Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Subjects ≥ 70 Years

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00561080
First received: November 19, 2007
Last updated: September 17, 2009
Last verified: September 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Zostavax
One dose (0.65 mL)
Experimental: 2 Biological: Zostavax
Two doses (0.65 mL) at one month interval
Experimental: 3 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:

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

Exclusion Criteria:

  1. Febrile illness within the last 72 hours before the first vaccination
  2. Prior herpes-zoster episode clinically diagnosed by a physician
  3. Prior receipt of varicella or zoster vaccine
  4. Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
  5. Significant underlying illness preventing completion of the study vaccination schedules,
  6. Known active tuberculosis,
  7. Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
  8. Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
  9. Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
  10. Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
  11. Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
  12. Concomitant use of non-topical antiviral therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Finland
Helsinki, Finland
Järvenpää, Finland
Kotka, Finland
Tampere, Finland
Vantaa, Finland
Germany
Berlin, Germany
Dülmen, Germany
Großheirath-Rossach, Germany
Haag, Germany
Hamburg, Germany
Heilbronn, Germany
Ingelheim, Germany
Künzing, Germany
Leipzig, Germany
Mainz, Germany
Nettersheim, Germany
Schwerin, Germany
Straubing, Germany
Italy
Chiavari, Italy
Genova, Italy
Monza, Italy
Ragusa, Italy
Taranto, Italy
Torino, Italy
Netherlands
DC Rotterdam, Netherlands
Spain
Albacete, Spain
Barcelona, Spain
Hospitalet de Llobregat
Barcelona, Spain
Madrid, Spain
Getxo
Pais Vasco, Spain
Valencia, Spain
Vigo, Spain
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne Fiquet, MD SPMSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET, MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00561080     History of Changes
Other Study ID Numbers: X06-Z-305
Study First Received: November 19, 2007
Last Updated: September 17, 2009
Health Authority: Netherland: Minister VWS (van Volksgezondheid, Welzijn en Sport)
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Italy: Not Applicable
Spain: AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios)

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014