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Trial record 1 of 1 for:    H-040-007
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Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

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ClinicalTrials.gov Identifier: NCT00981630
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : December 5, 2012
Last Update Posted : December 5, 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: Live attenuated Japanese encephalitis virus
Biological: ChimeriVax™ diluent (Placebo)
Enrollment 128
Recruitment Details Participants were enrolled from 01 December 2004 to 31 January 2005 at 2 clinical centers in Australia.
Pre-assignment Details A total of 128 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0. All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0. All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0 All participants received a single dose of Placebo (diluent) on Day 0.
Period Title: Overall Study
Started 32 32 32 32
Completed 32 32 32 32
Not Completed 0 0 0 0
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo Total
Hide Arm/Group Description All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0. All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0. All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0 All participants received a single dose of Placebo (diluent) on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 32 32 32 32 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 32 participants 32 participants 128 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
 100.0%
32
 100.0%
32
 100.0%
32
 100.0%
128
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 32 participants 32 participants 128 participants
29.3  (7.62) 26.7  (9.17) 27.4  (8.31) 29.4  (8.43) 28.2  (8.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 32 participants 32 participants 128 participants
Female
15
  46.9%
18
  56.3%
15
  46.9%
16
  50.0%
64
  50.0%
Male
17
  53.1%
14
  43.8%
17
  53.1%
16
  50.0%
64
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 32 participants 32 participants 32 participants 32 participants 128 participants
32 32 32 32 128
1.Primary Outcome
Title Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo
Hide Description Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Time Frame Day 11 and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description:
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
All participants received a single dose of Placebo (diluent) on Day 0.
Overall Number of Participants Analyzed 31 32 31 32
Measure Type: Number
Unit of Measure: Participants
Day 11 1 10 8 0
Day 30 31 30 29 1
2.Primary Outcome
Title Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Hide Description Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description:
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
All participants received a single dose of Placebo (diluent) on Day 0.
Overall Number of Participants Analyzed 31 32 31 32
Measure Type: Number
Unit of Measure: Participants
Genotype I 31 28 30 1
Genotype II 25 25 25 0
Genotype III Beijing 31 30 30 1
Genotype III P3 30 29 29 0
Genotype III Nakayama 31 27 27 1
Genotype IV 25 28 26 0
3.Primary Outcome
Title Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Hide Description Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.
Time Frame Day 0 (post-vaccination) up to Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description:
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
All participants received a single dose of Placebo (diluent) on Day 0.
Overall Number of Participants Analyzed 32 32 32 32
Measure Type: Number
Unit of Measure: Participants
Injection Site Pain 1 2 4 2
Injection Site Erythema 2 2 4 0
Injection Site Reaction 1 0 0 1
Injection Site Hemorrhage 0 3 2 1
Injection Site Induration 0 1 0 0
Injection Site Paresthesia 0 1 2 1
Headache 11 9 13 11
Lethargy 0 4 2 2
Fatigue 6 11 7 6
Malaise 4 7 5 2
Feeling Hot 0 2 2 3
Chills 0 2 2 1
Myalgia 2 6 9 2
Arthralgia 0 2 2 0
Nausea 0 6 3 2
Diarrhea 0 1 4 2
Abdominal Pain 0 4 1 1
Pharyngitis 2 3 3 4
Diarrhea Infectious 0 2 0 0
Rhinorrhea 2 1 0 1
Pruritus 0 1 1 2
Neutropenia 4 0 2 0
Leukopenia 2 3 0 0
Lymphadenopathy 0 2 1 1
4.Secondary Outcome
Title Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Hide Description Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.
Time Frame Day 11 and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description:
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
All participants received a single dose of Placebo (diluent) on Day 0.
Overall Number of Participants Analyzed 31 32 31 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 11
5.2
(4.8 to 5.7)
11.4
(7.0 to 18.7)
10.2
(6.3 to 16.5)
5.0
(5.0 to 5.0)
Day 30
1829.6
(916.6 to 3651.9)
2151.5
(994.1 to 4656.8)
1956.5
(913.4 to 4190.9)
5.8
(4.3 to 7.9)
5.Secondary Outcome
Title Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Hide Description The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description:
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
All participants received a single dose of Placebo (diluent) on Day 0.
