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CompletedNCT00982137Updated Sep 20, 2012Results posted

Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)

A Phase 2 interventional study of Live attenuated Japanese encephalitis virus; Yellow fever virus and Yellow fever virus; Live attenuated Japanese encephalitis virus in Japanese Encephalitis and Yellow Fever, sponsored by Sanofi. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-09-20.

Sponsored by Sanofi · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.

Objectives:

Safety:

  • Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever (YF) vaccination.

Immunogenicity:

  • Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers without prior JE (or YF) vaccination.
  • Assess the durability of the immune response in adult volunteers 6 months after administration of ChimeriVax™-JE and STAMARIL®.
Read the detailed description

All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.

02

Conditions studied

  • Japanese Encephalitis
  • Yellow Fever

Keywords

  • Japanese Encephalitis
  • Yellow Fever
  • ChimeriVax™-JE
  • STAMARIL®
  • Adult
03

In context

Encephalitis, Japanese

77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.

This study's enrollment of 108 is below the median of 278 across 69 interventional studies indexed under Encephalitis, Japanese.

Browse Encephalitis, Japanese studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All aspects of the protocol explained and written informed consent obtained from the participant.
  • Aged ≥ 18 to ≤ 55 years at Day 0.
  • In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
  • Participant must be available for the study duration, including all planned follow-up visits.
  • The participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination: (a) wear long-sleeved shirts and trousers; (b) apply N,N-Diethyl-meta-toluamide (DEET)-containing insect repellents; (c) sleep in screened enclosures.
  • Female participants of childbearing potential must have a negative serum pregnancy test. An efficacious hormonal method (i.e., oral, implantable or injectable) of contraception or an intrauterine contraceptive device (IUCD) must be used at least 1 month before Screening and at least 1 month after Day 60. These participants will sign an agreement that contraception will be practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation or hysterectomy).

Exclusion criteria

Exclusion Criteria :

  • A history of flavivirus infection or vaccination to Japanese encephalitis (JE) or yellow fever (YF). Previous vaccination will be determined by history (interview of subject) and/or by reviewing the participant's vaccination card or other official documentation (either a history of or documentation of vaccination fulfils the criterion for exclusion).
  • Impaired immunity, including known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (including corticosteroids > 10 mg prednisone, or equivalent, for more than 14 days in the last three months).
  • Clinically significant abnormal laboratory assessment results.
  • Serious adverse reactions characterised by urticaria or angioedema to a prior vaccine, chicken or eggs or egg protein.
  • Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin, within six months of the Screening Visit or up to Day 60.
  • Administration of another vaccine within 28 days of receiving study vaccination.
  • Physical examination indicating any clinically significant medical condition including any short-lived or long-standing illness which has become more severe.
  • Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to inoculation (participant may be rescheduled).
  • Intention to travel out of the area prior to the study visit on Day 60.
  • Seropositive to hepatitis C virus (HCV) or HIV or positive for hepatitis B virus (HBV) (antigen).
  • Lactation or intended pregnancy in female participants.
  • Excessive alcohol consumption, drug abuse, significant psychiatric illness.
  • A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g., significant hypertensive cerebrovascular disease, trauma, ischaemia, infection, inflammation of the brain).
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    ChimeriVax™-JE then STAMARIL®

    Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30

    Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus

  • Experimental
    STAMARIL® then ChimeriVax™-JE

    Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30

    Biological: Yellow fever virus; Live attenuated Japanese encephalitis virus

  • Experimental
    ChimeriVax™-JE and STAMARIL®, then Diluent

    Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30.

    Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus

  • Experimental
    Diluent then ChimeriVax™-JE and STAMARIL®

    Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30.

    Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus

Interventions

  • BiologicalLive attenuated Japanese encephalitis virus; Yellow fever virus

    ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.

    Also known as: ChimeriVax-JE, STAMARIL®

  • BiologicalYellow fever virus; Live attenuated Japanese encephalitis virus

    STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.

    Also known as: STAMARIL®, ChimeriVax™-JE

  • BiologicalLive attenuated Japanese encephalitis virus; Yellow fever virus

    ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.

    Also known as: ChimeriVax™-JE, STAMARIL®

  • BiologicalLive attenuated Japanese encephalitis virus; Yellow fever virus

    Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.

    Also known as: ChimeriVax™-JE, STAMARIL®

06

What researchers measure

Primary outcomes

  1. Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.

    Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

    Time frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

  2. Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.

    Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

    Time frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

  3. Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination

    Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.

    Time frame: Day 0 (Pre-vaccination) through Day 30 post-vaccination

  4. Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo

    Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.

    Time frame: Day 0 up to Day 60 post-vaccination

Secondary outcomes

  1. Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.

    Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)

    Time frame: Day 0 through 6 months post-vaccination

  2. Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo

    Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test. Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

    Time frame: Day 0 through 6 months post-vaccination

07

Results

Posted Sep 20, 2012

Participant flow

Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia.

Participant flow — Overall Study
MilestoneChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Started36361818
Completed36351817
Not completed0101
Withdrew: Lost to follow-up0001
Withdrew: Withdrawal by subject0100

Outcome measures

PrimaryNumber of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.

Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Time frame:
Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Reported as:
Number · Participants
Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
ParticipantsChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL, Then DiluentDiluent Then Coadministration With ChimeriVax™-JE and STAMARIL
Day 30 (N = 17, 23, 13, 10)172 (0 to 0)120
Day 60 (N = 17, 23, 13, 10)17211210
30 Days Post-JE Seroconversion (N = 17, 23, 23, 0)172122NA
PrimaryNumber of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.

Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Time frame:
Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Reported as:
Number · Participants
Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.
ParticipantsChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Day 30 (N = 17, 23, 13, 10)023131
Day 60 (N = 17, 23, 13, 10)17231310
Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0)172323NA
SecondaryGeometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.

Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)

Time frame:
Day 0 through 6 months post-vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
TitersChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
15 Days Post-vaccination (N = 17, 23, 13, 10)282.1 (130.8 to 608.3)140.2 (50.9 to 386.3)119.9 (53.6 to 267.9)386.5 (135.1 to 1106.4)
30 Days Post-vaccination (N = 17, 23, 13, 10)1461.6 (632.8 to 3375.8)426.4 (172.3 to 1055.1)221.2 (94.9 to 515.3)611.6 (188.4 to 1986.0)
45 Days Post-vaccination (N = 17, 0, 13, 0)1099.3 (465.9 to 2593.6)NA (NA to NA)146.3 (58.3 to 367.2)NA (NA to NA)
60 Days Post-vaccination (N = 17, 0, 13, 0)687.8 (315.4 to 1499.8)NA (NA to NA)103.1 (43.9 to 242.1)NA (NA to NA)
6 Months Post-vaccination (N = 16, 22, 13, 10)267.5 (122.4 to 584.4)134.0 (59.2 to 303.4)94.6 (37.8 to 236.9)99.9 (56.8 to 175.7)
SecondaryGeometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo

Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test. Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Time frame:
Day 0 through 6 months post-vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo
TitersChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Day 15 Post-vaccination (N = 17, 23, 13, 10)463.1 (156.2 to 1372.8)1080.7 (606.3 to 1926.2)1150.0 (527.3 to 2507.8)2044.1 (768.7 to 5435.2)
Day 30 Post-vaccination (N = 17, 23, 13, 10)3288.5 (1415.4 to 7640.4)3704.6 (2271.4 to 6042.0)1565.6 (897.9 to 2729.9)3054.9 (1230.2 to 7586.3)
Day 45 Post-vaccination (N = 0, 23, 13, 0)NA (NA to NA)2442.5 (1450.5 to 4112.8)974.6 (572.3 to 1659.8)NA (NA to NA)
Day 60 Post-vaccination (N = 0, 23, 13, 0)NA (NA to NA)2175.1 (1223.9 to 3865.4)653.1 (277.2 to 1539.0)NA (NA to NA)
6 Months Post-vaccination (N = 16, 22, 13, 10)2017.5 (842.0 to 4834.3)2058.7 (1302.5 to 3253.8)947.4 (431.3 to 2081.3)1351.8 (534.9 to 3416.4)
PrimaryNumber of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination

Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.

