A vaccine study to evaluate the safety of and the immune protection produced by different doses of two influenza vaccines in healthy children aged at least 6 months but less than 48 months

• Conditions: healthy volunteers (protection against influenza); MedDRA version: 16.1Level: LLTClassification code 10016794Term: Flu vaccinationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-002081-39-FI
• Lead Sponsor: ovartis Vaccines & Diagnostics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-16
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 672

Inclusion Criteria

1. Is a healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine

2. Has parent(s) or legal guardian(s) who have given written informed consent after the nature of the study has been explained according to local regulatory requirements

3. Is in good health as determined by medical history, the outcome of a physical examination, and the clinical judgment of the Investigator

4. Is able to comply with all study procedures and is available for all clinic visits scheduled in the study (including parents or guardians)
Are the trial subjects under 18? yes
Number of subjects for this age range: 672
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. Has parent(s) or legal guardian(s) who are not able to comprehend and to follow all required study procedures for the duration of the study

2. Has parent(s) or legal guardian(s) who are not able to read or write and are not able to delegate a designated person (information of whom will be entered in the study file) who:

a. Is an impartial person of legal age who is willing and able to witness the informed consent procedures as required by the protocol,

b. Is willing and able to undergo Diary Card training, and

c. Is willing and able to collect information on the Diary Card on a daily basis during the Post-vaccination Period through day 50 per protocol requirements;

3. Is a child from whom the minimal blood volume cannot be obtained prior to randomization, at the discretion of the investigator

4. Known or suspected impairment/alteration of immune function, including:

a. Long-term oral or parenteral corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

b. Any history of cancer chemotherapy

c. Receipt of immunostimulants within 60 days prior to day 1

d. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study

e. Known HIV infection or HIV-related disease

5. Has a history of Guillain–Barré syndrome

6. Has a bleeding disorder that would be a contraindication to intramuscular injection

7. Has a history of non-febrile seizures

8. Has a history of or clinically suspected developmental delay

9. Has a history of premature birth (<36 weeks of gestation) and/or low birth weight (<2.5 kg)

10. Had laboratory-confirmed influenza disease within 6 months prior to visit 1

11. Has received an antipyretic or analgesic in the past 24 hours prior to vaccination

12. Has medical 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 individual because of participation in the study

13. Has a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine (see section 5.1)

14. Has experienced acute disease and/or fever (i.e., body temperature measurement =38.0°C [=100.4°F]) within 3 days prior to vaccination.

15. Has been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study

16. Is the child of research staff involved with the clinical study at this institution or is otherwise related to research staff or has household members who are research staff associated with the investigator.

Study & Design

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