PSC26: Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older

• Sponsor: Protein Sciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02464163
• Collaborator: (none)
• Enrollment: 407
• Locations: 9
• Arms: 4
• Actual Duration (Months): 13
• Patients Per Site: 45.2
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Panblok; Biological: rHA adjuvant	Phase 1/Phase 2

Detailed Description

All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.

One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 407 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Phase 1/2 Adaptive Design Trial to Evaluate the Immunogenicity and Safety of Panblok (H7 rHA) at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With Unadjuvanted H7 rHA in Healthy Adults Aged 18 and Older
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panblok 30µg in 2% SE 30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle	Biological: Panblok; Intramuscular injection; Other Names: recombinant hemagglutinin rHA ; Biological: rHA adjuvant; Intramuscular injection; Other Names: SE
Experimental: Panblok 15µg in 2% SE 15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle	Biological: Panblok; Intramuscular injection; Other Names: recombinant hemagglutinin rHA ; Biological: rHA adjuvant; Intramuscular injection; Other Names: SE
Experimental: Panblok 7.5µg in 2% SE 7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle	Biological: Panblok; Intramuscular injection; Other Names: recombinant hemagglutinin rHA ; Biological: rHA adjuvant; Intramuscular injection; Other Names: SE
Experimental: Panblok 30µg (No Adjuvant) 30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle	Biological: Panblok; Intramuscular injection; Other Names: recombinant hemagglutinin rHA

Outcome Measures

Primary Outcome Measures

1. Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. [42 Days]

   The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age.

Secondary Outcome Measures

1. Reactogenicity Immediately After Each Injection, Extending to Day 7 [7 Days]

   Solicited events of local and systemic reactogenicity Days 0-7

2. Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination [13 months]

3. Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine [42 Days]

   Unsolicited adverse events (UAEs) Days 0-42.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Adults, regardless of gender, aged 18 years and above

2. Able to give written informed consent to participate.

3. Body temperature <100.0ºF.

4. The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on medical history.

5. Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.

6. Women are considered not of child-bearing potential if they are:

• Surgically sterile

• Menopausal, defined as no natural menses for ≥12 months

1. Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and remote contacts.

Exclusion Criteria:

1. Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study.

2. Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained.

3. Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses.

4. Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.

5. Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.

6. Persons with a history of documented autoimmune disease.

7. Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization.

8. Persons who have had a prior serious reaction to any influenza vaccine.

9. Persons with a known history of Guillain-Barré Syndrome (GBS).

10. Persons with a history of anaphylactic-type reaction to injected vaccines.

11. Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol.

12. Persons who received a seasonal influenza vaccine < 6 months prior to enrollment (may delay enrollment).

13. Persons who received any licensed inactivated or recombinant (non-live) vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment (may delay enrollment) (See separate exclusion criteria #1 and #12 for seasonal and H5N1 influenza vaccines.)

14. Persons who have had an acute illness or fever (>38º C or >100º F) within three days prior to study enrollment (enrollment may be delayed for full recovery, if acceptable to investigator).

15. Persons currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication) or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.

16. Persons who received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. Persons who expect to receive immunoglobulin or another blood product during the 42-day primary period of this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research	Mobile	Alabama	United States	36608
2	Avail Clinical Research	DeLand	Florida	United States	32720
3	Meridian Clinical Research	Savannah	Georgia	United States	31406
4	Meridian Clinical Research	Omaha	Nebraska	United States	68164
5	Regional Clinical Research, Inc.	Endwell	New York	United States	13760
6	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
7	Benchmark Reseach	Austin	Texas	United States	78705
8	Benchmark Research - Fort Worth	Fort Worth	Texas	United States	76135
9	Jean Brown Research	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Protein Sciences Corporation

Investigators

• Principal Investigator: John J Treanor, MD, University of Rochester Center for Vaccine Studies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Protein Sciences Corporation
• ClinicalTrials.gov Identifier: NCT02464163
• Other Study ID Numbers: PSC26
• First Posted: Jun 8, 2015
• Last Update Posted: Oct 26, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by Protein Sciences Corporation: Influenza
• Additional relevant MeSH terms: Influenza, Human; Hemagglutinins

Study Results

Participant Flow

Arm/Group Title	Panblok 30µg in 2% SE	Panblok 15µg in 2% SE	Panblok 7.5µg in 2% SE	Panblok 30µg (No Adjuvant)
Arm/Group Description	30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection
Period Title: Overall Study
STARTED	102	102	102	101
COMPLETED	99	94	97	96
NOT COMPLETED	3	8	5	5

Baseline Characteristics

Arm/Group Title	Panblok 7.5µg in 2% SE	Panblok 15µg in 2% SE	Panblok 30µg in 2% SE	Panblok 30µg (No Adjuvant)	Total
Arm/Group Description	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection	Total of all reporting groups
Overall Participants	95	94	99	94	382
Age, Customized (Count of Participants)
<65 Years	45 47.4%	45 47.9%	49 49.5%	42 44.7%	181 47.4%
>=65 Years	50 52.6%	49 52.1%	50 50.5%	52 55.3%	201 52.6%
Sex: Female, Male (Count of Participants)
Female	62 65.3%	54 57.4%	56 56.6%	61 64.9%	233 61%
Male	33 34.7%	40 42.6%	43 43.4%	33 35.1%	149 39%

Outcome Measures

1. Primary Outcome

Title	Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
Description	The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age.
Time Frame	42 Days

Outcome Measure Data

Analysis Population Description

Modified Per Protocol Population

Arm/Group Title	Panblok 7.5µg in 2% SE	Panblok 15µg in 2% SE	Panblok 30µg in 2% SE	Panblok 30µg (No Adjuvant)
Arm/Group Description	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection
Measure Participants	95	94	99	94
Count of Participants [Participants]	11 11.6%	9 9.6%	15 15.2%	1 1.1%

2. Secondary Outcome

Title	Reactogenicity Immediately After Each Injection, Extending to Day 7
Description	Solicited events of local and systemic reactogenicity Days 0-7
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Reactogenicity Population

Arm/Group Title	Panblok 7.5µg in 2% SE	Panblok 15µg in 2% SE	Panblok 30µg in 2% SE	Panblok 30µg (No Adjuvant)
Arm/Group Description	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection
Measure Participants	100	101	101	97
7 Days After First Vaccination	37 38.9%	33 35.1%	33 33.3%	27 28.7%
7 Days After Second Vaccination	30 31.6%	30 31.9%	26 26.3%	18 19.1%

3. Secondary Outcome

Title	Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Time Frame	13 months

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Panblok 7.5µg in 2% SE	Panblok 15µg in 2% SE	Panblok 30µg in 2% SE	Panblok 30µg (No Adjuvant)
Arm/Group Description	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection
Measure Participants	100	101	102	97
Angina unstable	0 0%	0 0%	1 1%	0 0%
Myocardial infarction	0 0%	0 0%	0 0%	1 1.1%
Sinus bradycardia	0 0%	0 0%	1 1%	0 0%
Chest pain	0 0%	0 0%	1 1%	0 0%
Appendicitis	1 1.1%	0 0%	0 0%	0 0%
Cellulitis	0 0%	1 1.1%	0 0%	0 0%
Rib fracture	1 1.1%	0 0%	0 0%	0 0%
Upper limb fracture	0 0%	0 0%	0 0%	1 1.1%
Arthralgia	1 1.1%	0 0%	0 0%	0 0%
Fracture malunion	0 0%	1 1.1%	0 0%	0 0%
Musculoskeletal pain	1 1.1%	0 0%	0 0%	0 0%
Osteoarthritis	2 2.1%	0 0%	0 0%	0 0%
Osteolysis	0 0%	1 1.1%	0 0%	0 0%
Cervicobrachial syndrome	1 1.1%	0 0%	0 0%	0 0%
Syncope	0 0%	0 0%	1 1%	0 0%
VIIth nerve paralysis	1 1.1%	0 0%	0 0%	0 0%
Suicide attempt	0 0%	1 1.1%	0 0%	0 0%
Peripheral arterial occlusive disease	0 0%	0 0%	1 1%	0 0%

4. Secondary Outcome

Title	Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Description	Unsolicited adverse events (UAEs) Days 0-42.
Time Frame	42 Days

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Panblok 7.5µg in 2% SE	Panblok 15µg in 2% SE	Panblok 30µg in 2% SE	Panblok 30µg (No Adjuvant)
Arm/Group Description	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection	30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection
Measure Participants	100	101	102	97
Cardiac disorders	0 0%	0 0%	1 1%	0 0%
Ear and labyrinth disorders	1 1.1%	0 0%	0 0%	0 0%
Endocrine disorders	0 0%	2 2.1%	0 0%	0 0%
Eye disorders	0 0%	0 0%	1 1%	0 0%
Gastrointestinal disorders	5 5.3%	2 2.1%	2 2%	4 4.3%
General disorders	4 4.2%	2 2.1%	1 1%	2 2.1%
Immune system disorders	1 1.1%	0 0%	0 0%	0 0%
Infections and infestations	6 6.3%	6 6.4%	4 4%	0 0%
Injury, poisoning and procedural complications	3 3.2%	3 3.2%	2 2%	0 0%
Investigations	0 0%	2 2.1%	0 0%	0 0%
Metabolism and nutrition disorders	1 1.1%	1 1.1%	0 0%	0 0%
Musculoskeletal and connective tissue disorders	4 4.2%	2 2.1%	5 5.1%	1 1.1%
Neoplasms benign, malignant and unspecified	1 1.1%	2 2.1%	0 0%	0 0%
Nervous system disorders	3 3.2%	2 2.1%	5 5.1%	1 1.1%
Psychiatric disorders	0 0%	0 0%	0 0%	1 1.1%
Reproductive system and breast disorders	0 0%	1 1.1%	0 0%	0 0%
Respiratory, thoracic and mediastinal disorders	6 6.3%	2 2.1%	1 1%	1 1.1%
Skin and subcutaneous tissue disorders	1 1.1%	0 0%	2 2%	1 1.1%
Vascular disorders	0 0%	1 1.1%	0 0%	1 1.1%

Adverse Events

Time Frame	Day 0 to Week 55
Arm/Group Title	Panblok 7.5µg in 2% SE		Panblok 15µg in 2% SE		Panblok 30µg in 2% SE		Panblok 30µg (No Adjuvant)
Arm/Group Description	7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection		15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection		30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection rHA adjuvant: Intramuscular injection		30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Panblok: Intramuscular injection
All Cause Mortality
	Panblok 7.5µg in 2% SE		Panblok 15µg in 2% SE		Panblok 30µg in 2% SE		Panblok 30µg (No Adjuvant)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/101 (0%)		0/102 (0%)		1/97 (1%)
Serious Adverse Events
	Panblok 7.5µg in 2% SE		Panblok 15µg in 2% SE		Panblok 30µg in 2% SE		Panblok 30µg (No Adjuvant)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/100 (4%)		4/101 (4%)		3/102 (2.9%)		2/97 (2.1%)
Cardiac disorders
Angina unstable	0/100 (0%)		0/101 (0%)		1/102 (1%)		0/97 (0%)
Myocardial infarction	0/100 (0%)		0/101 (0%)		0/102 (0%)		1/97 (1%)
Sinus bradycardia	0/100 (0%)		0/101 (0%)		1/102 (1%)		0/97 (0%)
General disorders
Chest pain	0/100 (0%)		0/101 (0%)		1/102 (1%)		0/97 (0%)
Infections and infestations
Cellulitis	0/100 (0%)		1/101 (1%)		0/102 (0%)		0/97 (0%)
Appendicitis	1/100 (1%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
Injury, poisoning and procedural complications
Rib fracture	1/100 (1%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
Upper limb fracture	0/100 (0%)		0/101 (0%)		0/102 (0%)		1/97 (1%)
Musculoskeletal and connective tissue disorders
Fracture malunion	0/100 (0%)		1/101 (1%)		0/102 (0%)		0/97 (0%)
Arthralgia	1/100 (1%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
Musculoskeletal pain	1/100 (1%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
Osteoarthritis	2/100 (2%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
Osteolysis	0/100 (0%)		1/101 (1%)		0/102 (0%)		0/97 (0%)
Nervous system disorders
Syncope	0/100 (0%)		0/101 (0%)		1/102 (1%)		0/97 (0%)
Cervicobrachial syndrome	1/100 (1%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
VIIth nerve paralysis	1/100 (1%)		0/101 (0%)		0/102 (0%)		0/97 (0%)
Psychiatric disorders
Suicide attempt	0/100 (0%)		1/101 (1%)		0/102 (0%)		0/97 (0%)
Vascular disorders
Peripheral arterial occlusive disease	0/100 (0%)		0/101 (0%)		1/102 (1%)		0/97 (0%)
Other (Not Including Serious) Adverse Events
	Panblok 7.5µg in 2% SE		Panblok 15µg in 2% SE		Panblok 30µg in 2% SE		Panblok 30µg (No Adjuvant)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/101 (0%)		0/102 (0%)		0/97 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.