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Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in 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: NCT01766921
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : August 10, 2015
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pandemic H5N1 Influenza
Intervention Biological: Adjuvanted H5N1 pandemic influenza vaccine
Enrollment 1393
Recruitment Details 1393 subjects were enrolled at 12 centers in the US, 5 centers in Australia, 2 centers in New Zealand and 4 centers in Thailand.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Period Title: Overall Study
Started 700 693
Completed 676 676
Not Completed 24 17
Reason Not Completed
Administrative Reason             5             5
Death             1             1
Lost to Follow-up             1             3
Unclassified             2             2
Protocol Violation             1             1
Withdrawal by Subject             14             5
Arm/Group Title High Dose Low Dose Total
Hide Arm/Group Description Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. Total of all reporting groups
Overall Number of Baseline Participants 700 693 1393
Hide Baseline Analysis Population Description
Analysis was done on All Enrolled population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 700 participants 693 participants 1393 participants
71.2  (5.1) 70.7  (4.7) 71.0  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 700 participants 693 participants 1393 participants
FEMALE
407
  58.1%
418
  60.3%
825
  59.2%
MALE
293
  41.9%
275
  39.7%
568
  40.8%
1.Primary Outcome
Title The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
Hide Description

The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.

The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.

Time Frame Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 693 683
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1
12
(10 to 15)
10
(8 to 12)
Day 43 (N=673,664)
81
(78 to 84)
63
(59 to 66)
2.Primary Outcome
Title The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Hide Description

Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.

Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.

The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.

Time Frame Three weeks after 2nd vaccination (day 43)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the FAS.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 673 664
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
74
(70 to 77)
52
(48 to 56)
3.Primary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
Hide Description Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Time Frame From day 1 through day 7 after any vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 693 683
Measure Type: Number
Unit of Measure: Number of subjects
Any Local 314 212
Injection site Erythema (N=693,681) 17 5
Injection site Induration (N=693,683) 20 11
Injection site Ecchymosis (N=692,682) 7 10
Injection site Pain (N=693,681) 309 203
Any Systemic 250 228
Nausea (N=692,681) 45 44
Myalgia (N=691,681) 91 85
Arthralgia (N=692,681) 65 69
Headache (N=692,678) 92 89
Fatigue (N=692,681) 116 112
Loss of Appetite (N=683,673) 40 42
Malaise (N=692,680) 116 117
Fever (≥38°C; N=693,681) 16 4
Prevention of Pain and (or) Fever (N=691,682) 18 26
Treatment of Pain and (or) Fever (N=691,682) 56 46
4.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Hide Description Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine
Time Frame Day 1 through day 387 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 694 686
Measure Type: Number
Unit of Measure: Number of subjects
Any AEs (Day 1 to 22; N=694,685) 147 149
At least possibly related AEs(Day1to22;N=694,685) 56 61
Any AEs (Day 23 to 43; N=689,681) 101 123
At least possibly related AEs(Day23to43;N=689,681) 21 37
Any SAEs 43 53
Deaths 1 1
Medically attended AEs 383 373
Premature withdrawal from study 1 1
AESIs 2 0
NOCD 108 92
5.Secondary Outcome
Title Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Hide Description

Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported.

The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age.

Time Frame Day 1; day 22; day 43 and day 387
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 681 673
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
A/H5N1 (Day22/Day1)
3.21
(2.85 to 3.62)
2.01
(1.78 to 2.26)
A/H5N1 (Day43/Day1; N=673,664)
16
(14 to 18)
5.72
(4.94 to 6.63)
A/H5N1 (Day387/Day1; N=658,651)
1.97
(1.79 to 2.17)
1.3
(1.18 to 1.44)
6.Secondary Outcome
Title Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain
Hide Description

Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion.

The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%.

Time Frame Day 1, day 22, day 43 and day 387.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 693 683
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1
12
(10 to 15)
10
(8 to 12)
Day 22 (N=681,673)
49
(45 to 52)
32
(28 to 35)
Day 43 (N=673,664)
81
(78 to 84)
63
(59 to 66)
Day 387 (N=658,651)
35
(31 to 39)
16
(13 to 19)
7.Secondary Outcome
Title The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
Hide Description

Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.

Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.

The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%.

Time Frame Day 22, day 43 and day 387
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title High Dose Low Dose
Hide Arm/Group Description:
Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Number of Participants Analyzed 681 673
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 22
36
(32 to 40)
21
(18 to 25)
Day 43 (N=673,664)
74
(70 to 77)
52
(48 to 56)
Day 387 (N=658,651)
23
(20 to 27)
10
(8 to 12)
Time Frame Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387.
Adverse Event Reporting Description

All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment.

Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689

 
Arm/Group Title High Dose Low Dose Total
Hide Arm/Group Description Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart. Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart. Total of subjects in both high and low dose groups.
All-Cause Mortality
High Dose Low Dose Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Low Dose Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/699 (6.15%)   51/689 (7.40%)   94/1388 (6.77%) 
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION * 1  1/699 (0.14%)  1/689 (0.15%)  2/1388 (0.14%) 
ANGINA UNSTABLE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
ATRIAL FIBRILLATION * 1  3/699 (0.43%)  2/689 (0.29%)  5/1388 (0.36%) 
ATRIAL FLUTTER * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
ATRIOVENTRICULAR BLOCK COMPLETE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
CARDIAC FAILURE CONGESTIVE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
CORONARY ARTERY DISEASE * 1  1/699 (0.14%)  2/689 (0.29%)  3/1388 (0.22%) 
MYOCARDIAL INFARCTION * 1  1/699 (0.14%)  1/689 (0.15%)  2/1388 (0.14%) 
PERICARDIAL EFFUSION * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
PERICARDITIS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
SICK SINUS SYNDROME * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
STRESS CARDIOMYOPATHY * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Ear and labyrinth disorders       
VERTIGO POSITIONAL * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
Eye disorders       
CATARACT * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Gastrointestinal disorders       
ABDOMINAL PAIN * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
DUODENAL ULCER HAEMORRHAGE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
DUODENAL ULCER PERFORATION * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
ENTERITIS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
EPIPLOIC APPENDAGITIS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
HAEMORRHOIDS * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
INGUINAL HERNIA * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
INTESTINAL OBSTRUCTION * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
SMALL INTESTINAL OBSTRUCTION * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
UPPER GASTROINTESTINAL HAEMORRHAGE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
General disorders       
CHEST DISCOMFORT * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
CHEST PAIN * 1  1/699 (0.14%)  2/689 (0.29%)  3/1388 (0.22%) 
PYREXIA  1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
Hepatobiliary disorders       
CHOLECYSTITIS * 1  3/699 (0.43%)  0/689 (0.00%)  3/1388 (0.22%) 
Immune system disorders       
DRUG HYPERSENSITIVITY * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Infections and infestations       
ANAL ABSCESS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
DIVERTICULITIS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
MENINGITIS VIRAL * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
PNEUMONIA * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
POST PROCEDURAL INFECTION * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
URINARY TRACT INFECTION * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
WOUND INFECTION * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Injury, poisoning and procedural complications       
ANKLE FRACTURE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
CLAVICLE FRACTURE * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
CONCUSSION * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
FALL * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
HEAD INJURY * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
