Immunogenicity and Safety of a 1-Dose Regimen of a Zoster Vaccine Versus Different 2-Dose Regimens in Subjects ≥ 70 Years - Full Text View

Sponsored by:	Sanofi Pasteur MSD
Information provided by:	Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:	NCT00561080

Purpose

Primary objective:

Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination

Secondary objectives Immunogenicity

To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®

Condition	Intervention	Phase
Prevention of : Herpes-Zoster	Biological: Zostavax	Phase III

MedlinePlus related topics: Chickenpox Shingles

Drug Information available for: Zostavax

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomised, Comparative, Multi-Centre Study of the Immunogenicity and Safety of a 1-Dose Regimen and Different 2-Dose Regimens of a Zoster Vaccine (Live), ZOSTAVAX ®, in Subjects ≥ 70 Years of Age

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:

The 4 weeks post-dose 1 and 4 weeks post-dose 2 VZV antibody titres in group 2 and in group 3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The 4 weeks post-dose 1 VZV antibody titres in group 1 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The VZV antibody titres individual fold rise from pre-vaccination to 4 weeks post-dose 1 in all groups and 4 weeks post-dose 2 in group 2 and in group 3 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The 12 months post-dose 1 VZV antibody titres in group 1 and the 12 months post-dose 2 VZV antibody titres in group 2 and in group 3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The VZV antibody titres individual fold rise from pre-vaccination to 12 months post-dose 1 in group 1 and from pre-vaccination to 12 months post-dose 2 in group 2 and in group 3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The 24 and 36 months post-dose 1 VZV antibody titres in group 1 and the 24 and 36 months post-dose 2 VZV antibody titres in group 2 and in group 3 [ Time Frame: 24 and 36 months ] [ Designated as safety issue: No ]
The VZV antibody titres individual fold rise from pre-vaccination to 24 and 36 months post-dose 1 in group 1 and from pre-vaccination to 24 and 36 months post-dose 2 in group 2 and in group 3 [ Time Frame: 24 and 36 months ] [ Designated as safety issue: No ]
Injection site erythema; Injection site swelling; Injection site pain [ Time Frame: Day 0 to Day 4 ] [ Designated as safety issue: Yes ]
Unsolicited injection-site adverse reactions; Herpes zoster/ varicella/ zoster-like rash/ varicella-like rash; Other systemic adverse events; Any serious adverse events [ Time Frame: Day 0 to Day 28 following each vaccination ] [ Designated as safety issue: Yes ]
Deaths; Vaccine-related serious adverse events; Herpes zoster/ zoster-like rash [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	750
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Biological: Zostavax One dose (0.65 mL)
2: Experimental	Biological: Zostavax Two doses (0.65 mL) at one month interval
3: Experimental	Biological: Zostavax Two doses (0.65 mL) at 3 months interval

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age ≥ 70 years
Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
Signed informed consent form prior to any study procedure

Exclusion Criteria:

Febrile illness within the last 72 hours before the first vaccination
Prior herpes-zoster episode clinically diagnosed by a physician
Prior receipt of varicella or zoster vaccine
Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
Significant underlying illness preventing completion of the study vaccination schedules,
Known active tuberculosis,
Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
Concomitant use of non-topical antiviral therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561080

Locations

Finland

Vantaa, Finland

Järvenpää, Finland

Kotka, Finland

Tampere, Finland

Helsinki, Finland
Germany

Berlin, Germany

Schwerin, Germany

Dülmen, Germany

Heilbronn, Germany

Nettersheim, Germany

Künzing, Germany

Großheirath-Rossach, Germany

Leipzig, Germany

Straubing, Germany

Ingelheim, Germany

Mainz, Germany

Haag, Germany

Hamburg, Germany
Italy

Monza, Italy

Taranto, Italy

Chiavari, Italy

Genova, Italy

Torino, Italy

Ragusa, Italy
Netherlands

DC Rotterdam, Netherlands
Spain

Madrid, Spain

Barcelona, Spain

Albacete, Spain

Vigo, Spain

Valencia, Spain
Getxo
Pais Vasco, Spain
Hospitalet de Llobregat
Barcelona, Spain

Sponsors and Collaborators

Sanofi Pasteur MSD

Investigators

Study Director:

LEDESMA Emilio, MD

SPMSD

More Information

Responsible Party:	Sanofi Pasteur MSD ( Emilio LEDESMA, MD )
Study ID Numbers:	X06-Z-305
Study First Received:	November 19, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00561080
Health Authority:	Netherland: Minister VWS (van Volksgezondheid, Welzijn en Sport); Finland: National Agency for Medicines; Germany: Paul-Ehrlich-Institut; Italy: Not Applicable; Spain: AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios)

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009