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Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children

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ClinicalTrials.gov Identifier: NCT01391819
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : April 26, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Dengue
Interventions: Other: Data collection
Procedure: Blood sample collection

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 2117 subjects originally enrolled in the study, one subject was excluded due to protocol violation.

Reporting Groups
  Description
Dengue Group Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.

Participant Flow:   Overall Study
    Dengue Group
STARTED   2116 
COMPLETED   1714 
NOT COMPLETED   402 
Withdrawal by Subject                56 
Migrated/moved from study area                82 
Lost to Follow-up                252 
Death                3 
Other                9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dengue Group Subjects, male and female, aged 5-13 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.

Baseline Measures
   Dengue Group 
Overall Participants Analyzed 
[Units: Participants]
 2116 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   2116 
   8.997  (2.4637) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   2116 
Female      1096  51.8% 
Male      1020  48.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Number of Laboratory Confirmed Symptomatic Dengue Infection Cases   [ Time Frame: At Year 1 (2012) ]

2.  Primary:   Number of Laboratory Confirmed Symptomatic Dengue Virus Cases   [ Time Frame: At Year 2 (2013) ]

3.  Primary:   Number of Laboratory Confirmed Symptomatic Dengue Cases   [ Time Frame: At Year 3 (2014) ]

4.  Secondary:   Number of Subjects With Immunoglobulin Type G (IgG) Antibodies Against Dengue   [ Time Frame: From Day 0 to Year 3 ]

5.  Secondary:   Number of Subjects With Asymptomatic Dengue Primary Infection   [ Time Frame: From Day 0 to Year 3 ]

6.  Secondary:   Number of Subjects With Laboratory Confirmed and Probable Dengue Cases   [ Time Frame: From Year 0 to Year 3 ]

7.  Secondary:   Number of Dengue Infection Cases by Virus Type (DENV)   [ Time Frame: From Day 0 to Year 3 ]

8.  Secondary:   Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases   [ Time Frame: From Day 0 to Year 3 ]

9.  Secondary:   Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases   [ Time Frame: From Day 0 to Year 3 ]

10.  Secondary:   Number of Working Days Missed of Primary Care Giver 1 and 2   [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]

11.  Secondary:   Caregiver Absenteeism Associated With Subject Dengue Illness   [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]

12.  Secondary:   Number of School Days Missed by Subjects   [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]

13.  Secondary:   Subjects Absenteeism Associated With Dengue Illness   [ Time Frame: Up to Day 35 post laboratory confirmed dengue onset ]

14.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 to Year 3 ]

15.  Secondary:   Direct Medical Resource Associated With Suspected Dengue Cases   [ Time Frame: From Day 0 to Year 3 ]

16.  Secondary:   Number of Hospitalization Days Due to Suspected Dengue Cases   [ Time Frame: From Day 0 to Year 3 ]

17.  Secondary:   Dengue Infection Episodes Related Temperature   [ Time Frame: From Day 0 to Year 3 ]

18.  Secondary:   Number of Dengue Episodes With Any Temperature Interval   [ Time Frame: From Day 0 to Year 3 ]

19.  Secondary:   Number of Dengue Episodes Associated With Clinical Symptoms   [ Time Frame: From Day 0 to Year 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01391819     History of Changes
Other Study ID Numbers: 112994
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: March 16, 2017
Results First Posted: April 26, 2017
Last Update Posted: February 1, 2018