Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Fluarix™; Biological: Havrix™ Junior

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196026

114451

Details and patient eligibility

About

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.

Enrollment: 162 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
• Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

Exclusion criteria

• Active participation in other clinical trials.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• History of seizures or progressive neurological disease.
• Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
• Child in care.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 6 patient groups

Fluarix 6-11 months Group

Experimental group

Description:

Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine

Treatment:

Biological: Fluarix™

Fluarix 12-35 months Group

Experimental group

Description:

Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine

Treatment:

Biological: Fluarix™

Fluarix 3-9 years Group

Experimental group

Description:

Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine

Treatment:

Biological: Fluarix™

Havrix Junior 6-11 months Group

Active Comparator group

Description:

Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine

Treatment:

Biological: Havrix™ Junior

Havrix Junior 12-35 months Group

Active Comparator group

Description:

Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine

Treatment:

Biological: Havrix™ Junior

Havrix Junior 3-9 years Group

Active Comparator group

Description:

Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine

Treatment:

Biological: Havrix™ Junior