Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: GSK investigational vaccine GSK2340272A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972517

113638

2009-015011-41 (EudraCT Number)

Details and patient eligibility

About

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

Full description

This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.

Enrollment

245 patients

Sex

All

Ages

3 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
Healthy children as established by medical history and clinical examination when 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

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.
Clinically or virologically confirmed influenza infection within six months preceding the study start.
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.
Previous administration of any H1N1 A/California-like vaccine.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
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.
Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
Child in Care.