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Phase 3 N=923 Randomized Quadruple-blind Prevention

Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue

Dengue Fever

Enrolled (actual)
923
Serious AEs
2.2%
Results posted
Oct 2020
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset — 5.3; 202.9; 293.8; 322.1 titer

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
TAK-003 (Biological); Placebo (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Takeda
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset
5.3; 202.9; 293.8; 322.1; 6.3; 3090.3
SECONDARY
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset
1.7; 97.5; 96.9; 99.2; 6.7; 99.2
SECONDARY
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset
5.4; 122.5; 136.7; 168.4; 5.8; 1507.2
SECONDARY
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination
17.5; 51.0; 48.4; 50.0; 16.7; 45.5
SECONDARY
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
34.7; 43.3; 39.5; 42.9; 22.5; 28.9
SECONDARY
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
13.7; 18.6; 18.0; 16.7; 7.8; 10.5
SECONDARY
Percentage of Participants With Serious Adverse Events (SAEs)
3.1; 3.8; 1.1; 1.1
SECONDARY
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
13.7; 17.8; 12.3; 11.8

Summary

The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.

Eligibility Criteria

Inclusion Criteria

  • Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
  • Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.

Exclusion Criteria

  • Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
  • Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
  • Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
  • Known or suspected impairment/alteration of immune function, including:
  • Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed)
  • Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0).
  • Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
  • Receipt of immunostimulants within 60 days prior to Day 1 (M0).
  • Hepatitis C virus infection.
  • Genetic immunodeficiency.
  • Has abnormalities of splenic or thymic function.
  • Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  • Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  • Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in meters^2]).
  • Has history of substance or alcohol abuse within the past 2 years.
  • Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
  • Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03423173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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