E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis for seasonal flu. |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety of a single 0.5mL dose of Agrippal® S1 administered to Vietnamese volunteers. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Healthy, male and female, volunteers aged 1 to 45 years;
b. Subjects with no previous influenza vaccination;
c. Females of childbearing potential that agree to use birth control measures during the study period;
d. Subjects who did not have any acute or chronic diseases by screening;
e. Subjects able to understand and comply with all study procedures;
f. Subjects who voluntary consent to study participation;
g. Subjects who agree to be vaccinated according to study protocol and comply with
follow up procedure within 30 days after vaccination |
|
E.4 | Principal exclusion criteria |
a. Subjects who had the suspected symptoms of influenza: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat;
b. Subjects with prior history of allergy to any components of candidate vaccine;
c. Subjects with hypersensitivity to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80;
d. Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
e. Subjects immunodeficient due to treatment;
f. Subjects using immunosuppressive drugs (belong to steroid group) within 6 months before vaccination;
g. Subjects who had sickness or cancer or HIV (+);
h. Subjects participating in other study on drug or vaccination;
i. Subjects who received another vaccine within 4 weeks before participating in the present study;
j. Subjects with congenital malformation, mental disorder or members of family having the mental disorder;
k. Subjects using immune globulin or blood products within 3 months before
vaccination;
l. Subjects having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation;
m. Subjects with body temperature over 37.5°C within 1 week before vaccination;
n. Subject with history of drug or alcohol abuse within 5 years;
o. Subjects planning to travel away from the study site among the visits |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of subjects with any solicited reaction after a single vaccination. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 7 days after vaccination. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 5 |