Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02492165
• Collaborator: National Institute of Hygiene and Epidemiology, Vietnam (Other)
• Enrollment: 250
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 20.8

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations.

Primary objective:

• To describe the safety profile of a single dose of IMOJEV®.

Secondary objectives:

• To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Condition or Disease	Intervention/Treatment	Phase
Japanese Encephalitis	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)	Phase 3

Detailed Description

Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Age 9 Months through 4 Years Group Participants age 9 Months through 4 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®
Experimental: Age 5 Years through 11 Years Group Participants age 5 Years through 11 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®
Experimental: Age 12 Years through 17 Years Group Participants age 12 Years through 17 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®
Experimental: Age 18 Years through 60 Years Group Participants age 18 Years through 60 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Day 0 up to Day 14 post-vaccination]

   Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years). Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.

2. Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Day 0 (pre-vaccination) and Day 28 post-vaccination]

   Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).

3. Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Day 0 (pre-vaccination) and Day 28 post-vaccination]

   Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.

4. Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [Day 0 (pre-vaccination) and Day 28 post-vaccination]

   Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Months to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 9 months through 60 years on the day of inclusion.

• For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Institution Ethics Committee / Institution Review Board requirements and as appropriate for the age of the subject, the subject may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years.

• Subject and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria:

• Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).

• Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.

• Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine

• Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE), dengue, and yellow fever.

• Receipt of immune globulins, blood, or blood-derived products in the past 3 months that might interfere with the assessment of the immune response.

• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (for more than 2 consecutive weeks within the 4 weeks preceding vaccination).

• History of flavivirus infection (confirmed either clinically, serologically, or virologically).

• History of central nervous system disorder or disease, including seizures.

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.

• Known thrombocytopenia, contraindicating vaccination.

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination.

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

• Current alcohol abuse or drug addiction.

• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.

• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.

• Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or planned receipt of any anti-viral in the 4 weeks following the study vaccination. Short-term antiviral drugs for flu or herpes can be administered provided there is a wash-out period of 1 week before the administration of the vaccine.

• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Preventive Medicine Centre of Hoa Binh Province	Hoa Binh		Vietnam

Sponsors and Collaborators

• Sanofi Pasteur, a Sanofi Company
• National Institute of Hygiene and Epidemiology, Vietnam

Investigators

• Study Director: Medical Director, Sanofi Pasteur SA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT02492165
• Other Study ID Numbers: JEC13; U1111-1143-8142; NCT02821221
• First Posted: Jul 8, 2015
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Sanofi Pasteur, a Sanofi Company: Japanese Encephalitis; Japanese encephalitis chimeric virus vaccine; IMOJEV®; Live attenuated vaccine
• Additional relevant MeSH terms: Encephalitis, Japanese; Encephalitis; Vaccines

Study Results

Participant Flow

Recruitment Details	Study participants were enrolled from 27 June 2015 to 24 August 2015 at 1 clinic center in Vietnam.
Pre-assignment Detail	A total of 250 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.

Arm/Group Title	9 Months to 4 Years	5 to 11 Years	12 to 17 Years	18 to 60 Years
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Period Title: Overall Study
STARTED	100	60	60	30
COMPLETED	100	59	60	30
NOT COMPLETED	0	1	0	0

Baseline Characteristics

Arm/Group Title	9 Months to 4 Years	5 to 11 Years	12 to 17 Years	18 to 60 Years	Total
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Total of all reporting groups
Overall Participants	100	60	60	30	250
Age (Count of Participants)
<=18 years	100 100%	60 100%	60 100%	0 0%	220 88%
Between 18 and 65 years	0 0%	0 0%	0 0%	30 100%	30 12%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Age Continuous	0.7 (0.6)	8.7 (1.5)	13.9 (1.4)	38.7 (10.0)	15.75 (3.375)
Sex: Female, Male (Count of Participants)
Female	46 46%	31 51.7%	42 70%	22 73.3%	141 56.4%
Male	54 54%	29 48.3%	18 30%	8 26.7%	109 43.6%
Region of Enrollment (Number) [Number]
Vietnam	100 100%	60 100%	60 100%	30 100%	250 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Description	Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years). Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Time Frame	Day 0 up to Day 14 post-vaccination

Outcome Measure Data

Analysis Population Description

Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.

Arm/Group Title	9 Months to 4 Years	5 to 11 Years	12 to 17 Years	18 to 60 Years
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Measure Participants	100	60	60	30
Injection-site Tenderness/Pain	35 35%	8 13.3%	11 18.3%	8 26.7%
Grade 3 Injection-site Tenderness/Pain	0 0%	0 0%	0 0%	0 0%
Injection-site Erythema	6 6%	3 5%	0 0%	0 0%
Grade 3 Injection-site Erythema	0 0%	0 0%	0 0%	0 0%
Injection-site Swelling	1 1%	1 1.7%	0 0%	0 0%
Grade 3 Injection-site Swelling	0 0%	0 0%	0 0%	0 0%
Fever	14 14%	0 0%	0 0%	0 0%
Grade 3 Fever	2 2%	1 1.7%	0 0%	0 0%
Vomiting	12 12%	NA NaN	NA NaN	NA NaN
Grade 3 Vomiting	0 0%	NA NaN	NA NaN	NA NaN
Crying abnormal	20 20%	NA NaN	NA NaN	NA NaN
Grade 3 Crying abnormal	0 0%	NA NaN	NA NaN	NA NaN
Drowsiness	12 12%	NA NaN	NA NaN	NA NaN
Grade 3 Drowsiness	0 0%	NA NaN	NA NaN	NA NaN
Appetite loss	38 38%	NA NaN	NA NaN	NA NaN
Grade 3 Appetite loss	1 1%	NA NaN	NA NaN	NA NaN
Irritability	21 21%	NA NaN	NA NaN	NA NaN
Grade 3 Irritability	0 0%	NA NaN	NA NaN	NA NaN
Headache	NA NaN	9 15%	14 23.3%	10 33.3%
Grade 3 Headache	NA NaN	0 0%	0 0%	0 0%
Malaise	1 1%	8 13.3%	16 26.7%	9 30%
Grade 3 Malaise	0 0%	0 0%	0 0%	0 0%
Myalgia	0 0%	5 8.3%	9 15%	5 16.7%
Grade 3 Myalgia	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Description	Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroprotection was assessed in the Per-Protocol Analysis Set.

Arm/Group Title	9 Months to 4 Years	5 to 11 Years	12 to 17 Years	18 to 60 Years
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Measure Participants	76	60	19	5
Pre-vaccination (Day 0)	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Post-vaccination (Day 28)	97.4 97.4%	100.0 166.7%	100.0 166.7%	100.0 333.3%

3. Primary Outcome

Title	Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Description	Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroconversion was assessed in the Per-Protocol Analysis Set.

Arm/Group Title	9 Months to 4 Years	5 to 11 Years	12 to 17 Years	18 to 60 Years
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Measure Participants	76	60	19	5
Number [Percentage of participants]	97.4 97.4%	100.0 166.7%	100.0 166.7%	100.0 333.3%

4. Primary Outcome

Title	Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Description	Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric mean titers were assessed in the Per Protocol Analysis Set.

Arm/Group Title	9 Months to 4 Years	5 to 11 Years	12 to 17 Years	18 to 60 Years
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Measure Participants	76	34	19	5
Pre-vaccination (Day 0)	5.00	5.00	5.00	5.00
Post-vaccination (Day 28)	277	1738	1481	970

Adverse Events

Time Frame	Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Arm/Group Title	9 Months to 4 Years		5 to 11 Years		12 to 17 Years		18 to 60 Years
Arm/Group Description	Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).		Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).		Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).		Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
All Cause Mortality
	9 Months to 4 Years		5 to 11 Years		12 to 17 Years		18 to 60 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	9 Months to 4 Years		5 to 11 Years		12 to 17 Years		18 to 60 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		0/60 (0%)		1/60 (1.7%)		0/30 (0%)
Nervous system disorders
Syncope	0/100 (0%)	0	0/60 (0%)	0	1/60 (1.7%)	1	0/30 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis	1/100 (1%)	1	0/60 (0%)	0	0/60 (0%)	0	0/30 (0%)	0
Other (Not Including Serious) Adverse Events
	9 Months to 4 Years		5 to 11 Years		12 to 17 Years		18 to 60 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/100 (38%)		9/60 (15%)		16/60 (26.7%)		10/30 (33.3%)
Gastrointestinal disorders
Diarrhea	5/100 (5%)	7	0/60 (0%)	0	0/60 (0%)	0	0/30 (0%)	0
Vomiting	12/100 (12%)	12	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
General disorders
Injection site Tenderness/Pain	34/100 (34%)	34	8/60 (13.3%)	8	11/60 (18.3%)	11	8/30 (26.7%)	8
Injection site Erythema	6/100 (6%)	6	3/60 (5%)	3	0/60 (0%)	0	0/30 (0%)	0
Fever	14/100 (14%)	14	7/60 (11.7%)	7	2/60 (3.3%)	2	1/30 (3.3%)	1
Malaise	0/100 (0%)	0	8/60 (13.3%)	8	16/60 (26.7%)	16	9/30 (30%)	9
Metabolism and nutrition disorders
Appetite loss	38/100 (38%)	38	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Myalgia	0/100 (0%)	0	5/60 (8.3%)	5	9/60 (15%)	9	5/30 (16.7%)	5
Nervous system disorders
Drowsiness	12/100 (12%)	12	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
Headache	0/100 (0%)	0	9/60 (15%)	9	14/60 (23.3%)	14	10/30 (33.3%)	10
Psychiatric disorders
Crying abnormal	20/100 (20%)	20	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
Irritability	21/100 (21%)	21	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
Respiratory, thoracic and mediastinal disorders
Cough	7/100 (7%)	7	0/60 (0%)	0	0/60 (0%)	0	0/30 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.