Time frame:
Day 0 (Pre-vaccination) through Day 30 post-vaccination
Reported as:
Number · Participants
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
ParticipantsChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
JE Homologous Virus17211210
Genotype I17211310
Genotype II151699
Genotype III1620910
Genotype IV151559
PrimaryNumber of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo

Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.

Time frame:
Day 0 up to Day 60 post-vaccination
Reported as:
Number · Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo
ParticipantsChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
Injection Site Pain (N = 71, 72, 36, 36)131364
Injection Site Erythema (N = 71, 72, 36, 36)6931
Injection Site Swelling (N = 71, 72, 36, 36)4031
Injection Site Hemorrhage (N = 71, 72, 36, 36)1210
Venipuncture Site Hemorrhage (N = 71, 72, 36, 36)0200
Fatigue (N = 36, 36, 18, 18)1615310
Malaise (N = 36, 36, 18, 18)101226
Pyrexia (N = 36, 36, 18, 18)3403
Chills (N = 36, 36, 18, 18)1412
Headache (N = 36, 36, 18, 18)182068
Dizziness (N = 36, 36, 18, 18)0200
Myalgia (N = 36, 36, 18, 18)71234
Abdominal Pain (N = 36, 36, 18, 18)5423
Diarrhea (N = 36, 36, 18, 18)7223
Nausea (N = 36, 36, 18, 18)3112
Pharyngolaryngeal Pain (N = 36, 36, 18, 18)0201

Adverse events

Collected over Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination.. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ChimeriVax™-JE Then STAMARIL®—0/36 (0%)18/71 (25.4%)
STAMARIL® Then ChimeriVax™-JE—0/36 (0%)20/72 (27.8%)
Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent—0/18 (0%)6/36 (16.7%)
Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®—0/18 (0%)10/36 (27.8%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®
FatigueGeneral disorders16/3615/363/1810/18
HeadacheNervous system disorders18/3620/366/188/18
MalaiseGeneral disorders10/3612/362/186/18
MyalgiaMusculoskeletal and connective tissue disorders7/3612/363/184/18
DiarrheaGastrointestinal disorders7/362/362/183/18
Injection Site PainGeneral disorders13/7113/726/364/36
PyrexiaGeneral disorders3/364/360/183/18
Abdominal PainGastrointestinal disorders5/364/362/183/18
Injection Site ErythemaGeneral disorders6/719/723/361/36
ChillsGeneral disorders1/364/361/182/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®Total
<=18 years00000
Between 18 and 65 years36361818108
>=65 years00000
Age Continuous
Age Continuous(Years)ChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®Total
Mean27.2 ± 9.7123.4 ± 6.9527.5 ± 10.1925.8 ± 8.2625.8 ± 8.77
Sex: Female, Male
Sex: Female, Male(Participants)ChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®Total
Female161310746
Male202381162
Region of Enrollment
Region of Enrollment(Participants)ChimeriVax™-JE Then STAMARIL®STAMARIL® Then ChimeriVax™-JECo-administration of ChimeriVax™-JE and STAMARIL® Then DiluentDiluent Then Coadministration With ChimeriVax-JE and STAMARIL®Total
Australia36361818108
08

Study locations

1 site
  • Herston, Queensland QLD 4006, Australia
09

References and documents

Publications

  • Nasveld PE, Marjason J, Bennett S, Aaskov J, Elliott S, McCarthy K, Kanesa-Thasan N, Feroldi E, Reid M. Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. Hum Vaccin. 2010 Nov;6(11):906-14. doi: 10.4161/hv.6.11.12854. Epub 2010 Nov 1. PubMed 20864814 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00982137
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Sep 22, 2009
Start date
Jul 2004
Primary completion
Apr 2005
Completion
Mar 2007
Results posted
Sep 20, 2012
Last update
Sep 20, 2012

Study contacts

Medical Director
study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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