A Phase IIIB, observer-blind, randomized, parallel groups, extension study to evaluate the immunogenicity and safety following a single intramuscular dose of FLUAD or Agrippal S1 influenza vaccines in healthy children previously vaccinated in the V70P5 study.

Conditions: Influenza
MedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza

Registration Number: EUCTR2010-021644-18-FI

Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1970

Inclusion Criteria

- Male and female children who have received two doses of at least one of the study vaccines in the previous V70P5 trial, influenza season 2008/2009 or 2009/2010.
- Children's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
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

- Children 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.
- Children with any progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
- Children's parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- 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.
- Children with suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system.
- Children with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Children with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Children who have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
- Children with history of allergy to vaccine components.
- Children participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- Children who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines.
- Children who have ever received blood, blood products and/or plasma derivatives or any parenteral
immunoglobulin preparation in the past 12 weeks.
- Children who have received antibiotics within 6 days before vaccination.
Individuals who are family members of study personnel conducting this study.
Individuals with axillary temperature =37.3 degrees Celsius within 3 days of intended study vaccination.