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Completed

NCT Number: NCT01092507

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

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.

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Key information

Conditions

Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Japanese Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

9 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bangkok, Thailand

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Japanese encephalitis chimeric virus vaccine (JE-CV)

Biological

0.5 mL, Subcutaneous

Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)

Biological

0.5 mL, Subcutaneous

Primary outcomes

  1. 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®)

    Time frame: Day 0 through Day 28 after vaccination

    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.

Secondary outcomes

  1. 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®)

    Time frame: Day 28 post-vaccination

    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.

  2. 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®)

    Time frame: Day 28 post-vaccination

    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.

  3. 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®)

    Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination

    Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

  4. 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®)

    Time frame: Day 28 up to 12 months post-vaccination

    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.

  5. 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®)

    Time frame: Day 0 (pre-vaccination) and up to 12 months post-vaccination

    Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

  6. 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®)

    Time frame: Day 0 through Day 14 post-vaccination

    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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2010
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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