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Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500266
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : September 16, 2011
Last Update Posted : September 16, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Intervention Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Enrollment 1053
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 13vPnC
Hide Arm/Group Description Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Period Title: Overall Study
Started 1053
Treated 1049
Completed 1040
Not Completed 13
Reason Not Completed
Death             3
Lost to Follow-up             3
Withdrawal by Subject             3
Assigned, not treated             4
Arm/Group Title 13vPnC
Hide Arm/Group Description Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Overall Number of Baseline Participants 1049
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1049 participants
75.3  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1049 participants
Female
584
  55.7%
Male
465
  44.3%
1.Primary Outcome
Title Percentage of Participants With Pre-specified Local Reactions
Hide Description Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Time Frame Days 1 through 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting "yes" for at least 1 day or "no" for all days.
Arm/Group Title 13vPnC
Hide Arm/Group Description:
Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Overall Number of Participants Analyzed 1049
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Redness: Any (n=666)
14.3
(11.7 to 17.2)
Redness: Mild (n=660)
12.6
(10.1 to 15.3)
Redness: Moderate (n=649)
6.5
(4.7 to 8.6)
Redness: Severe (n=638)
1.1
(0.4 to 2.2)
Swelling: Any (n=664)
12.8
(10.4 to 15.6)
Swelling: Mild (n=658)
10.9
(8.7 to 13.6)
Swelling: Moderate (n=651)
5.5
(3.9 to 7.6)
Swelling: Severe (n=636)
0.6
(0.2 to 1.6)
Pain: Any (n=777)
51.0
(47.4 to 54.5)
Pain: Mild (n=770)
49.4
(45.8 to 52.9)
Pain: Moderate (n=656)
9.0
(6.9 to 11.4)
Pain: Severe (n=634)
0.2
(0.0 to 0.9)
Limitation of arm movement: Any (n=679)
16.2
(13.5 to 19.2)
Limitation of arm movement: Mild (n=674)
14.8
(12.2 to 17.7)
Limitation of arm movement: Moderate (n=636)
1.6
(0.8 to 2.9)
Limitation of arm movement: Severe (n=640)
1.6
(0.8 to 2.9)
Any local reaction (n=802)
56.6
(53.1 to 60.1)
Any severe local reaction (n=643)
2.6
(1.5 to 4.2)
2.Primary Outcome
Title Percentage of Participants With Pre-specified Systemic Events
Hide Description Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.
Time Frame Days 1 through 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.
Arm/Group Title 13vPnC
Hide Arm/Group Description:
Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Overall Number of Participants Analyzed 1049
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Fever (any): >=38 degrees C (n=641)
2.0
(1.1 to 3.4)
Fever: >=38 degrees C but <38.5 degrees C (n=636)
0.8
(0.3 to 1.8)
Fever: >=38.5 degrees C but <39 degrees C (n=634)
0.0
(0.0 to 0.6)
Fever: >=39 degrees C but <=40 degrees C (n=635)
0.3
(0.0 to 1.1)
Fever: >40 degrees C (n=638)
0.9
(0.3 to 2.0)
Fatigue: Any (n=733)
34.4
(30.9 to 37.9)
Fatigue: Mild (n=710)
28.7
(25.4 to 32.2)
Fatigue: Moderate (n=683)
15.2
(12.6 to 18.1)
Fatigue: Severe (n=639)
2.0
(1.1 to 3.5)
Headache: Any (n=702)
26.1
(22.9 to 29.5)
Headache: Mild (n=696)
24.1
(21.0 to 27.5)
Headache: Moderate (n=655)
9.0
(6.9 to 11.5)
Headache: Severe (n=637)
0.8
(0.3 to 1.8)
Chills (n=651)
7.5
(5.6 to 9.8)
Rash (n=658)
8.4
(6.4 to 10.7)
Vomiting: Any (vomiting present; n=638)
0.9
(0.3 to 2.0)
Vomiting: Mild (1 to 2 times in 24 hours;n=637)
0.8
(0.3 to 1.8)
Vomiting: Moderate (>2 times in 24 hours;n=635)
0.2
(0.0 to 0.9)
Vomiting: Severe (prevents routine activity;n=634)
0.0
(0.0 to 0.6)
Decreased appetite (n=668)
11.2
(8.9 to 13.9)
Diarrhea: Any (diarrhea present; n=684)
14.5
(11.9 to 17.3)
Diarrhea: Mild (2 to 3 loose stools/day; n=678)
12.8
(10.4 to 15.6)
Diarrhea: Moderate (4 to 5 loose stools/day;n=644)
3.4
(2.2 to 5.1)
Diarrhea: Severe (>=6 loose stools/day; n=635)
0.3
(0.0 to 1.1)
New generalized muscle pain: Any (n=700)
25.3
(22.1 to 28.7)
New generalized muscle pain: Mild (n=679)
20.5
(17.5 to 23.7)
New generalized muscle pain: Moderate (n=658)
7.9
(6.0 to 10.2)
New generalized muscle pain: Severe (n=636)
0.6
(0.2 to 1.6)
Aggravated generalized muscle pain: Any (n=669)
12.3
(9.9 to 15.0)
Aggravated generalized muscle pain: Mild (n=650)
7.5
(5.6 to 9.8)
Aggravated generalized muscle pain:Moderate(n=655)
6.4
(4.7 to 8.6)
Aggravated generalized muscle pain: Severe (n=639)
1.4
(0.6 to 2.7)
New generalized joint pain: Any (n=665)
12.8
(10.3 to 15.6)
New generalized joint pain: Mild (n=651)
8.1
(6.2 to 10.5)
New generalized joint pain: Moderate (n=648)
5.7
(4.1 to 7.8)
New generalized joint pain: Severe (n=637)
0.8
(0.3 to 1.8)
Aggravated generalized joint pain: Any (n=661)
9.7
(7.5 to 12.2)
Aggravated generalized joint pain: Mild (n=647)
5.7
(4.1 to 7.8)
Aggravated generalized joint pain: Moderate(n=647)
