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Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

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ClinicalTrials.gov Identifier: NCT01245751
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : May 29, 2013
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
University of Colorado, Denver
Duke University
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Herpes Zoster
Varicella-zoster Vaccine
Intervention Biological: Zoster Vaccine, Live
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age
Hide Arm/Group Description Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Period Title: Part 1: Day 1 to Week 52 (1 Year)
Started 201 199 100 100
Completed 42-day Postvaccination Period 201 199 100 100
Completed 199 194 100 98
Not Completed 2 5 0 2
Reason Not Completed
Death             2             1             0             0
Lost to Follow-up             0             0             0             2
Withdrawal by Subject             0             4             0             0
Period Title: Part 2: Week 156 (3 Year) Visit
Started 161 [1] 139 [1] 0 [2] 0 [2]
Completed 161 139 0 0
Not Completed 0 0 0 0
[1]
Enrollment in Part 2 was voluntary
[2]
Part 2 was planned for Groups 1 and 2 only
Arm/Group Title Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age Total
Hide Arm/Group Description Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 201 199 100 100 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 199 participants 100 participants 100 participants 600 participants
77.1  (4.5) 76.3  (5.1) 64.1  (3.1) 55.5  (2.8) 71.1  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 199 participants 100 participants 100 participants 600 participants
Female
107
  53.2%
94
  47.2%
65
  65.0%
77
  77.0%
343
  57.2%
Male
94
  46.8%
105
  52.8%
35
  35.0%
23
  23.0%
257
  42.8%
1.Primary Outcome
Title Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
Hide Description VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time Frame Day 1 (Baseline) and Week 6 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.
Arm/Group Title Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age
Hide Arm/Group Description:
Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Overall Number of Participants Analyzed 201 199
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA Units/mL
Day 1 (Baseline), n=201, 199
248.0
(219.7 to 280.0)
254.2
(223.5 to 289.3)
Week 6 postvaccination, n=198, 195
389.1
(351.4 to 430.8)
368.6
(330.5 to 411.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Booster Dose Participants ≥70 Years of Age, Group 2: First Dose Participants ≥70 Years of Age
Comments Week 6 analysis
Type of Statistical Test Non-Inferiority or Equivalence
Comments Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is >0.67
Statistical Test of Hypothesis P-Value <0.001
Comments The alpha threshold for statistical significance is 0.025 (1-sided)
Method Longitudinal regression model
Comments The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.97 to 1.15
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
Hide Description VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
Time Frame Day 1 (Baseline) and Week 6 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 only.
Arm/Group Title Group 1: Booster Dose Participants ≥70 Years of Age
Hide Arm/Group Description:
Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Overall Number of Participants Analyzed 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
1.5
(1.4 to 1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Booster Dose Participants ≥70 Years of Age
Comments A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is >1.0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The alpha threshold for statistical significance is 0.025 (1-sided)
Method Longitudinal regression model
Comments The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.44 to 1.66
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Reporting One or More Adverse Experiences
Hide Description An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.
Time Frame Up to 42 days postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all vaccinated participants who had any safety follow-up
Arm/Group Title Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age
Hide Arm/Group Description:
Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Overall Number of Participants Analyzed 201 199 100 100
Measure Type: Number
Unit of Measure: Participants
Any Adverse Event 104 95 72 72
Injection-site Adverse Event 68 61 56 57
Non-Injection-site Adverse Event 66 57 34 38
Serious Adverse Event 3 5 1 0
Vaccine-related Serious Adverse Event 0 0 0 0
Time Frame Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age
Hide Arm/Group Description Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
All-Cause Mortality
Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/201 (14.43%)      29/199 (14.57%)      6/100 (6.00%)      2/100 (2.00%)    
Blood and lymphatic system disorders         
Haemorrhagic anaemia  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Cardiac disorders         
Atrial Fibrillation  1  1/201 (0.50%)  1 2/199 (1.01%)  2 1/100 (1.00%)  1 0/100 (0.00%)  0
Atrial flutter  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Cardiovascular disorder  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Coronary artery disease  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Myocardial infarction  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Palpitations  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Gastrointestinal disorders         
Ileus  1  0/201 (0.00%)  0 2/199 (1.01%)  2 0/100 (0.00%)  0 0/100 (0.00%)  0
Intestinal obstruction  1  0/201 (0.00%)  0 1/199 (0.50%)  2 0/100 (0.00%)  0 0/100 (0.00%)  0
Abdominal hernia  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Diverticulum intestinal haemorrhagic  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Duodenal ulcer haemorrhage  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Femoral hernia  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Gastric ulcer haemorrhage  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Gastritis  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Inguinal hernia  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Large intestinal ulcer haemorrhage  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Localised intraabdominal fluid collection  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Pancreatic pseudocyst  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Pancreatitis  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Hepatobiliary disorders         
Bile duct obstruction  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Cholelithiasis  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Hepatic cirrhosis  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Infections and infestations         
Appendicitis  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Lower respiratory tract infection  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Pelvic abscess  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Peritonitis  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Appendicitis perforated  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Bronchitis  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Cellulitis  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Device related infection  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Diverticulitis  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Gastroenteritis  1  1/201 (0.50%)  1 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Pneumonia  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Pyelonephritis  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Rhinitis  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Sepsis  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Injury, poisoning and procedural complications         
Pelvic fracture  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Wound haemorrhage  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Fall  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Fibula fracture  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Incisional hernia, obstructive  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Patella fracture  1  1/201 (0.50%)  2 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Postoperative ileus  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Procedural hypertension  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Rib fracture  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Tibia fracture  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Hyponatraemia  1  0/201 (0.00%)  0 0/199 (0.00%)  0 0/100 (0.00%)  0 1/100 (1.00%)  1
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Osteoarthritis  1  1/201 (0.50%)  1 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Spinal column stenosis  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate cancer metastatic  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Basal cell carcinoma  1  1/201 (0.50%)  1 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Breast cancer  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Chronic lymphocytic leukemia  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Lung adenocarcinoma recurrent  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Lung neoplasm malignant  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Malignant melanoma  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Pancreatic carcinoma  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Pancreatic carcinoma metastatic  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Plasma cell myeloma recurrent  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Pleural mesothelioma  1  1/201 (0.50%)  2 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Prostate cancer  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Squamous cell carcinoma  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Nervous system disorders         
Dementia Alzheimer's type  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Syncope  1  1/201 (0.50%)  1 3/199 (1.51%)  3 0/100 (0.00%)  0 0/100 (0.00%)  0
Aphasia  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Cerebrovascular accident  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Cervical radiculopathy  1  0/201 (0.00%)  0 0/199 (0.00%)  0 0/100 (0.00%)  0 1/100 (1.00%)  1
Seizure  1  0/201 (0.00%)  0 0/199 (0.00%)  0 1/100 (1.00%)  1 0/100 (0.00%)  0
Psychiatric disorders         
Mental status changes  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  0/201 (0.00%)  0 2/199 (1.01%)  2 1/100 (1.00%)  1 0/100 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Hypoxia  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Pulmonary embolism  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Vascular disorders         
Haematoma  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Aortic dissection  1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/100 (0.00%)  0 0/100 (0.00%)  0
Hypertension  1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/100 (0.00%)  0 0/100 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Booster Dose Participants ≥70 Years of Age Group 2: First Dose Participants ≥70 Years of Age Group 3: First Dose Participants ≥60 and <70 Years of Age Group 4: First Dose Participants ≥50 and <60 Years of Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/201 (37.81%)      58/199 (29.15%)      61/100 (61.00%)      62/100 (62.00%)    
General disorders         
Injection-site erythema  1  44/201 (21.89%)  44 47/199 (23.62%)  47 41/100 (41.00%)  41 40/100 (40.00%)  40
Injection-site pain  1  47/201 (23.38%)  47 28/199 (14.07%)  29 42/100 (42.00%)  46 48/100 (48.00%)  48
Injection-site pruritus  1  10/201 (4.98%)  10 9/199 (4.52%)  9 9/100 (9.00%)  9 11/100 (11.00%)  11
Injection-site swelling  1  31/201 (15.42%)  31 24/199 (12.06%)  24 29/100 (29.00%)  29 33/100 (33.00%)  33
Infections and infestations         
Nasopharyngitis  1  11/201 (5.47%)  11 2/199 (1.01%)  2 5/100 (5.00%)  5 7/100 (7.00%)  7
Nervous system disorders         
Headache  1  8/201 (3.98%)  11 4/199 (2.01%)  8 3/100 (3.00%)  3 9/100 (9.00%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01245751     History of Changes
Other Study ID Numbers: V211-029
First Submitted: November 19, 2010
First Posted: November 22, 2010
Results First Submitted: April 10, 2013
Results First Posted: May 29, 2013
Last Update Posted: April 12, 2017