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A Phase II, double-blind, controlled trial to assess the Safety and Immunogenicity of different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and < 18 years and living in dengue endemic countries in Asia and Latin America

PHRR140804-000219

DEN-204

2014-CT0226

A Phase II, double-blind, controlled trial to assess the Safety and Immunogenicity of different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and < 18 years and living in dengue endemic countries in Asia and Latin America

Trial Design: • This is a Phase II, double-blind, controlled, randomized trial that will enroll 1,800 healthy children aged 2 to < 18 years old into 1 of 4 treatment groups: - Group 1 (TDV 2-dose): receiving a two-dose primary vaccination at Day 1 (M0) and Day 91 (M3) with the trial vaccine. These subjects will also receive a placebo injection at Day 365 (M12). - Group 2 (TDV 1-dose): receiving a one-dose primary vaccination at Day 1 (M0) with the trial vaccine. These subjects will also receive a placebo injection at Day 91 (M3) and Day 365 (M12). - Group 3 (TDV 1-dose with booster): receiving a one-dose primary vaccination at Day 1 (M0) and booster vaccination at Day 365 (M12) with the trial vaccine. These subjects will also receive a placebo injection at Day 91 (M3). - Group 4 (Placebo Control): receiving injections of placebo at Day 1 (M0), Day 91 (M3), and at Day 365 (M12). Subjects will be randomized to these groups in a 1:2:5:1 ratio. Randomization will be stratified by age group based on the age at the time of informed consent: (1) 2 to 5 years of age, inclusive, (2) 6 to 11 years of age, inclusive, and (3) 12 to < 18 years of age and by region for the CMI group (Panama and Colombia) x non-CMI group (Dominican Republic; Philippines and Thailand).

Start Date Duration in Months Target Completion Date Actual Completion Date
2014-12-05 3 2015-03-05 2020-01-23

Completed

Institution Classification Region LTO #
Takeda Vaccines, Pte. Ltd. Private Business United States of America Not Applicable
Institution Classification Region LTO #
Quintiles Philippines, Inc. Private Business NCR CDRR-NCR-CRO-2
Institution Region
Takeda Vaccines, Pte. Ltd. United States of America
Name E-Mail Institution and Institution Address
Maria Inez G. Pacia QMNL.HealthRegistrymailbox@quintiles.com Quintiles Philippines, Inc., 41F Unionbank Plaza Bldg., Meralco Ave., cor. Onyx Road, Ortigas Center, Pasig City, 1600
Name E-Mail Institution and Institution Address
Pedro Garbes, MD pedro.garbes@takeda.com Takeda Brazil , Rua do Estilo Barroco, 721. Sao Paulo. 04.709-011. SP. Brazil
Name Expertise Affiliation
Delia Caparas-Yu, MD Pediatrics De La Salle University - Dasmariñas
Project Location Institutional Ethics Review Board
De La Salle University - Dasmariñas N/A

Dengue Vaccine

To assess the humoral immune responses to subcutaneously administered TDV in a subset of healthy subjects aged between 2 and < 18 years and living in dengue endemic countries.

• To assess seropositivity rates following subcutaneously administered TDV in a subset of healthy subjects aged between 2 and < 18 years and living in dengue endemic countries. Safety: • To evaluate the safety of subcutaneously administered TDV in healthy subjects aged between 2 and < 18 years and living in dengue endemic countries.

Recruiting

  • Colombia
  • Dominican Republic
  • Panama
  • Philippines
  • Thailand

Clinical Trial

DEN-204

Unspecified

2014-07-07

0000-00-00

200

500

re-distribution of target sample size to other study sites including Philippines

05 Dec 2014

Criteria for Inclusion: 1. The subject is aged 2 to < 18 years at the time of enrollment. 2. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator. 3. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent/informed assent form (and assent form where applicable) 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. 4. Individuals who can comply with trial procedures and are available for the duration of follow-up. Criteria for Exclusion: Any subject who meets any of the following criteria will not qualify for entry into the trial: 1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection at the time of enrollment. Trial entry should be delayed until the illness has improved. 2. Individuals 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 subjects due to participation in the trial, including but not limited to: a. Known hypersensitivity or allergy to any of the vaccine components. b. Female subjects who are pregnant or breastfeeding. c. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome). d. Known or suspected impairment/alteration of immune function, including: i. 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 (use of inhaled, intranasal, or topical corticosteroids is allowed). ii. 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. iii. Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the investigational vaccine or planned administration during the trial. iv. Receipt of immunostimulants within 60 days prior to Day 1. v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months preceding (first) vaccination. vi. HIV infection or HIV-related disease. vii. Genetic immunodeficiency. 3. Individuals who received any other vaccines 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 investigational vaccine administration. 4. Individuals participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial. 5. Individuals who participated in a previous dengue vaccine trial . 6. Individuals who are first degree relatives of individuals involved in trial conduct. 7. If female of childbearing potential, sexually active, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to trial entry: a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal (for at least 2 years), bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy. b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring). ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse. iii. Intrauterine device (IUD). iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subjects’ trial entry. v. Sexual abstinence agreement 8. If female of childbearing potential, sexually active and refuses to use an “acceptable contraceptive method” through to 6 weeks after the last dose of investigational vaccine. There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (e.g., body temperature elevation or recent use of excluded medication or vaccine). Under these circumstances, a subject may be considered eligible for trial enrollment if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible.

Interventional

Tetravalent Dengue Vaccine (TDV)

Trial Design: • This is a Phase II, double-blind, controlled, randomized trial that will enroll 1,800 healthy children aged 2 to < 18 years old into 1 of 4 treatment groups: - Group 1 (TDV 2-dose): receiving a two-dose primary vaccination at Day 1 (M0) and Day 91 (M3) with the trial vaccine. These subjects will also receive a placebo injection at Day 365 (M12). - Group 2 (TDV 1-dose): receiving a one-dose primary vaccination at Day 1 (M0) with the trial vaccine. These subjects will also receive a placebo injection at Day 91 (M3) and Day 365 (M12). - Group 3 (TDV 1-dose with booster): receiving a one-dose primary vaccination at Day 1 (M0) and booster vaccination at Day 365 (M12) with the trial vaccine. These subjects will also receive a placebo injection at Day 91 (M3). - Group 4 (Placebo Control): receiving injections of placebo at Day 1 (M0), Day 91 (M3), and at Day 365 (M12). Subjects will be randomized to these groups in a 1:2:5:1 ratio. Randomization will be stratified by age group based on the age at the time of informed consent: (1) 2 to 5 years of age, inclusive, (2) 6 to 11 years of age, inclusive, and (3) 12 to < 18 years of age and by region for the CMI group (Panama and Colombia) x non-CMI group (Dominican Republic; Philippines and Thailand).

Date Amendment Classification Reason
2016-02-17 Amendments related to the protocol Protocol Amendment 3.0 dated 23 July 2015; ICF v04.PHI01.DLSHSIv01 dated 23 Nov 2015; Philippine Informed Assent Form v04.PHI01.DLSHSIv01 dated 16 Oct 2015
2016-05-19 Amendments related to the protocol 1.) Updated ICFs (Parent-Legal Guardian) (Young Adult) 2.) Extension Consenting Material (V01.PHL.EN.01 DLSHSIv01 dated 09 Mar2016 and V01.PHL.TG01 DLSHSIv01 dated 17 Mar2016)
2016-11-28 Amendments related to the protocol 1.) Protocol Version 4.0 dated 21 Jul 2016 2.) ICF Parent-Legal Guardian (English - V07.PHI01.DLSHSIv01 dated 22 Aug 2016; Tagalog - V07.PHI01.DLSHSIv01 dated 16 Sep 2016) 3.) ICF - Young Adults (English - V07.PHI01.DLSHSIv01 dated 22 Aug 2016; Tagalog - V07.PHI01.DLSHSIv01 dated 16 Sep 2016) 4.) Informed Assent Form (English - V05.PHI01.DLSHSIv01 dated 22 Aug 2016; Tagalog - V05.PHI01.DLSHSIv01 dated 16 Sep 2016)

Randomized

Double Blind

Unspecified

Parallel

• To assess the humoral immune responses to subcutaneously administered TDV in a subset of healthy subjects aged between 2 and < 18 years and living in dengue endemic countries.

Phase II

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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