Japanese Encephalitis, Yellow Fever
Conditions
Keywords
Japanese Encephalitis, Yellow Fever, ChimeriVax™-JE, STAMARIL®, Adult
Brief 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®.
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.
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.
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.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
: * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) | 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). |
| 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. | Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) | 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). |
| Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Day 0 (Pre-vaccination) through Day 30 post-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. |
| 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 | Day 0 up to Day 60 post-vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 0 through 6 months post-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) |
| 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 | Day 0 through 6 months post-vaccination | 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). |
Countries
Australia
Participant flow
Recruitment details
Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia.
Pre-assignment details
A total of 108 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| ChimeriVax™-JE Then STAMARIL® All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. | 36 |
| STAMARIL® Then ChimeriVax™-JE All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. | 36 |
| Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. | 18 |
| Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. | 18 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | STAMARIL® Then ChimeriVax™-JE | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | ChimeriVax™-JE Then STAMARIL® | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 18 Participants | 36 Participants | 18 Participants | 108 Participants |
| Age Continuous | 23.4 Years STANDARD_DEVIATION 6.95 | 27.5 Years STANDARD_DEVIATION 10.19 | 27.2 Years STANDARD_DEVIATION 9.71 | 25.8 Years STANDARD_DEVIATION 8.26 | 25.8 Years STANDARD_DEVIATION 8.77 |
| Region of Enrollment Australia | 36 Participants | 18 Participants | 36 Participants | 18 Participants | 108 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 16 Participants | 7 Participants | 46 Participants |
| Sex: Female, Male Male | 23 Participants | 8 Participants | 20 Participants | 11 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 71 | 20 / 72 | 6 / 36 | 10 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 18 | 0 / 18 |
Outcome results
Primary
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
Population: Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Then STAMARIL® | 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 | Venipuncture Site Hemorrhage (N = 71, 72, 36, 36) | 0 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Injection Site Erythema (N = 71, 72, 36, 36) | 6 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Injection Site Swelling (N = 71, 72, 36, 36) | 4 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Injection Site Hemorrhage (N = 71, 72, 36, 36) | 1 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Injection Site Pain (N = 71, 72, 36, 36) | 13 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Fatigue (N = 36, 36, 18, 18) | 16 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Malaise (N = 36, 36, 18, 18) | 10 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Pyrexia (N = 36, 36, 18, 18) | 3 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Chills (N = 36, 36, 18, 18) | 1 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Headache (N = 36, 36, 18, 18) | 18 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Dizziness (N = 36, 36, 18, 18) | 0 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Myalgia (N = 36, 36, 18, 18) | 7 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Abdominal Pain (N = 36, 36, 18, 18) | 5 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Diarrhea (N = 36, 36, 18, 18) | 7 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Nausea (N = 36, 36, 18, 18) | 3 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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 | Pharyngolaryngeal Pain (N = 36, 36, 18, 18) | 0 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Fatigue (N = 36, 36, 18, 18) | 15 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Chills (N = 36, 36, 18, 18) | 4 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Pharyngolaryngeal Pain (N = 36, 36, 18, 18) | 2 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Myalgia (N = 36, 36, 18, 18) | 12 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Nausea (N = 36, 36, 18, 18) | 1 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Headache (N = 36, 36, 18, 18) | 20 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Injection Site Swelling (N = 71, 72, 36, 36) | 0 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Dizziness (N = 36, 36, 18, 18) | 2 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Venipuncture Site Hemorrhage (N = 71, 72, 36, 36) | 2 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Malaise (N = 36, 36, 18, 18) | 12 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Injection Site Hemorrhage (N = 71, 72, 36, 36) | 2 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Injection Site Erythema (N = 71, 72, 36, 36) | 9 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Abdominal Pain (N = 36, 36, 18, 18) | 4 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Pyrexia (N = 36, 36, 18, 18) | 4 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Diarrhea (N = 36, 36, 18, 18) | 2 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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 | Injection Site Pain (N = 71, 72, 36, 36) | 13 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Fatigue (N = 36, 36, 18, 18) | 3 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Venipuncture Site Hemorrhage (N = 71, 72, 36, 36) | 0 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Diarrhea (N = 36, 36, 18, 18) | 2 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Malaise (N = 36, 36, 18, 18) | 2 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Pyrexia (N = 36, 36, 18, 18) | 0 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Pharyngolaryngeal Pain (N = 36, 36, 18, 18) | 0 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Chills (N = 36, 36, 