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:
Sanofi Pasteur MSD
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00561080
First received: November 19, 2007
Last updated: September 17, 2009
Last verified: September 2009
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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:
- 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 | |
| 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
| 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 May 19, 2013