HUMERUS FRACTURE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
MULTIPLE FRACTURES * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
RIB FRACTURE * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
STERNAL FRACTURE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
TRAUMATIC HAEMOTHORAX * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
WRIST FRACTURE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
Metabolism and nutrition disorders       
DYSLIPIDAEMIA * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
BACK PAIN * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
MUSCULOSKELETAL CHEST PAIN * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
OSTEOARTHRITIS * 1  2/699 (0.29%)  3/689 (0.44%)  5/1388 (0.36%) 
ROTATOR CUFF SYNDROME * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BONE CANCER * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
ENDOMETRIAL ADENOCARCINOMA * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
HEPATIC CANCER * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
LENTIGO MALIGNA * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
LUNG ADENOCARCINOMA * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
LUNG NEOPLASM MALIGNANT * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
MALIGNANT MELANOMA IN SITU * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
MENINGIOMA * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
PROSTATE CANCER * 1  2/699 (0.29%)  2/689 (0.29%)  4/1388 (0.29%) 
Nervous system disorders       
BASAL GANGLIA INFARCTION * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
BRAIN STEM INFARCTION * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
CAROTID ARTERY DISEASE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
CEREBRAL INFARCTION * 1  1/699 (0.14%)  1/689 (0.15%)  2/1388 (0.14%) 
CEREBROVASCULAR ACCIDENT * 1  1/699 (0.14%)  1/689 (0.15%)  2/1388 (0.14%) 
EMBOLIC STROKE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
HEADACHE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
ISCHAEMIC STROKE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
METABOLIC ENCEPHALOPATHY * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
SYNCOPE * 1  0/699 (0.00%)  3/689 (0.44%)  3/1388 (0.22%) 
TRANSIENT ISCHAEMIC ATTACK * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
VIITH NERVE PARALYSIS * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Psychiatric disorders       
GRIEF REACTION * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
SUICIDAL IDEATION * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Renal and urinary disorders       
NEPHROLITHIASIS * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
RENAL COLIC * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
RENAL FAILURE ACUTE * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Reproductive system and breast disorders       
RECTOCELE * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
UTERINE POLYP * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
HYPOXIA * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
PULMONARY EMBOLISM * 1  0/699 (0.00%)  2/689 (0.29%)  2/1388 (0.14%) 
PULMONARY MASS * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Skin and subcutaneous tissue disorders       
ECCHYMOSIS * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
PSORIASIS * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Surgical and medical procedures       
HIP ARTHROPLASTY * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
Vascular disorders       
AORTIC ANEURYSM * 1  1/699 (0.14%)  0/689 (0.00%)  1/1388 (0.07%) 
AORTIC STENOSIS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
HYPERTENSIVE CRISIS * 1  0/699 (0.00%)  1/689 (0.15%)  1/1388 (0.07%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Dose Low Dose Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   481/699 (68.81%)   427/689 (61.97%)   908/1388 (65.42%) 
Gastrointestinal disorders       
NAUSEA  1  48/699 (6.87%)  47/689 (6.82%)  95/1388 (6.84%) 
General disorders       
FATIGUE  1  119/699 (17.02%)  117/689 (16.98%)  236/1388 (17.00%) 
INJECTION SITE PAIN  1  317/699 (45.35%)  210/689 (30.48%)  527/1388 (37.97%) 
MALAISE  1  116/699 (16.60%)  119/689 (17.27%)  235/1388 (16.93%) 
Infections and infestations       
UPPER RESPIRATORY TRACT INFECTION * 1  32/699 (4.58%)  36/689 (5.22%)  68/1388 (4.90%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  87/699 (12.45%)  87/689 (12.63%)  174/1388 (12.54%) 
MYALGIA  1  103/699 (14.74%)  93/689 (13.50%)  196/1388 (14.12%) 
Nervous system disorders       
HEADACHE  1  108/699 (15.45%)  104/689 (15.09%)  212/1388 (15.27%) 
Psychiatric disorders       
EATING DISORDER  1  40/699 (5.72%)  43/689 (6.24%)  83/1388 (5.98%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01766921     History of Changes
Other Study ID Numbers: V89_13
First Submitted: January 10, 2013
First Posted: January 11, 2013
Results First Submitted: May 5, 2015
Results First Posted: August 10, 2015
Last Update Posted: January 30, 2019