18, 18) | 1 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Headache (N = 36, 36, 18, 18) | 6 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Nausea (N = 36, 36, 18, 18) | 1 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Dizziness (N = 36, 36, 18, 18) | 0 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Myalgia (N = 36, 36, 18, 18) | 3 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Injection Site Pain (N = 71, 72, 36, 36) | 6 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Injection Site Erythema (N = 71, 72, 36, 36) | 3 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Abdominal Pain (N = 36, 36, 18, 18) | 2 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Injection Site Swelling (N = 71, 72, 36, 36) | 3 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Injection Site Hemorrhage (N = 71, 72, 36, 36) | 1 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Pharyngolaryngeal Pain (N = 36, 36, 18, 18) | 1 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Pyrexia (N = 36, 36, 18, 18) | 3 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Injection Site Swelling (N = 71, 72, 36, 36) | 1 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Injection Site Pain (N = 71, 72, 36, 36) | 4 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Diarrhea (N = 36, 36, 18, 18) | 3 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Malaise (N = 36, 36, 18, 18) | 6 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Abdominal Pain (N = 36, 36, 18, 18) | 3 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Injection Site Erythema (N = 71, 72, 36, 36) | 1 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Venipuncture Site Hemorrhage (N = 71, 72, 36, 36) | 0 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Headache (N = 36, 36, 18, 18) | 8 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Fatigue (N = 36, 36, 18, 18) | 10 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Dizziness (N = 36, 36, 18, 18) | 0 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Nausea (N = 36, 36, 18, 18) | 2 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Chills (N = 36, 36, 18, 18) | 2 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Injection Site Hemorrhage (N = 71, 72, 36, 36) | 0 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Myalgia (N = 36, 36, 18, 18) | 4 Participants |
Primary
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
Population: Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Then STAMARIL® | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype III | 16 Participants |
| ChimeriVax™-JE Then STAMARIL® | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype I | 17 Participants |
| ChimeriVax™-JE Then STAMARIL® | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | JE Homologous Virus | 17 Participants |
| ChimeriVax™-JE Then STAMARIL® | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype IV | 15 Participants |
| ChimeriVax™-JE Then STAMARIL® | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype II | 15 Participants |
| STAMARIL® Then ChimeriVax™-JE | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype IV | 15 Participants |
| STAMARIL® Then ChimeriVax™-JE | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | JE Homologous Virus | 21 Participants |
| STAMARIL® Then ChimeriVax™-JE | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype III | 20 Participants |
| STAMARIL® Then ChimeriVax™-JE | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype II | 16 Participants |
| STAMARIL® Then ChimeriVax™-JE | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype I | 21 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype IV | 5 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | JE Homologous Virus | 12 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype I | 13 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype II | 9 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype III | 9 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype IV | 9 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype III | 10 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype I | 10 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | JE Homologous Virus | 10 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Genotype II | 9 Participants |
Primary
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)
Population: Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Then STAMARIL® | 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. | Day 30 (N = 17, 23, 13, 10) | 17 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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. | 30 Days Post-JE Seroconversion (N = 17, 23, 23, 0) | 17 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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. | Day 60 (N = 17, 23, 13, 10) | 17 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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. | Day 30 (N = 17, 23, 13, 10) | 2 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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. | 30 Days Post-JE Seroconversion (N = 17, 23, 23, 0) | 21 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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. | Day 60 (N = 17, 23, 13, 10) | 21 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | Day 60 (N = 17, 23, 13, 10) | 12 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | Day 30 (N = 17, 23, 13, 10) | 12 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | 30 Days Post-JE Seroconversion (N = 17, 23, 23, 0) | 22 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | Day 30 (N = 17, 23, 13, 10) | 0 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | 30 Days Post-JE Seroconversion (N = 17, 23, 23, 0) | NA Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | Day 60 (N = 17, 23, 13, 10) | 10 Participants |
Primary
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)
Population: Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Then STAMARIL® | 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. | Day 30 (N = 17, 23, 13, 10) | 0 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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. | Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0) | 17 Participants |
| ChimeriVax™-JE Then STAMARIL® | 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. | Day 60 (N = 17, 23, 13, 10) | 17 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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. | Day 30 (N = 17, 23, 13, 10) | 23 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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. | Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0) | 23 Participants |
