Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01096056
First received: March 29, 2010
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Influenzae Disease
Biological: Influenza vaccine GSK2186877A formulation 1
Biological: Influenza vaccine GSK2186877A formulation 2
Biological: Fluarix
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of GSK2186877A Candidate Seasonal Influenza Vaccine in Healthy Children 6 to 35 Months of Age.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Fever Grade 2 or Higher [ Time Frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A ] [ Designated as safety issue: No ]
    Fever grade greater than or equal to 2 i.e. ≥2 was defined as axillary temperature >38 degree centigrade (°C).


Secondary Outcome Measures:
  • Haemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Day 0 and Day 42 ] [ Designated as safety issue: No ]
    Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

  • The Number of Subjects Seropositive to HI Antibodies [ Time Frame: At Day 0 and Day 42 ] [ Designated as safety issue: No ]
    A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

  • The Number of Subjects Seroprotected to HI Antibodies [ Time Frame: At Day 0 and Day 42 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

  • The Number of Subjects Seroconverted to HI Antibodies [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

  • HI Antibody Geometric Mean Fold Rise (GMFR) [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.

  • Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [ Time Frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A ] [ Designated as safety issue: No ]
    Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.

  • Duration of Solicited Local AEs [ Time Frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A ] [ Designated as safety issue: No ]
    Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.

  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [ Time Frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A ] [ Designated as safety issue: No ]
    Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.

  • Duration of Solicited General AEs [ Time Frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A ] [ Designated as safety issue: No ]
    Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.

  • Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs [ Time Frame: Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A ] [ 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.

  • Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) [ Time Frame: Day 0 up to Month 7 ] [ Designated as safety issue: No ]
    For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs) [ Time Frame: Day 0 up to Month 7 ] [ Designated as safety issue: No ]
    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 Any and Related Serious Adverse Events (SAEs) [ Time Frame: Day 0 up to Month 7 ] [ 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine GSK2186877A formulation 1 Group
Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
Biological: Influenza vaccine GSK2186877A formulation 1
Intramuscular administration, 2 doses
Biological: Fluarix
Intramuscular administration, 1 dose
Experimental: Influenza vaccine GSK2186877A formulation 2 Group
Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
Biological: Influenza vaccine GSK2186877A formulation 2
Intramuscular administration, 1 dose
Biological: Fluarix
Intramuscular administration, 1 dose

  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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096056

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: NCT01096056     History of Changes
Other Study ID Numbers: 114182
Study First Received: March 29, 2010
Results First Received: April 12, 2012
Last Updated: April 12, 2012
Health Authority: Spain: Agencia Espanola de Medicamentosy Productos Sanitarios

Keywords provided by GlaxoSmithKline:
Children
Influenza
Safety
Immunogenicity
Vaccine

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

ClinicalTrials.gov processed this record on April 23, 2014