Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    H-040-004
Previous Study | Return to List | Next Study

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

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: NCT00441259
Recruitment Status : Completed
First Posted : February 28, 2007
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Sponsor:
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
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
Hide 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
Arm/Group Title ChimeriVax™-JE Mouse Brain Derived Vaccine Total
Hide 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
Hide 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
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
Hide Description [Not Specified]
Time Frame Day 14 up to Day 42 Post-vaccination
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Day 14 up to Day 42 Post-vaccination
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--      --/--    
Hide 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%)    
Hide 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
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
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