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Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)

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ClinicalTrials.gov Identifier: NCT00561080
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : December 22, 2017
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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 or disease Intervention/treatment Phase
Prevention of : Herpes-Zoster Biological: Zostavax Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 759 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : October 26, 2007
Actual Primary Completion Date : June 3, 2009
Actual Study Completion Date : June 3, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Dose of Zostavax
Zostavax 0.65mL intramuscular injection administered on Day 0
Biological: Zostavax
Other Name: Zoster vaccine live
Experimental: Zostavax - Day 0 and Month 1
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1
Biological: Zostavax
Other Name: Zoster vaccine live
Experimental: Zostavax - Day 0 and Month 3
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3
Biological: Zostavax
Other Name: Zoster vaccine live



Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 [ Time Frame: 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3) ]
    Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).


Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1 [ Time Frame: 4 weeks post-dose (Month 1) ]
    Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA.

  2. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3 [ Time Frame: Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3) ]
    Blood sample taken at predose (Day 0) and 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The GMFR was calculated following each vaccination as GMT Post-dose/GMT Pre-vaccination

  3. Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose [ Time Frame: 1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15) ]
    Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.

  4. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3 [ Time Frame: predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15) ]
    Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT.

  5. Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3 [ Time Frame: 24 and 36 months post-last dose ]
    Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.

  6. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres 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 Groups 2 and 3 [ Time Frame: Predose 1 and 24 and 36 months post-last dose ]
    Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT.

  7. Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1 [ Time Frame: up to 4 days after 1st vaccination ]
    Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain

  8. Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2 [ Time Frame: up to 4 days after 2nd vaccination ]
    Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain

  9. Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1 [ Time Frame: up to 28 days after 1st of study drug ]
    The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded.

  10. Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2 [ Time Frame: up to 28 days post-dose 2 ]
    The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded.

  11. Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1 [ Time Frame: up to 28 days post-dose 1 ]
    Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded.

  12. Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2 [ Time Frame: up to 28 days post-dose 2 ]
    Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded.

  13. Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1 [ Time Frame: up to 28 days post-dose 1 ]
    Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded.

  14. Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2 [ Time Frame: up to 28 days post-dose 2 ]
    Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded.

  15. Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1 [ Time Frame: up to 28 days after 1st vaccination ]
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized

  16. Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2 [ Time Frame: up to 28 days after 2nd vaccination ]
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized,

  17. Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1 [ Time Frame: up to 28 days after 1st vaccination ]
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized

  18. Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2 [ Time Frame: up to 28 days after 2nd vaccination ]
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized,

  19. Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1 [ Time Frame: up to 28 days after 1st vaccination ]
    A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded.

  20. Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2 [ Time Frame: up to 28 days after 2nd vaccination ]
    A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded.

  21. Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event [ Time Frame: up to end of study (approximately 15 months) ]
    A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE during the entire study period that was considered at least possibly -related to the vaccine were recorded.

  22. Percentage of Participants Who Died During the Study [ Time Frame: up to end of study (approximately 15 months) ]
    The number of participants who died for any reason during the study was summarized.



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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561080


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00561080     History of Changes
Other Study ID Numbers: V211-043
X06-Z-305 ( Other Identifier: MCMVaccBV (SPMSD) Protocol ID )
2007-000744-28 ( EudraCT Number )
First Posted: November 20, 2007    Key Record Dates
Results First Posted: December 22, 2017
Last Update Posted: February 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs