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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
  Purpose

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.


Condition Intervention Phase
Influenza Disease
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Biological: GSK Bio's influenza vaccine GSK2321138A
Biological: Fluarix™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2584786A vaccine 1 dose of Formulation A1 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 2 doses of Formulation A1 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 1 dose of Formulation A2 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 2 doses of Formulation A2 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 1 dose of Formulation A3 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 2 doses of Formulation A3 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 1 dose of Formulation B1 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 2 doses of Formulation B1 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 1 dose of Formulation B2 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 2 doses of Formulation B2 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 1 dose of Formulation B3 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2584786A vaccine 2 doses of Formulation B3 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
Experimental: GSK2321138A vaccine Group
Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
Biological: GSK Bio's influenza vaccine GSK2321138A
Intramuscular injections
Active Comparator: Fluarix Group
Subjects received 2 doses of Fluarix Vaccine.
Biological: Fluarix™
Intramuscular injections

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195779

Locations
Spain
GSK Investigational Site
Sevilla, Spain, 41013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01195779     History of Changes
Other Study ID Numbers: 114294
Study First Received: September 3, 2010
Results First Received: March 22, 2012
Last Updated: June 15, 2012
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by GlaxoSmithKline:
immunogenicity
safety
Influenza
children
vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014