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OpenTrials
Completed

NCT Number: NCT02526550

Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

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Key information

Conditions

Encephalitis Brain Diseases Central Nervous System Diseases Digestive System Diseases Hepatitis Liver Diseases Nervous System Diseases Neuroinflammatory Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 1 to <5 years on the day of inclusion
  • History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
  • In good general health at the time of inclusion
  • Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion criteria

  • Receipt of blood or blood products in the past 3 months
  • Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
  • Previous receipt of 2 doses of any vaccine against JE virus
  • Known hypersensitivity to any of the vaccine components
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination

Treatment and study plan

Live attenuated chimeric Japanese Encephalitis vaccine

Biological

0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh

Other names: Imojev

Inactivated hepatitis A vaccine

Biological

0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Other names: Havrix

Primary outcomes

  1. Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination

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

    Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).

Secondary outcomes

  1. Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination

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

    Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.

  2. Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™

    Time frame: Up to 28 days post booster vaccination

    Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study title

Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 18, 2015
Registry last updated
Dec 7, 2016

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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