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Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01187433
First received: August 20, 2010
Last updated: September 25, 2016
Last verified: September 2016
Results First Received: September 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Dengue
Dengue Hemorrhagic Fever
Interventions: Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
Biological: NaCl 0.9%
Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
Biological: Meningococcal A+C vaccine

  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 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.

Reporting Groups
  Description
CYD Dengue Vaccine Group Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Control Group Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.

Participant Flow:   Overall Study
    CYD Dengue Vaccine Group   Control Group
STARTED   100   50 
COMPLETED   89   46 
NOT COMPLETED   11   4 
Protocol Violation                6                2 
Withdrawal by Subject                5                2 



  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 Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Control Group Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Total Total of all reporting groups

Baseline Measures
   CYD Dengue Vaccine Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   50   150 
Age 
[Units: Participants]
     
<=18 years   100   50   150 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age Continuous   12.7  (2.1)   12.7  (2.2)   12.7  (2.15) 
Gender 
[Units: Participants]
     
Female   59   23   82 
Male   41   27   68 
Region of Enrollment 
[Units: Participants]
     
Brazil   100   50   150 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

2.  Primary:   Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

3.  Primary:   Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 Days after each injection ]

4.  Primary:   Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

5.  Primary:   Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

6.  Primary:   Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

7.  Primary:   Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

8.  Primary:   Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

9.  Primary:   Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

10.  Primary:   Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Before and 28 days after each injection ]

11.  Primary:   Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo   [ Time Frame: Day 0 up to Day 14 post each vaccination ]


  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: NCT01187433     History of Changes
Other Study ID Numbers: CYD30
UTN: U1111-1111-6073 ( Other Identifier: WHO )
Study First Received: August 20, 2010
Results First Received: September 25, 2016
Last Updated: September 25, 2016