Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

• ClinicalTrials.gov Identifier: NCT00441259
• Recruitment Status: Completed
• First Posted: February 28, 2007
• Results First Posted: August 27, 2012
• Last Update Posted: August 27, 2012
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Japanese Encephalitis
• Interventions: Biological: ChimeriVax™-JE; Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine
• Enrollment: 96

Participant Flow

Recruitment Details	Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.
Pre-assignment Details	A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Period Title: Overall Study
Started	48	48
Completed	48	48
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		ChimeriVax™-JE	Mouse Brain Derived Vaccine	Total
Arm/Group Description		Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.	Total of all reporting groups
Overall Number of Baseline Participants		48	48	96
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	48 participants	96 participants
	<=18 years	48 100.0%	48 100.0%	96 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	48 participants	48 participants	96 participants
		3.8 (2.98)	3.7 (2.89)	3.7 (2.52)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	48 participants	96 participants
	Female	27 56.3%	21 43.8%	48 50.0%
	Male	21 43.8%	27 56.3%	48 50.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
India	Number Analyzed	48 participants	48 participants	96 participants
		48	48	96

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description	[Not Specified]
Time Frame	Day 14 up to Day 42 Post-vaccination

Outcome Measure Data

Analysis Population Description

Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description:	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Overall Number of Participants Analyzed	48	48
Measure Type: Number; Unit of Measure: Participants
Nasopharyngitis (All; N = 48, 48)	2	2
Otitis Media Acute (All; N = 48, 48)	1	0
Diarrhea Infectious (All; N = 48, 48)	1	0
Dysentery (All; N = 48, 48)	1	0
Hepatitis A (All; N = 48, 48)	1	0
Rash Pustular (All; N = 48, 48)	1	0
Tonsillitis (All; N = 48, 48)	1	0
Upper Respiratory Tract Infection (All; N=48, 48)	1	0
Varicella (All; N = 48, 48)	1	0
Impetigo (All; N = 48, 48)	0	1
Pharyngitis (All; N = 48, 48)	0	1
Viral Upper Respiratory Tract Infect. (All;N=48,48	0	1
Diarrhea (All; N = 48, 48)	3	2
Vomiting (All; N = 48, 48)	2	1
Haematochezia (All; N = 48, 48)	1	0
Mucous Stools (All; N = 48, 48)	1	0
Constipation (All; N = 48, 48)	0	1
Rhinorrhea (All; N = 48, 48)	3	3
