Follow-Up Study of Thai Children From Dengue-003 and Evaluation of a Booster Dose of Dengue Vaccine
This study has been completed.
Sponsor:
U.S. Army Office of the Surgeon General
Collaborator:
GlaxoSmithKline
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00318916
First received: April 25, 2006
Last updated: May 22, 2006
Last verified: April 2006
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Purpose
The purpose of this study is to assess the immunogenicity of a booster dose of tetravalent live attenuated dengue vaccine administered approximately one year following the second dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue |
Biological: Live attenuated tetravalent dengue (DEN) vaccine Biological: Formulation 17 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase I/II, Open, Five-Year, Clinical Follow-Up Study of Thai Children Who Participated in Dengue-003 (" Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Children ") With Evaluation of a Booster Dose Given One Year After Primary Dengue Vaccination Series |
Resource links provided by NLM:
Further study details as provided by Walter Reed Army Institute of Research (WRAIR):
Primary Outcome Measures:
- Neutralizing antibodies (seropositivity rates and GMTs) to each dengue virus serotype, 30 days after the dengue vaccine booster dose
Secondary Outcome Measures:
- Safety
- Occurrence of solicited adverse events (AE) within 21 days follow-up after the dengue vaccine dose; Occurrence of unsolicited non-serious AEs within 31 days (days 0-30) after the dengue vaccine dose;
- Occurrence of serious adverse events (SAEs) within 31 days (days 0-30) after the dengue vaccine dose;
- Occurrence of alert values for safety laboratory determinations within 31 days after the dengue vaccine dose;
- Occurrence of dengue (suspected or confirmed) that prompted evaluation by a physician after the conclusion of Dengue-003 to the one year follow-up visit, and during Dengue-005, (with clinical outcome);
- Occurrence of hospitalized dengue for five years following the two-dose primary vaccination series;
- Immunogenicity
- Flavivirus immunity before administration of the dengue vaccine dose, assessed as the ratio of DEN IgM:IgG by isotype capture EIA in serum collected at the time of vaccination and 30 days after the dengue vaccine booster dose;
- Tetravalent N antibody, 30 days after the dengue vaccine booster dose;
- Tetravalent N antibody, assessed the day of dengue vaccine booster dose administration;
- Neutralizing antibodies (seropositivity rates and GMT) to each dengue virus serotype, before the dengue vaccine booster dose at Visit 1;
- Presence of dengue viremia 10 days after the dengue vaccine dose;
- Tetravalent N antibody and neutralizing antibodies (seropositivity rates and GMT) to each dengue virus serotype one year after the booster dose.
| Estimated Enrollment: | 7 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | March 2006 |
Follow-up of Dengue-003 Study (in Dengue-003; 7 Thai children received two doses of dengue vaccine six months apart followed by two doses of JE vaccine. In this study the same children will receive a booster dose approximately one year after the primary vaccination series. A one year safety follow-up after the primary vaccination series and a 4 year safety follow-up after the booster dose (one visit each year for 4 years) will be conducted. Blood samples will be collected before the booster dose and one month and again one year after the booster.
Eligibility| Ages Eligible for Study: | 7 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects who received two doses of dengue vaccine in the Dengue-003 study.
- Subjects whose parents sign an informed consent form for participation.
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318916
Locations
| Thailand | |
| Department of Pediatrics, Pharamongkutklao Hospital | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
GlaxoSmithKline
Investigators
| Principal Investigator: | Mammen P. Mammen, Jr., MD | U.S. Army Medical Component Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS) |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00318916 History of Changes |
| Other Study ID Numbers: | WRAIR 1159, HSRRB Log No A-13227 |
| Study First Received: | April 25, 2006 |
| Last Updated: | May 22, 2006 |
| Health Authority: | United States: Food and Drug Administration United States: USAMMDA Belgium: GSK |
Keywords provided by Walter Reed Army Institute of Research (WRAIR):
|
Dengue Attenuated vaccine |
Additional relevant MeSH terms:
|
Dengue Arbovirus Infections Virus Diseases Flavivirus Infections |
Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |
ClinicalTrials.gov processed this record on June 17, 2013