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

Influenza Clinical Trial

Official title:

Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01195779
• Other study ID #: 114294
• Secondary ID: 2010-020312-12
• Status: Terminated
• Phase: Phase 2
• Start date: September 30, 2010
• Est. completion date: March 22, 2011

Study information

• Verified date: October 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 22, 2011
• Est. primary completion date: March 22, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza Vaccines
• Influenza, Human

Intervention

Biological:
• GSK Bio's influenza vaccine GSK2584786A, different formulations
Intramuscular injections
• GSK Bio's influenza vaccine GSK2321138A
Intramuscular injections
• Fluarix™
Intramuscular injections

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Haemagglutination-inhibition (HI) Antibody Titers	Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.	at Day 28/ Day 56
Primary	Serum Neutralizing Antibody Titers		at Day 28/ Day 56
Primary	Geometric Mean Number of All-CD4 Cytokine Positive Cells	Geometric mean of the number of CD4 cytokine positive T cells per million T cells.	at Day 28/ Day 56
Primary	Number of Subjects Reporting Fever of at Least Grade 2 or Higher	Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.	Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Secondary	Serum HI Antibody Titers	Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.	on Days 0, 28/56 and 180
Secondary	Serum Neutralising Antibody Titers	Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.	on Days 0, 28/56 and 180
Secondary	Number of Subjects Reporting Solicited Local and General Symptoms	Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.	during a 7 day follow-up period (Day 0 to 6) after any vaccination
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AEs)	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.	within 28 days (Day 0 to Day 27) after any vaccination
Secondary	Number of Subjects Reporting Adverse Events With Medically Attended Visits	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.	From Day 0 to 179
Secondary	Number of Subjects Reporting Potential Immune-mediated Diseases	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.	From Day 0 to 179
Secondary	Number of Subjects Reporting Serious Adverse Events	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.	From Day 0 to 179