Cough (All; N = 48, 48)	2	2
Wheezing (All; N = 48, 48)	0	2
Pyrexia (All; N = 48, 48)	2	1
Face Edema (All; N = 48, 48)	1	0
Injection Site Pain (All; N = 48, 48)	1	2
Injection Site Swelling (All; N = 48, 48)	0	1
Malaise (All; N = 48, 48)	1	1
Pain (All; N = 48, 48)	1	0
Irritability (All; N = 48, 48)	0	2
Anorexia (All; N = 48, 48)	2	1
Anemia (All; N = 48, 48)	2	2
Eosinophilia (All; N = 48, 48)	0	1
Lacrimation Increased (All; N = 48, 48)	0	1
Laziness (All; N = 48, 48)	2	1
Erythema (All; N = 48, 48)	1	0
Rash (All; N = 48, 48)	1	0
Injury (All; N = 48, 48)	1	0
Eosinophil Count Increased (All; N = 48, 48)	0	1
Hemoglobin Decreased (All; N = 48, 48)	1	0
Pyrexia (≥5 to <10 yr; N = 16, 16)	2	0
Injection Site Pain (≥5 to <10 yr; N = 16, 16)	1	0
Pain (≥5 to <10 yr; N = 16, 16)	1	0
Upper Respiratory Tract Infection (≥5 to <10 yr;	1	0
Eosinophil Count Increased (≥5 to <10 yr; N=16, 16	0	1
Otitis Media Acute (≥2 to <5 yr: N=16, 16)	1	0
Diarrhea Infectious (≥2 to <5 yr: N=16, 16)	1	0
Hepatitis A (≥2 to <5 yr: N=16, 16)	1	0
Rash Pustular (≥2 to <5 yr: N=16, 16)	1	0
Tonsillitis (≥2 to <5 yr: N=16, 16)	1	0
Varicella (≥2 to <5 yr: N=16, 16)	1	0
Vomiting (≥2 to <5 yr: N=16, 16)	1	0
Injection Site Pain (≥2 to <5 yr: N=16, 16)	0	1
Injection Site Swelling (≥2 to <5 yr: N=16, 16)	0	1
Pyrexia (≥2 to <5 yr: N=16, 16)	0	1
Rhinorrhea (≥2 to <5 yr: N=16, 16)	1	0
Diarrhea (≥9 mo to <2 yr; N = 16, 16)	3	2
Vomiting (≥9 mo to <2 yr; N = 16, 16)	1	1
Haematochezia (≥9 mo to <2 yr; N = 16, 16)	1	0
Mucous Stools (≥9 mo to <2 yr; N = 16, 16)	1	0
Constipation (≥9 mo to <2 yr; N = 16, 16)	0	1
Cough (≥9 mo to <2 yr; N = 16, 16)	2	2
Rhinorrhea (≥9 mo to <2 yr; N = 16, 16)	2	3
Wheezing (≥9 mo to <2 yr; N = 16, 16)	0	2
Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16)	2	2
Dysentery (≥9 mo to <2 yr; N = 16, 16)	1	0
Impetigo (≥9 mo to <2 yr; N = 16, 16)	0	1
Pharyngitis (≥9 mo to <2 yr; N = 16, 16)	0	1
Viral Upper Respiratory Tract Inf (≥9 mo to <2 yr)	0	1
Anorexia (≥9 mo to <2 yr; N = 16, 16)	2	1
Anemia (≥9 mo to <2 yr; N = 16, 16)	2	2
Eosinophilia (≥9 mo to <2 yr; N = 16, 16)	0	1
Irritability (≥9 mo to <2 yr; N = 16, 16)	0	2
Face Edema (≥9 mo to <2 yr; N = 16, 16)	1	0
Malaise (≥9 mo to <2 yr; N = 16, 16)	1	1
Injection Site Pain (≥9 mo to <2 yr; N = 16, 16)	0	1
Laziness (≥9 mo to <2 yr; N = 16, 16)	2	1
Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16)	0	1
Erythema (≥9 mo to <2 yr; N = 16, 16)	1	0
Rash (≥9 mo to <2 yr; N = 16, 16)	1	0
Injury (≥9 mo to <2 yr; N = 16, 16)	1	0
Hemoglobin Decreased (≥9 mo to <2 yr; N = 16, 16)	1	0

2. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description	[Not Specified]
Time Frame	Day 14 up to Day 42 Post-vaccination

Outcome Measure Data

Analysis Population Description

Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description:	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Overall Number of Participants Analyzed	48	48
Measure Type: Number; Unit of Measure: Participants
Nasopharyngitis (All; N = 48, 48)	2	2
Upper Respiratory Tract Infection (All; N =48, 48)	1	0
Impetigo (All; N = 48, 48)	0	1
Pharyngitis (All; N = 48, 48)	0	1
Diarrhea (All; N = 48, 48)	1	2
Vomiting (All; N = 48, 48)	1	1
Hematochezia (All; N = 48, 48)	1	0
Mucous Stools (All; N = 48, 48)	1	0
Rhinorrhea (All; N = 48, 48)	1	3
Cough (All; N = 48, 48)	2	2
Wheezing (All; N = 48, 48)	0	2
Pyrexia (All; N = 48, 48)	2	0
Injection Site Pain (All; N = 48, 48)	1	2
Injection Site Swelling (All; N = 48, 48)	0	1
Malaise (All; N = 48, 48)	1	0
Pain (All; N = 48, 48)	1	0
Irritability (All; N = 48, 48)	0	1
Anorexia (All; N = 48, 48)	1	1
Anemia (All; N = 48, 48)	1	0
Lacrimation Increased (All; N = 48, 48)	0	1
Rash (All; N = 48, 48)	1	0
Pyrexia (≥5 to <10 yr; N = 16, 16)	2	0
Injection Site Pain (≥5 to <10 yr; N = 16, 16)	1	0
Pain (≥5 to <10 yr; N = 16, 16)	1	0
Upper Respiratory Tract Infection (≥5 to <10 yr)	1	0
Injection Site Pain (≥2 to <5 yr; N = 16, 16)	0	1
Injection Site Swelling (≥2 to <5 yr; N = 16, 16)	0	1
Diarrhea (≥9 mo to <2 yr; N = 16, 16)	1	2
Vomiting (≥9 mo to <2 yr; N = 16, 16)	1	1
Hematochezia (≥9 mo to <2 yr; N = 16, 16)	1	0
Mucous Stools (≥9 mo to <2 yr; N = 16, 16)	1	0
Cough (≥9 mo to <2 yr; N = 16, 16)	2	2
Rhinorrhea(≥9 mo to <2 yr; N = 16, 16)	1	3
Wheezing (≥9 mo to <2 yr; N = 16, 16)	0	2
Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16)	2	2
Impetigo (≥9 mo to <2 yr; N = 16, 16)	0	1
Pharyngitis (≥9 mo to <2 yr; N = 16, 16)	0	1
Anorexia (≥9 mo to <2 yr; N = 16, 16)	1	1
Anemia (≥9 mo to <2 yr; N = 16, 16)	1	0
Irritability (≥9 mo to <2 yr; N = 16, 16)	0	1
Malaise (≥9 mo to <2 yr; N = 16, 16)	1	0
Injection Site Pain (≥9 mo to <2 yr; N = 16, 16)	0	1
Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16)	0	1
Rash (≥9 mo to <2 yr; N = 16, 16)	1	0

3. Primary Outcome

Title	Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description	Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Time Frame	Day 42 Post-vaccination

Outcome Measure Data

Analysis Population Description

Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description:	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Overall Number of Participants Analyzed	33	35
Measure Type: Number; Unit of Measure: Participants
Homologous JE-CV virus PRNT (N = 33, 0)	33	NA [1]
Homologous virus Nakayama strain PRNT (N = 0, 35)	NA [2]	8
JE-CV PRNT (N = 33, 35)	33	33
Nakayama PRNT (N = 32, 35)	8	8
Indian WT virus PRNT (N = 33, 35)	27	26

[1]

Homologous JE-CV virus PRNT used for the assessment of the immune response in ChimeriVax™-JE Vaccine recipients only

[2]

Homologous virus Nakayama strain used for the assessment of the immune response in Mouse Brain Derived Vaccine recipients only

4. Primary Outcome

Title	Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description	Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Time Frame	Day 42 Post Dose 1

Outcome Measure Data

Analysis Population Description

Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description:	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Overall Number of Participants Analyzed	34	35
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Homologous JE-CV virus PRNT (N = 34, 0)	313.5; (40 to 5120)	NA [1]; (NA to NA)
Homologous virus Nakayama strain PRNT (N = 0, 35)	NA [2]; (NA to NA)	8.0; (5 to 160)
JE-CV PRNT (N = 34, 35)	313.5; (40 to 5120)	49.7; (5 to 320)
Nakayama PRNT (N = 33, 35)	7.8; (5 to 160)	8.0; (5 to 160)
Indian WT virus PRNT (N = 34, 35)	60.1; (5 to 2560)	17.1; (5 to 320)

[1]

Homologous JE-CV virus PRNT used for the assessment of the immune response in ChimeriVax™-JE Vaccine recipients only

[2]

Homologous virus Nakayama strain used for the assessment of the immune response in Mouse Brain Derived Vaccine recipients.

