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Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550289
First Posted: March 9, 2012
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Results First Submitted: September 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Interventions: Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
Biological: Placebo: NaCl 0.9% solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.

Reporting Groups
  Description
CYD Dengue Vaccine Group Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Placebo Group Healthy adult participants received 3 vaccinations of placebo vaccine.

Participant Flow:   Overall Study
    CYD Dengue Vaccine Group   Placebo Group
STARTED   128   61 
COMPLETED   115   57 
NOT COMPLETED   13   4 
Protocol Violation                1                0 
Lost to Follow-up                1                1 
Withdrawal by Subject                11                3 



  Baseline Characteristics
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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
CYD Dengue Vaccine Group Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Placebo Group Healthy adult participants received 3 vaccinations of placebo vaccine.
Total Total of all reporting groups

Baseline Measures
   CYD Dengue Vaccine Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   61   187 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      126 100.0%      61 100.0%      187 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.5  (7.17)   29.6  (6.41)   29.5  (6.91) 
Gender 
[Units: Participants]
Count of Participants
     
Female      27  21.4%      9  14.8%      36  19.3% 
Male      99  78.6%      52  85.2%      151  80.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
India   126   61   187 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

2.  Primary:   Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

3.  Primary:   Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

4.  Primary:   Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

5.  Primary:   Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo   [ Time Frame: Day 0 up to Day 14 post each injection ]

6.  Secondary:   Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

7.  Secondary:   Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

8.  Secondary:   Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

9.  Secondary:   Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

10.  Secondary:   Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

11.  Secondary:   Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

12.  Secondary:   Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]

13.  Secondary:   Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo   [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


Publications of Results:

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01550289     History of Changes
Other Study ID Numbers: CYD47
UTN: U1111-1114-7909 ( Other Identifier: WHO )
First Submitted: March 7, 2012
First Posted: March 9, 2012
Results First Submitted: September 14, 2016
Results First Posted: November 3, 2016
Last Update Posted: December 28, 2016