A phase II study, performed over a period of approximately 20 months, at one study site in Colombia in a population of subjects 18 to 40 years of age. Its aim was to evaluate the immunogenicity, safety and tolerability of H5N1 adjuvanted vaccine given either sequentially, concomitantly or using extemporaneous mixing with a seasonal trivalent influenza vaccine (Agrippal).

• Register: EUCTR
• Last refreshed on: 27 October 2014
• Main ID: EUCTR2014-004515-37-Outside-EU/EEA
• Date of registration: 21/10/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Vaccines and Diagnostics
• Public title: A phase II study, performed over a period of approximately 20 months, at one study site in Colombia in a population of subjects 18 to 40 years of age. Its aim was to evaluate the immunogenicity, safety and tolerability of H5N1 adjuvanted vaccine given either sequentially, concomitantly or using extemporaneous mixing with a seasonal trivalent influenza vaccine (Agrippal).
• Scientific title: A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of Fluad-H5N1 and Seasonal Influenza Vaccine in Adult Subjects. - V87P5
• Target sample size: 400
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004515-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Agrippal Number of treatment arms in the trial: 8

Countries of recruitment

Colombia

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Vaccines and Diagnostics

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Vaccines and Diagnostics

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects aged 18 to 40 years of age who were mentally competent and who signed an informed consent form after having received a detailed explanation of the study protocol;
2. Subjects who were in good health as determined by:
? Medical history,
? Physical examination,
? Clinical judgment of the Investigator;
3. Subjects who were able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 405
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Who received another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and were unwilling to refuse participation in another clinical study through the end of the study;
2. Who received influenza vaccination for current season 2007;
3. Who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy within the past 7 days;
4. Who experienced fever (defined as axillary temperature =38.0°C) within 3 days prior to Visit 1;
5. Who were Pregnant or breastfeeding;
6. Females who refused to use an acceptable method of birth control for the duration of the study.
7. Who had any serious disease, such as:
a. Cancer,
b. Autoimmune disease (including rheumatoid arthritis),
c. Diabetes mellitus,
d. Chronic pulmonary disease,
e. Acute or progressive hepatic disease,
f. Acute or progressive renal disease;
8. Who had surgery planned during the study period;
9. Who had bleeding diathesis;
10. Who had hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
11. Who had history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
12. Who had known or suspected impairment/alteration of immune function, for
example, resulting from:
a. Receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
chemotherapy),
b. Receipt of immunostimulants,
c. High risk for developing an immunocompromising disease;
13. Who had received another vaccine within 3 weeks prior and following each study vaccination;
14. Who had history of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
15. Who had any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Influenza

Intervention(s)

Product Name: Fluad-H5N1
Pharmaceutical Form: Solution for injection

Trade Name: Agrippal
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Secondary Objective: 1. To evaluate the safety of the administration of two or three 0.5 mL intramuscular (IM) vaccination of Fluad-H5N1 (H5N1 adjuvanted) influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal Agrippal.
2. To evaluate the kinetics of antibody responses to one booster dose of Fluad-H5N1 (H5N1 adjuvanted vaccine) mixed extemporaneously with seasonal Agrippal when given 12 months after the first or second dose.

Primary end point(s): 1. Number of Subjects Who Responded to Two or Three Vaccinations of the Fluad-H5N1 Influenza Vaccine.
2. Geometric Mean Ratio After Two or Three Vaccinations of the Fluad-H5N1 Influenza Vaccine.
3. Number of Subjects Who Responded to Two Vaccinations of the Seasonal Agrippal (Strain H1N1).
4. Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal Agrippal (Strain H3N2).
5. Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal Agrippal (Strain B).
6. Geometric Mean Ratio After Two Doses of the Seasonal Agrippal (Strain H1N1).
7. Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal Agrippal (Strain H3N1).
8. Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal Agrippal (Strain B).

Main Objective: To evaluate the magnitude of antibody responses to two or three doses of Fluad-H5N1 (H5N1 adjuvanted) influenza vaccine and seasonal Agrippal.

Timepoint(s) of evaluation of this end point: 1. 21 days after second and third vaccinations (day 43 and day 403).
2. 21 days after second and third vaccinations (day 22 and day 43).
3. 21 days after second vaccination (day 43).
4. 21 days after second and third vaccinations (day 43 and day 403).
5. 21 days after second and third vaccinations (day 43 and day 403).
6. 21 days after second vaccination (day 43).
7. 21 days after second and third vaccinations (day 43 and day 403).
8. 21 days after second and third vaccinations (day 43 and day 403).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. 21 days after second and third vaccinations (day 43 and day 403).
2. 21 days after booster vaccination (day 403).
3. 21 days after booster vaccination (day 403).

Secondary end point(s): 1. Number of Subjects Reporting Local and Systemic Reactions by Vaccination.
2. Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the Fluad-H5N1 Influenza Vaccine Mixed extemporaneously With the Seasonal Agrippal.
3. Geometric Mean Ratio After the Booster Vaccination Against the Fluad-H5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal Agrippal.

Secondary ID(s)

V87P5

Source(s) of Monetary Support

Novartis Vaccines and Diagnostics