NCT01195779

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

September 30, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 24, 2012

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

September 3, 2010

Results QC Date

March 22, 2012

Last Update Submit

October 8, 2020

Conditions

InfluenzaInfluenza Vaccines

Keywords

immunogenicitysafetyInfluenzachildrenvaccine

Outcome Measures

Primary Outcomes (4)

  • 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

  • Serum Neutralizing Antibody Titers

    at Day 28/ Day 56

  • 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

  • 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 Outcomes (7)

  • Serum HI Antibody Titers

    on Days 0, 28/56 and 180

  • Serum Neutralising Antibody Titers

    on Days 0, 28/56 and 180

  • Number of Subjects Reporting Solicited Local and General Symptoms

    during a 7 day follow-up period (Day 0 to 6) after any vaccination

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    within 28 days (Day 0 to Day 27) after any vaccination

  • Number of Subjects Reporting Adverse Events With Medically Attended Visits

    From Day 0 to 179

  • +2 more secondary outcomes

Study Arms (14)

GSK2584786A vaccine 1 dose of Formulation A1 Group

EXPERIMENTAL

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation A1 Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation A2 Group

EXPERIMENTAL

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation A2 Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation A3 Group

EXPERIMENTAL

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation A3 Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation B1 Group

EXPERIMENTAL

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation B1 Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation B2 Group

EXPERIMENTAL

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation B2 Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 1 dose of Formulation B3 Group

EXPERIMENTAL

Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2584786A vaccine 2 doses of Formulation B3 Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations

GSK2321138A vaccine Group

EXPERIMENTAL

Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).

Biological: GSK Bio's influenza vaccine GSK2321138A

Fluarix Group

ACTIVE COMPARATOR

Subjects received 2 doses of Fluarix Vaccine.

Biological: Fluarix™

Interventions

GSK Bio's influenza vaccine GSK2584786A, different formulationsBIOLOGICAL

Intramuscular injections

GSK2584786A vaccine 1 dose of Formulation A1 GroupGSK2584786A vaccine 1 dose of Formulation A2 GroupGSK2584786A vaccine 1 dose of Formulation A3 GroupGSK2584786A vaccine 1 dose of Formulation B1 GroupGSK2584786A vaccine 1 dose of Formulation B2 GroupGSK2584786A vaccine 1 dose of Formulation B3 GroupGSK2584786A vaccine 2 doses of Formulation A1 GroupGSK2584786A vaccine 2 doses of Formulation A2 GroupGSK2584786A vaccine 2 doses of Formulation A3 GroupGSK2584786A vaccine 2 doses of Formulation B1 GroupGSK2584786A vaccine 2 doses of Formulation B2 GroupGSK2584786A vaccine 2 doses of Formulation B3 Group
GSK Bio's influenza vaccine GSK2321138ABIOLOGICAL

Intramuscular injections

GSK2321138A vaccine Group
Fluarix™BIOLOGICAL

Intramuscular injections

Fluarix Group

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (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.
  • Born after gestation period of 36 to 42 weeks inclusive

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory 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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 6, 2010

Study Start

September 30, 2010

Primary Completion

March 22, 2011

Study Completion

March 22, 2011

Last Updated

October 30, 2020

Results First Posted

April 24, 2012

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)