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

NCT ID: NCT01096056

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-05
• Study Completion Date: 2010-12-13

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2186877A formulation 1

Intervention Type: BIOLOGICAL

Intramuscular administration, 2 doses

Fluarix

Intervention Type: BIOLOGICAL

Intramuscular administration, 1 dose

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.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2186877A formulation 2

Intervention Type: BIOLOGICAL

Intramuscular administration, 1 dose

Fluarix

Intervention Type: BIOLOGICAL

Intramuscular administration, 1 dose

Interventions

Influenza vaccine GSK2186877A formulation 1

Intramuscular administration, 2 doses

Intervention Type: BIOLOGICAL

Influenza vaccine GSK2186877A formulation 2

Intramuscular administration, 1 dose

Intervention Type: BIOLOGICAL

Fluarix

Intramuscular administration, 1 dose

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Seville, , Spain

Countries

Spain

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

114182

Identifier Type: -

Identifier Source: org_study_id