Overall Number of Participants Analyzed 31 32 31 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Genotype I
208.6
(134.8 to 322.9)
193.0
(109.4 to 340.5)
188.3
(122.1 to 290.6)
5.3
(4.7 to 5.9)
Genotype II
50.9
(33.8 to 76.5)
69.2
(41.4 to 115.7)
49.6
(32.2 to 76.3)
5.0
(5.0 to 5.0)
Genotype III (Beijing)
232.6
(147.0 to 368.1)
162.3
(91.0 to 289.6)
253.4
(152.8 to 420.1)
5.4
(4.7 to 6.2)
Genotype III (P3)
223.6
(147.3 to 339.4)
238.7
(125.7 to 453.2)
315.5
(182.0 to 547.0)
5.3
(4.9 to 5.9)
Genotype III (Nakayama)
192.3
(127.3 to 290.6)
180.6
(95.4 to 341.7)
155.0
(83.6 to 287.3)
5.6
(4.7 to 6.6)
Genotype IV
70.4
(42.4 to 117.1)
80.4
(47.1 to 137.2)
67.1
(41.3 to 108.8)
5.0
(5.0 to 5.0)
6.Secondary Outcome
Title Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Hide Description Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer < 1:10.
Time Frame Day 30 up to 12 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description:
All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
All participants received a single dose of Placebo (diluent) on Day 0.
Overall Number of Participants Analyzed 31 32 31 32
Measure Type: Number
Unit of Measure: Participants
Day 30 [N = 31; 32; 31; 32] 31 30 29 1
Month 6 [N = 31; 30; 28; 32] 30 28 27 0
Month 12 [N = 31; 30; 30; 29] 27 26 29 0
Time Frame Adverse events data were collected from Day 0 (post-vaccination) up to Month 12 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Hide Arm/Group Description All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0. All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0. All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0 All participants received a single dose of Placebo (diluent) on Day 0.
All-Cause Mortality
ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/32 (6.25%)      1/32 (3.13%)      0/32 (0.00%)      2/32 (6.25%)    
Infections and infestations         
Gastroenteritis † 1  0/32 (0.00%)  0 1/32 (3.13%)  1 0/32 (0.00%)  0 0/32 (0.00%)  0
Cellulitis † 1  0/32 (0.00%)  0 0/32 (0.00%)  0 0/32 (0.00%)  0 1/32 (3.13%)  1
Peritonsillar Abscess † 1  1/32 (3.13%)  1 0/32 (0.00%)  0 0/32 (0.00%)  0 0/32 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral Disc Protrusion † 1  0/32 (0.00%)  0 0/32 (0.00%)  0 0/32 (0.00%)  0 1/32 (3.13%)  1
Reproductive system and breast disorders         
Pregnancy † 1  1/32 (3.13%)  1 0/32 (0.00%)  0 0/32 (0.00%)  0 0/32 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 7.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
ChimeriVax™-JE 3 log10 PFU ChimeriVax™-JE 4 log10 PFU ChimeriVax™-JE 5 log10 PFU Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/32 (50.00%)      16/32 (50.00%)      16/32 (50.00%)      17/32 (53.13%)    
Blood and lymphatic system disorders         
Neutropenia † 1  4/32 (12.50%)  0/32 (0.00%)  2/32 (6.25%)  0/32 (0.00%) 
Leukopenia † 1  2/32 (6.25%)  3/32 (9.38%)  0/32 (0.00%)  0/32 (0.00%) 
Lymphadenopathy † 1  0/32 (0.00%)  2/32 (6.25%)  1/32 (3.13%)  1/32 (3.13%) 
