Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00764790

Purpose

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

Condition	Intervention	Phase
Influenza	Biological: Fluarix Biological: Fluzone	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin Thimerosal

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Immunogenicity and Safety of GSK Biologicals' Thimerosal-Free TIV Flu Vaccine Versus a Licensed Comparator in Children.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Humoral immune response in terms of serum anti-haemagglutinin (HA) antibodies against each of the vaccine influenza virus strains, in each group. [ Time Frame: Day 0, Day 28, Day 56 ] [ Designated as safety issue: No ]
Geometric mean titres (GMTs) of HI antibody titres [ Time Frame: Day 0, Day 28, Day 56 ] [ Designated as safety issue: No ]
Seroconversion Rate (SCR) [ Time Frame: Day 28, Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Humoral immune response in terms of serum anti-haemagglutinin (HA) antibodies against each of the vaccine influenza virus strains, in each group. [ Time Frame: Day 0, Day 28, Day 56 ] [ Designated as safety issue: No ]
Seroprotection Rate (SPR) [ Time Frame: Day 0, Day 28, Day 56 ] [ Designated as safety issue: No ]
Seroconversion Factor (SCF) [ Time Frame: Day 28, Day 56 ] [ Designated as safety issue: No ]
Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
Percentage, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During a 28-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events and new onset chronic illnesses [ Time Frame: During the entire study ] [ Designated as safety issue: Yes ]
Occurrence of rare serious adverse events [ Time Frame: During the entire study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3039
Study Start Date:	October 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group C: Active Comparator	Biological: Fluzone One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
Group A: Experimental	Biological: Fluarix One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Group B: Experimental	Biological: Fluarix One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.

Eligibility

Ages Eligible for Study:	6 Months to 35 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764790

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 72 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111751
Study First Received:	October 1, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00764790
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 13, 2009