A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT00735475
Collaborator
(none)
1,268
13
2
8
97.5
12.2
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1268 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Afluria®
|
Biological: CSL Limited Influenza Virus Vaccine (Afluria®)
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
|
| Active Comparator: Fluzone®
|
Biological: US Licensed Influenza Virus Vaccine (Fluzone®)
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Titer 21 Days After the Study Vaccination [21 days after vaccination]
- Percentage of Participants With Seroconversion 21 Days After the Study Vaccination [21 days after vaccination]
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Secondary Outcome Measures
- Frequency and Intensity of Local and Systemic Solicited Symptoms [5 days after vaccination]
- Duration of Local and Systemic Solicited Symptoms [5 days after vaccination]
- Frequency and Intensity of Unsolicited Adverse Events (UAEs) [21 days after vaccination]
Abbreviation UAE stands for Unsolicited Adverse Event.
- Serious Adverse Events [180 days after vaccination]
- New Onsets of Chronic Illness [180 days after vaccination]
A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
-
Written informed consent ;
-
Willingness to provide a blood sample.
Exclusion Criteria:
-
Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
-
Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
-
Known history of Guillain-Barré Syndrome;
-
Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
-
Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
-
History of seizures;
-
Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
-
Clinically significant history of malignancy
-
Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
-
Current immunosuppressive or immunomodulative therapy;
-
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
-
Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
-
Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
-
Current treatment with warfarin or other anticoagulants;
-
Major congenital defects;
-
Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
-
Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
-
History of psychiatric disorders;
-
Resident of long term care facility.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Central Arkansas Medical Association | Mountain Home | Arkansas | United States | 72635 |
| 2 | Covance CRU, Inc | Boise | Idaho | United States | 83704 |
| 3 | The University of Iowa | Iowa City | Iowa | United States | 52242 |
| 4 | Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | United States | 40004 |
| 5 | Saint Louis University Medical Center | Saint Louis | Missouri | United States | 63104 |
| 6 | University of Rochester School of Medicine and Dentistry | Rochester | New York | United States | 14642 |
| 7 | Duke University Medical Center | Durham | North Carolina | United States | 27704 |
| 8 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 9 | Covance CRU, Inc. | Portland | Oregon | United States | 97239 |
| 10 | Primary Physicians Research, Inc. | Pittsburgh | Pennsylvania | United States | 15241 |
| 11 | Clinical Partners, LLC | Johnston | Rhode Island | United States | 02919 |
| 12 | Vanderbilt Medical Center | Nashville | Tennessee | United States | 37232 |
| 13 | Covance CRU Inc. | Austin | Texas | United States | 78752 |
Sponsors and Collaborators
- Seqirus
Investigators
- Study Director: Clinical Director Vaccines, Seqirus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00735475
Other Study ID Numbers:
- CSLCT-USF-07-41
First Posted:
Aug 15, 2008
Last Update Posted:
May 23, 2018
Last Verified:
Apr 1, 2018
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Period Title: Overall Study | ||
| STARTED | 631 | 637 |
| COMPLETED | 623 | 626 |
| NOT COMPLETED | 8 | 11 |
Baseline Characteristics
| Arm/Group Title | Afluria® Group | Fluzone® Group | Total |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. | Total of all reporting groups |
| Overall Participants | 630 | 636 | 1266 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
630
100%
|
636
100%
|
1266
100%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
71.7
(5.56)
|
71.7
(5.53)
|
71.7
(5.54)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
364
57.8%
|
362
56.9%
|
726
57.3%
|
| Male |
266
42.2%
|
274
43.1%
|
540
42.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
630
100%
|
636
100%
|
1266
100%
|
Outcome Measures
| Title | Geometric Mean Titer 21 Days After the Study Vaccination |
|---|---|
| Description | |
| Time Frame | 21 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication. |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 622 | 630 |
| H1N1 (A/Brisbane/59/2007) |
58.60
|
58.45
|
| H3N2 (A/Uruguay/716/2007) |
377.94
|
337.23
|
| B (B/Florida/4/2006) |
30.16
|
33.31
|
| Title | Percentage of Participants With Seroconversion 21 Days After the Study Vaccination |
|---|---|
| Description | Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination. |
| Time Frame | 21 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication. |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 622 | 630 |
| H1N1 (A/Brisbane/59/2007) |
38.6
6.1%
|
43.2
6.8%
|
| H3N2 (A/Uruguay/716/2007) |
69.0
11%
|
68.7
10.8%
|
| B (B/Florida/4/2006) |
28.9
4.6%
|
33.8
5.3%
|
| Title | Frequency and Intensity of Local and Systemic Solicited Symptoms |
|---|---|
| Description | |
| Time Frame | 5 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data. |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 630 | 636 |
| Any local solicited symptom |
40.2
6.4%
|
35.7
5.6%
|
| Any tenderness |
36.2
5.7%
|
31.4
4.9%
|
| Any pain |
15.1
2.4%
|
13.8
2.2%
|
| Any swelling / induration |
7.1
1.1%
|
7.9
1.2%
|
| Any redness |
3.0
0.5%
|
0.9
0.1%
|
| Any bruising |
0.5
0.1%
|
0.6
0.1%
|
| Any systemic solicited symptom |
17.6
2.8%
|
17.5
2.8%
|
| Any headache |
8.6
1.4%
|
10.5
1.7%
|
| Any myalgia |
9.0
1.4%
|
7.7
1.2%
|
| Any malaise |
6.8
1.1%
|
6.1
1%
|
| Any chills |
2.2
0.3%
|
2.4
0.4%
|
| Any nausea |
1.7
0.3%
|
1.4
0.2%
|
| Any fever |
0.5
0.1%
|
0.6
0.1%
|
| Any vomiting |
0.3
0%
|
0.3
0%
|
| Title | Duration of Local and Systemic Solicited Symptoms |
|---|---|
| Description | |
| Time Frame | 5 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 630 | 636 |
| Any pain |
1.62
(2.094)
|
1.70
(2.288)
|
| Any tenderness |
2.04
(2.147)
|
1.90
(1.450)
|
| Any redness |
1.42
(0.692)
|
2.67
(1.751)
|
| Any swelling / induration |
2.58
(3.031)
|
2.25
(2.028)
|
| Any bruising |
6.50
(8.021)
|
10.50
(9.883)
|
| Any fever |
1
(0)
|
1
(0)
|
| Any headache |
2.08
(3.004)
|
1.70
(1.782)
|
| Any malaise |
1.86
(1.850)
|
2.08
(1.607)
|
| Any myalgia |
2.10
(3.193)
|
2.65
(3.961)
|
| Any chills |
1.40
(0.737)
|
2.29
(4.341)
|
| Any nausea |
1.62
(1.193)
|
1.78
(0.972)
|
| Any vomiting |
1
(0)
|
1
(0)
|
| Title | Frequency and Intensity of Unsolicited Adverse Events (UAEs) |
|---|---|
| Description | Abbreviation UAE stands for Unsolicited Adverse Event. |
| Time Frame | 21 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 630 | 636 |
| Number of participants with at least one UAE |
169
26.8%
|
171
26.9%
|
| Number of participants reported Grade 1 UAE |
77
12.2%
|
68
10.7%
|
| Number of participants reported Grade 2 UAE |
57
9%
|
68
10.7%
|
| Number of participants reported Grade 3 UAE |
35
5.6%
|
35
5.5%
|
| Title | Serious Adverse Events |
|---|---|
| Description | |
| Time Frame | 180 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data. |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 630 | 636 |
| Number of participants with at least one SAE |
22
3.5%
|
26
4.1%
|
| Number of participants with related SAE |
0
0%
|
0
0%
|
| Title | New Onsets of Chronic Illness |
|---|---|
| Description | A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension). |
| Time Frame | 180 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data. |
| Arm/Group Title | Afluria® Group | Fluzone® Group |
|---|---|---|
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. |
| Measure Participants | 630 | 636 |
| Number of participants with at least one NOCI |
14
2.2%
|
11
1.7%
|
| Number of participants with related NOCI |
0
0%
|
0
0%
|
| Neoplasms benign, maligant and unspecified |
2
0.3%
|
3
0.5%
|
| Psychiatric disorders |
1
0.2%
|
3
0.5%
|
| Nervous system disorders |
0
0%
|
1
0.2%
|
| Eye disorders |
1
0.2%
|
0
0%
|
| Cardiac disorders |
2
0.3%
|
0
0%
|
| Vascular disorders |
3
0.5%
|
1
0.2%
|
| Gastrointestinal disorders |
1
0.2%
|
1
0.2%
|
| Hepatobiliary disorders |
1
0.2%
|
0
0%
|
| Musculoskeletal and connective tissue disorders |
2
0.3%
|
2
0.3%
|
| Renal and urinary disorders |
1
0.2%
|
0
0%
|
| Reproductive system and breast disorders |
2
0.3%
|
0
0%
|
Adverse Events
| Time Frame | SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination. | |||
| Arm/Group Title | Afluria® Group | Fluzone® Group | ||
| Arm/Group Description | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. | ||
All Cause Mortality |
||||
| Afluria® Group | Fluzone® Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Afluria® Group | Fluzone® Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/630 (3.5%) | 26/636 (4.1%) | ||
| Blood and lymphatic system disorders | ||||
| Thrombocytopenia | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Cardiac disorders | ||||
| Coronary artery disease | 4/630 (0.6%) | 4 | 1/636 (0.2%) | 1 |
| Acute myocardial infarction | 2/630 (0.3%) | 2 | 2/636 (0.3%) | 2 |
| Myocardial infarction | 0/630 (0%) | 0 | 4/636 (0.6%) | 4 |
| Atrial fibrillation | 3/630 (0.5%) | 3 | 0/636 (0%) | 0 |
| Cardiac failure congestive | 2/630 (0.3%) | 3 | 0/636 (0%) | 0 |
| Angina pectoris | 0/630 (0%) | 0 | 2/636 (0.3%) | 2 |
| Angina unstable | 2/630 (0.3%) | 2 | 0/636 (0%) | 0 |
| Bradycardia | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Cardiac arrest | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Left ventricular dysfunction | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Ear and labyrinth disorders | ||||
| Vertigo | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Colitis | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Gastrointestinal haemorrhage | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| General disorders | ||||
| Generalised oedema | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Infections and infestations | ||||
| Pneumonia | 1/630 (0.2%) | 1 | 2/636 (0.3%) | 2 |
| Postoperative wound infection | 1/630 (0.2%) | 1 | 1/636 (0.2%) | 1 |
| Diverticulitis | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Gastroenteritis | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Pneumonia bacterial | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Tracheobronchitis | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/630 (0%) | 0 | 2/636 (0.3%) | 2 |
| Anaemia postoperative | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Contusion | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Facial bones fracture | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Femoral neck fracture | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Hip fracture | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Joint dislocation | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Postoperative ileus | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Pubic rami fracture | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Therapeutic agent toxicity | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/630 (0.2%) | 1 | 1/636 (0.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral disc degeneration | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Musculoskeletal chest pain | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Benign salivary gland neoplasm | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Breast cancer | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Colon cancer | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Lung neoplasm malignant | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Non-samall cell lung cancer | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Non-small cell lung cancer stage IIIA | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Nervous system disorders | ||||
| Intraventricular haemorrhage | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Presyncope | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Syncope | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Transient ischaemic attack | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Renal and urinary disorders | ||||
| Renal failure acute | 3/630 (0.5%) | 3 | 0/636 (0%) | 0 |
| Calculus baddder | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Haematuria | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
| Pulmonary oedema | 0/630 (0%) | 0 | 0/636 (0%) | 0 |
| Respiratory failure | 0/630 (0%) | 0 | 0/636 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Hypertensive crisis | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Hypovolaemic shock | 1/630 (0.2%) | 1 | 0/636 (0%) | 0 |
| Thrombophlebitis superficial | 0/630 (0%) | 0 | 1/636 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Afluria® Group | Fluzone® Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 142/630 (22.5%) | 119/636 (18.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 9/630 (1.4%) | 10 | 8/636 (1.3%) | 9 |
| General disorders | ||||
| Chills | 9/630 (1.4%) | 10 | 3/636 (0.5%) | 3 |
| Infections and infestations | ||||
| Nasopharyngitis | 9/630 (1.4%) | 9 | 17/636 (2.7%) | 18 |
| Sinusitis | 5/630 (0.8%) | 5 | 7/636 (1.1%) | 7 |
| Upper respiratory tract infection | 9/630 (1.4%) | 9 | 3/636 (0.5%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 9/630 (1.4%) | 10 | 8/636 (1.3%) | 12 |
| Back pain | 13/630 (2.1%) | 16 | 3/636 (0.5%) | 5 |
| Pain in extremity | 7/630 (1.1%) | 10 | 9/636 (1.4%) | 9 |
| Arthralgia | 6/630 (1%) | 9 | 8/636 (1.3%) | 14 |
| Nervous system disorders | ||||
| Headache | 33/630 (5.2%) | 43 | 22/636 (3.5%) | 27 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 8/630 (1.3%) | 8 | 16/636 (2.5%) | 16 |
| Oropharyngeal pain | 14/630 (2.2%) | 17 | 8/636 (1.3%) | 8 |
| Rhinorrhea | 11/630 (1.7%) | 13 | 7/636 (1.1%) | 7 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Study Disclosure Manager |
|---|---|
| Organization | Seqirus |
| Phone | 1-855-358-8966 |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT00735475
Other Study ID Numbers:
- CSLCT-USF-07-41
First Posted:
Aug 15, 2008
Last Update Posted:
May 23, 2018
Last Verified:
Apr 1, 2018