Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children

This study has been terminated.
(The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01195779
First received: September 3, 2010
Last updated: June 15, 2012
Last verified: June 2012

September 3, 2010
June 15, 2012
September 2010
March 2011   (final data collection date for primary outcome measure)
  • Serum Haemagglutination-inhibition (HI) Antibody Titers [ Time Frame: at Day 28/ Day 56 ] [ Designated as safety issue: No ]
    Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
  • Serum Neutralizing Antibody Titers [ Time Frame: at Day 28/ Day 56 ] [ Designated as safety issue: No ]
  • Geometric Mean Number of All-CD4 Cytokine Positive Cells [ Time Frame: at Day 28/ Day 56 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.
  • Humoral Immune Response in Terms of Neutralizing and Haemagglutination-inhibition (HI) Antibodies Against Vaccine Strains [ Time Frame: at Day 28 ] [ Designated as safety issue: No ]
  • Humoral Immune Response in Terms of Neutralizing and HI Antibodies Against Vaccine Strains [ Time Frame: at Day 56 ] [ Designated as safety issue: No ]
  • Cell mediate immune response against vaccine strains contained in the vaccine [ Time Frame: at Day 56 ] [ Designated as safety issue: No ]
  • Incidence of Fever Grade ≥2 (Axillary Temperature >38°C) [ Time Frame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine ] [ Designated as safety issue: No ]
  • Cell Mediate Immune Response Against Vaccine Strains Contained in the Vaccine [ Time Frame: at Day 28 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01195779 on ClinicalTrials.gov Archive Site
  • Serum HI Antibody Titers [ Time Frame: on Days 0, 28/56 and 180 ] [ Designated as safety issue: No ]
    Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
  • Serum Neutralising Antibody Titers [ Time Frame: on Days 0, 28/56 and 180 ] [ Designated as safety issue: No ]
    Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
  • Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: during a 7 day follow-up period (Day 0 to 6) after any vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.
  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: within 28 days (Day 0 to Day 27) after any vaccination ] [ Designated as safety issue: No ]
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
  • Number of Subjects Reporting Adverse Events With Medically Attended Visits [ Time Frame: From Day 0 to 179 ] [ Designated as safety issue: No ]
    A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
  • Number of Subjects Reporting Potential Immune-mediated Diseases [ Time Frame: From Day 0 to 179 ] [ Designated as safety issue: No ]
    Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: From Day 0 to 179 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
  • Humoral immune response in terms of HI antibodies against vaccine strains [ Time Frame: on Days 0, 28/56 and 180 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralising antibodies against vaccine strains [ Time Frame: on Days 0, 28/56 and 180 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: during a 7 day follow-up period (Day 0 to 6) after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: within 28 days (Day 0 to Day 27) after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of adverse events with medically attended visits [ Time Frame: From Day 0 to 179 ] [ Designated as safety issue: No ]
  • Occurrence of potential Immune-mediated diseases [ Time Frame: From Day 0 to Day 365 ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From Day 0 to Day 365 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza Disease
  • Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
    Intramuscular injections
  • Biological: GSK Bio's influenza vaccine GSK2321138A
    Intramuscular injections
  • Biological: Fluarix™
    Intramuscular injections
  • Experimental: GSK2584786A vaccine 1 dose of Formulation A1 Group
    Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 2 doses of Formulation A1 Group
    Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 1 dose of Formulation A2 Group
    Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 2 doses of Formulation A2 Group
    Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 1 dose of Formulation A3 Group
    Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 2 doses of Formulation A3 Group
    Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 1 dose of Formulation B1 Group
    Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 2 doses of Formulation B1 Group
    Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 1 dose of Formulation B2 Group
    Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 2 doses of Formulation B2 Group
    Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 1 dose of Formulation B3 Group
    Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2584786A vaccine 2 doses of Formulation B3 Group
    Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
    Intervention: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
  • Experimental: GSK2321138A vaccine Group
    Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
    Intervention: Biological: GSK Bio's influenza vaccine GSK2321138A
  • Active Comparator: Fluarix Group
    Subjects received 2 doses of Fluarix Vaccine.
    Intervention: Biological: Fluarix™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01195779
114294
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP