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Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01373281
First received: June 8, 2011
Last updated: March 24, 2016
Last verified: March 2016
Results First Received: September 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Interventions: Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
Biological: Placebo: NaCl 0.9%

  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 subjects were enrolled from 03 June 2011 to 01 December 2011 at 9 sites in Indonesia, 5 in Malaysia, 3 in Thailand, 5 in Philippines, and 2 in Vietnam.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 10275 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 3 subjects were not vaccinated and were excluded from the Full Analysis Set for Efficacy and the Safety Analysis Set.

Reporting Groups
  Description
CYD Dengue Vaccine Group Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Placebo Group Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.

Participant Flow:   Overall Study
    CYD Dengue Vaccine Group   Placebo Group
STARTED   6851   3424 
COMPLETED   6772   3379 
NOT COMPLETED   79   45 
Withdrawal by Subject                52                31 
Protocol Violation                13                4 
Lost to Follow-up                4                1 
Adverse Event                4                4 
Serious adverse event                6                5 



  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 Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Placebo Group Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Total Total of all reporting groups

Baseline Measures
   CYD Dengue Vaccine Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 6851   3424   10275 
Age 
[Units: Participants]
     
<=18 years   6851   3424   10275 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age Continuous   8.8  (3.45)   8.8  (3.42)   8.8  (3.44) 
Gender 
[Units: Participants]
     
Female   3524   1767   5291 
Male   3327   1657   4984 
Region of Enrollment 
[Units: Participants]
     
Philippines   2335   1166   3501 
Malaysia   937   464   1401 
Indonesia   1246   624   1870 
Thailand   778   392   1170 
Vietnam   1555   778   2333 


  Outcome Measures
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1.  Primary:   Number of Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine   [ Time Frame: 28 days and up to 13 months post-injection 3 ]

2.  Primary:   The Person-years at Risk for Participants With Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine   [ Time Frame: 28 days and up to 14 months post-injection 3 ]

3.  Primary:   Density Incidence of Symptomatic Virologically Confirmed Dengue Cases Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine   [ Time Frame: 28 days and up to 14 months post-injection 3 ]

4.  Secondary:   Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With CYD Dengue Tetravalent Vaccine   [ Time Frame: Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07) ]

5.  Secondary:   Percentage of Flavi Virus-Immuned 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: Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07) ]

6.  Secondary:   Percentage of Subjects With Solicited Injection-site and Systemic Reactions Following Any and Each Injection With CYD Dengue Tetravalent Vaccine   [ 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:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01373281     History of Changes
Other Study ID Numbers: CYD14
UTN: U1111-1116-4957 ( Other Identifier: WHO )
Study First Received: June 8, 2011
Results First Received: September 15, 2015
Last Updated: March 24, 2016
Health Authority: United States: Food and Drug Administration
Philippines: Department of Health
Malaysia: Ministry of Health
Indonesia: National Agency of Drug and Food Control
Vietnam: Ministry of Health