Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00993447
First received: October 9, 2009
Last updated: October 4, 2016
Last verified: October 2016
Results First Received: October 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Dengue
Dengue Hemorrhagic Fever
Dengue Virus
Dengue Fever
Interventions: Biological: CYD Dengue Vaccine
Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

  Participant Flow
  Hide Participant Flow

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 09 October 2009 to 25 February 2010 in 3 clinic centers in Colombia, 1 in Honduras, 3 in Mexico, and 1 in Puerto Rico.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 600 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Dengue Vaccine Group Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Control Group Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.

Participant Flow:   Overall Study
    Dengue Vaccine Group   Control Group
STARTED   401   199 
COMPLETED   364   180 
NOT COMPLETED   37   19 
Withdrawal by Subject                23                8 
Protocol Violation                12                8 
Lost to Follow-up                1                3 
Adverse Event                1                0 



  Baseline Characteristics
  Hide 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 Vaccine Group Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Control Group Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Total Total of all reporting groups

Baseline Measures
   Dengue Vaccine Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 401   199   600 
Age 
[Units: Participants]
     
<=18 years   401   199   600 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.6  (2.1)   12.5  (2.1)   12.55  (2.1) 
Gender 
[Units: Participants]
     
Female   204   108   312 
Male   197   91   288 
Region of Enrollment 
[Units: Participants]
     
Colombia   105   54   159 
Honduras   106   52   158 
Mexico   119   58   177 
Puerto Rico   71   35   106 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination ]

2.  Primary:   Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination ]

3.  Primary:   Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination ]

4.  Primary:   Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine   [ Time Frame: Day 0 (before each vaccination) and Day 28 post each vaccination ]

5.  Primary:   Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine   [ Time Frame: Day 0 (before each vaccination) and Day 28 post each vaccination ]

6.  Primary:   Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine   [ Time Frame: Day 0 (before each vaccination) and Day 28 post each vaccination ]

7.  Primary:   Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (before each vaccination) and Day 28 post-each vaccination ]

8.  Primary:   Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (before each vaccination) and Day 28 post each vaccination ]

9.  Primary:   Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (before each vaccination) and Day 28 post each vaccination ]

10.  Primary:   Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (pre each vaccination) and Day 28 post each vaccination ]

11.  Primary:   Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination ]

12.  Primary:   Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination ]

13.  Primary:   Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine   [ Time Frame: Day 0 up to Day 14 post-each vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: 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: NCT00993447     History of Changes
Other Study ID Numbers: CYD13
UTN: U1111-1111-5511
Study First Received: October 9, 2009
Results First Received: October 4, 2016
Last Updated: October 4, 2016
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Honduras: Secretaria de Salud, Subsecretaria de Riesgos Poblacionales
Mexico: Ministry of Health