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

This study has been terminated.

(The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.)

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01195779

First received: September 3, 2010

Last updated: June 15, 2012

Last verified: June 2012

History of Changes

Results First Received: March 22, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza Disease
Interventions:	Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations Biological: GSK Bio's influenza vaccine GSK2321138A Biological: Fluarix™

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Since this study was prematurely terminated (not because of safety issues or lack of immunogenicity but for logistic reasons) only 4 of 1120 planned subjects were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
GSK2584786A Vaccine 1 Dose of Formulation A1 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 2 Doses of Formulation A1 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 1 Dose of Formulation A2 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 2 Doses of Formulation A2 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 1 Dose of Formulation A3 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 2 Doses of Formulation A3 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 1 Dose of Formulation B1 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 2 Doses of Formulation B1 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 1 Dose of Formulation B2 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 2 Doses of Formulation B2 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 1 Dose of Formulation B3 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2584786A Vaccine 2 Doses of Formulation B3 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2321138A Vaccine Group	Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
Fluarix Group	Subjects received 2 doses of Fluarix Vaccine.

Participant Flow: Overall Study

	GSK2584786A Vaccine 1 Dose of Formulation A3 Group	GSK2584786A Vaccine 2 Doses of Formulation B1 Group	GSK2584786A Vaccine 2 Doses of Formulation B3 Group	Fluarix Group
STARTED	1	1	1	1
COMPLETED	1	1	1	1
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
GSK2584786A Vaccine 1 Dose of Formulation A1 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 2 Doses of Formulation A1 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 1 Dose of Formulation A2 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 2 Doses of Formulation A2 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 1 Dose of Formulation A3 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 2 Doses of Formulation A3 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 1 Dose of Formulation B1 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 2 Doses of Formulation B1 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 1 Dose of Formulation B2 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 2 Doses of Formulation B2 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 1 Dose of Formulation B3 Group	Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2584786A Vaccine 2 Doses of Formulation B3 Group	Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2321138A Vaccine Group	Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
Fluarix Group	Subjects received 2 doses of Fluarix Vaccine.
Total	Total of all reporting groups

Baseline Measures

	GSK2584786A Vaccine 1 Dose of Formulation A1 Group	GSK2584786A Vaccine 2 Doses of Formulation A1 Group	GSK2584786A Vaccine 1 Dose of Formulation A2 Group	GSK2584786A Vaccine 2 Doses of Formulation A2 Group	GSK2584786A Vaccine 1 Dose of Formulation A3 Group	GSK2584786A Vaccine 2 Doses of Formulation A3 Group	GSK2584786A Vaccine 1 Dose of Formulation B1 Group	GSK2584786A Vaccine 2 Doses of Formulation B1 Group	GSK2584786A Vaccine 1 Dose of Formulation B2 Group	GSK2584786A Vaccine 2 Doses of Formulation B2 Group	GSK2584786A Vaccine 1 Dose of Formulation B3 Group	GSK2584786A Vaccine 2 Doses of Formulation B3 Group	GSK2321138A Vaccine Group	Fluarix Group	Total
Number of Participants [units: participants]	0	0	0	0	1	0	0	1	0	0	0	1	0	1	4
Age [units: Months] Mean ± Standard Deviation
Months					28 ± NA ^[1]			17 ± NA ^[1]				14 ± NA ^[1]		14 ± NA ^[1]	18.25 ± 6.65
Gender [units: Subjects]
Female					0			1				0		1	2
Male					1			0				1		0	2

[1]	Since only a single subject was enrolled in 4 of the study groups, there was insufficient data to calculate the within-group standard deviation.

Outcome Measures

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1. Primary:

Serum Haemagglutination-inhibition (HI) Antibody Titers [ Time Frame: at Day 28/ Day 56 ]

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2. Primary:

Serum Neutralizing Antibody Titers [ Time Frame: at Day 28/ Day 56 ]

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3. Primary:

Geometric Mean Number of All-CD4 Cytokine Positive Cells [ Time Frame: at Day 28/ Day 56 ]

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4. Primary:

Number of Subjects Reporting Fever of at Least Grade 2 or Higher [ Time Frame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine ]

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5. Secondary:

Serum HI Antibody Titers [ Time Frame: on Days 0, 28/56 and 180 ]

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6. Secondary:

Serum Neutralising Antibody Titers [ Time Frame: on Days 0, 28/56 and 180 ]

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7. Secondary:

Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: during a 7 day follow-up period (Day 0 to 6) after any vaccination ]

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8. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: within 28 days (Day 0 to Day 27) after any vaccination ]

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9. Secondary:

Number of Subjects Reporting Adverse Events With Medically Attended Visits [ Time Frame: From Day 0 to 179 ]

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10. Secondary:

Number of Subjects Reporting Potential Immune-mediated Diseases [ Time Frame: From Day 0 to 179 ]

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11. Secondary:

Number of Subjects Reporting Serious Adverse Events [ Time Frame: From Day 0 to 179 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01195779 History of Changes
Other Study ID Numbers:	114294
Study First Received:	September 3, 2010
Results First Received:	March 22, 2012
Last Updated:	June 15, 2012
Health Authority:	Finland: Ministry of Social Affairs and Health

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