Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months

GlaxoSmithKline1 site in 1 country4 target enrollmentSeptember 30, 2010

ConditionsInfluenza Influenza Vaccines

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 4
Locations: 1
Primary Endpoint: Serum Neutralizing Antibody Titers
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.

Registry

clinicaltrials.gov

Start Date

September 30, 2010

End Date

March 22, 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects must satisfy ALL the following criteria at study entry:
•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
•Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
•Born after gestation period of 36 to 42 weeks inclusive

Exclusion Criteria

•The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
•Child in "care"
•Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Prior receipt of any influenza vaccination or planned administration 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 six months prior to the first vaccine dose.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•A family history of congenital or hereditary immunodeficiency.
•A family history of febrile seizures or/and epilepsy
•Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to any constituent of influenza vaccine.

Outcomes

Primary Outcomes

Serum Neutralizing Antibody Titers

Time Frame: at Day 28/ Day 56

Geometric Mean Number of All-CD4 Cytokine Positive Cells

Time Frame: at Day 28/ Day 56

Geometric mean of the number of CD4 cytokine positive T cells per million T cells.

Number of Subjects Reporting Fever of at Least Grade 2 or Higher

Time Frame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine

Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.

Serum Haemagglutination-inhibition (HI) Antibody Titers

Time Frame: at Day 28/ Day 56

Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.

Secondary Outcomes

Number of Subjects Reporting Potential Immune-mediated Diseases(From Day 0 to 179)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)(within 28 days (Day 0 to Day 27) after any vaccination)
Number of Subjects Reporting Adverse Events With Medically Attended Visits(From Day 0 to 179)
Number of Subjects Reporting Serious Adverse Events(From Day 0 to 179)
Serum HI Antibody Titers(on Days 0, 28/56 and 180)
Serum Neutralising Antibody Titers(on Days 0, 28/56 and 180)
Number of Subjects Reporting Solicited Local and General Symptoms(during a 7 day follow-up period (Day 0 to 6) after any vaccination)