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CompletedNCT00788151Updated Apr 5, 2022Results posted

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

A Phase 2 interventional study of CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 and Pneumococcal polysaccharide vaccine in Dengue Virus, Dengue Fever and Dengue Hemorrhagic Fever, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Peru. Open to participants aged 2 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
2 Years to 11 Years
Sex
All
01

Study 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).
Read the 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.

02

Conditions studied

  • Dengue Virus
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Diseases

Keywords

  • Dengue virus
  • Dengue fever
  • Dengue Hemorrhagic fever
  • Dengue diseases
  • Dengue vaccine
03

In context

Dengue

284 studies on the registry are indexed under Dengue; 44 are open to participants now.

This study's enrollment of 300 is above the median of 132 across 199 interventional studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

First submitted after Sanofi Pasteur became part of Sanofi.

Browse Sanofi Pasteur studies →All Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalCYD Dengue Vaccine Serotypes 1, 2, 3, and 4

    0.5 mL, Subcutaneous (SC)

    Also known as: ChimeriVax™

  • BiologicalPneumococcal polysaccharide vaccine

    0.5 mL, SC

    Also known as: Pneumo23®

06

What researchers measure

Primary outcomes

  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

    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.

    Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

  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

    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.

    Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

  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

    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.

    Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

Secondary outcomes

  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

    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

  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

    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

  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

    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

  4. Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \>= 10 1/dilution.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  5. Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  6. Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  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

    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

  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

    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>= 10 1/dilution.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

  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

    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

  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

    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  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

    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>= 10 1/dilution.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  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

    Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  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

    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.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3

  14. Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo

    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.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 1

  15. GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo

    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.

    Time frame: Pre-Injection 1 and 28 days Post-Injection 1

  16. GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo

    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.

    Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

07

Results

Posted Jul 29, 2019

Participant flow

Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.

Participant flow — Overall Study
MilestoneCYD Dengue Vaccine GroupControl Group
Started200100
Received vaccination 119999
Received vaccination 218892
Received vaccination 318690
Completed18690
Not completed1410
Withdrew: Other adverse event02
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject136
Withdrew: Enrolled but not treated11

Outcome measures

PrimaryPercentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo

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.

Time frame:
Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Inj. site Pain; Post-Inj. 1 (2-11 years)20.617.2
Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years)0.00.0
Inj. site Erythema; Post-Inj. 1 (2-11 years)7.54.0
Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years)0.00.0
Inj. site Swelling; Post-Inj. 1 (2-11 years)5.55.1
Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years)0.00.0
Inj. site Pain; Post-Inj. 2 (2-11 years)19.717.4
Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years)0.01.1
Inj. site Erythema; Post-Inj. 2 (2-11 years)4.31.1
Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years)0.00.0
Inj. site Swelling; Post-Inj. 2 (2-11 years)2.10.0
Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years)0.00.0
Inj. site Pain; Post-Inj. 3 (2-11 years)17.732.2
Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years)0.52.2
Inj. site Erythema; Post-Inj. 3 (2-11 years)4.311.1
Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years)0.03.3
Inj. site Swelling; Post-Inj. 3 (2-11 years)3.28.9
Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years)0.03.3
Fever; Post-Inj. 1 (2-11 years)31.310.1
Grade 3 Fever; Post-Inj. 1 (2-11 years)3.50.0
Headache; Post-Inj. 1 (2-11 years)35.716.2
Grade 3 Headache; Post-Inj. 1 (2-11 years)0.50.0
Malaise; Post-Inj. 1 (2-11 years)33.723.2
Grade 3 Malaise; Post-Inj. 1 (2-11 years)0.50.0
Myalgia; Post-Inj. 1 (2-11 years)19.113.1
Grade 3 Myalgia; Post-Inj. 1 (2-11 years)0.00.0
Asthenia; Post-Inj. 1 (2-11 years)13.613.1
Grade 3 Asthenia; Post-Inj. 1 (2-11 years)0.50.0
Fever; Post-Inj. 2 (2-11 years)19.716.3
Grade 3 Fever; Post-Inj. 2 (2-11 years)0.50.0
Headache; Post-Inj. 2 (2-11 years)22.319.6
Grade 3 Headache; Post-Inj. 2 (2-11 years)0.51.1
Malaise; Post-Inj. 2 (2-11 years)18.116.3
Grade 3 Malaise; Post-Inj. 2 (All ages)0.52.2
Myalgia; Post-Inj. 2 (2-11 years)14.910.9
Grade 3 Myalgia; Post-Inj. 2 (2-11 years)1.10.0
Asthenia; Post-Inj. 2 (2-11 years)11.27.6
Grade 3 Asthenia; Post-Inj. 2 (2-11 years)0.51.1
Fever; Post-Inj. 3 (2-11 years)18.422.5
Grade 3 Fever; Post-Inj. 3 (2-11 years)0.03.4
Headache; Post-Inj. 3 (2-11 years)18.827.8
Grade 3 Headache; Post-Inj. 3 (2-11 years)0.03.3
Malaise; Post-Inj. 3 (2-11 years)16.723.3
Grade 3 Malaise; Post-Inj. 3 (2-11 years)0.02.2
Myalgia; Post-Inj. 3 (2-11 years)13.426.7
Grade 3 Myalgia; Post-Inj. 3 (2-11 years)0.02.2
Asthenia; Post-Inj. 3 (2-11 years)10.216.7
Grade 3 Asthenia; Post-Inj. 3 (2-11 years)0.01.1
PrimaryPercentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

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.

