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Phase 3 N=900 Randomized Double-blind Prevention

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine

Healthy Volunteers

Enrolled (actual)
900
Serious AEs
1.9%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30 — 97.1; 9.1; 98.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
TDV (Biological); HAV Vaccine (Biological); TDV Placebo (Biological); HAV Vaccine Placebo (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Takeda
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30
97.1; 9.1; 98.7
SECONDARY
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
5.0; 108.2; 152.5; 6.0; 2897.9; 3960.0
SECONDARY
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
0; 88.3; 95.4; 8.2; 91.7; 96.9
SECONDARY
Geometric Mean Concentrations (GMC) of Anti-HAV Antibodies at Day 30 in Participants HAV/DENV-naive at Baseline
82.1; 6.7; 93.0
SECONDARY
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
45.0; 15.4; 49.1; 44.6; 14.4; 48.4
SECONDARY
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
47.4; 44.2; 49.5; 28.7; 32.5; 31.2
SECONDARY
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
14.7; 17.0; 18.8; 14.4; 10.0; 11.7
SECONDARY
Percentage of Participants With Serious Adverse Events (SAEs)
0.7; 2.7; 2.3
SECONDARY
Percentage of Participants With Medically Attended AEs (MAAEs)
23.1; 21.0; 20.1

Summary

The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous [SC] injection) and of hepatitis A virus (HAV) vaccine (intramuscular [IM] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.

Eligibility Criteria

Inclusion Criteria

  • The participant is aged 18 to 60 years, inclusive.
  • Participants who are 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.
  • The participant 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.
  • Participants who can comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria

  • Participants with 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 vaccines or placebo).
  • Participants with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
  • Participants with any history of progressive or severe neurologic disorder, seizure disorder orneuro-inflammatory disease (eg, Guillain-Barré syndrome).
  • Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participant due to participation in the trial.
  • 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 (Month 0) (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 (Month 0).
  • Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
  • Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
  • Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
  • Human immunodeficiency virus (HIV) infection or HIV-related disease.
  • Hepatitis A virus (HAV) infection.
  • Hepatitis C virus infection.
  • Genetic immunodeficiency.
  • Abnormalities of splenic or thymic function.
  • Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  • Participants with any serious chronic or progressive disease according to judgment of the Investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  • Participants with body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in kg/[height in meters^2]).
  • Participants participating in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
  • Participants who received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of trial vaccine administration.
  • Previous HAV vaccination (in a clinical trial or with an approved product).
  • Participants involved in the trial conduct or their first degree relatives.
  • Participants with history of substance or alcohol abuse within the past 2 years.
  • Female participants who are pregnant or breastfeeding.
  • Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0).
  • Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditio
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03525119). 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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