Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age.
- Conditions
- Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of AgeTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-004498-17-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1764
1. Males and females aged 3 to 17 years (inclusive) on the day of enrollment.
2. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
3. Documented consent provided by parents or legal guardians after the nature of the study was explained to them according to local regulatory requirements.
4. For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study was explained to them in terms they could understand better.
5. Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1386
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Parents/legal guardians and individuals who had to provide assent, who were not able to comprehend and follow all required study procedures for the whole period of the study.
2. Parents/legal guardians and individuals who had to provide assent, who could not consent to the retention of the subject’s serum samples after study completion.
3. Individuals with behavioral/cognitive impairment/psychiatric disease that, in the opinion of the investigator, interfered with the subject's ability to participate in the study.
4. Individuals with history/any illness that, in the opinion of investigator, interfered with the results of the study or posed additional risk to the subjects due to study participation
5. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, any excipients, and eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propriolactone, or nonoxynol-9
6. History of any serious disease, such as:
a. cancer
b. history of serious chronic diseases (cardiac, renal, hepatic, metabolic (including diabetes mellitus), rheumatologic (including autoimmune disease such as rheumatoid arthritis), neurologic (including history of atypical febrile seizure or history of Guillain-Barré disease), and hematologic (including bleeding diathesis).
c. history of underlying medical condition such as inborn errors of metabolism, failure to thrive, broncho-pulmonary dysplasia, or any major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome).
7. Known/suspected impairment/alteration of immune function, included:
a. chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
b. received immuno-stimulants within 60 days prior to Visit 1
c. received parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
d. HIV infection or HIV-related disease
e. Heritable immunodeficiency
f. Abnormalities of splenic or thymic function
8. Pregnant or breast-feeding female
9. Any positive or indetermined pregnancy test
10. If female, ?of childbearing potential?, sexually active, and did not use any of the
?acceptable contraceptive methods for at least 2 months prior to study entry
a. Of childbearing potential was defined as status post onset of menarche and not surgically sterile
b. Acceptable birth control methods were defined as one or more of the following:
i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
iii. Intrauterine device (IUD)
iv. Monogamous relationship with vasectomized partner. Partner had
to be vasectomized for at least six months prior to the subject’s
study entry
11. If female of childbearing potential and sexually active, refused to use an
?acceptable contraceptive method? during the first 3 weeks after vaccination
12. If female of childbearing potential, refused to submit for pregnancy testing prior to study vaccination
13. Received influenza vaccine within 6 months prior to Visit 1
14. Laboratory-confirmed or suspected influenza
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method