Time frame:
Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Inj. site Pain: Post-Inj.1 (2-5 years)19.016.0
Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years)0.00.0
Inj. site Erythema; Post-Inj. 1 (2-5 years)11.06.0
Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years)0.00.0
Inj. site Swelling; Post-Inj. 1 (2-5 years)6.08.0
Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years)0.00.0
Inj. site Pain; Post-Inj. 2 (2-5 years)17.415.6
Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years)0.02.2
Inj. site Erythema; Post-Inj. 2 (2-5 years)4.30.0
Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years)0.00.0
Inj. site Swelling; Post-Inj. 2 (2-5 years)2.20.0
Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years)0.00.0
Inj. site Pain; Post-Inj. 3 (2-5 years)14.423.3
Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years)0.04.7
Inj. site Erythema; Post-Inj. 3 (2-5 years)3.39.3
Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years0.02.3
Inj. site Swelling; Post-Inj. 3 (2-5 years)3.37.0
Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years)0.02.3
Fever; Post-Inj. 1 (2-5 years)36.416.0
Grade 3 Fever; Post-Inj. 1 (2-5 years)4.00.0
Headache; Post-Inj. 1 (2-5 years)23.08.0
Grade 3 Headache; Post-Inj. 1 (2-5 years)1.00.0
Malaise; Post-Inj. 1 (2-5 years)33.026.0
Grade 3 Malaise; Post-Inj. 1 (2-5 years)1.00.0
Myalgia; Post-Inj. 1 (2-5 years)12.010.0
Grade 3 Myalgia; Post-Inj. 1 (2-5 years)0.00.0
Asthenia; Post-Inj. 1 (2-5 years)13.012.0
Grade 3 Asthenia; Post-Inj. 1 (2-5 years)1.00.0
Fever; Post-Inj. 2 (2-5 years)23.917.8
Grade 3 Fever; Post-Inj. 2 (2-5 years)0.00.0
Headache; Post-Inj. 2 (2-5 years)14.16.7
Grade 3 Headache; Post-Inj. 2 (2-5 years)0.00.0
Malaise; Post-Inj. 2 (2-5 years)15.213.3
Grade 3 Malaise; Post-Inj. 2 (2-5 years)1.12.2
Myalgia; Post-Inj. 2 (2-5 years)9.86.7
Grade 3 Myalgia; Post-Inj. 2 (2-5 years)1.10.0
Asthenia; Post-Inj. 2 (2-5 years)9.88.9
Grade 3 Asthenia; Post-Inj. 2 (2-5 years)1.12.2
Fever; Post-Inj. 3 (2-5 years)16.926.2
Grade 3 Fever; Post-Inj. 3 (2-5 years)0.07.1
Headache; Post-Inj. 3 (2-5 years)6.718.6
Grade 3 Headache; Post-Inj. 3 (2-5 years)0.02.3
Malaise; Post-Inj. 3 (2-5 years)6.723.3
Grade 3 Malaise; Post-Inj. 3 (2-5 years)0.02.3
Myalgia; Post-Inj. 3 (2-5 years)6.720.9
Grade 3 Myalgia; Post-Inj. 3 (2-5 years)0.02.3
Asthenia; Post-Inj. 3 (2-5 years)4.423.3
Grade 3 Asthenia; Post-Inj. 3 (2-5 years)0.02.3
PrimaryPercentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

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.

Time frame:
Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Inj. site Pain; Post-Inj.1 (6-11 years)22.218.4
Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years)0.00.0
Inj. site Erythema; Post-Inj. 1 (6-11 years)4.02.0
Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years)0.00.0
Inj. site Swelling; Post-Inj. 1 (6-11 years)5.12.0
Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years)0.00.0
Inj. site Pain; Post-Inj. 2 (6-11 years)21.919.1
Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years)0.00.0
Inj. site Erythema; Post-Inj. 2 (6-11 years)4.22.1
Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years)0.00.0
Inj. site Swelling; Post-Inj. 2 (6-11 years)2.10.0
Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years)0.00.0
Inj. site Pain; Post-Inj. 3 (6-11 years)20.840.4
Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years)1.00.0
Inj. site Erythema; Post-Inj. 3 (6-11 years)5.212.8
Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years)0.04.3
Inj. site Swelling; Post-Inj. 3 (6-11 years)3.110.6
Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years)0.04.3
Fever; Post-Inj. 1 (6-11 years)26.34.1
Grade 3 Fever; Post-Inj. 1 (6-11 years)3.00.0
Headache; Post-Inj. 1 (6-11 years)48.524.5
Grade 3 Headache; Post-Inj. 1 (6-11 years)0.00.0
Malaise; Post-Inj. 1 (6-11 years)34.320.4
Grade 3 Malaise; Post-Inj. 1 (6-11 years)0.00.0
Myalgia; Post-Inj. 1 (6-11 years)26.316.3
Grade 3 Myalgia; Post-Inj. 1 (6-11 years)0.00.0
Asthenia; Post-Inj. 1 (6-11 years)14.114.3
Grade 3 Asthenia; Post-Inj. 1 (6-11 years)0.00.0
Fever; Post-Inj. 2 (6-11 years)15.614.9
Grade 3 Fever; Post-Inj. 2 (6-11 years)1.00.0
Headache; Post-Inj. 2 (6-11 years)30.231.9
Grade 3 Headache; Post-Inj. 2 (6-11 years)1.02.1
Malaise; Post-Inj. 2 (6-11 years)20.819.1
Grade 3 Malaise; Post-Inj. 2 (6-11 years)0.02.1
Myalgia; Post-Inj. 2 (6-11 years)19.814.9
Grade 3 Myalgia; Post-Inj. 2 (6-11 years)1.00.0
Asthenia; Post-Inj. 2 (6-11 years)12.56.4
Grade 3 Asthenia; Post-Inj. 2 (6-11 years)0.00.0
Fever; Post-Inj. 3 (6-11 years)19.819.1
Grade 3 Fever; Post-Inj. 3 (6-11 years)0.00.0
Headache; Post-Inj. 3 (6-11 years)30.236.2
Grade 3 Headache; Post-Inj. 3 (6-11 years)0.04.3
Malaise; Post-Inj. 3 (6-11 years)26.023.4
Grade 3 Malaise; Post-Inj. 3 (6-11 years)0.02.1
Myalgia; Post-Inj. 3 (6-11 years)19.831.9
Grade 3 Myalgia; Post-Inj. 3 (6-11 years)0.02.1
Asthenia; Post-Inj. 3 (6-11 years)15.610.6
Grade 3 Asthenia; Post-Inj. 3 (6-11 years)0.00.0
SecondaryPercentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Dengue parental serotype 1; Pre-Inj. 129.638.4
Dengue parental serotype 1; 28 days Post-Inj. 155.437.9
Dengue parental serotype 1; Pre-Inj. 242.339.1
Dengue parental serotype 1; 28 days Post-Inj. 298.439.1
Dengue parental serotype 1; Pre-Inj. 374.741.8
Dengue parental serotype 1; 28 days Post-Inj. 398.446.1
Dengue parental serotype 2; Pre-Inj. 117.121.2
Dengue parental serotype 2; 28 days Post-Inj. 140.421.1
Dengue parental serotype 2; Pre-Inj. 232.820.4
Dengue parental serotype 2; 28 days Post-Inj. 268.116.3
Dengue parental serotype 2; Pre-Inj. 335.520.9
Dengue parental serotype 2; 28 days Post-Inj. 379.020.2
Dengue parental serotype 3; Pre-Inj. 130.738.4
Dengue parental serotype 3; 28 days Post-Inj.168.438.9
Dengue parental serotype 3; Pre-Inj. 251.939.8
Dengue parental serotype 3; 28 days Post-Inj. 2100.040.2
Dengue parental serotype 3; Pre-Inj. 372.639.6
Dengue parental serotype 3; 28 days Post-Inj. 398.943.8
Dengue parental serotype 4; Pre-Inj. 114.118.2
Dengue parental serotype 4; 28 days Post-Inj. 174.118.9
Dengue parental serotype 4; Pre-Inj. 257.720.4
Dengue parental serotype 4; 28 days Post-Inj. 297.919.6
Dengue parental serotype 4; Pre-Inj. 382.818.7
Dengue parental serotype 4; 28 days Post-Inj. 398.923.6
SecondaryPercentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Dengue parental serotype 1; Pre-Inj. 130.032.0
Dengue parental serotype 1; 28 days Post-Inj. 154.733.3
Dengue parental serotype 1; Pre-Inj. 238.731.1
Dengue parental serotype 1; 28 days Post-Inj. 297.831.1
Dengue parental serotype 1; Pre-Inj. 372.236.4
Dengue parental serotype 1; 28 days Post-Inj. 398.944.2
Dengue parental serotype 2; Pre-Inj. 114.016.0
Dengue parental serotype 2; 28 days Post-Inj. 132.616.7
Dengue parental serotype 2; Pre-Inj. 229.015.2
Dengue parental serotype 2; 28 days Post-Inj. 264.111.1
Dengue parental serotype 2; Pre-Inj. 328.918.2
Dengue parental serotype 2; 28 days Post-Inj. 377.820.9
Dengue parental serotype 3; Pre-Inj. 128.032.0
Dengue parental serotype 3; 28 days Post-Inj. 162.135.4
Dengue parental serotype 3; Pre-Inj. 245.232.6
Dengue parental serotype 3; 28 days Post-Inj. 2100.033.3
Dengue parental serotype 3; Pre-Inj. 370.034.1
Dengue parental serotype 3; 28 days Post-Inj. 3100.039.5
Dengue parental serotype 4; Pre-Inj. 113.018.0
Dengue parental serotype 4; 28 days Post-Inj. 174.722.9
Dengue parental serotype 4; Pre-Inj. 260.217.4
Dengue parental serotype 4; 28 days Post-Inj. 2100.020.0
Dengue parental serotype 4; Pre-Inj. 387.822.7
Dengue parental serotype 4; 28 days Post-Inj. 3100.027.9
SecondaryPercentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Dengue parental serotype 1; Pre-Inj. 129.344.9
Dengue parental serotype 1; 28 days Post-Inj. 156.142.6
Dengue parental serotype 1; Pre-Inj. 245.846.8
Dengue parental serotype 1; 28 days Post-Inj. 299.046.8
Dengue parental serotype 1; Pre-Inj. 377.146.8
Dengue parental serotype 1; 28 days Post-Inj. 397.947.8
Dengue parental serotype 2; Pre-Inj. 120.226.5
Dengue parental serotype 2; 28 days Post-Inj. 148.025.5
Dengue parental serotype 2; Pre-Inj. 236.525.5
Dengue parental serotype 2; 28 days Post-Inj. 271.921.3
Dengue parental serotype 2; Pre-Inj. 341.723.4
Dengue parental serotype 2; 28 days Post-Inj. 380.219.6
Dengue parental serotype 3; Pre-Inj. 133.344.9
Dengue parental serotype 3; 28 days Post-Inj 174.542.6
Dengue parental serotype 3; Pre-Inj. 258.346.8
Dengue parental serotype 3; 28 days Post-Inj. 2100.046.8
Dengue parental serotype 3; Pre-Inj. 375.044.7
Dengue parental serotype 3; 28 days Post-Inj. 397.947.8
Dengue parental serotype 4; Pre-Inj. 115.218.4
Dengue parental serotype 4; 28 days Post-Inj. 173.514.9
Dengue parental serotype 4; Pre-Inj. 255.223.4
Dengue parental serotype 4; 28 days Post-Inj. 295.819.1
Dengue parental serotype 4; Pre-Inj. 378.114.9
Dengue parental serotype 4; 28 days Post-Inj. 397.919.6
SecondaryPercentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \>= 10 1/dilution.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Dengue parental serotype 1; Pre-Inj. 130.636.4
Dengue parental serotype 1; 28 days Post-Inj. 294.739.1
Dengue parental serotype 1; 28 days Post-Inj. 396.248.3
Dengue parental serotype 2; Pre-Inj. 131.541.4
Dengue parental serotype 2; 28 days Post-Inj. 297.943.5
Dengue parental serotype 2; 28 days Post-Inj. 398.447.2
Dengue parental serotype 3; Pre-Inj. 135.046.5
Dengue parental serotype 3; 28 days Post-Inj. 298.951.1
Dengue parental serotype 3; 28 days Post-Inj. 398.467.4
Dengue parental serotype 4; Pre-Inj. 119.322.2
Dengue parental serotype 4; 28 days Post-Inj. 298.435.9
Dengue parental serotype 4; 28 days Post-Inj. 398.948.3
SecondaryPercentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Dengue parental serotype 1; Pre-Inj. 130.330.0
Dengue parental serotype 1; 28 days Post-Inj. 296.731.1
Dengue parental serotype 1; 28 days Post-Inj. 397.841.9
Dengue parental serotype 2; Pre-Inj. 130.338.0
Dengue parental serotype 2; 28 days Post-Inj. 296.737.8
Dengue parental serotype 2; 28 days Post-Inj. 3100.044.2
Dengue parental serotype 3; Pre-Inj. 135.438.0
Dengue parental serotype 3; 28 days Post-Inj. 298.953.3
Dengue parental serotype 3; 28 days Post-Inj. 398.965.1
Dengue parental serotype 4; Pre-Inj. 116.222.0
Dengue parental serotype 4; 28 days Post-Inj. 297.835.6
Dengue parental serotype 4; 28 days Post-Inj. 3100.046.5
SecondaryPercentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Number · Percentage of participants
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Dengue parental serotype 1; Pre-Inj. 130.942.9
Dengue parental serotype 1; 28 days Post-Inj. 292.646.8
Dengue parental serotype 1; 28 days Post-Inj. 394.854.3
Dengue parental serotype 2; Pre-Inj. 132.744.9
Dengue parental serotype 2; 28 days Post-Inj. 298.948.9
Dengue parental serotype 2; 28 days Post-Inj. 396.950.0
Dengue parental serotype 3; Pre-Inj. 134.755.1
Dengue parental serotype 3; 28 days Post-Inj. 298.948.9
Dengue parental serotype 3; 28 days Post-Inj. 397.969.6
Dengue parental serotype 4; Pre-Inj. 122.422.4
Dengue parental serotype 4; 28 days Post-Inj. 298.936.2
Dengue parental serotype 4; 28 days Post-Inj. 397.950.0
SecondaryPercentage 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

