A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

Japanese Encephalitis Clinical Trial

Official title:

A Controlled Study of the Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Comparison With SA14-14-2 Vaccine in Infants and Toddlers in Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092507
• Other study ID #: JEC07
• Secondary ID: UTN: U1111-1112-
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2010
• Last updated: November 30, 2013
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers.

Primary Objective:

• To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0).

Secondary Objectives:

• To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine

• To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination.

• To describe only related SAEs and all death from 6 month to 12-month follow-up.

Description:

All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 18 Months

Eligibility

Inclusion Criteria :

• Aged 9 to 18 months on the day of inclusion

• In good general health, without significant medical history

• Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations

• Subject and parent/legally acceptable representatives able to attend all scheduled visits and comply with all trial procedures

• Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination

• Planned participation in another clinical trial during the present trial period

• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy

• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances

• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator

• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of the immune response

• Previous vaccination against flavivirus disease, including Japanese encephalitis (JE)

• Administration of any anti-viral within 2 months preceding first vaccination and up to the 4 weeks following the last trial vaccination at Month 3

• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination

• Planned receipt of any vaccine from the inclusion up to the 4 weeks following the last trial vaccination

• Planned receipt of any Japanese encephalitis vaccine during the course of the study

• History of central nervous system disorder or disease, including seizures

• History of flavivirus infection (confirmed either clinically, serologically or microbiologically)

• Febrile illness (temperature = 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• Japanese encephalitis chimeric virus vaccine (JE-CV)
0.5 mL, Subcutaneous
• Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)	Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50).; Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer = 10 1/dil; or a pre-vaccination titer = 10 1/dil and a 4-fold increase from pre- to post-vaccination.	Day 0 through Day 28 after vaccination	No
Secondary	Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)	Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.; Japanese encephalitis seroprotection defined as participant with antibody titer = 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.	Day 28 post-vaccination	No
Secondary	Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)	Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.; Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer = 10 1/dil, or a pre-vaccination titer = 10 and a 4-fold increase from pre- to post-vaccination.	Day 28 post-vaccination	No
Secondary	Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)	Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)	Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.; Japanese encephalitis seroprotection defined as participant with antibody titer = 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.	Day 28 up to 12 months post-vaccination	No
Secondary	Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)	Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.	Day 0 (pre-vaccination) and up to 12 months post-vaccination	No
Secondary	Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)	Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.; Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - = 5 cm; Fever - temperature > 39.5ºC; Vomiting - = 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused = 3 feeds or refused most feeds; and Irritability - inconsolable.	Day 0 through Day 14 post-vaccination	No

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