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: October 16, 2015
Last verified: October 2015
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.
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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  
Number of Participants  
[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:
Publications automatically indexed to this study:

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: October 16, 2015
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