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 positive serotype; Pre-Inj. 132.240.4
At least 1 positive serotype; 28 days Post-Inj. 180.840.0
At least 1 positive serotype; Pre-Inj. 269.840.9
At least 1 positive serotype; 28 days Post-Inj. 2100.042.4
At least 1 positive serotype; Pre-Inj. 388.742.9
At least 1 positive serotype; 28 days Post-Inj. 398.948.3
At least 2 positive serotypes; Pre-Inj. 129.138.4
At least 2 positive serotypes; 28 days Post-Inj. 166.838.9
At least 2 positive serotypes; Pre-Inj. 249.239.8
At least 2 positive serotypes; 28 days Post-Inj. 2100.040.2
At least 2 positive serotypes; Pre-Inj. 375.339.6
At least 2 positive serotypes; 28 days Post-Inj. 398.943.8
At least 3 positive serotypes; Pre-Inj. 119.624.2
At least 3 positive serotypes; 28 days Post-Inj. 152.825.3
At least 3 positive serotypes; Pre-Inj. 238.122.6
At least 3 positive serotypes; 28 days Post-Inj. 298.421.7
At least 3 positive serotypes; Pre-Inj. 367.725.3
At least 3 positive serotypes; 28 days Post-Inj. 398.425.8
All 4 positive serotypes; Pre-Inj. 110.613.1
All 4 positive serotypes; 28 days Post-Inj. 137.812.6
All 4 positive serotypes; Pre-Inj. 227.516.1
All 4 positive serotypes; 28 days Post-Inj. 266.010.9
All 4 positive serotypes; Pre-Inj. 333.913.2
All 4 positive serotypes; 28 days Post-Inj. 379.015.7
SecondaryPercentage 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

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>= 10 1/dilution.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 positive serotype; Pre-Inj. 131.034.0
At least 1 positive serotype; 28 days Post-Inj. 178.935.4
At least 1 positive serotype; Pre-Inj. 267.732.6
At least 1 positive serotype; 28 days Post-Inj. 2100.033.3
At least 1 positive serotype; Pre-Inj. 390.036.4
At least 1 positive serotype; 28 days Post-Inj. 3100.044.2
At least 2 positive serotypes; Pre-Inj. 128.032.0
At least 2 positive serotypes; 28 days Post-Inj. 165.335.4
At least 2 positive serotypes; Pre-Inj. 246.232.6
At least 2 positive serotypes; 28 days Post-Inj. 2100.033.3
At least 2 positive serotypes; Pre-Inj. 375.634.1
At least 2 positive serotypes; 28 days Post-Inj. 3100.039.5
At least 3 positive serotypes; Pre-Inj. 117.024.0
At least 3 positive serotypes; 28 days Post-Inj. 148.427.1
At least 3 positive serotypes; Pre-Inj. 233.319.6
At least 3 positive serotypes; 28 days Post-Inj. 298.920.0
At least 3 positive serotypes; Pre-Inj. 365.627.3
At least 3 positive serotypes; 28 days Post-Inj. 398.930.2
All 4 positive serotypes; Pre-Inj. 19.08.0
All 4 positive serotypes; 28 days Post-Inj. 131.610.4
All 4 positive serotypes; Pre-Inj. 225.810.9
All 4 positive serotypes; 28 days Post-Inj. 263.08.9
All 4 positive serotypes; Pre-Inj. 327.813.6
All 4 positive serotypes; 28 days Post-Inj. 377.818.6
SecondaryPercentage 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

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 positive serotype; Pre-Inj. 133.346.9
At least 1 positive serotype; 28 days Post-Inj. 182.744.7
At least 1 positive serotype; Pre-Inj. 271.948.9
At least 1 positive serotype; 28 days Post-Inj. 2100.051.1
At least 1 positive serotype; Pre-Inj. 387.548.9
At least 1 positive serotype; 28 days Post-Inj. 397.952.2
At least 2 positive serotypes; Pre-Inj. 130.344.9
At least 2 positive serotypes; 28 days Post-Inj. 168.442.6
At least 2 positive serotypes; Pre-Inj. 252.146.8
At least 2 positive serotypes; 28 days Post-Inj. 2100.046.8
At least 2 positive serotypes; Pre-Inj. 375.044.7
At least 2 positive serotypes; 28 days Post-Inj. 397.947.8
At least 3 positive serotypes; Pre-Inj. 122.224.5
At least 3 positive serotypes; 28 days Post-Inj. 157.123.4
At least 3 positive serotypes; Pre-Inj. 242.725.5
At least 3 positive serotypes; 28 days Post-Inj. 297.923.4
At least 3 positive serotypes; Pre-Inj. 369.823.4
At least 3 positive serotypes; 28 days Post-Inj. 397.921.7
All 4 positive serotypes; Pre-Inj. 112.118.4
All 4 positive serotypes; 28 days Post-Inj. 143.914.9
All 4 positive serotypes; Pre-Inj. 229.221.3
All 4 positive serotypes; 28 days Post-Inj. 268.812.8
All 4 positive serotypes; Pre-Inj. 339.612.8
All 4 positive serotypes; 28 days Post-Inj. 380.213.0
SecondaryPercentage 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

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 positive serotype; Pre-Inj. 137.648.5
At least 1 positive serotype; 28 days Post-Inj. 2100.057.6
At least 1 positive serotype; 28 days Post-Inj. 399.573.0
At least 2 positive serotypes; Pre-Inj. 131.541.4
At least 2 positive serotypes; 28 days Post-Inj. 299.541.3
At least 2 positive serotypes; 28 days Post-Inj. 399.552.8
At least 3 positive serotypes; Pre-Inj. 129.937.4
At least 3 positive serotypes; 28 days Post-Inj. 298.441.3
At least 3 positive serotypes; 28 days Post-Inj. 398.446.1
All 4 positive serotypes; Pre-Inj. 117.319.2
All 4 positive serotypes; 28 days Post-Inj. 290.929.3
All 4 positive serotypes; 28 days Post-Inj. 394.139.3
SecondaryPercentage 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

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>= 10 1/dilution.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 positive serotype; Pre-Inj. 139.442.0
At least 1 positive serotype; 28 days Post-Inj. 2100.064.4
At least 1 positive serotype; 28 days Post-Inj. 3100.074.4
At least 2 positive serotypes; Pre-Inj. 130.336.0
At least 2 positive serotypes; 28 days Post-Inj. 2100.033.3
At least 2 positive serotypes; 28 days Post-Inj. 3100.044.2
At least 3 positive serotypes; Pre-Inj. 128.334.0
At least 3 positive serotypes; 28 days Post-Inj. 297.833.3
At least 3 positive serotypes; 28 days Post-Inj. 310041.9
All 4 positive serotypes; Pre-Inj. 114.116.0
All 4 positive serotypes; 28 days Post-Inj. 290.226.7
All 4 positive serotypes; 28 days Post-Inj. 396.737.2
SecondaryPercentage 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

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 positive serotype; Pre-Inj. 135.755.1
At least 1 positive serotype; 28 days Post-Inj. 2100.051.1
At least 1 positive serotype; 28 days Post-Inj. 399.071.7
At least 2 positive serotypes; Pre-Inj. 132.746.9
At least 2 positive serotypes; 28 days Post-Inj. 298.948.9
At least 2 positive serotypes; 28 days Post-Inj. 399.060.9
At least 3 positive serotypes; Pre-Inj. 131.640.8
At least 3 positive serotypes; 28 days Post-Inj. 298.948.9
At least 3 positive serotypes; 28 days Post-Inj. 396.950.0
All 4 positive serotypes; Pre-Inj. 120.422.4
All 4 positive serotypes; 28 days Post-Inj. 291.631.9
All 4 positive serotypes; 28 days Post-Inj. 391.741.3
SecondaryGeometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo

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.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 2 and 3
Reported as:
Geometric mean · Titers (1/dilution)
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
Titers (1/dilution)CYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Inj. 1, All17.4 (13.0 to 23.2)22.8 (14.9 to 34.8)
Serotype 1; 28 days Post-Inj. 2, All125 (98.5 to 159)26.4 (16.7 to 41.8)
Serotype 1; 28 days Post-Inj. 3, All179 (143 to 224)38.1 (23.4 to 62.1)
Serotype 2; Pre-Inj. 1, All14.4 (11.2 to 18.3)18.2 (12.8 to 25.8)
Serotype 2; 28 days Post-Inj. 2, All151 (128 to 178)17.3 (12.5 to 23.9)
Serotype 2; 28 days Post-Inj. 3, All178 (152 to 207)21.6 (14.8 to 31.5)
Serotype 3; Pre-Inj. 1, All16.4 (12.7 to 21.2)21.8 (15.2 to 31.3)
Serotype 3; 28 days Post-Inj. 2, All155 (129 to 186)26.6 (18.1 to 39.0)
Serotype 3; 28 days Post-Inj. 3, All190 (162 to 224)36.2 (25.1 to 52.0)
Serotype 4; Pre-Inj. 1, All8.12 (6.91 to 9.54)8.94 (6.97 to 11.5)
Serotype 4; 28 days Post-Inj. 2, All144 (126 to 166)12.8 (9.50 to 17.2)
Serotype 4; 28 days Post-Inj. 3, All184 (159 to 212)16.7 (12.2 to 22.8)
Serotype 1; Pre-Inj. 1, 2-5 years16.4 (11.1 to 24.3)16.2 (9.47 to 27.5)
Serotype 1; 28 days Post-Inj. 2, 2-5 years135 (97.2 to 187)19.0 (10.1 to 35.7)
Serotype 1; 28 days Post-Inj. 3, 2-5 years205 (149 to 282)31.3 (14.9 to 65.9)
Serotype 2; Pre-Inj. 1, 2-5 years11.8 (8.94 to 15.6)13.9 (9.31 to 20.6)
Serotype 2; 28 days Post-Inj. 2, 2-5 years135 (109 to 168)13.2 (8.80 to 19.9)
Serotype 2; 28 days Post-Inj. 3, 2-5 years195 (163 to 234)21.8 (12.1 to 39.2)
Serotype 3; Pre-Inj. 1, 2-5 years16.2 (11.2 to 23.4)16.7 (10.2 to 27.4)
Serotype 3; 28 days Post-Inj. 2, 2-5 years171 (131 to 224)26.5 (15.4 to 45.7)
Serotype 3; 28 days Post-Inj. 3, 2-5 years214 (169 to 270)35.0 (20.3 to 60.6)
Serotype 4; Pre-Inj. 1, 2-5 years7.76 (6.20 to 9.70)9.02 (6.27 to 13.0)
Serotype 4; 28 days Post-Inj. 2, 2-5 years165 (134 to 203)14.4 (8.83 to 23.6)
Serotype 4; 28 days Post-Inj. 3, 2-5 years223 (181 to 276)18.7 (11.2 to 31.4)
Serotype 1; Pre-Inj. 1, 6-11 years18.4 (12.0 to 28.4)32.3 (16.6 to 63.1)
Serotype 1; 28 days Post-Inj. 2, 6-11 years116 (81.7 to 165)36.2 (18.5 to 71.0)
Serotype 1; 28 days Post-Inj. 3, 6-11 years157 (115 to 216)45.8 (23.6 to 88.8)
Serotype 2; Pre-Inj. 1, 6-11 years17.5 (11.6 to 26.3)24.0 (13.4 to 43.1)
Serotype 2; 28 days Post-Inj. 2, 6-11 years168 (130 to 216)22.3 (13.4 to 37.0)
Serotype 2; 28 days Post-Inj. 3, 6-11 years163 (127 to 208)21.4 (12.9 to 35.6)
Serotype 3; Pre-Inj. 1, 6-11 years16.6 (11.5 to 24.0)28.6 (16.7 to 48.7)
Serotype 3; 28 days Post-Inj. 2, 6-11 years141 (109 to 182)26.6 (15.1 to 46.8)
Serotype 3; 28 days Post-Inj. 3, 6-11 years171 (137 to 213)37.3 (22.5 to 61.6)
Serotype 4; Pre-Inj. 1, 6-11 years8.50 (6.72 to 10.8)8.87 (6.21 to 12.6)
Serotype 4; 28 days Post-Inj. 2, 6-11 years127 (106 to 153)11.4 (7.96 to 16.3)
Serotype 4; 28 days Post-Inj. 3, 6-11 years152 (126 to 184)15.0 (10.2 to 22.0)
SecondaryPercentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo

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.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 1
Reported as:
Number · Percentage of participants
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Pre-Inj. 1; All participants81.483.8
28 days Post-Inj. 1; All participants86.583.2
Pre-Inj. 1; 2-5 years68.074.0
28 days Post-Inj. 1; 2-5 years76.672.9
Pre-Inj. 1; 6-11 years94.993.9
28 days Post-Inj. 1; 6-11 years95.993.6
SecondaryGMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo

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.

Time frame:
Pre-Injection 1 and 28 days Post-Injection 1
Reported as:
Geometric mean · Titers (1/dilution)
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
Titers (1/dilution)CYD Dengue Vaccine GroupControl Group
Pre-Inj. 1; All participants32.3 (26.5 to 39.4)36.0 (27.1 to 47.7)
28 days Post-Inj. 1; All participants43.7 (36.1 to 52.8)36.0 (27.3 to 47.3)
Pre-Inj. 1; 2-5 years15.9 (12.3 to 20.6)20.5 (13.7 to 30.7)
28 days Post-Inj. 1; 2-5 years22.4 (17.5 to 28.7)21.2 (14.4 to 31.1)
Pre-Inj. 1; 6-11 years66.1 (52.8 to 82.9)63.9 (45.8 to 89.2)
28 days Post-Inj. 1; 6-11 years82.9 (66.2 to 104)61.8 (44.0 to 86.7)
SecondaryGMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo

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.

Time frame:
Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Reported as:
Geometric mean · Titers (1/dilution)
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Titers (1/dilution)CYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Inj. 1, All18.8 (13.8 to 25.6)23.9 (15.5 to 36.9)
Serotype 1; 28 days Post-Inj.1, All43.1 (30.0 to 61.9)22.8 (14.8 to 35.1)
Serotype 1; Pre-Inj. 2, All29.2 (20.5 to 41.7)26.0 (16.2 to 41.5)
Serotype 1; 28 days Post-Inj. 2, All214 (171 to 266)26.1 (16.3 to 42.0)
Serotype 1; Pre-Inj. 3, All64.1 (46.1 to 89.2)28.9 (17.7 to 49.3)
Serotype 1; 28 days Post-Inj. 3, All254 (203 to 318)35.3 (21.2 to 58.7)
Serotype 2; Pre-Inj. 1, All7.55 (6.50 to 8.78)7.76 (6.31 to 9.53)
Serotype 2; 28 days Post-Inj.1, All15.5 (12.4 to 19.4)7.51 (6.19 to 9.12)
Serotype 2; Pre-Inj. 2, All11.6 (9.52 to 14.1)7.32 (6.06 to 8.84)
Serotype 2; 28 days Post-Inj. 2, All21.4 (17.6 to 25.9)6.99 (5.82 to 8.39)
Serotype 2; Pre-Inj. 3, All11.4 (9.39 to 13.8)7.26 (6.01 to 8.78)
Serotype 2; 28 days Post-Inj. 3, All22.3 (18.9 to 26.4)7.73 (6.24 to 9.58)
Serotype 3; Pre-Inj. 1, All13.1 (10.3 to 16.5)16.3 (11.6 to 22.8)
Serotype 3; 28 days Post-Inj.1, All41.4 (30.9 to 55.4)15.3 (11.0 to 21.3)
Serotype 3; Pre-Inj. 2, All22.6 (17.3 to 29.5)15.4 (11.2 to 21.2)
Serotype 3; 28 days Post-Inj. 2, All128 (108 to 150)15.5 (11.2 to 21.5)
Serotype 3; Pre-Inj. 3, All31.0 (24.3 to 39.6)14.0 (10.3 to 19.0)
Serotype 3; 28 days Post-Inj. 3, All99.2 (84.8 to 116)16.0 (11.5 to 22.2)
Serotype 4; Pre-Inj. 1, All7.52 (6.37 to 8.87)8.08 (6.39 to 10.2)
Serotype 4; 28 days Post-Inj.1, All87.9 (65.4 to 118)7.84 (6.25 to 9.83)
Serotype 4; Pre-Inj. 2, All21.3 (16.9 to 26.8)7.73 (6.27 to 9.53)
Serotype 4; 28 days Post-Inj. 2, All158 (134 to 186)7.81 (6.27 to 9.74)
Serotype 4; Pre-Inj. 3, All39.2 (31.7 to 48.5)7.49 (6.06 to 9.26)
Serotype 4; 28 days Post-Inj. 3, All147 (126 to 172)8.54 (6.71 to 10.9)
Serotype 1; Pre-Inj. 1, 2-5 years20.3 (12.9 to 32.0)18.6 (10.4 to 33.4)
Serotype 1; 28 days Post-Inj. 1, 2-5 years44.8 (25.9 to 77.3)19.6 (10.6 to 36.1)
Serotype 1; Pre-Inj. 2, 2-5 years31.3 (18.1 to 53.9)19.7 (10.1 to 38.2)
Serotype 1; 28 days Post-Inj. 2, 2-5 years281 (204 to 386)20.9 (10.5 to 41.7)
Serotype 1; Pre-Inj. 3, 2-5 years65.2 (39.6 to 107)22.1 (11.0 to 44.5)
Serotype 1; 28 days Post-Inj. 3, 2-5 years315 (228 to 436)35.9 (16.4 to 78.6)
Serotype 2; Pre-Inj. 1, 2-5 years6.66 (5.63 to 7.88)6.48 (5.30 to 7.92)
Serotype 2; 28 days Post-Inj. 1, 2-5 years12.7 (9.35 to 17.3)6.73 (5.39 to 8.41)
Serotype 2; Pre-Inj. 2, 2-5 years10.1 (7.85 to 12.9)6.28 (5.19 to 7.61)
Serotype 2; 28 days Post-Inj. 2, 2-5 years17.1 (13.4 to 21.8)6.13 (5.06 to 7.44)
Serotype 2; Pre-Inj. 3, 2-5 years9.03 (7.17 to 11.4)6.68 (5.37 to 8.32)
Serotype 2; 28 days Post-Inj. 3, 2-5 years19.7 (15.9 to 24.5)7.93 (5.76 to 10.9)
Serotype 3; Pre-Inj. 1, 2-5 years11.8 (8.54 to 16.4)12.2 (8.00 to 18.7)
Serotype 3; 28 days Post-Inj. 1, 2-5 years37.4 (23.9 to 58.3)12.9 (8.39 to 20.0)
Serotype 3; Pre-Inj. 2, 2-5 years19.8 (13.4 to 29.4)12.3 (7.92 to 19.0)
Serotype 3; 28 days Post-Inj. 2, 2-5 years129 (104 to 160)12.6 (8.01 to 19.7)
Serotype 3; Pre-Inj. 3, 2-5 years26.7 (18.7 to 38.2)12.2 (7.85 to 19.1)
Serotype 3; 28 days Post-Inj. 3, 2-5 years108 (86.9 to 135)15.3 (9.29 to 25.2)
Serotype 4; Pre-Inj. 1, 2-5 years7.04 (5.67 to 8.74)7.74 (5.60 to 10.7)
Serotype 4; 28 days Post-Inj. 1, 2-5 years114 (74.0 to 176)8.43 (5.97 to 11.9)
Serotype 4; Pre-Inj. 2, 2-5 years22.3 (16.0 to 31.0)7.64 (5.53 to 10.6)
Serotype 4; 28 days Post-Inj. 2, 2-5 years200 (166 to 240)8.22 (5.76 to 11.7)
Serotype 4; Pre-Inj. 3, 2-5 years39.4 (29.5 to 52.8)7.97 (5.69 to 11.2)
Serotype 4; 28 days Post-Inj. 3, 2-5 years176 (143 to 217)9.37 (6.35 to 13.8)
Serotype 1; Pre-Inj. 1, 6-11 years17.4 (11.4 to 26.6)31.0 (16.1 to 59.6)
Serotype 1; 28 days Post-Inj. 1, 6-11 years41.5 (25.5 to 67.5)26.7 (14.2 to 50.0)
Serotype 1; Pre-Inj. 2, 6-11 years27.4 (17.2 to 43.6)33.9 (17.2 to 66.9)
Serotype 1; 28 days Post-Inj. 2, 6-11 years165 (122 to 222)32.4 (16.6 to 63.2)
Serotype 1; Pre-Inj. 3, 6-11 years63.2 (40.5 to 98.7)37.2 (18.4 to 75.4)
Serotype 1;28 days Post-Inj. 3, 6-11 years207 (152 to 283)34.7 (17.4 to 69.1)
Serotype 2; Pre-Inj. 1, 6-11 years8.57 (6.67 to 11.0)9.32 (6.48 to 13.4)
Serotype 2; 28 days Post-Inj. 1, 6-11 years18.8 (13.5 to 26.2)8.40 (6.07 to 11.6)
Serotype 2; Pre-Inj. 2, 6-11 years13.3 (9.80 to 18.0)8.50 (6.14 to 11.8)
Serotype 2; 28 days Post-Inj. 2, 6-11 years26.5 (19.7 to 35.7)7.92 (5.82 to 10.8)
Serotype 2; Pre-Inj. 3, 6-11 years14.1 (10.5 to 19.0)7.85 (5.75 to 10.7)
Serotype 2; 28 days Post-Inj. 3, 6-11 years25.0 (19.4 to 32.3)7.55 (5.59 to 10.2)
Serotype 3; Pre-Inj. 1, 6-11 years14.4 (10.3 to 20.2)21.8 (12.8 to 37.1)
Serotype 3; 28 days Post-Inj. 1, 6-11 years45.6 (31.0 to 67.1)18.3 (11.0 to 30.4)
Serotype 3; Pre-Inj. 2, 6-11 years25.6 (17.8 to 37.0)19.2 (11.9 to 31.1)
Serotype 3; 28 days Post-Inj. 2, 6-11 years126 (98.6 to 162)19.1 (11.8 to 30.8)
Serotype 3; Pre-Inj. 3, 6-11 years35.6 (25.3 to 50)15.8 (10.2 to 24.6)
Serotype 3; 28 days Post-Inj. 3, 6-11 years91.3 (73.0 to 114)16.7 (10.7 to 26.0)
Serotype 4; Pre-Inj. 1, 6-11 years8.03 (6.23 to 10.3)8.43 (5.94 to 12.0)
Serotype 4; 28 days Post-Inj. 1, 6-11 years68.2 (45.6 to 102)7.28 (5.36 to 9.88)
Serotype 4; Pre-Inj. 2, 6-11 years20.3 (14.6 to 28.1)7.82 (5.90 to 10.3)
Serotype 4; 28 days Post-Inj. 2, 6-11 years126 (96.3 to 164)7.44 (5.63 to 9.83)
Serotype 4; Pre-Inj. 3, 6-11 years39.0 (28.6 to 53.2)7.06 (5.37 to 9.29)
Serotype 4; 28 days Post-Inj. 3, 6-11 years125 (98.9 to 157)7.82 (5.79 to 10.6)

Adverse events

Collected over Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CYD Dengue Vaccine Group0/199 (0%)2/199 (1%)71/199 (35.7%)
Control Group0/99 (0%)4/99 (4%)29/99 (29.3%)
Most frequent serious events
Most frequent serious events
EventCYD Dengue Vaccine GroupControl Group
Food poisoningGastrointestinal disorders0/1991/99
Inguinal herniaGastrointestinal disorders0/1991/99
Gastrointestinal infectionInfections and infestations0/1991/99
PneumoniaInfections and infestations0/1991/99
Vascular purpuraSkin and subcutaneous tissue disorders1/1990/99
Epiphyseal disorderMusculoskeletal and connective tissue disorders1/1990/99
Most frequent other events
Most frequent other events
EventCYD Dengue Vaccine GroupControl Group
Injection site Pain; Post-injection 3, All participantsGeneral disorders33/18629/90
Injection site Pain; Post-injection 1, All participantsGeneral disorders41/19917/99
Injection site Pain; Post-injection 2, All participantsGeneral disorders37/18816/92
Injection site Erythema; Post-injection 3, All participantsGeneral disorders8/18610/90
Injection site Swelling; Post-injection 3, All participantsGeneral disorders6/1868/90
Injection site Erythema; Post-injection 1, All participantsGeneral disorders15/1994/99
Injection site Swelling; Post-injection 1, all participantsGeneral disorders11/1995/99

Baseline characteristics

Analysis was performed in Full analysis set which included all the participants present at vaccination 1 and received at least 1 dose of vaccine.

Age, Continuous
Age, Continuous(years)CYD Dengue Vaccine GroupControl GroupTotal
Mean6.4 ± 2.86.4 ± 2.96.4 ± 2.9
Age, Customized
Age, Customized(Participants)CYD Dengue Vaccine GroupControl GroupTotal
2 to 5 years10050150
6 to 11 years9949148
Sex: Female, Male
Sex: Female, Male(Participants)CYD Dengue Vaccine GroupControl GroupTotal
Female9853151
Male10146147
08

Study locations

1 site
  • Chulucanas Morropon, Piura, Peru
09

References and documents

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.
  • Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, Saville M, Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012 Sep 7;30(41):5935-41. doi: 10.1016/j.vaccine.2012.07.043. Epub 2012 Jul 31. PubMed 22863660 ↗

Related links

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient 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. Patient 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://vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2008 to primary completion in Feb 2010, 16 months.

Results were first posted in Jul 2019, 9 years 5 months after primary completion.

Of 23 industry-sponsored phase 2 interventional studies under Dengue, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's 16 months is below that.

Counting every sponsor, half of 34 studies reached it within 21 months; a quarter within 14 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2008
First posted
Nov 10, 2008
StartActual
Sep 26, 2008
Primary completionActual
Feb 16, 2010
CompletionActual
Aug 16, 2010
Results first posted
Jul 29, 2019
Last update
Apr 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00788151
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Nov 10, 2008
Start date
Sep 26, 2008
Primary completion
Feb 16, 2010
Completion
Aug 16, 2010
Results posted
Jul 29, 2019
Last update
Apr 5, 2022

Study contacts

Medical Monitor
study director · Sanofi Pasteur SA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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