Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

NCT ID: NCT00802464

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-12
• Study Completion Date: 2010-07-02

Brief Summary

The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GSK1437173A formulation 1 Group

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Group Type: EXPERIMENTAL

Herpes zoster vaccine GSK1437173A

Intervention Type: BIOLOGICAL

2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

GSK1437173A formulation 2 Group

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Group Type: EXPERIMENTAL

Herpes zoster vaccine GSK1437173A

Intervention Type: BIOLOGICAL

2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

GSK1437173A formulation 3 Group

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Group Type: EXPERIMENTAL

Herpes zoster vaccine GSK1437173A

Intervention Type: BIOLOGICAL

2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

Control Group

Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

2 vaccinations at Months 0 and 2 with placebo

Interventions

Herpes zoster vaccine GSK1437173A

2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

Intervention Type: BIOLOGICAL

Placebo

2 vaccinations at Months 0 and 2 with placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

gE/AS01E; gE/AS01B; Placebo/Saline

Eligibility Criteria

Inclusion Criteria

• A male or female 50 years of age or above at the time of the first vaccination;
• Written informed consent obtained from the subject;
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria

• 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;
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
• Previous vaccination against HZ;
• Previous vaccination against varicella;
• History of HZ;
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
• Acute disease at the time of enrolment.
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
• History of or current drug and/or alcohol abuse;
• Pregnant or lactating female;
• Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.

• Minimum Eligible Age: 50 Years
• 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

Phoenix, Arizona, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Edison, New Jersey, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Mahadahonda( Madrid, , Spain

GSK Investigational Site

Marid, , Spain

Countries

United States; Czechia; Spain

References

Chlibek R, Bayas JM, Collins H, de la Pinta ML, Ledent E, Mols JF, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31.

Reference Type: BACKGROUND

PMID: 23904292 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

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: Informed Consent Form

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: Dataset Specification

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

View Document

Document Type: Annotated Case Report Form

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

2008-005120-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

112077

Identifier Type: -

Identifier Source: org_study_id