (GBS);
- Neoplastic disease or any hematologic malignancy (except localized skin or
prostate cancer that is stable at the time of vaccination in the absence of
therapy and participants who have a history of neoplastic disease and have been
disease free for * 5 years)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000655-14-NL |
| CCMO | NL69640.000.19 |
| Other | U1111-1225-0952 |