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Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

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ClinicalTrials.gov Identifier: NCT01254422
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 6, 2010
Results First Submitted Date  ICMJE May 23, 2019
Results First Posted Date  ICMJE July 29, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE December 2, 2010
Actual Primary Completion Date September 28, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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-any and each vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity.
  • Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine [ Time Frame: Day 0 up to Day 14 post-each vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample.
  • Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine [ Time Frame: Day 0 up to Day 14 post-each vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
  • 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: Pre-Injection 1 and Post-Injections 2 and 3 ]
    Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
  • Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Pre-Injection 1 and Post-Injections 2 and 3 ]
    Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT.
  • Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Pre-Injection 1 and Post-Injections 2 and 3 ]
    GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT.
  • 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: Flavivirus-Immune Participants [ Time Frame: Pre-Injection 1 and Post-Injections 2 and 3 ]
    Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
  • 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: Flavivirus-Naive Participants [ Time Frame: Pre-Injection 1 and Post-Injections 2 and 3 ]
    Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
  • GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Pre-Injection 1 and Post-Injections 2 and 3 ]
    GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
  • GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Pre-Injection 1 and Post- Injections 2 and 3 ]
    GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • Information concerning the safety of CYD Dengue vaccine following each dose of vaccine [ Time Frame: Up to 6 months post-dose 3 ]
    Safety parameters: solicited injection site pain, erythema, and swelling; solicited systemic reactions - fever (temperature), headache, malaise, myalgia, and asthenia; and unsolicited adverse events.
  • Information on the antibody levels against each of the four parental dengue virus strains of CYD dengue vaccine constructs post Dose 2 and post Dose 3 [ Time Frame: 28 days post dose 2 and 3, respectively. ]
Change History Complete list of historical versions of study NCT01254422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Official Title  ICMJE Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Brief Summary

The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.

Primary Objectives:

  • To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection.
  • To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.
Detailed Description Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue Fever
  • Dengue Hemorrhagic Fever
Intervention  ICMJE
  • Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
    0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
    Other Name: CYD Dengue vaccine
  • Biological: Placebo: NaCl 0.9%
    0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
    Other Name: Saline
Study Arms  ICMJE
  • Experimental: CYD Dengue vaccine group
    Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
    Intervention: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
  • Placebo Comparator: Placebo Group
    Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
    Intervention: Biological: Placebo: NaCl 0.9%
Publications * Hss AS, Koh MT, Tan KK, Chan LG, Zhou L, Bouckenooghe A, Crevat D, Hutagalung Y. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2-11 years in Malaysia: a randomized, placebo-controlled, Phase III study. Vaccine. 2013 Dec 2;31(49):5814-21. doi: 10.1016/j.vaccine.2013.10.013. Epub 2013 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2010)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date September 28, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 2 to 11 years on the day of inclusion
  • Assent form was signed and dated by the participant (for participants ≥ 7 years) and informed consent form was signed and dated by the parent(s) or another legally accepted representative, and by an independent witness if the two parents or legally accepted representative were illiterate
  • Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all trial procedures
  • Participants in good health, based on medical history and physical examination
  • For a female participant of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination

Exclusion Criteria:

  • Known pregnancy, or a positive urine pregnancy test (for female participant of child-bearing potential only)
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion
  • Participants who plan to move to another country/region within the 18 coming months
  • Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254422
Other Study ID Numbers  ICMJE CYD32
UTN: U1111-1115-6579 ( Other Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Singapore
PRS Account Sanofi
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP