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Trial record 50 of 1402 for:    Peru

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00788151
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : July 29, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.

Primary Objectives:

  • To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
  • To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
  • To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

Condition or disease Intervention/treatment Phase
Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 Biological: Pneumococcal polysaccharide vaccine Phase 2

Detailed Description:
Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru
Actual Study Start Date : September 26, 2008
Actual Primary Completion Date : February 16, 2010
Actual Study Completion Date : August 16, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: CYD Dengue vaccine group
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4
0.5 mL, Subcutaneous (SC)
Other Name: ChimeriVax™

Placebo Comparator: Control group
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Biological: Pneumococcal polysaccharide vaccine
0.5 mL, SC
Other Name: Pneumo23®




Primary Outcome Measures :
  1. Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo [ Time Frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.

  2. Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.

  3. Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.


Secondary Outcome Measures :
  1. Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

  2. Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

  3. Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

  4. Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution.

  5. Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

  6. Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

  7. Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

  8. Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution.

  9. Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

  10. Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

  11. Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution.

  12. Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

  13. Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3 ]
    GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

  14. Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 1 ]
    Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

  15. GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1 and 28 days Post-Injection 1 ]
    GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

  16. GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 ]
    GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 2 to 11 years on the day of inclusion.
  • Participant in good health, based on medical history, physical examination and laboratory parameters.
  • Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
  • Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
  • For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
  • Documented receipt of yellow fever vaccine since at least one month before the first vaccination.

Exclusion Criteria :

  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
  • For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the trial.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
  • Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
  • Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
  • Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
  • Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
  • Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
  • Known previous vaccination with pneumococcal polysaccharide vaccine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788151


Locations
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Peru
Chulucanas Morropon, Piura, Peru
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur SA

Additional Information:
Publications of Results:
Other Publications:
Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00788151     History of Changes
Other Study ID Numbers: CYD24
2014-001711-40 ( EudraCT Number )
First Posted: November 10, 2008    Key Record Dates
Results First Posted: July 29, 2019
Last Update Posted: August 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue virus
Dengue fever
Dengue Hemorrhagic fever
Dengue diseases
Dengue vaccine
Additional relevant MeSH terms:
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Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs