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A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

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: NCT01352793
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Meningitis, Meningococcal
Interventions Biological: rLP2086 vaccine
Biological: control
Enrollment 5715
Recruitment Details  
Pre-assignment Details A total of 5712 participants in 12 countries were enrolled in this study. Of these, 8 participants were randomized but did not receive study vaccination.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Period Title: Overall Study
Started 3804 1908
Vaccination 1 3796 1908
Vaccination 2 3530 1806
Vaccination 3 3314 1710
Completed 3219 1663
Not Completed 585 245
Reason Not Completed
Lost to Follow-up             289             125
Withdrawal by Subject             120             55
Protocol Violation             44             23
Adverse Event             44             10
Physician Decision             1             0
Pregnancy             26             8
Other             25             7
Medication error             2             2
Death             1             0
Randomized but not vaccinated             8             0
No longer meets eligibility criteria             25             15
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV Total
Hide Arm/Group Description Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month Total of all reporting groups
Overall Number of Baseline Participants 3804 1908 5712
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3804 participants 1908 participants 5712 participants
17.4  (4.6) 17.4  (4.6) 17.4  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3804 participants 1908 participants 5712 participants
Female
1962
  51.6%
994
  52.1%
2956
  51.8%
Male
1842
  48.4%
914
  47.9%
2756
  48.2%
1.Primary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Time Frame Vaccination 1 up to 6 months after Vaccination 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.55
(1.2 to 2.0)
2.52
(1.9 to 3.3)
2.Primary Outcome
Title Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
Hide Description A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame Within 30 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.03
(6.2 to 7.9)
6.13
(5.1 to 7.3)
3.Primary Outcome
Title Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
Hide Description A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame Within 30 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3529 1806
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.50
(4.8 to 6.3)
6.09
(5.0 to 7.3)
4.Primary Outcome
Title Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
Hide Description A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame Within 30 days after Vaccination 3
Hide Outcome Measure Data
Hide Analysis Population Description
Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3313 1710
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.34
(4.6 to 6.2)
5.50
(4.50 to 6.7)
5.Secondary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Hide Description An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30 days after Vaccination 1 (N=3796, 1908)
0.18
(0.1 to 0.4)
0.42
(0.2 to 0.8)
30 days after Vaccination 2 (N=3529, 1806)
0.17
(0.1 to 0.4)
0.44
(0.2 to 0.9)
30 days after Vaccination 3 (N=3313, 1710)
0.33
(0.2 to 0.6)
0.12
(0.0 to 0.4)
30 days after any vaccination (N=3796, 1908)
0.61
(0.4 to 0.9)
0.94
(0.6 to 1.5)
Vaccination phase (N=3796, 1908)
1.16
(0.8 to 1.6)
1.83
(1.3 to 2.5)
Follow-up phase (N=3400, 1733)
0.44
(0.2 to 0.7)
0.87
(0.5 to 1.4)
6.Secondary Outcome
Title Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Hide Description A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30 days after any vaccination (N=3796, 1908)
14.38
(13.3 to 15.5)
14.57
(13.0 to 16.2)
Vaccination phase (N=3796, 1908)
24.60
(23.2 to 26.0)
24.53
(22.6 to 26.5)
Follow-up phase (N=3400, 1733)
11.24
(10.2 to 12.3)
11.43
(10.0 to 13.0)
Throughout study (N=3796, 1908)
29.00
(27.6 to 30.5)
29.04
(27.0 to 31.1)
7.Secondary Outcome
Title Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Hide Description A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30 days after Vaccination 1 (N=3796, 1908)
0.21
(0.1 to 0.4)
0.10
(0.0 to 0.4)
30 days after Vaccination 2 (N=3529, 1806)
0.17
(0.1 to 0.4)
0.33
(0.1 to 0.7)
30 days after Vaccination 3 (N=3313, 1710)
0.09
(0.0 to 0.3)
0.12
(0.0 to 0.4)
30 days after any vaccination (N=3796, 1908)
0.45
(0.3 to 0.7)
0.52
(0.3 to 1.0)
Vaccination phase (N=3796, 1908)
1.03
(0.7 to 1.4)
1.05
(0.6 to 1.6)
Follow-up phase (N=3400, 1733)
0.44
(0.2 to 0.7)
0.52
(0.2 to 1.0)
Throughout study (N=3796, 1908)
1.40
(1.0 to 1.8)
1.52
(1.0 to 2.2)
8.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
Hide Description An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30 days after Vaccination 1 (N=3796, 1908)
31.48
(30.0 to 33.0)
19.03
(17.3 to 20.9)
30 days after Vaccination 2 (N=3529, 1806)
20.37
(19.1 to 21.7)
12.35
(10.9 to 14.0)
30 days after Vaccination 3 (N=3313, 1710)
15.00
(13.8 to 16.3)
10.76
(9.3 to 12.3)
30 days after any vaccination (N=3796, 1908)
43.02
(41.4 to 44.6)
31.45
(29.4 to 33.6)
Vaccination phase (N=3796, 1908)
51.08
(49.5 to 52.7)
42.51
(40.3 to 44.8)
9.Secondary Outcome
Title Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Hide Description An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame Within 30 minutes after Vaccination 1, 2, 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Vaccination 1 (N=3796, 1908)
1.05
(0.8 to 1.4)
0.84
(0.5 to 1.4)
Vaccination 2 (N=3529, 1806)
0.54
(0.3 to 0.8)
0.06
(0.0 to 0.3)
Vaccination 3 (N=3313, 1710)
0.45
(0.3 to 0.7)
0.41
(0.2 to 0.8)
10.Secondary Outcome
Title Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Vaccination 1 up to 1 month after Vaccination 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description:
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Overall Number of Participants Analyzed 3796 1908
Median (Full Range)
Unit of Measure: days
3.0
(1 to 110)
3.0
(1 to 136)
Time Frame AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
Adverse Event Reporting Description SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
 
Arm/Group Title Group 1: rLP2086 Group 2: HAV/Saline/HAV
Hide Arm/Group Description Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
All-Cause Mortality
Group 1: rLP2086 Group 2: HAV/Saline/HAV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: rLP2086 Group 2: HAV/Saline/HAV
Affected / at Risk (%) Affected / at Risk (%)
Total   59/3796 (1.55%)   48/1908 (2.52%) 
Blood and lymphatic system disorders     
Neutropenia * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Endocrine disorders     
Autoimmune thyroiditis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Hyperprolactinaemia * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Hypothalamo-pituitary disorder * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/3796 (0.00%)  2/1908 (0.10%) 
Constipation * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Duodenal perforation * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Duodenal ulcer perforation * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Enteritis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Hepatobiliary disorders     
Biliary dyskinesia * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Immune system disorders     
Allergy to arthropod sting * 1  0/3796 (0.00%)  2/1908 (0.10%) 
Anaphylactic reaction * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Drug hypersensitivity * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Infections and infestations     
Appendicitis * 1  3/3796 (0.08%)  4/1908 (0.21%) 
Gastroenteritis * 1  0/3796 (0.00%)  3/1908 (0.16%) 
Peritonsillar abscess * 1  2/3796 (0.05%)  1/1908 (0.05%) 
Meningitis viral * 1  2/3796 (0.05%)  0/1908 (0.00%) 
Abdominal abscess * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Acute tonsillitis * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Breast abscess * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Carbuncle * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Cellulitis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Cystitis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Gastrointestinal viral infection * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Meningitis enterococcal * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Meningitis enteroviral * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Pertussis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Pilonidal cyst * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Pneumonia * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Postoperative wound infection * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Rectal abscess * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Salpingitis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Tick-borne viral encephalitis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Pyelonephritis * 1  1/3796 (0.03%)  1/1908 (0.05%) 
Injury, poisoning and procedural complications     
Concussion * 1  1/3796 (0.03%)  2/1908 (0.10%) 
Intentional overdose * 1  2/3796 (0.05%)  0/1908 (0.00%) 
Cartilage injury * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Clavicle fracture * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Contusion * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Craniocerebral injury * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Fibula fracture * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Forearm fracture * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Gun shot wound * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Head injury * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Heat stroke * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Jaw fracture * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Lower limb fracture * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Overdose * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Snake bite * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Spinal compression fracture * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Traumatic intracranial haemorrhage * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Type 1 diabetes mellitus * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Osteochondrosis * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Pain in extremity * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Central Nervous System germinoma * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Nervous system disorders     
Migraine * 1  1/3796 (0.03%)  1/1908 (0.05%) 
Multiple sclerosis * 1  1/3796 (0.03%)  1/1908 (0.05%) 
Convulsion * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Demyelination * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Headache * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Meningism * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Neuralgia * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Radicular syndrome * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Tension headache * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  2/3796 (0.05%)  3/1908 (0.16%) 
Abortion missed * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Ectopic pregnancy * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Psychiatric disorders     
Suicidal ideation * 1  3/3796 (0.08%)  1/1908 (0.05%) 
Depression * 1  0/3796 (0.00%)  3/1908 (0.16%) 
Major depression * 1  1/3796 (0.03%)  1/1908 (0.05%) 
Substance abuse * 1  2/3796 (0.05%)  0/1908 (0.00%) 
Attention deficit or hyperactivity disorder * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Psychotic disorder * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Schizoaffective disorder * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Renal and urinary disorders     
Renal tubular necrosis * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Reproductive system and breast disorders     
Menorrhagia * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Testicular torsion * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  3/3796 (0.08%)  0/1908 (0.00%) 
Hyperventilation * 1  1/3796 (0.03%)  0/1908 (0.00%) 
Status asthmaticus * 1  0/3796 (0.00%)  1/1908 (0.05%) 
Skin and subcutaneous tissue disorders     
Ingrowing nail * 1  1/3796 (0.03%)  0/1908 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Group 1: rLP2086 Group 2: HAV/Saline/HAV
Affected / at Risk (%) Affected / at Risk (%)
Total   1671/3796 (44.02%)   640/1908 (33.54%) 
Gastrointestinal disorders     
Nausea * 1  89/3796 (2.34%)  33/1908 (1.73%) 
Vomiting * 1  60/3796 (1.58%)  27/1908 (1.42%) 
Abdominal pain * 1  47/3796 (1.24%)  32/1908 (1.68%) 
Diarrhoea * 1  42/3796 (1.11%)  17/1908 (0.89%) 
General disorders     
Injection site pain * 1  722/3796 (19.02%)  149/1908 (7.81%) 
Pyrexia * 1  237/3796 (6.24%)  44/1908 (2.31%) 
Injection site erythema * 1  142/3796 (3.74%)  6/1908 (0.31%) 
Vaccination site pain * 1  126/3796 (3.32%)  9/1908 (0.47%) 
Fatigue * 1  82/3796 (2.16%)  19/1908 (1.00%) 
Injection site swelling * 1  84/3796 (2.21%)  6/1908 (0.31%) 
Infections and infestations     
Upper respiratory tract infection * 1  157/3796 (4.14%)  87/1908 (4.56%) 
Nasopharyngitis * 1  149/3796 (3.93%)  84/1908 (4.40%) 
Pharyngitis * 1  75/3796 (1.98%)  47/1908 (2.46%) 
Gastroenteritis * 1  64/3796 (1.69%)  38/1908 (1.99%) 
Bronchitis * 1  65/3796 (1.71%)  36/1908 (1.89%) 
Sinusitis * 1  54/3796 (1.42%)  33/1908 (1.73%) 
Urinary tract infection * 1  50/3796 (1.32%)  24/1908 (1.26%) 
Pharyngitis streptococcal * 1  45/3796 (1.19%)  22/1908 (1.15%) 
Tonsillitis * 1  38/3796 (1.00%)  21/1908 (1.10%) 
Viral pharyngitis * 1  41/3796 (1.08%)  13/1908 (0.68%) 
Injury, poisoning and procedural complications     
Ligament sprain * 1  60/3796 (1.58%)  30/1908 (1.57%) 
Contusion * 1  50/3796 (1.32%)  23/1908 (1.21%) 
Fall * 1  38/3796 (1.00%)  24/1908 (1.26%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  76/3796 (2.00%)  26/1908 (1.36%) 
Back pain * 1  49/3796 (1.29%)  26/1908 (1.36%) 
Arthralgia * 1  40/3796 (1.05%)  27/1908 (1.42%) 
Nervous system disorders     
Headache * 1  249/3796 (6.56%)  102/1908 (5.35%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  83/3796 (2.19%)  41/1908 (2.15%) 
Cough * 1  73/3796 (1.92%)  34/1908 (1.78%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
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.
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: Pfizer
ClinicalTrials.gov Identifier: NCT01352793     History of Changes
Other Study ID Numbers: B1971014
2009-015198-11 ( EudraCT Number )
6108A1-3003 ( Other Identifier: Alias Study Number )
First Submitted: May 11, 2011
First Posted: May 12, 2011
Results First Submitted: February 25, 2015
Results First Posted: March 11, 2015
Last Update Posted: March 11, 2015