Clinical trial NCT01096056: Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children
Official title: Safety and Immunogenicity of GSK2186877A Candidate Seasonal Influenza Vaccine in Healthy Children 6 to 35 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Children
Influenza
Safety
Immunogenicity
Vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 40
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 study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.

This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.


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.

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 (drug or vaccine) 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 (seasonal or pandemic) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone \>0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* 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 consumption of egg proteins.
* History of any neurological disorders or seizures (including febrile convulsion).
* 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 (such as mild diarrhoea, mild upper respiratory infection) 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: Number of Subjects Reporting Fever Grade 2 or Higher
timeFrame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Secondary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: At Day 0 and Day 42
measure: The Number of Subjects Seropositive to HI Antibodies
timeFrame: At Day 0 and Day 42
measure: The Number of Subjects Seroprotected to HI Antibodies
timeFrame: At Day 0 and Day 42
measure: The Number of Subjects Seroconverted to HI Antibodies
timeFrame: Day 42
measure: HI Antibody Geometric Mean Fold Rise (GMFR)
timeFrame: Day 42
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
measure: Duration of Solicited Local AEs
timeFrame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
measure: Duration of Solicited General AEs
timeFrame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
timeFrame: Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A
measure: Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
timeFrame: Day 0 up to Month 7
measure: Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)
timeFrame: Day 0 up to Month 7
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: Day 0 up to Month 7
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: