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

NCT01096056 | Completed Phase 1 Results

• 1 other identifier: 114182
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Children; Influenza; Safety; Immunogenicity; Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Fever Grade 2 or Higher

  Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).

  Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A

Secondary Outcomes (13)

• Haemagglutination Inhibition (HI) Antibody Titers

  At Day 0 and Day 42

• The Number of Subjects Seropositive to HI Antibodies

  At Day 0 and Day 42

• The Number of Subjects Seroprotected to HI Antibodies

  At Day 0 and Day 42

• The Number of Subjects Seroconverted to HI Antibodies

  Day 42

• HI Antibody Geometric Mean Fold Rise (GMFR)

  Day 42

Study Arms (2)

Influenza vaccine GSK2186877A formulation 1 Group

EXPERIMENTAL

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; Biological: Fluarix

Influenza vaccine GSK2186877A formulation 2 Group

EXPERIMENTAL

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; Biological: Fluarix

Interventions

Influenza vaccine GSK2186877A formulation 1 BIOLOGICAL

Intramuscular administration, 2 doses

Influenza vaccine GSK2186877A formulation 1 Group

Influenza vaccine GSK2186877A formulation 2 BIOLOGICAL

Intramuscular administration, 1 dose

Influenza vaccine GSK2186877A formulation 2 Group

Fluarix BIOLOGICAL

Intramuscular administration, 1 dose

Influenza vaccine GSK2186877A formulation 1 Group; Influenza vaccine GSK2186877A formulation 2 Group

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Seville, 41013, Spain

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: April 5, 2010
• Primary Completion: December 13, 2010
• Study Completion: December 13, 2010
• Last Updated: September 24, 2018
• Results First Posted: May 10, 2012

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)