5.1
(3.5 to 7.1)
Aggravated generalized joint pain: Severe (n=637)
1.1
(0.4 to 2.3)
Any systemic event (n=832)
58.4
(55.0 to 61.8)
3.Primary Outcome
Title Percentage of Participants Taking Pain or Antipyretic Medication
Hide Description Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Time Frame Days 1 through 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.
Arm/Group Title 13vPnC
Hide Arm/Group Description:
Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
Overall Number of Participants Analyzed 1049
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Use of medication to treat pain (n=677)
17.0
(14.2 to 20.0)
Use of medication to treat fever (n=655)
6.4
(4.7 to 8.6)
Time Frame Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3.
Adverse Event Reporting Description Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.
 
Arm/Group Title 13vPnC: Visit 1 to Visit 2 13vPnC: 6-month Follow-up
Hide Arm/Group Description Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study. Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
All-Cause Mortality
13vPnC: Visit 1 to Visit 2 13vPnC: 6-month Follow-up
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
13vPnC: Visit 1 to Visit 2 13vPnC: 6-month Follow-up
Affected / at Risk (%) Affected / at Risk (%)
Total   10/1049 (0.95%)   41/1049 (3.91%) 
Cardiac disorders     
Bradyarrhythmia * 1  1/1049 (0.10%)  1/1049 (0.10%) 
Tachyarrhythmia * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Myocardial infarction * 1  0/1049 (0.00%)  3/1049 (0.29%) 
Atrial fibrillation * 1  0/1049 (0.00%)  2/1049 (0.19%) 
Acute coronary syndrome * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Cardiac arrest * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Cardiac failure * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Cardiac failure congestive * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Coronary artery disease * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Ischaemic cardiomyopathy * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Gastrointestinal disorders     
Gastritis * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Small intestinal obstruction * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Infections and infestations     
Appendicitis * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Pneumonia * 1  0/1049 (0.00%)  3/1049 (0.29%) 
Abscess limb * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Bacteraemia * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Bronchitis * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Cellulitis * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Enteritis infectious * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Lower respiratory tract infection * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Septic shock * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Injury, poisoning and procedural complications     
Hip fracture * 1  1/1049 (0.10%)  1/1049 (0.10%) 
Fall * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Fracture displacement * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Postoperative renal failure * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Rib fracture * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Wrist fracture * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Hyperkalaemia * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Hypovolaemia * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  2/1049 (0.19%)  0/1049 (0.00%) 
Breast cancer * 1  0/1049 (0.00%)  2/1049 (0.19%) 
Bladder cancer * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Breast cancer in situ * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Colon cancer * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Fibrosarcoma * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Lung neoplasm malignant * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Metastases to lymph nodes * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Metastatic neoplasm * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Non-small cell lung cancer * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Ovarian cancer * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Renal cancer * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Renal neoplasm * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Nervous system disorders     
Loss of consciousness * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Carotid artery stenosis * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Cerebral infarction * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Cerebrovascular accident * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Guillain-Barre syndrome * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Transient ischaemic attack * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Psychiatric disorders     
Hallucination * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Mental status changes * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Renal and urinary disorders     
Renal failure * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Renal failure acute * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/1049 (0.00%)  3/1049 (0.29%) 
Respiratory failure * 1  0/1049 (0.00%)  2/1049 (0.19%) 
Dyspnoea * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Pleural effusion * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Pulmonary oedema * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Skin and subcutaneous tissue disorders     
Skin burning sensation * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Surgical and medical procedures     
Percutaneous coronary intervention * 1  0/1049 (0.00%)  1/1049 (0.10%) 
Vascular disorders     
Peripheral arterial occlusive disease * 1  1/1049 (0.10%)  0/1049 (0.00%) 
Deep vein thrombosis * 1  0/1049 (0.00%)  1/1049 (0.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC: Visit 1 to Visit 2 13vPnC: 6-month Follow-up
Affected / at Risk (%) Affected / at Risk (%)
Total   486/1049 (46.33%)   77/1049 (7.34%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Leukocytosis * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Cardiac disorders     
Bradycardia * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Angina unstable * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Aortic valve incompetence * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Arteriosclerosis coronary artery * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Coronary artery disease * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Left ventricular hypertrophy * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Tricuspid valve incompetence * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Ear and labyrinth disorders     
Vertigo * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Deafness neurosensory * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Eye disorders     
Blepharitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Conjunctivitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Diabetic retinopathy * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Cataract * 3  0/1049 (0.00%)  3/1049 (0.29%) 
Gastrointestinal disorders     
Diarrhoea * 3  6/1049 (0.57%)  0/1049 (0.00%) 
Nausea * 3  6/1049 (0.57%)  0/1049 (0.00%) 
Vomiting * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Constipation * 3  2/1049 (0.19%)  1/1049 (0.10%) 
Abdominal discomfort * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Haemorrhoidal haemorrhage * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Retching * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Gastrooesophageal reflux disease * 3  0/1049 (0.00%)  3/1049 (0.29%) 
Diverticulum * 3  0/1049 (0.00%)  2/1049 (0.19%) 
Haemorrhoids * 3  0/1049 (0.00%)  2/1049 (0.19%) 
General disorders     
Fever (any)  2 [1]  13/641 (2.03%)  0/0 
Fever (mild)  2 [2]  5/636 (0.79%)  0/0 
Fever (moderate)  2 [3]  0/634 (0.00%)  0/0 
Fever (severe)  2 [4]  2/635 (0.31%)  0/0 
Fever (potentially life threatening)  2 [5]  6/638 (0.94%)  0/0 
Fatigue (any)  2 [6]  252/733 (34.38%)  0/0 
Fatigue (mild)  2 [7]  204/710 (28.73%)  0/0 
Fatigue (moderate)  2 [8]  104/683 (15.23%)  0/0 
Fatigue (severe)  2 [9]  13/639 (2.03%)  0/0 
Headache (any)  2 [10]  183/702 (26.07%)  0/0 
Headache (mild)  2 [11]  168/696 (24.14%)  0/0 
Headache (moderate)  2 [12]  59/655 (9.01%)  0/0 
Headache (severe)  2 [13]  5/637 (0.78%)  0/0 
Chills  2  49/651 (7.53%)  0/0 
Rash  2  55/658 (8.36%)  0/0 
Vomiting (any)  2 [14]  6/638 (0.94%)  0/0 
Vomiting (mild)  2 [15]  5/637 (0.78%)  0/0 
Vomiting (moderate)  2 [16]  1/635 (0.16%)  0/0 
Vomiting (severe)  2 [17]  0/634 (0.00%)  0/0 
Decreased appetite  2  75/668 (11.23%)  0/0 
Diarrhea (any)  2 [18]  99/684 (14.47%)  0/0 
Diarrhea (mild)  2 [19]  87/678 (12.83%)  0/0 
Diarrhea (moderate)  2 [20]  22/644 (3.42%)  0/0 
Diarrhea (severe)  2 [21]  2/635 (0.31%)  0/0 
New generalized muscle pain (any)  2 [22]  177/700 (25.29%)  0/0 
New generalized muscle pain (mild)  2 [23]  139/679 (20.47%)  0/0 
New generalized muscle pain (moderate)  2 [24]  52/658 (7.90%)  0/0 
New generalized muscle pain (severe)  2 [25]  4/636 (0.63%)  0/0 
Aggravated generalized muscle pain (any)  2 [26]  82/669 (12.26%)  0/0 
Aggravated generalized muscle pain (mild)  2 [27]  49/650 (7.54%)  0/0 
Aggravated generalized muscle pain (moderate)  2 [28]  42/655 (6.41%)  0/0 
Aggravated generalized muscle pain (severe)  2 [29]  9/639 (1.41%)  0/0 
New generalized joint pain (any)  2 [30]  85/665 (12.78%)  0/0 
New generalized joint pain (mild)  2 [31]  53/651 (8.14%)  0/0 
New generalized joint pain (moderate)  2 [32]  37/648 (5.71%)  0/0 
New generalized joint pain (severe)  2 [33]  5/637 (0.78%)  0/0 
Aggravated generalized joint pain (any)  2 [34]  64/661 (9.68%)  0/0 
Aggravated generalized joint pain (mild)  2 [35]  37/647 (5.72%)  0/0 
Aggravated generalized joint pain (moderate)  2 [36]  33/647 (5.10%)  0/0 
Aggravated generalized joint pain (severe)  2 [37]  7/637 (1.10%)  0/0 
Fatigue * 3  4/1049 (0.38%)  1/1049 (0.10%) 
Injection site pain * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Injection site haematoma * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Injection site pruritus * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Injection site swelling * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Oedema peripheral * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Pain * 3  1/1049 (0.10%)  1/1049 (0.10%) 
Pain * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Suprapubic pain * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Hepatobiliary disorders     
Cholelithiasis * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Immune system disorders     
Seasonal allergy * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Infections and infestations     
Bronchitis * 3  6/1049 (0.57%)  1/1049 (0.10%) 
Sinusitis * 3  4/1049 (0.38%)  1/1049 (0.10%) 
Upper respiratory tract infection * 3  4/1049 (0.38%)  0/1049 (0.00%) 
Urinary tract infection * 3  4/1049 (0.38%)  1/1049 (0.10%) 
Gastroenteritis * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Gastroenteritis viral * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Herpes zoster * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Acute sinusitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Cellulitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Ear infection * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Eye infection * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Laryngitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Localised infection * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Nail infection * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Nasopharyngitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Staphylococcal skin infection * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Tinea cruris * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Viral infection * 3  1/1049 (0.10%)  1/1049 (0.10%) 
Oral herpes * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Pneumonia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Injury, poisoning and procedural complications     
Skin laceration * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Contusion * 3  2/1049 (0.19%)  1/1049 (0.10%) 
Limb injury * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Electric shock * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Excoriation * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Fall * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Joint sprain * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Facial bones fracture * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Incisional hernia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Joint injury * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Procedural pain * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Investigations     
Blood glucose increased * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Blood thyroid stimulating hormone increased * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Cardiac murmur * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Metabolism and nutrition disorders     
Dehydration * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Glucose tolerance impaired * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Hyperlipidaemia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Type 2 diabetes mellitus * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 3  6/1049 (0.57%)  4/1049 (0.38%) 
Myalgia * 3  6/1049 (0.57%)  0/1049 (0.00%) 
Musculoskeletal pain * 3  3/1049 (0.29%)  2/1049 (0.19%) 
Pain in extremity * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Spinal osteoarthritis * 3  2/1049 (0.19%)  1/1049 (0.10%) 
Back pain * 3  1/1049 (0.10%)  2/1049 (0.19%) 
Bone pain * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Bursitis * 3  1/1049 (0.10%)  1/1049 (0.10%) 
Musculoskeletal chest pain * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Musculoskeletal discomfort * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Neck pain * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Osteoarthritis * 3  1/1049 (0.10%)  5/1049 (0.48%) 
Osteoporosis * 3  1/1049 (0.10%)  3/1049 (0.29%) 
Plantar fasciitis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Rotator cuff syndrome * 3  1/1049 (0.10%)  1/1049 (0.10%) 
Osteopenia * 3  0/1049 (0.00%)  3/1049 (0.29%) 
Tendonitis * 3  0/1049 (0.00%)  2/1049 (0.19%) 
Joint range of motion decreased * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Lumbar spinal stenosis * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Sacroiliitis * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign breast neoplasm * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Endobronchial lipoma * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Lung neoplasm * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Meningioma benign * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Nervous system disorders     
Dizziness * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Headache * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Paraesthesia * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Carotid artery stenosis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Carpal tunnel syndrome * 3  1/1049 (0.10%)  1/1049 (0.10%) 
Hypoaesthesia * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Polyneuropathy * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Tremor * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Narcolepsy * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Restless legs syndrome * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Psychiatric disorders     
Bipolar disorder * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Depression * 3  1/1049 (0.10%)  2/1049 (0.19%) 
Stress * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Suicidal ideation * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Insomnia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Renal and urinary disorders     
Bladder spasm * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Renal failure * 3  1/1049 (0.10%)  2/1049 (0.19%) 
Haematuria * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Hypertonic bladder * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Renal mass * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Reproductive system and breast disorders     
Atrophic vulvovaginitis * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Benign prostatic hyperplasia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Erectile dysfunction * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 3  3/1049 (0.29%)  0/1049 (0.00%) 
Oropharyngeal pain * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Pleural effusion * 3  2/1049 (0.19%)  0/1049 (0.00%) 
Asthma * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Nasal congestion * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Pulmonary fibrosis * 3  1/1049 (0.10%)  3/1049 (0.29%) 
Respiratory disorder * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Rhinitis allergic * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Rhinorrhoea * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Sinus congestion * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Upper respiratory tract congestion * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Chronic obstructive pulmonary disease * 3  0/1049 (0.00%)  3/1049 (0.29%) 
Dyspnoea * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Emphysema * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Sleep apnoea syndrome * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Skin and subcutaneous tissue disorders     
Redness (any)  1 [38]  95/666 (14.26%)  0/0 
Redness (mild)  1 [39]  83/660 (12.58%)  0/0 
Redness (moderate)  1 [40]  42/649 (6.47%)  0/0 
Redness (severe) * 1 [41]  7/638 (1.10%)  0/0 
Swelling (any)  1 [42]  85/664 (12.80%)  0/0 
Swelling (mild)  1 [43]  72/658 (10.94%)  0/0 
Swelling (moderate)  1 [44]  36/651 (5.53%)  0/0 
Swelling (severe)  1 [45]  4/636 (0.63%)  0/0 
Pain (any)  1 [46]  396/777 (50.97%)  0/0 
Pain (mild)  1 [47]  380/770 (49.35%)  0/0 
Pain (moderate)  1 [48]  59/656 (8.99%)  0/0 
Pain (severe)  1 [49]  1/634 (0.16%)  0/0 
Limitation of arm movement (any)  1 [50]  110/679 (16.20%)  0/0 
Limitation of arm movement (mild)  1 [51]  100/674 (14.84%)  0/0 
Limitation of arm movement (moderate)  1 [52]  10/636 (1.57%)  0/0 
Limitation of arm movement (severe)  1 [53]  10/640 (1.56%)  0/0 
Actinic keratosis * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Dermatitis allergic * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Intertrigo * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Rash * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Rash pruritic * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Skin discolouration * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Skin lesion * 3  1/1049 (0.10%)  1/1049 (0.10%) 
Skin mass * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Eczema * 3  0/1049 (0.00%)  2/1049 (0.19%) 
Erythema * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Milia * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Social circumstances     
Joint prosthesis user * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Vascular disorders     
Hypertension * 3  3/1049 (0.29%)  3/1049 (0.29%) 
Hypotension * 3  1/1049 (0.10%)  0/1049 (0.00%) 
Peripheral arterial occlusive disease * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Peripheral vascular disorder * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Temporal arteritis * 3  0/1049 (0.00%)  1/1049 (0.10%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Local reactions
2
Term from vocabulary, Systemic events
3
Term from vocabulary, MedDRA
[1]
Fever (any) = ≥38 degrees C
[2]
Fever (mild) = ≥38 degrees C but <38.5 degrees C
[3]
Fever (moderate) = ≥38.5 degrees C but <39 degrees C.
[4]
Fever (severe) = ≥39 degrees C but ≤40 degrees C
[5]
Fever (potentially life threatening) = >40 degrees C
[6]
Fatigue (any) = fatigue present
[7]
Fatigue (mild) = no interference with activity.
[8]
Fatigue (moderate) = some interference with activity.
[9]
Fatigue (severe) = prevents routine daily activity.
[10]
Headache (any) = headache present.
[11]
Headache (mild) = no interference with activity.
[12]
Headache (moderate) = some interference with activity.
[13]
Headache (severe) = prevents routine daily activity.
[14]
Vomiting (any) = vomiting present.
[15]
Vomiting (mild) = no interference with activity or 1 to 2 times in 24 hours.
[16]
Vomiting (moderate) = some interference with activity or more than 2 times in 24 hours.
[17]
Vomiting (severe) = prevents routine daily activity.
[18]
Diarrhea (any) = diarrhea present.
[19]
Diarrhea (mild) = 2 to 3 loose stools in 24 hours.
[20]
Diarrhea (moderate) = 4 to 5 loose stools in 24 hours.
[21]
Diarrhea (severe) = 6 or more loose stools in 24 hours.
[22]
New generalized muscle pain (any) = new generalized muscle pain present.
[23]
New generalized muscle pain (mild) = no interference with activity.
[24]
New generalized muscle pain (moderate) = some interference with activity.
[25]
New generalized muscle pain (severe) = prevents routine daily activity.
[26]
Aggravated generalized muscle pain (any) = aggravated generalized muscle pain present.
[27]
Aggravated generalized muscle pain (mild) = no interference with activity.
[28]
Aggravated generalized muscle pain (moderate) = some interference with activity.
[29]
Aggravated generalized muscle pain (severe) = prevents routine daily activity.
[30]
New generalized joint pain (any) = new generalized joint pain present.
[31]
New generalized joint pain (mild) = no interference with activity.
[32]
New generalized joint pain (moderate) = some interference with activity.
[33]
New generalized joint pain (severe) = prevents routine daily activity.
[34]
Aggravated generalized joint pain (any) = aggravated generalized joint pain present.
[35]
Aggravated generalized joint pain (mild) = no interference with activity.
[36]
Aggravated generalized joint pain (moderate) = some interference with activity.
[37]
Aggravated generalized joint pain (severe) = prevents routine daily activity.
[38]
Redness (any) = present at site of vaccination.
[39]
Redness (mild) = 2.5 to 5.0 cm
[40]
Redness (moderate) = 5.1 to 10.0 cm
[41]
Redness (severe) = >10.0 cm
[42]
Swelling (any) = present at site of vaccination
[43]
Swelling (mild) = 2.5 to 5.0 cm
[44]
Swelling (moderate) = 5.1 to 10.0 cm
[45]
Swelling (severe) = 10.0 cm
[46]
Pain (any) = present at site of vaccination.
[47]
Pain (mild) = no interference with activity.
[48]
Pain (moderate) = some interference with activity.
[49]
Pain (severe) = prevents routine daily activity.
[50]
Limitation of arm movement (any) = present due to vaccination.
[51]
Limitation of arm movement (mild) = some limitation of arm movement.
[52]
Limitation of arm movement (moderate) = unable to move arm above head but able to move arm above shoulder.
[53]
Limitation of arm movement (severe) = unable to move arm above shoulder.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00500266    
Other Study ID Numbers: 6115A1-3000
First Submitted: July 9, 2007
First Posted: July 11, 2007
Results First Submitted: August 11, 2011
Results First Posted: September 16, 2011
Last Update Posted: September 16, 2011