Clinical trial NCT01195779: Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
Official title: Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Influenza
Influenza Vaccines
Keywords: immunogenicity
safety
Influenza
children
vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
* History of any progressive neurological disorders or seizures.
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
* Acute disease and/or fever at the time of enrolment:
* - Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥38.0°C on rectal setting.
* Subjects with a minor illness without fever might be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
* Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.

Primary outcomes:
measure: Serum Haemagglutination-inhibition (HI) Antibody Titers
timeFrame: at Day 28/ Day 56
measure: Serum Neutralizing Antibody Titers
timeFrame: at Day 28/ Day 56
measure: Geometric Mean Number of All-CD4 Cytokine Positive Cells
timeFrame: at Day 28/ Day 56
measure: Number of Subjects Reporting Fever of at Least Grade 2 or Higher
timeFrame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Secondary outcomes:
measure: Serum HI Antibody Titers
timeFrame: on Days 0, 28/56 and 180
measure: Serum Neutralising Antibody Titers
timeFrame: on Days 0, 28/56 and 180
measure: Number of Subjects Reporting Solicited Local and General Symptoms
timeFrame: during a 7 day follow-up period (Day 0 to 6) after any vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: within 28 days (Day 0 to Day 27) after any vaccination
measure: Number of Subjects Reporting Adverse Events With Medically Attended Visits
timeFrame: From Day 0 to 179
measure: Number of Subjects Reporting Potential Immune-mediated Diseases
timeFrame: From Day 0 to 179
measure: Number of Subjects Reporting Serious Adverse Events
timeFrame: From Day 0 to 179
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: