Clinical Study to Evaluate theImmunogenicity and Safety of Influvac® in adults.
- Registration Number
- CTRI/2018/02/012222
- Lead Sponsor
- Abbott India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 480
1. Male and female subjects more than or equal to 18 years of age at the time of enrolment who the investigator
believes that they can and will comply with the requirements of the protocol (e.g. completion
of the subject diaries, return for follow-up visits and be available for telephone contacts).
2. Subjects in stable health determined from medical history, physical examination and clinical
judgment of the Investigator. Subjects may have underlying illnesses as long as their
symptoms/signs are controlled. If at the time of enrolment the subject has been on regular
prescribed medication for at least 3 months for a preexisting condition, the dose must have
been stable for at least 3 months preceding study vaccination.
3. The subjects sign and date a written, informed consent form (ICF).
4. Females of childbearing potential may be enrolled in the study, if the subject:
a. has practiced highly effective contraception for 30 days prior to vaccination, and
b. has a negative urine pregnancy test on the day of vaccination, and
c. has agreed to continue highly effective contraception during the entire study period.
1. History of adverse reaction or hypersensitivity to influenza vaccines or its components,
incl. egg, or chicken proteins.
2. History of Guillain-Barré syndrome, other progressive neurological diseases or seizures
(subject who had a single uncomplicated febrile convulsion in the past could be
included).
3. Any confirmed, acute or historic (within 6 months prior to enrollment), or suspected
immunosuppressive or immunodeficient condition based on medical history and physical
examination (no laboratory testing required).
4. Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational)
or laboratory-confirmed influenza infection in the 6 months preceding the study
vaccination.
5. Receipt of any vaccine within the preceding 30 days or planned vaccination during the
study within 30 days after any study vaccine administration.
6. Having fever and/or acute disease or infection on the day of study vaccination (enrolment
can be deferred for up to 2 weeks provided subject remains otherwise eligible). Fever is
defined as a body temperature more than or equal to 38.0 oC (measured by oral method). Subjects with a
minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may
be enrolled at the discretion of the investigator.
7. Chronic systemic administration (defined as more than 14 days) of immunosuppressant
or immune-modifying medication (such as corticosteroids and monoclonal antibodies)
during 3 months prior to the study vaccination or planned use thereof during the study.Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal
sprays), within the dosage noted on the product label, is allowed.
8. Receipt of immunoglobulins or any blood products within the 3 months preceding the
study vaccination and planned administration during the study period.
9. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months
before the day of study vaccination.
10. Being a solid organ or bone marrow/stem cell transplant recipient.
11. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to
entering this study if the treatment arm is not known.
12. Any condition that in the opinion of the Investigator would pose a health risk to the
subject if enrolled or could interfere with the evaluation of the vaccine including (but not
limited to) bleeding disorder, acute or progressive clinically-significant pulmonary,
cardiovascular, hepatic or renal functional abnormality, as determined by medical history
and/or physical examination. Receipt of another investigational agent within 30 days
prior to study vaccination, or planned exposure to an investigational or noninvestigational
product (pharmaceutical product or device) during the entire study period.
14. Pregnant or lactating female.
15. Known drug or alcohol abuse.
16. Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient
hospitalization for at least 24 hours during the entire study period.
17. Being an employee (or family member of the employee) of the Sponsor/ Contract
Research Organization conducting this study or (family members of) personnel of the
s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method