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Phase 2 N=300 Randomized Quadruple-blind Prevention

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

Dengue Virus · Dengue Fever · Dengue Hemorrhagic Fever · Dengue Diseases

Enrolled (actual)
300
Serious AEs
2.0%
Results posted
Jul 2019
Primary outcome: Primary: 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 — 20.6; 17.2; 0.0; 0.0 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 (Biological); Pneumococcal polysaccharide vaccine (Biological)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Sanofi Pasteur, a Sanofi Company
Primary completion
Feb 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
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
20.6; 17.2; 0.0; 0.0; 7.5; 4.0
PRIMARY
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
19.0; 16.0; 0.0; 0.0; 11.0; 6.0
PRIMARY
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
22.2; 18.4; 0.0; 0.0; 4.0; 2.0
SECONDARY
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
29.6; 38.4; 55.4; 37.9; 42.3; 39.1
SECONDARY
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
30.0; 32.0; 54.7; 33.3; 38.7; 31.1
SECONDARY
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
29.3; 44.9; 56.1; 42.6; 45.8; 46.8
SECONDARY
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
30.6; 36.4; 94.7; 39.1; 96.2; 48.3
SECONDARY
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
30.3; 30.0; 96.7; 31.1; 97.8; 41.9
SECONDARY
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
30.9; 42.9; 92.6; 46.8; 94.8; 54.3
SECONDARY
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
32.2; 40.4; 80.8; 40.0; 69.8; 40.9
SECONDARY
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
31.0; 34.0; 78.9; 35.4; 67.7; 32.6
SECONDARY
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
33.3; 46.9; 82.7; 44.7; 71.9; 48.9
SECONDARY
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
37.6; 48.5; 100.0; 57.6; 99.5; 73.0
SECONDARY
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
39.4; 42.0; 100.0; 64.4; 100.0; 74.4
SECONDARY
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
35.7; 55.1; 100.0; 51.1; 99.0; 71.7
SECONDARY
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
17.4; 22.8; 125; 26.4; 179; 38.1
SECONDARY
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
81.4; 83.8; 86.5; 83.2; 68.0; 74.0
SECONDARY
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
32.3; 36.0; 43.7; 36.0; 15.9; 20.5
SECONDARY
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
18.8; 23.9; 43.1; 22.8; 29.2; 26.0

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).

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00788151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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