| STAMARIL® Then ChimeriVax™-JE | 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. | Day 60 (N = 17, 23, 13, 10) | 23 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | Day 60 (N = 17, 23, 13, 10) | 13 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | Day 30 (N = 17, 23, 13, 10) | 13 Participants |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0) | 23 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | Day 30 (N = 17, 23, 13, 10) | 1 Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0) | NA Participants |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | Day 60 (N = 17, 23, 13, 10) | 10 Participants |
Secondary
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
Population: GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax™-JE Then STAMARIL® | 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. | 60 Days Post-vaccination (N = 17, 0, 13, 0) | 687.8 Titers |
| ChimeriVax™-JE Then STAMARIL® | 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. | 30 Days Post-vaccination (N = 17, 23, 13, 10) | 1461.6 Titers |
| ChimeriVax™-JE Then STAMARIL® | 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. | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 267.5 Titers |
| ChimeriVax™-JE Then STAMARIL® | 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. | 45 Days Post-vaccination (N = 17, 0, 13, 0) | 1099.3 Titers |
| ChimeriVax™-JE Then STAMARIL® | 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. | 15 Days Post-vaccination (N = 17, 23, 13, 10) | 282.1 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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. | 45 Days Post-vaccination (N = 17, 0, 13, 0) | NA Titers |
| STAMARIL® Then ChimeriVax™-JE | 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. | 60 Days Post-vaccination (N = 17, 0, 13, 0) | NA Titers |
| STAMARIL® Then ChimeriVax™-JE | 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. | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 134.0 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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. | 30 Days Post-vaccination (N = 17, 23, 13, 10) | 426.4 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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. | 15 Days Post-vaccination (N = 17, 23, 13, 10) | 140.2 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | 45 Days Post-vaccination (N = 17, 0, 13, 0) | 146.3 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | 15 Days Post-vaccination (N = 17, 23, 13, 10) | 119.9 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | 30 Days Post-vaccination (N = 17, 23, 13, 10) | 221.2 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | 60 Days Post-vaccination (N = 17, 0, 13, 0) | 103.1 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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. | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 94.6 Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | 60 Days Post-vaccination (N = 17, 0, 13, 0) | NA Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | 30 Days Post-vaccination (N = 17, 23, 13, 10) | 611.6 Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | 15 Days Post-vaccination (N = 17, 23, 13, 10) | 386.5 Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | 45 Days Post-vaccination (N = 17, 0, 13, 0) | NA Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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. | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 99.9 Titers |
Secondary
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
Population: GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax™-JE Then STAMARIL® | 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 | Day 60 Post-vaccination (N = 0, 23, 13, 0) | NA Titers |
| ChimeriVax™-JE Then STAMARIL® | 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 | Day 30 Post-vaccination (N = 17, 23, 13, 10) | 3288.5 Titers |
| ChimeriVax™-JE Then STAMARIL® | 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 | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 2017.5 Titers |
| ChimeriVax™-JE Then STAMARIL® | 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 | Day 45 Post-vaccination (N = 0, 23, 13, 0) | NA Titers |
| ChimeriVax™-JE Then STAMARIL® | 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 | Day 15 Post-vaccination (N = 17, 23, 13, 10) | 463.1 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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 | Day 45 Post-vaccination (N = 0, 23, 13, 0) | 2442.5 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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 | Day 60 Post-vaccination (N = 0, 23, 13, 0) | 2175.1 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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 | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 2058.7 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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 | Day 30 Post-vaccination (N = 17, 23, 13, 10) | 3704.6 Titers |
| STAMARIL® Then ChimeriVax™-JE | 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 | Day 15 Post-vaccination (N = 17, 23, 13, 10) | 1080.7 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Day 45 Post-vaccination (N = 0, 23, 13, 0) | 974.6 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Day 15 Post-vaccination (N = 17, 23, 13, 10) | 1150.0 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Day 30 Post-vaccination (N = 17, 23, 13, 10) | 1565.6 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | Day 60 Post-vaccination (N = 0, 23, 13, 0) | 653.1 Titers |
| Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent | 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 | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 947.4 Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Day 60 Post-vaccination (N = 0, 23, 13, 0) | NA Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Day 30 Post-vaccination (N = 17, 23, 13, 10) | 3054.9 Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Day 15 Post-vaccination (N = 17, 23, 13, 10) | 2044.1 Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | Day 45 Post-vaccination (N = 0, 23, 13, 0) | NA Titers |
| Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL | 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 | 6 Months Post-vaccination (N = 16, 22, 13, 10) | 1351.8 Titers |