5. Secondary Outcome

Title	Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description	Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Time Frame	Day 42 Post Dose 1

Outcome Measure Data

Analysis Population Description

Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description:	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Overall Number of Participants Analyzed	34	35
Measure Type: Number; Unit of Measure: Participants
Homologous JE-CV virus PRNT (N = 33, 0)	33	NA [1]
Homologous virus Nakayama strain PRNT (N=0,35)	NA [2]	8
JE-CV Virus (All; N = 33, 35)	33	33
Nakayama Strain (All; N = 32, 35)	8	8
Wild Type Virus (All; N = 33, 35)	27	26
JE-CV Virus (≥5 to <10 yr; N = 12, 13)	12	12
JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13)	6	0
Wild Type Virus (≥5 to <10 yr; N = 12, 13)	12	11
JE-CV Virus (≥2 to <5 yr; N = 8, 9)	8	9
JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9)	1	6
Wild Type Virus (≥2 to <5 yr; N = 8, 9)	2	6
JE-CV Virus (≥9 mo to <2 yr; N = 13, 13)	13	12
JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13)	1	2
Wild Type Virus (≥9 mo to <2 yr; N=13, 13)	13	9

[1]

Homologous JE-CV virus PRNT used for the assessment of the immune response in ChimeriVax™-JE Vaccine recipients only

[2]

Homologous virus Nakayama strain used for the assessment of the immune response in Mouse Brain Derived Vaccine recipients

6. Secondary Outcome

Title	Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description	Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Time Frame	Day 42 Post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.

Arm/Group Title	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Arm/Group Description:	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.	Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Overall Number of Participants Analyzed	34	35
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
JE-CV Virus (All; N = 34, 35)	313.5; (40 to 5120)	49.7; (5 to 320)
JE Nakayama Strain (All; N = 33, 35)	7.8; (5 to 160)	8.0; (5 to 160)
Wild Type Virus (All; N = 34, 35)	60.1; (5 to 2560)	17.1; (5 to 320)
JE-CV Virus (≥5 to <10 yr; N = 12, 13)	226.3; (80 to 5120)	34.1; (5 to 160)
JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13)	13.3; (5 to 160)	5.0; (5 to 5)
Wild Type virus (≥5 to <10 yr; N = 12, 13)	100.8; (10 to 2560)	17.0; (5 to 40)
JE-CV Virus (≥2 to <5 yr; N = 9, 9)	254.0; (80 to 1280)	74.1; (40 to 160)
JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9)	6.3; (5 to 40)	27.2; (5 to 160)
Wild Type Virus (≥2 to <5 yr; N = 9, 9)	9.3; (5 to 40)	17.1; (5 to 80)
JE-CV Virus (≥9 mo to <2 yr; N = 13, 13)	490.2; (40 to 5120)	55.1; (5 to 320)
JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13)	5.3; (5 to 10)	5.6; (5 to 10)
Wild Type Virus (≥9 mo to <2 yr; N = 13, 13)	136.3; (10 to 1280)	17.0; (5 to 320)

Adverse Events

Time Frame	Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	ChimeriVax™-JE		Mouse Brain Derived Vaccine
Arm/Group Description	Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.		Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
All-Cause Mortality
	ChimeriVax™-JE		Mouse Brain Derived Vaccine
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	ChimeriVax™-JE		Mouse Brain Derived Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0.00%)		0/48 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.00%
	ChimeriVax™-JE		Mouse Brain Derived Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/48 (12.50%)		5/48 (10.42%)
Gastrointestinal disorders
Diarrhea * 1	3/48 (6.25%)	3	2/48 (4.17%)	5
Respiratory, thoracic and mediastinal disorders
Rhinorrhea * 1	3/48 (6.25%)	4	3/48 (6.25%)	7
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 9.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

Results Point of Contact

• Name/Title: Medical Director
• Organization: Sanofi Pasteur Inc.
• EMail: RegistryContactUs@sanofipasteur.com

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00441259
• Other Study ID Numbers: H-040-004
• First Submitted: February 27, 2007
• First Posted: February 28, 2007
• Results First Submitted: June 6, 2012
• Results First Posted: August 27, 2012
• Last Update Posted: August 27, 2012