A Phase II Trial of a Live Attenuated Virus Tetravalent D... | NCT00370682

NCT00370682

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
Study no: 103854 (T-DEN-002)	Other Identifier	GSK
HSRRB A-13699	Other Identifier	USAMRMC

Status Module

Name	Class
GlaxoSmithKline	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T-DEN F17	Experimental	Full Dose (0.5 mL) 0 and 6 months	Biological: T-DEN F17
T-DEN F19	Experimental	Full Dose (0.5 mL) at 0 and 6 months	Biological: T-DEN F-19
Placebo Comparator	Placebo Comparator	0.5 mL sterile buffer at 0 and 6, subcutaneous injection	Other: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T-DEN F17	Biological	A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1	Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)	0-21 days after dose 1
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2	Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)	30 and 90 days after dose 2

Secondary Outcomes

Measure	Description	Time Frame
Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine	Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2	0-21 days after dose 2 of study vaccine
Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A healthy male or female adult 20-25 years of age (≥20 years of age and ≤25 years of age) at the time of vaccination;
Free of obvious health problems as established by medical history and physical examination before entering into the study;
Written informed consent obtained from the subject;
Able to read the Subject Information Sheet and Consent Form;
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study;
females must be of non-childbearing potential, i.e. surgically sterilized or, if of childbearing potential, she must be abstinent or on adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series

Exclusion Criteria:

Pregnant or lactating female, planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
History of drug abuse or alcohol consumption (more than 2 drinks per day);
History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
Acute or chronic, pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;
Any confirmed or suspected immunosuppressive or immunodeficient condition or seropositive for HBsAg, anti-HCV or anti-HIV;
Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever);
Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;
Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;
Hypertension; chest pain, palpitations, dizziness, shortness of breath, arrhythmias or friction rubs;
Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine (includes placebo) or planned use during the study period;
Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of the study vaccine/placebo and ending 30 days after the second dose;
A planned move to a location that will prohibit participating in the trial for 9 months after the initial vaccination;
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 90 days preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;
Administration of immunoglobulins and/or blood products within 90 days preceding the first dose or planned administration during the study period;
Any chronic systemic drug therapy to be continued during the study period (except for vitamin/mineral supplements or routine treatment for gastro-esophageal reflux);
No easy access to a fixed or mobile telephone

Name	Affiliation	Role
Robert Gibbons, MD, MPH	Department of Virology, Armed Forces Research Institute of Medical Sciences (AFRIMS)	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
24865677	Derived	Watanaveeradej V, Gibbons RV, Simasathien S, Nisalak A, Jarman RG, Kerdpanich A, Tournay E, De La Barrerra R, Dessy F, Toussaint JF, Eckels KH, Thomas SJ, Innis BL. Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial. Am J Trop Med Hyg. 2014 Jul;91(1):119-28. doi: 10.4269/ajtmh.13-0452. Epub 2014 May 27.

Arm/Group Information

ID	Title	Description
FG000	T-DEN F17	Full Dose (0.5 mL) 0 and 6 months T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
FG001	T-DEN F19	Full Dose (0.5 mL) at 0 and 6 months T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
FG002	Placebo Comparator	0.5 mL sterile buffer at 0 and 6, subcutaneous injection Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	T-DEN F17	Full Dose (0.5 mL) 0 and 6 months T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
BG001	T-DEN F19

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1

Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)

Posted

Number

95% Confidence Interval

percentage of subjects

0-21 days after dose 1

ID	Title	Description
OG000	T-DEN F17	Full Dose (0.5 mL) 0 and 6 months T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
OG001	T-DEN F19	Full Dose (0.5 mL) at 0 and 6 months T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	T-DEN F17	Full Dose (0.5 mL) 0 and 6 months T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Eptopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (Unspecified)	Non-systematic Assessment

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections