A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of Fluad® or Agrippal® in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

Phase 1

• Conditions: influenza; MedDRA version: 14.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-023791-63-BE
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Children of 6 to <36 months of age, whose parent(s) or legal guardian(s) have given written informed consent prior to study entry;
2. Children good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator;
3. Children and children’s parent(s) or legal guardian(s) that are able to comply with all study procedures and are available for all clinic visits scheduled in the study.
4. Willingness to allow for samples to be stored beyond the study period, for potential additional future testing to better characterize immune responses.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Exclusion Criteria

1. Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol can be given after the active trial phase (3 weeks after last vaccination) has been concluded;
2. Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
3. Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable);
4. Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 6 days prior to study start;
5. Experience a body temperature ?38.0°C within the 3 days before enrollment.
6. Children with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
7. Children with known or suspected impairment/alteration of immune function, for example resulting from:
a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800µg/day or fluticasone 750µg/day) within 60 days prior to Visit 1,
b. receipt of immunostimulants within 60 days prior to Visit 1,
c. receipt of parenteral immunoglobulin preparartion, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
d. known HIV infection or HIV-related disease;
8. Children with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
9. History of hypersensitivity to any component of the study medication or chemically related substances;
10. History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component;
11. Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1;
12. History of neurological disorder or seizures (febrile seizures allowed).
13. Ever received any influenza vaccine.
14. Major surgery planned during the study period.
15. Children hospitalized
16. Children with any fatal prognosis of an underlying medical condition (<12 month life expectancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified