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Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

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ClinicalTrials.gov Identifier: NCT00534248
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : May 2, 2011
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Shingles
Interventions Biological: Zoster Vaccine, Live (Zostavax™)
Biological: Comparator: Placebo
Enrollment 22439
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zostavax™ Placebo
Hide Arm/Group Description Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Period Title: Overall Study
Started 11211 11228
VACCINATED 11186 11210
Completed 10550 10555
Not Completed 661 673
Reason Not Completed
Adverse Event             19             29
Lost to Follow-up             353             375
Other protocol specified criteria             13             3
Physician Decision             10             7
Protocol Violation             3             4
Withdrawal by Subject             263             255
Arm/Group Title Zostavax™ Placebo Total
Hide Arm/Group Description Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo. Total of all reporting groups
Overall Number of Baseline Participants 11211 11228 22439
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11211 participants 11228 participants 22439 participants
54.9  (2.8) 54.8  (2.8) 54.8  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11211 participants 11228 participants 22439 participants
Female
6913
  61.7%
6972
  62.1%
13885
  61.9%
Male
4298
  38.3%
4256
  37.9%
8554
  38.1%
1.Primary Outcome
Title Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
Hide Description Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned.
Arm/Group Title Zostavax™ Placebo
Hide Arm/Group Description:
Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Overall Number of Participants Analyzed 11211 11228
Mean (95% Confidence Interval)
Unit of Measure: number of HZ cases/1000 person-years
1.994
(1.346 to 2.847)
6.596
(5.361 to 8.030)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zostavax™, Placebo
Comments Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Conditional Exact Method
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value .698
Confidence Interval (2-Sided) 95%
.541 to .806
Estimation Comments The point estimate was for vaccine efficacy with respect to incidence of HZ.
2.Secondary Outcome
Title Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group
Hide Description VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded.
Arm/Group Title Zostavax™ Placebo
Hide Arm/Group Description:
Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Overall Number of Participants Analyzed 1088 1087
Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
660.0
(624.7 to 697.2)
293.1
(274.7 to 312.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zostavax™, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method linear mixed longitudinal analysis model
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean titre ratio
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
2.2 to 2.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period
Hide Description

A serious adverse event is defined as 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.

Time Frame Through 42 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Arm/Group Title Zostavax™ Placebo
Hide Arm/Group Description:
Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Overall Number of Participants Analyzed 11094 11116
Measure Type: Number
Unit of Measure: participants
69 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zostavax™, Placebo
Comments Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.133
Confidence Interval (2-Sided) 95%
.805 to 1.595
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination.
Adverse Event Reporting Description AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
 
Arm/Group Title Zostavax™ Placebo
Hide Arm/Group Description Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
All-Cause Mortality
Zostavax™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zostavax™ Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   243/11094 (2.19%)      233/11116 (2.10%)    
Blood and lymphatic system disorders     
Anaemia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Nephrogenic anaemia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Splenic infarction  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cardiac disorders     
Acute myocardial infarction  1  3/11094 (0.03%)  3 2/11116 (0.02%)  2
Angina pectoris  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Angina unstable  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Arteriosclerosis coronary artery  1  1/11094 (0.01%)  1 3/11116 (0.03%)  3
Atrial fibrillation  1  2/11094 (0.02%)  2 6/11116 (0.05%)  6
Bradycardia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Cardiac arrest  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Cardiac failure congestive  1  5/11094 (0.05%)  5 1/11116 (0.01%)  1
Cardio-respiratory arrest  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cardiomegaly  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cardiomyopathy  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Coronary artery disease  1  2/11094 (0.02%)  2 2/11116 (0.02%)  2
Coronary artery occlusion  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Coronary artery stenosis  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Coronary artery thrombosis  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Hypertensive heart disease  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Hypertrophic cardiomyopathy  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Mitral valve prolapse  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Myocardial infarction  1  4/11094 (0.04%)  4 5/11116 (0.04%)  5
Stress cardiomyopathy  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Supraventricular tachycardia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Tachycardia  1  3/11094 (0.03%)  3 0/11116 (0.00%)  0
Ventricular tachycardia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Congenital, familial and genetic disorders     
Congenital diaphragmatic hernia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Porphyria acute  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Ear and labyrinth disorders     
Deafness neurosensory  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Vertigo  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Vertigo positional  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Endocrine disorders     
Goitre  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Hyperparathyroidism  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Thyroiditis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Eye disorders     
Diplopia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Retinal vein occlusion  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Gastrointestinal disorders     
Abdominal hernia  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Abdominal pain upper  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Anal fistula  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Ascites  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Colitis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Colitis ulcerative  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Colonic polyp  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Constipation  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Diverticulum  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Duodenal ulcer haemorrhage  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Gastrointestinal haemorrhage  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Haematemesis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Inguinal hernia  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Intestinal obstruction  1  2/11094 (0.02%)  3 0/11116 (0.00%)  0
Large intestinal obstruction  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Large intestine perforation  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Mechanical ileus  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Oesophageal achalasia  1  1/11094 (0.01%)  2 0/11116 (0.00%)  0
Oesophageal ulcer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Oesophageal varices haemorrhage  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Pancreatic disorder  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Pancreatitis  1  0/11094 (0.00%)  0 4/11116 (0.04%)  4
Pancreatitis acute  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Peritonitis  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Rectal prolapse  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Small intestinal obstruction  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Upper gastrointestinal haemorrhage  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
General disorders     
Chest discomfort  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Chest pain  1  7/11094 (0.06%)  7 7/11116 (0.06%)  7
Death  1  3/11094 (0.03%)  3 2/11116 (0.02%)  2
Hernia obstructive  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Impaired healing  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Inflammation  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Non-cardiac chest pain  1  5/11094 (0.05%)  5 7/11116 (0.06%)  7
Pyrexia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Hepatobiliary disorders     
Alcoholic liver disease  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cholangitis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Cholecystitis  1  3/11094 (0.03%)  3 3/11116 (0.03%)  3
Cholecystitis acute  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Cholelithiasis  1  2/11094 (0.02%)  2 3/11116 (0.03%)  3
Hepatic cirrhosis  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Hepatic failure  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Perforation bile duct  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Immune system disorders     
Allergic oedema  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Anaphylactic reaction  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Anaphylactic shock  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Infections and infestations     
Abdominal abscess  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Appendicitis  1  6/11094 (0.05%)  6 7/11116 (0.06%)  7
Arthritis bacterial  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Bursitis infective staphylococcal  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cellulitis  1  2/11094 (0.02%)  2 5/11116 (0.04%)  5
Device related infection  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Diabetic gangrene  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Diverticulitis  1  3/11094 (0.03%)  3 2/11116 (0.02%)  2
Endocarditis bacterial  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Epidemic nephropathy  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Erysipelas  1  4/11094 (0.04%)  4 2/11116 (0.02%)  2
Furuncle  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Gastroenteritis  1  3/11094 (0.03%)  3 3/11116 (0.03%)  3
Gastroenteritis viral  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Infection  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Lobar pneumonia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Localised infection  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Meningitis aseptic  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Osteomyelitis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Peritonitis bacterial  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Pharyngeal abscess  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Pneumonia  1  4/11094 (0.04%)  4 8/11116 (0.07%)  8
Pneumonia bacterial  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Post procedural infection  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Pyelonephritis  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Pyelonephritis acute  1  1/11094 (0.01%)  1 2/11116 (0.02%)  2
Respiratory tract infection  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Sepsis  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Sinusitis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Superinfection  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Upper respiratory tract infection  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Urosepsis  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Vestibular neuronitis  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Injury, poisoning and procedural complications     
Accidental overdose  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Alcohol poisoning  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Ankle fracture  1  1/11094 (0.01%)  1 4/11116 (0.04%)  4
Bladder injury  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Brain contusion  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cervical vertebral fracture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Concussion  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Contusion  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Device failure  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Drug toxicity  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Facial bones fracture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Foot fracture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Hand fracture  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Head injury  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Hip fracture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Humerus fracture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Incisional hernia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Joint dislocation  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Limb traumatic amputation  1  1/11094 (0.01%)  2 0/11116 (0.00%)  0
Meniscus lesion  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Overdose  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Postoperative ileus  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Rib fracture  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Skull fracture  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Soft tissue injury  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Spinal compression fracture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Splenic rupture  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Stent occlusion  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Subdural haemorrhage  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Synovial rupture  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Tendon rupture  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Tibia fracture  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Traumatic brain injury  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Ureteric injury  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Urinary retention postoperative  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Wound  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Wound complication  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Wrist fracture  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Metabolism and nutrition disorders     
Dehydration  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Diabetes mellitus  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Diabetes mellitus inadequate control  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Hyperglycaemia  1  1/11094 (0.01%)  1 2/11116 (0.02%)  2
Hypoglycaemia  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Hypokalaemia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Hyponatraemia  1  0/11094 (0.00%)  0 2/11116 (0.02%)  3
Obesity  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Type 2 diabetes mellitus  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Arthritis  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Back pain  1  3/11094 (0.03%)  3 1/11116 (0.01%)  1
Intervertebral disc degeneration  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Intervertebral disc protrusion  1  4/11094 (0.04%)  4 2/11116 (0.02%)  2
Joint effusion  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Musculoskeletal chest pain  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Osteoarthritis  1  2/11094 (0.02%)  2 2/11116 (0.02%)  2
Osteonecrosis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Patellofemoral pain syndrome  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Rhabdomyolysis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Rotator cuff syndrome  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Spinal column stenosis  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Anal cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Basal cell carcinoma  1  14/11094 (0.13%)  14 10/11116 (0.09%)  10
Benign lung neoplasm  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Benign neoplasm of cervix uteri  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Bladder cancer  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Borderline ovarian tumour  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Breast cancer  1  10/11094 (0.09%)  10 7/11116 (0.06%)  7
Breast cancer in situ  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Breast cancer stage II  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Bronchial carcinoma  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Chronic lymphocytic leukaemia  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Colon cancer  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Endometrial cancer metastatic  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Endometrial cancer stage III  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Fallopian tube cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Fibroadenoma of breast  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Gastric cancer  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Hepatic cancer metastatic  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Hepatic neoplasm malignant  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Lung neoplasm malignant  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Lymphoma  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Malignant melanoma  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Meningioma  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Metastases to liver  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Metastatic neoplasm  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Multiple myeloma  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Myelodysplastic syndrome  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Nasal cavity cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Neoplasm malignant  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Neurilemmoma benign  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Non-small cell lung cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Oesophageal carcinoma  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Ovarian cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Ovarian epithelial cancer  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Pancreatic carcinoma  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Pancreatic carcinoma metastatic  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Prostate cancer  1  1/11094 (0.01%)  1 2/11116 (0.02%)  2
Rectal cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Squamous cell carcinoma  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Squamous cell carcinoma of skin  1  3/11094 (0.03%)  3 4/11116 (0.04%)  4
Throat cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Thyroid cancer  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Uterine cancer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Uterine leiomyoma  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Waldenstrom's macroglobulinaemia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Nervous system disorders     
Brain stem infarction  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Cerebellar infarction  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Cerebral infarction  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Cerebrovascular accident  1  0/11094 (0.00%)  0 3/11116 (0.03%)  3
Cervical root pain  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Cervicobrachial syndrome  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Convulsion  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Cubital tunnel syndrome  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Encephalopathy  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Epilepsy  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Facial palsy  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Headache  1  0/11094 (0.00%)  0 2/11116 (0.02%)  2
Hypoaesthesia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Intracranial aneurysm  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Migraine  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Migraine with aura  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Myasthenia gravis  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Nerve compression  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Neuropathy peripheral  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Paraesthesia  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Parkinson's disease  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Transient ischaemic attack  1  2/11094 (0.02%)  2 2/11116 (0.02%)  2
Psychiatric disorders     
Acute psychosis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Affective disorder  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Alcohol abuse  1  2/11094 (0.02%)  2 0/11116 (0.00%)  0
Alcohol withdrawal syndrome  1  1/11094 (0.01%)  1 3/11116 (0.03%)  6
Completed suicide  1  0/11094 (0.00%)  0 3/11116 (0.03%)  3
Confusional state  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Depression  1  4/11094 (0.04%)  4 1/11116 (0.01%)  1
Depression suicidal  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Drug dependence  1  1/11094 (0.01%)  2 0/11116 (0.00%)  0
Major depression  1  2/11094 (0.02%)  2 2/11116 (0.02%)  2
Post-traumatic stress disorder  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Suicidal behaviour  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Suicidal ideation  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Suicide attempt  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Renal and urinary disorders     
Calculus urinary  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Nephrolithiasis  1  1/11094 (0.01%)  1 2/11116 (0.02%)  2
Renal colic  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Renal failure acute  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Renal failure chronic  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Renal infarct  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Endometrial hyperplasia  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Uterine prolapse  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Asthma  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Chronic obstructive pulmonary disease  1  3/11094 (0.03%)  3 2/11116 (0.02%)  2
Haemothorax  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Laryngeal cyst  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Pneumothorax  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Pulmonary arterial hypertension  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Pulmonary embolism  1  3/11094 (0.03%)  3 3/11116 (0.03%)  3
Respiratory failure  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Psoriasis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Skin ulcer  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Vascular disorders     
Aortic stenosis  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Arterial occlusive disease  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Deep vein thrombosis  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Haemorrhage  1  1/11094 (0.01%)  1 1/11116 (0.01%)  1
Hypertension  1  2/11094 (0.02%)  2 1/11116 (0.01%)  1
Hypertensive crisis  1  1/11094 (0.01%)  1 0/11116 (0.00%)  0
Orthostatic hypotension  1  0/11094 (0.00%)  0 1/11116 (0.01%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zostavax™ Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7228/11094 (65.15%)      2183/11116 (19.64%)    
General disorders     
Injection site erythema  1  5351/11094 (48.23%)  5409 483/11116 (4.35%)  484
Injection site pain  1  6005/11094 (54.13%)  6276 1025/11116 (9.22%)  1052
Injection site pruritus  1  1287/11094 (11.60%)  1307 78/11116 (0.70%)  84
Injection site swelling  1  4500/11094 (40.56%)  4549 309/11116 (2.78%)  311
Nervous system disorders     
Headache  1  1041/11094 (9.38%)  1509 917/11116 (8.25%)  1357
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
Results Point of Contact
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00534248     History of Changes
Other Study ID Numbers: V211-022
2007_551
First Submitted: September 21, 2007
First Posted: September 24, 2007
Results First Submitted: January 4, 2011
Results First Posted: May 2, 2011
Last Update Posted: April 12, 2017