Thrombocytopena * 1  2/32 (6.25%)  0/32 (0.00%)  0/32 (0.00%)  1/32 (3.13%) 
Cardiac disorders         
Bradycardia * 1  1/32 (3.13%)  2/32 (6.25%)  1/32 (3.13%)  1/32 (3.13%) 
Gastrointestinal disorders         
Nausea † 1  2/32 (6.25%)  6/32 (18.75%)  3/32 (9.38%)  3/32 (9.38%) 
Diarrhoea † 1  0/32 (0.00%)  2/32 (6.25%)  4/32 (12.50%)  3/32 (9.38%) 
Abdominal Pain † 1  0/32 (0.00%)  6/32 (18.75%)  1/32 (3.13%)  1/32 (3.13%) 
General disorders         
Fatigue † 1  6/32 (18.75%)  16/32 (50.00%)  10/32 (31.25%)  7/32 (21.88%) 
Injection Site Pain † 1  1/32 (3.13%)  2/32 (6.25%)  4/32 (12.50%)  2/32 (6.25%) 
Injection Site Erythema † 1  2/32 (6.25%)  2/32 (6.25%)  4/32 (12.50%)  0/32 (0.00%) 
Injection Site Hemorrhage † 1  0/32 (0.00%)  3/32 (9.38%)  2/32 (6.25%)  1/32 (3.13%) 
Injection Site Paresthesia † 1  0/32 (0.00%)  1/32 (3.13%)  2/32 (6.25%)  1/32 (3.13%) 
Malaise † 1  7/32 (21.88%)  7/32 (21.88%)  6/32 (18.75%)  7/32 (21.88%) 
Feeling Hot † 1  0/32 (0.00%)  2/32 (6.25%)  2/32 (6.25%)  3/32 (9.38%) 
Chills † 1  0/32 (0.00%)  2/32 (6.25%)  2/32 (6.25%)  1/32 (3.13%) 
Infections and infestations         
Pharyngitis † 1  3/32 (9.38%)  3/32 (9.38%)  3/32 (9.38%)  5/32 (15.63%) 
Diarrhea Infectious † 1  0/32 (0.00%)  2/32 (6.25%)  0/32 (0.00%)  0/32 (0.00%) 
Upper respiratory tract infection * 1  1/32 (3.13%)  6/32 (18.75%)  1/32 (3.13%)  3/32 (9.38%) 
Sinusitis * 1  1/32 (3.13%)  2/32 (6.25%)  2/32 (6.25%)  2/32 (6.25%) 
Injury, poisoning and procedural complications         
Muscle strain * 1  2/32 (6.25%)  0/32 (0.00%)  0/32 (0.00%)  0/32 (0.00%) 
Investigations         
Blood creatinine phosphokinase increased * 1  2/32 (6.25%)  2/32 (6.25%)  1/32 (3.13%)  1/32 (3.13%) 
Blood bilirubin increased * 1  0/32 (0.00%)  0/32 (0.00%)  2/32 (6.25%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia † 1  2/32 (6.25%)  6/32 (18.75%)  10/32 (31.25%)  2/32 (6.25%) 
Arthralgia † 1  0/32 (0.00%)  2/32 (6.25%)  2/32 (6.25%)  0/32 (0.00%) 
Nervous system disorders         
Headache † 1  16/32 (50.00%)  16/32 (50.00%)  16/32 (50.00%)  17/32 (53.13%) 
Lethargy † 1  0/32 (0.00%)  4/32 (12.50%)  2/32 (6.25%)  2/32 (6.25%) 
Syncope vasovagal * 1  1/32 (3.13%)  1/32 (3.13%)  1/32 (3.13%)  2/32 (6.25%) 
Reproductive system and breast disorders         
Dysmenorrhoea * 1  3/32 (9.38%)  3/32 (9.38%)  2/32 (6.25%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders         
Rhinorrhea † 1  2/32 (6.25%)  2/32 (6.25%)  0/32 (0.00%)  1/32 (3.13%) 
Nasal congestion * 1  0/32 (0.00%)  1/32 (3.13%)  0/32 (0.00%)  2/32 (6.25%) 
Skin and subcutaneous tissue disorders         
Pruritus † 1  0/32 (0.00%)  1/32 (3.13%)  1/32 (3.13%)  2/32 (6.25%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 7.1
[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: NCT00981630    
Other Study ID Numbers: H-040-007
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: November 6, 2012
Results First Posted: December 5, 2012
Last Update Posted: December 5, 2012