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Trial record 33 of 465 for:    Shingles

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.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Prevention of : Herpes-Zoster
Intervention: Biological: Zostavax

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 779 participants were screened. Twenty participants were not randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: Single Dose of Zostavax Single injection of the 0.65 mL of Zostavax administered on Day 0
Group 2: Zostavax - Day 0 and Month 1 0.65 mL of Zostavax administered on Day 0 and Month 1
Group 3: Zostavax - Day 0 and Month 3 0.65 mL of Zostavax administered on Day 0 and Month 3

Participant Flow for 4 periods

Period 1:   Vaccination Period (up to Month 4)
    Group 1: Single Dose of Zostavax   Group 2: Zostavax - Day 0 and Month 1   Group 3: Zostavax - Day 0 and Month 3
STARTED   253   255   251 
Received at Least 1 Vaccination   253   254   250 
COMPLETED   250   229   225 
NOT COMPLETED   3   26   26 
Adverse Event                0                4                6 
Definitive Contra-indication                0                2                3 
Protocol Violation                0                1                3 
Withdrawal by Subject                3                16                13 
Lost to Follow-up                0                1                0 
Other                0                2                1 

Period 2:   12-month Post Last Dose Follow-up
    Group 1: Single Dose of Zostavax   Group 2: Zostavax - Day 0 and Month 1   Group 3: Zostavax - Day 0 and Month 3
STARTED   250   229   225 
COMPLETED   243   220   215 
NOT COMPLETED   7   9   10 
Adverse Event                3                3                1 
Protocol Violation                0                0                4 
Withdrawal by Subject                2                6                5 
Lost to Follow-up                2                0                0 

Period 3:   24-month Post Last Dose Follow-up
    Group 1: Single Dose of Zostavax   Group 2: Zostavax - Day 0 and Month 1   Group 3: Zostavax - Day 0 and Month 3
STARTED   0 [1]   0 [1]   0 [1] 
COMPLETED   0   0   0 
NOT COMPLETED   0   0   0 
[1] Study stopped at 1 year post last dose

Period 4:   36 Month Post Last Dose Follow-up
    Group 1: Single Dose of Zostavax   Group 2: Zostavax - Day 0 and Month 1   Group 3: Zostavax - Day 0 and Month 3
STARTED   0 [1]   0 [1]   0 [1] 
COMPLETED   0   0   0 
NOT COMPLETED   0   0   0 
[1] Study stopped at 1 year post last dose



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline age missing for 1 participant in Group 2 and 1 participant in Group 3.

Reporting Groups
  Description
Group 1: Single Dose of Zostavax Single injection of the 0.65 mL of Zostavax administered on Day 0
Group 2: Zostavax - Day 0 and Month 1 0.65 mL of Zostavax administered on Day 0 and Month 1
Group 3: Zostavax - Day 0 and Month 3 0.65 mL of Zostavax administered on Day 0 and Month 3
Total Total of all reporting groups

Baseline Measures
   Group 1: Single Dose of Zostavax   Group 2: Zostavax - Day 0 and Month 1   Group 3: Zostavax - Day 0 and Month 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 253   255   251   759 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   253   254   250   757 
   76.2  (5.5)   76.0  (5.4)   76.1  (5.3)   76.1  (5.4) 
[1] Baseline age missing for 1 participant in Group 2 and 1 participant in Group 3.
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   253   255   251   759 
Female      148  58.5%      138  54.1%      135  53.8%      421  55.5% 
Male      105  41.5%      117  45.9%      116  46.2%      338  44.5% 


  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1   [ Time Frame: 4 weeks post-dose (Month 1) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1   [ Time Frame: up to 4 days after 1st vaccination ]

9.  Secondary:   Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2   [ Time Frame: up to 4 days after 2nd vaccination ]

10.  Secondary:   Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1   [ Time Frame: up to 28 days after 1st of study drug ]

11.  Secondary:   Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2   [ Time Frame: up to 28 days post-dose 2 ]

12.  Secondary:   Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1   [ Time Frame: up to 28 days post-dose 1 ]

13.  Secondary:   Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2   [ Time Frame: up to 28 days post-dose 2 ]

14.  Secondary:   Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1   [ Time Frame: up to 28 days post-dose 1 ]

15.  Secondary:   Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2   [ Time Frame: up to 28 days post-dose 2 ]

16.  Secondary:   Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1   [ Time Frame: up to 28 days after 1st vaccination ]

17.  Secondary:   Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2   [ Time Frame: up to 28 days after 2nd vaccination ]

18.  Secondary:   Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1   [ Time Frame: up to 28 days after 1st vaccination ]

19.  Secondary:   Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2   [ Time Frame: up to 28 days after 2nd vaccination ]

20.  Secondary:   Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1   [ Time Frame: up to 28 days after 1st vaccination ]

21.  Secondary:   Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2   [ Time Frame: up to 28 days after 2nd vaccination ]

22.  Secondary:   Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event   [ Time Frame: up to end of study (approximately 15 months) ]

23.  Secondary:   Percentage of Participants Who Died During the Study   [ Time Frame: up to end of study (approximately 15 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


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 Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: October 2, 2017
Results First Posted: December 22, 2017
Last Update Posted: February 16, 2018