Title

Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    chimerivax ...
  • Study Participants

    2004
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Study Started
Oct 31
2005
Primary Completion
Nov 30
2006
Study Completion
Nov 30
2006
Results Posted
Dec 05
2012
Estimate
Last Update
Dec 06
2012
Estimate

Biological ChimeriVax-JE, Japanese Encephalitis vaccine

0.5 mL, Subcutaneous

  • Other names: ChimeriVax™

Biological 0.9% Saline

0.5 mL, Subcutaneous

Placebo Placebo Comparator

All subjects received a single injection of placebo on Day 0.

ChimeriVax™ JE 4 log10 PFU Vaccine Experimental

All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.

Criteria

Inclusion Criteria:

Informed consent obtained from the subject.
Aged 18 years or above at screening.
In good general health
Subject available for the study duration
For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.

Exclusion Criteria:

A history of vaccination against or infection with JE.
Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
History of thymoma, thymic surgery (removal) or myasthenia gravis.
Clinically significant abnormalities on laboratory assessment
Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
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 30.
Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
Physical examination indicating any clinically significant medical condition.
Oral temperature >38°C (100.4°F) or acute illness within 3 days prior to inoculation.
Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
Lactation or intended pregnancy in female subjects.
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. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
Participation in another clinical study within 30 days of the screening visit for this study.
Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.

Summary

Placebo

ChimeriVax™-JE 4 log10 PFU Vaccine

All Events

Event Type Organ System Event Term Placebo ChimeriVax™-JE 4 log10 PFU Vaccine

Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo

Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.

Placebo

Abdominal Pain

21.0
Participants

Arthralgia

21.0
Participants

Chills

17.0
Participants

Diarrhea

25.0
Participants

Dyspnea

10.0
Participants

Fatigue

90.0
Participants

Feeling Hot

27.0
Participants

Headache

99.0
Participants

Injection Site Erythema

14.0
Participants

Injection Site Pain

36.0
Participants

Injection Site Pruritus

11.0
Participants

Malaise

69.0
Participants

Myalgia

48.0
Participants

Nasal Congestion

9.0
Participants

Nasopharyngitis

13.0
Participants

Nausea

26.0
Participants

Pharyngolaryngeal Pain

10.0
Participants

ChimeriVax™-JE 4 log10 PFU Vaccine

Abdominal Pain

89.0
Participants

Arthralgia

119.0
Participants

Chills

112.0
Participants

Diarrhea

140.0
Participants

Dyspnea

53.0
Participants

Fatigue

365.0
Participants

Feeling Hot

152.0
Participants

Headache

417.0
Participants

Injection Site Erythema

74.0
Participants

Injection Site Pain

199.0
Participants

Injection Site Pruritus

64.0
Participants

Malaise

297.0
Participants

Myalgia

265.0
Participants

Nasal Congestion

14.0
Participants

Nasopharyngitis

10.0
Participants

Nausea

114.0
Participants

Pharyngolaryngeal Pain

55.0
Participants

Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo

Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.

Placebo

Arthralgia

28.0
Participants

Chills

26.0
Participants

Diarrhea

36.0
Participants

Fatigue

112.0
Participants

Headache

124.0
Participants

Injection Site Erythema

15.0
Participants

Injection Site Hemorrhage

4.0
Participants

Injection Site Induration

Injection Site Joint Pain

Injection Site Pain

36.0
Participants

Injection Site Paresthesia

1.0
Participants

Injection Site Pruritus

12.0
Participants

Injection Site Rash

3.0
Participants

Injection Site Reaction

3.0
Participants

Injection Site Stinging

Injection Site Swelling

4.0
Participants

Injection Site Warmth

Malaise

92.0
Participants

Myalgia

67.0
Participants

Nausea

37.0
Participants

Pyrexia

7.0
Participants

Rash

13.0
Participants

Vomiting

12.0
Participants

ChimeriVax™-JE 4 log10 PFU Vaccine

Arthralgia

179.0
Participants

Chills

147.0
Participants

Diarrhea

183.0
Participants

Fatigue

479.0
Participants

Headache

597.0
Participants

Injection Site Erythema

74.0
Participants

Injection Site Hemorrhage

21.0
Participants

Injection Site Induration

1.0
Participants

Injection Site Joint Pain

1.0
Participants

Injection Site Pain

199.0
Participants

Injection Site Paresthesia

Injection Site Pruritus

66.0
Participants

Injection Site Rash

5.0
Participants

Injection Site Reaction

10.0
Participants

Injection Site Stinging

1.0
Participants

Injection Site Swelling

17.0
Participants

Injection Site Warmth

1.0
Participants

Malaise

383.0
Participants

Myalgia

352.0
Participants

Nausea

164.0
Participants

Pyrexia

26.0
Participants

Rash

34.0
Participants

Vomiting

37.0
Participants

Total

2004
Participants

Age Continuous

34.7
Years (Mean)
Standard Deviation: 14.22

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Placebo

ChimeriVax™-JE 4 log10 PFU Vaccine

Drop/Withdrawal Reasons

Placebo

ChimeriVax™-JE 4 log10 PFU Vaccine