Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule
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| ClinicalTrials.gov Identifier: NCT02824198 |
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Recruitment Status :
Completed
First Posted : July 6, 2016
Results First Posted : June 14, 2019
Last Update Posted : December 16, 2019
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
| Conditions |
Dengue Fever Dengue Hemorrhagic Fever |
| Interventions |
Biological: CYD Dengue Vaccine (5 dose formulation) Biological: Placebo, NaCl 0.9% |
| Enrollment | 118 |
Participant Flow
| Recruitment Details | Study participants were enrolled from 01 July 2016 to 18 February 2017 at 3 sites in Singapore. |
| Pre-assignment Details | A total of 118 participants who received 3 doses of CYD dengue vaccine in study CYD28 (NCT00880893) were enrolled and randomized in this study (CYD63). |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
 Arm/Group Description |
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63). | Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63). |
| Period Title: Overall Study | ||
| Started | 89 | 29 |
| Completed | 74 | 26 |
| Not Completed | 15 | 3 |
| Reason Not Completed | ||
| Non-compliance with the protocol | 5 | 1 |
| Lost to Follow-up | 5 | 2 |
| Withdrawal by Subject | 5 | 0 |
Baseline Characteristics
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63). | Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 89 | 29 | 118 | |
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Baseline Analysis Population Description |
Analysis was performed on all randomized participants.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 89 participants | 29 participants | 118 participants | |
| <=18 years |
11 12.4%
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0 0.0%
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11 9.3%
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| Between 18 and 65 years |
78 87.6%
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29 100.0%
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107 90.7%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 89 participants | 29 participants | 118 participants | |
| 28.1 (11.18) | 28.2 (9.18) | 28.2 (10.69) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 89 participants | 29 participants | 118 participants | |
| Female |
43 48.3%
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15 51.7%
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58 49.2%
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| Male |
46 51.7%
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14 48.3%
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60 50.8%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 0 participants | 0 participants | 0 participants | |
| 0 | ||||
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[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
| Name/Title: | Medical Director |
| Organization: | Sanofi Pasteur |
| Phone: | 800-633-1610 ext ext 1# |
| EMail: | Contact-US@sanofi.com |
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT02824198 |
| Other Study ID Numbers: |
CYD63 U1111-1161-2813 ( Other Identifier: WHO ) |
| First Submitted: | July 1, 2016 |
| First Posted: | July 6, 2016 |
| Results First Submitted: | May 24, 2019 |
| Results First Posted: | June 14, 2019 |
| Last Update Posted: | December 16, 2019 |