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OpenTrials
Completed

NCT Number: NCT03109600

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

This study is to assess the safety of Vi-DT vaccine in adults and children.

Completed

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Key information

Conditions

Age range

2 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Puskesmas Jatinegara, Jakarta, DKI Jaya, Indonesia

Loading trial locations.

About this study

To describe the safety of this vaccine following first and second dose immunization.

To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • Subjects/Parents have been informed properly regarding the study and signed the informed consent form
  • Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion criteria

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
  • Known history of allergy to any component of the vaccines
  • History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
  • Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
  • Pregnancy & lactation (Adults)
  • Individuals who have previously received any vaccines against typhoid fever.
  • Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
  • Individuals who have a previously ascertained typhoid fever.
  • History of alcohol or substance abuse.
  • Subject planning to move from the study area before the end of study period.

Treatment and study plan

Vi-DT (Bio Farma)

Biological

Typhoid Conjugate Vaccine

Vi Polysaccharide Vaccine

Biological

Vi polysaccharide vaccine

Influenzae vaccine

Biological

1 dose of Influenzae vaccine

pneumococcal conjugate vaccine

Biological

1 dose of Pneumococcal conjugate Vaccine

Primary outcomes

  1. Local reaction and systemic event after vaccination

    Time frame: 28 days

    Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

Secondary outcomes

  1. Adverse events after vaccination

    Time frame: 28 days

    Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each vaccination.

  2. Serious adverse events after vaccination

    Time frame: 28 days

    Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.

  3. Routine laboratory evaluation that probably related to the vaccination.

    Time frame: 7 days

    Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.

  4. Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)

    Time frame: 28 days

    Percentage of subjects with > 4 times increasing antibody

  5. Geometric Mean Titers (GMT) following immunization

    Time frame: 28 days

    Geometric Mean Titers (GMT) 28 days following immunization

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Mar 6, 2018

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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