Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age.
- Conditions
- Prophylaxis: InfluenzaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-001223-13-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
- 2040
In order to participate in this study, all subjects met all of the inclusion criteria described.
1. Males and females =4 to =17 years of age at the time of enrollment.
2. Individuals' parents or legal guardians who have given written consent after the nature of the study has been explained according to local regulatory requirements (and where applicable according to local regulations, informed assent for subjects above the
specified age).
3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
4. Individuals and individuals’ parents or legal guardians who can comply with study procedures and were available for follow-up.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2040
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
In order to participate in this study, all subjects met none of the exclusion criteria described.
1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
2. Individuals who took any analgesic/antipyretic medication within 24 hours of study vaccination.
3. Experienced a temperature =38.0°C or =100.4°F and/or any acute illness (defined as any moderate or severe symptom) within 3 days prior to day 1.
4. Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome (history of febrile convulsions was allowed).
5. Individuals/children's parents or legal guardians who were not able to comprehend and to follow all required study procedures for the whole period of the study.
6. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study.
7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (including but not limited to insulin dependent diabetes, cardiac and renal or hepatic disease).
8. Individuals with known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders (excluding stable Eczema and Hashimoto disease), immunosuppressive therapy, chronic use of systemic corticosteroids etc).
a. Stable eczema is defined as eczema involving less than 5% body surface, no significant morphological worsening and/or increase in medication in the previous 3 months.
b. Hashimoto disease is defined as an autoimmune disease attacking the thyroid gland and often resulting in hypothyroidism.
c. Chronic use of systemic corticosteroids is defined as use of systemic corticosteroids for more than 15 out of 30 days within the month prior to enrollment. The use of topic, inhaled and intranasal corticosteroids is not seen as systemic and therefore allowed.
9. Individuals who were pregnant or breastfeeding.
10. If =9 to =17 years female, of childbearing potential”, sexually active, and has not used any of the acceptable contraceptive methods” for at least 2 months prior to study entry:
a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
b. Acceptable birth control methods are defined as one or more of the following:
- Sexual abstinence;
- Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
- Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
- Intrauterine device (IUD);
- Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the Subject’s study entry.
11. Female subjects of childbearing potential with a positive or indeterminate pregnancy test.
12. Any =9 to =17 year female of childbearing potential who was sexually active and refused to use an acceptable contraceptive method” through to the end of the study.
13. Individuals who were allergic to any of the vaccine components.
14. Individuals who have had ever a malignancy.
15. Individuals who have been diagnosed in the past 2 years wit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate safety and tolerability of one or two doses (administered 4 weeks apart) of mammalian cell culture-derived influenza vaccine (TIVc) and Fluvirin (TIVf) in children and adolescents =4 to =17 years of age.;Secondary Objective: Not applicable;Primary end point(s): Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.<br>Number Of Subjects Reporting SAEs, NOCDs, AEs leading to withdrawal from study and medically attended AEs After Any Vaccination.;Timepoint(s) of evaluation of this end point: Number of subjects reporting solicited AEs - Day 1 through Day7 and Day29 through Day35<br>Number of subjects reporting unsolicited AEs - Day1 through Day28; and from Day29 through Day49<br>Number of subjects reporting SAEs, NOCD, AEs leading to vaccine/study withdrawal and medically attended AEs - Day 213 for not previously vaccinated” subjects =4 to =8 years of age or Day 183 for all other subjects
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable