ClinicalTrials.gg
Sign In
CompletedNCT01187433Updated Mar 21, 2022Results posted

Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

A Phase 2 interventional study of Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus and NaCl 0.9% in Dengue and Dengue Hemorrhagic Fever, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Brazil. Open to participants aged 9 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.

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

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
9 Years to 16 Years
Sex
All
01

Study summary

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.

Primary Objectives:

  • To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
  • To evaluate the safety of each vaccination with CYD dengue vaccine.
Read the detailed description

Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.

02

Conditions studied

  • Dengue
  • Dengue Hemorrhagic Fever

Keywords

  • Dengue
  • Dengue hemorrhagic fever
  • CYD Dengue Vaccines
03

In context

Dengue

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

This study's enrollment of 150 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
9 Years to 16 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 9 to 16 years on the day of inclusion
  • Participant in good health, based on medical history and physical examination
  • Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
  • Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
  • For a female participant of child-bearing potential, 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

Exclusion criteria

Exclusion Criteria :

  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
  • For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Breast-feeding woman
  • Planned participation in another clinical trial during the present trial period
  • 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 components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the preceding 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
  • Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
  • Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
05

Study design

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

Study arms

  • Experimental
    Dengue Vaccine Group

    Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine

    Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus

  • Placebo comparator
    Control Group

    Participants will receive a placebo, NaCl 0.9%.

    Biological: NaCl 0.9% · Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed · Biological: Meningococcal A+C vaccine

Interventions

  • BiologicalLive, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus

    0.5 mL, Subcutaneous (SC)

    Also known as: CYD Dengue Vaccine

  • BiologicalNaCl 0.9%

    0.5 mL, Subcutaneous

  • BiologicalTetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed

    0.5 mL, Intramuscular

    Also known as: ADACEL®

  • BiologicalMeningococcal A+C vaccine

    0.5 mL, Intramuscular

06

What researchers measure

Primary outcomes

  1. 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

    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

    Time frame: Before and 28 days after each injection

  2. Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

    Time frame: Before and 28 days after each injection

  3. Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

    Time frame: Before and 28 Days after each injection

  4. Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

    Time frame: Before and 28 days after each injection

  5. Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

    Time frame: Before and 28 days after each injection

  6. Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

    Time frame: Before and 28 days after each injection

  7. Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

    Time frame: Before and 28 days after each injection

  8. Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

    Time frame: Before and 28 days after each injection

  9. Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

    Time frame: Before and 28 days after each injection

  10. Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

    Time frame: Before and 28 days after each injection

  11. Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo

    Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.

    Time frame: Day 0 up to Day 14 post each vaccination

07

Results

Posted Nov 11, 2016

Participant flow

Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.

Participant flow — Overall Study
MilestoneCYD Dengue Vaccine GroupControl Group
Started10050
Completed8946
Not completed114
Withdrew: Protocol violation62
Withdrew: Withdrawal by subject52

Outcome measures

PrimaryPercentage 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

Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

Time frame:
Before and 28 days after each injection
Reported as:
Number · Percentage of participants
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
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Injection 1 (n=99, 49)59.663.3
Serotype 1; Post-Injection 1 (n=99, 49)79.869.4
Serotype 1; Pre-Injection 2 (n=94, 47)80.972.3
Serotype 1; Post Injection 2 (n=94, 47)95.772.3
Serotype 1; Pre-Injection 3 (n=90, 46)78.969.6
Serotype 1; Post-Injection 3 (n=89, 46)96.669.6
Serotype 2; Pre-Injection 1 (n=99, 49)65.767.3
Serotype 2; Post-Injection 1 (n=99, 49)80.867.3
Serotype 2; Pre-Injection 2 (n=94, 47)80.974.5
Serotype 2; Post-Injection 2 (n=94, 47)98.972.3
Serotype 2; Pre-Injection 3 (n=90, 46)85.676.1
Serotype 2; Post-Injection 3 (n=89, 46)98.976.1
Serotype 3; Pre-Injection 1 (n=99, 49)62.665.3
Serotype 3; Post-Injection 1 (n=99, 49)92.967.3
Serotype 3; Pre-Injection 2 (n=94, 47)89.472.3
Serotype 3; Post-Injection 2 (n=94, 47)100.072.3
Serotype 3; Pre-Injection 3 (n=89, 46)94.471.7
Serotype 3; Post-Injection 3 (n=89, 46)100.073.9
Serotype 4; Pre-Injection 1 (n=99, 49)47.551
Serotype 4; Post -njection 1 (n=99, 48)89.958.3
Serotype 4; Pre-Injection 2 (n=94, 47)92.657.4
Serotype 4; Post-Injection 2 (n=94, 47)100.059.6
Serotype 4; Pre-Injection 3 (n=88, 46)97.769.6
Serotype 4; Post-Injection 3 (n=89, 46)100.073.9
PrimaryPercentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

Time frame:
Before and 28 days after each injection
Reported as:
Number · Percentage of participants
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Injection 1 (n=80, 41)73.875.6
Serotype 1; Post-Injection 1 (n=80, 41)88.882.9
Serotype 1; Pre-Injection 2 (n=78, 39)91.087.2
Serotype 1; Post-Injection 2 (n=78, 39)100.087.2
Serotype 1; Pre-Injection 3 (n=74, 38)87.881.6
Serotype 1; Post-Injection 3 (n=73, 38)98.681.6
Serotype 2; Pre-Injection 1 (n=80, 41)81.380.5
Serotype 2; Post-Injection 1 (n=80, 41)93.880.5
Serotype 2; Pre-Injection 2 (n=78, 39)92.389.7
Serotype 2; Post-Injection 2 (n=78, 39)100.087.2
Serotype 2; Pre-Injection 3 (n=74, 38)91.989.5
Serotype 2; Post-Injection 3 (n=73, 38)100.089.5
Serotype 3; Pre-Injection 1 (n=80, 41)77.578
Serotype 3; Post-Injection 1 (n=80, 41)95.080.5
Serotype 3; Pre-Injection 2 (n=78, 39)93.687.2
Serotype 3; Post-Injection 2 (n=78, 39)100.087.2
Serotype 3; Pre-Injection 3 (n=74, 38)97.384.2
Serotype 3; Post-Injection 3 (n=73, 38)100.086.8
Serotype 4; Pre-Injection 1 (n=80, 41)58.861
Serotype 4; Post-Injection 1 (n=80, 40)95.070
Serotype 4; Pre-Injection 2 (n=78, 39)94.969.2
Serotype 4; Post-Injection 2 (n=78, 39)100.071.8
Serotype 4; Pre-Injection 3 (n=73, 38)98.681.6
Serotype 4; Post-Injection 3 (n=73, 38)100.084.2
PrimaryPercentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

Time frame:
Before and 28 Days after each injection
Reported as:
Number · Percentage of participants
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Injection 1 (n=19, 8)0.00
Serotype 1; Post-Injection 1 (n=19, 8)42.10
Serotype 1; Pre-Injection 2 (n=16, 8)31.30
Serotype 1; Post-Injection 2 (n=16, 8)75.00
Serotype 1; Pre-Injection 3 (n=16, 8)37.512.5
Serotype 1; Post-Injection 3 (n=16, 8)87.512.5
Serotype 2; Pre-Injection 1 (n=19, 8)0.00
Serotype 2; Post-Injection 1 (n=19, 8)26.30
Serotype 2; Pre-Injection 2 (n=16, 8)25.00
Serotype 2; Post-Injection 2 (n=16, 8)93.80
Serotype 2; Pre-Injection 3 (n=16, 8)56.312.5
Serotype 2; Post-Injection 3 (n=16, 8)93.812.5
Serotype 3; Pre-Injection 1 (n=19, 8)0.00
Serotype 3; Post-Injection 1 (n=19, 8)84.20
Serotype 3; Pre-Injection 2 (n=16, 8)68.80
Serotype 3; Post-Injection 2 (n=16, 8)100.00
Serotype 3; Pre-Injection 3 (n=15, 8)80.012.5
Serotype 3; Post-Injection 3 (n=16, 8)100.012.5
Serotype 4; Pre-Injection 1 (n=19, 8)0.00
Serotype 4; Post-Injection 1 (n=19, 8)68.40
Serotype 4; Pre-Injection 2 (n=16, 8)81.30
Serotype 4; Post-Injection 2 (n=16, 8)100.00
Serotype 4; Pre-Injection 3 (n=15, 8)93.312.5
Serotype 4; Post-Injection 3 (n=16, 8)100.025
PrimaryPercentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

Time frame:
Before and 28 days after each injection
Reported as:
Number · Percentage of participants
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 serotype; Pre-Injection 1 (n=99, 49)68.771.4
At least 1 serotype; Post-Injection 1 (n=99, 49)97.071.4
At least 1 serotype; Pre-Injection 2 (n=94, 47)94.774.5
At least 1 serotype; Post-Injection 2 (n=94, 47)100.074.5
At least 1 serotype; Pre-Injection 3 (n=90, 46)98.978.3
At least 1 serotype; Post-Injection 3 (n=89, 46)100.078.3
At least 2 serotypes; Pre-Injection 1 (n=99, 49)62.667.3
At least 2 serotypes; Post-Injection 1 (n=99, 49)91.971.4
At least 2 serotypes; Pre-Injection 2 (n=94, 47)92.674.5
At least 2 serotypes; Post-Injection 2 (n=94, 47)100.072.3
At least 2 serotypes; Pre-Injection 3 (n=90, 46)91.173.9
At least 2 serotypes; Post-Injection 3 (n=89, 46)100.076.1
At least 3 serotypes; Pre-Injection 1 (n=99, 49)56.661.2
At least 3 serotypes; Post-Injection 1 (n=99, 49)81.865.3
At least 3 serotypes; Pre-Injection 2 (n=94, 47)81.972.3
At least 3 serotypes; Post-Injection 2 (n=94, 47)98.970.2
At least 3 serotypes; Pre-Injection 3 (n=90, 46)86.771.7
At least 3 serotypes; Post-Injection 3 (n=89, 46)98.971.7
All 4 serotypes; Pre-Injection 1 (n=99, 49)47.546.9
All 4 serotypes; Post-Injection 1 (n=99, 49)72.753.1
All 4 serotypes; Pre-Injection 2 (n=94, 47)74.555.3
All 4 serotypes; Post-Injection 2 (n=94, 47)95.759.6
All 4 serotypes; Pre-Injection 3 (n=90, 46)76.763
All 4 serotypes; Post-Injection 3 (n=89, 46)96.667.4
PrimaryPercentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

Time frame:
Before and 28 days after each injection
Reported as:
Number · Percentage of participants
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 serotype; Pre-Injection 1 (n=80, 41)85.085.4
At least 1 serotype; Post-Injection 1 (n=80, 41)97.585.4
At least 1 serotype; Pre-Injection 2 (n=78, 39)97.489.7
At least 1 serotype; Post-Injection 2 (n=78, 39)100.089.7
At least 1 serotype; Pre-Injection 3 (n=74, 38)100.092.1
At least 1 serotype; Post-Injection 3 (n=73, 38)100.089.5
At least 2 serotypes; Pre-Injection 1 (n=80, 41)77.580.5
At least 2 serotypes; Post-Injection 1 (n=80, 41)95.085.4
At least 2 serotypes; Pre-Injection 2 (n=78, 39)97.489.7
At least 2 serotypes; Post-Injection 2 (n=78, 39)100.087.2
At least 2 serotypes; Pre-Injection 3 (n=74, 38)95.986.8
At least 2 serotypes; Post-Injection 3 (n=73, 38)100.089.5
At least 3 serotypes; Pre-Injection 1 (n=80, 41)70.073.2
At least 3 serotypes; Post-Injection 1 (n=80, 41)92.578
At least 3 serotypes; Pre-Injection 2 (n=78, 39)91.087.2
At least 3 serotypes; Post-Injection 2 (n=78, 39)100.084.6
At least 3 serotypes; Pre-Injection 3 (n=74, 38)93.284.2
At least 3 serotypes; Post-Injection 3 (n=73, 38)100.084.2
All 4 serotypes; Pre-Injection 1 (n=80, 41)58.856.1
All 4 serotypes; Post-Injection 1 (n=80, 41)87.563.4
All 4 serotypes; Pre-Injection 2 (n=78, 39)85.966.7
All 4 serotypes; Post-Injection 2 (n=78, 39)100.071.8
All 4 serotypes; Pre-Injection 3 (n=74, 38)85.173.7
All 4 serotypes; Post-Injection 3 (n=73, 38)98.678.9
PrimaryPercentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

Time frame:
Before and 28 days after each injection
Reported as:
Number · Percentage of participants
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
At least 1 serotype; Pre-Injection 1 (n=19, 8)0.00
At least 1 serotype; Post-Injection 1 (n=19, 8)94.70
At least 1 serotype; Pre-Injection 2 (n=16, 8)81.30
At least 1 serotype; Post-Injection 2 (n=16, 8)100.00
At least 1 serotype; Pre-Injection 3 (n=16, 8)93.812.5
At least 1 serotype; Post-Injection 3 (n=16, 8)100.025
At least 2 serotypes; Pre-Injection 1 (n=19, 8)0.00
At least 2 serotypes; Post-Injection 1 (n=19, 8)78.90
At least 2 serotypes; Pre-Injection 2 (n=16, 8)68.80
At least 2 serotypes; Post-Injection 2 (n=16, 8)100.00
At least 2 serotypes; Pre-Injection 3 (n=16, 8)68.812.5
At least 2 serotypes; Post-Injection 3 (n=16, 8)100.012.5
At least 3 serotypes; Pre-Injection 1 (n=19, 8)0.00
At least 3 serotypes; Post-Injection 1 (n=19, 8)36.80
At least 3 serotypes; Pre-Injection 2 (n=16, 8)37.50
At least 3 serotypes; Post-Injection 2 (n=16, 8)93.80
At least 3 serotypes; Pre-Injection 3 (n=16, 8)56.312.5
At least 3 serotypes; Post-Injection 3 (n=16, 8)93.812.5
All 4 serotypes; Pre-Injection 1 (n=19, 8)0.00
All 4 serotypes; Post-Injection 1 (n=19, 8)10.50
All 4 serotypes; Pre-Injection 2 (n=16, 8)18.80
All 4 serotypes; Post-Injection 2 (n=16, 8)75.00
All 4 serotypes; Pre-Injection 3 (n=16, 8)37.512.5
All 4 serotypes; Post-Injection 3 (n=16, 8)87.512.5
PrimaryGeometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

Time frame:
Before and 28 days after each injection
Reported as:
Geometric mean · Titer ratio
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Titer ratioCYD Dengue Vaccine GroupControl Group
Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)4.67 (3.37 to 6.47)0.834 (0.699 to 0.994)
Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)7.26 (5.51 to 9.57)2.11 (1.12 to 4)
Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)1.66 (1.31 to 2.10)1.25 (0.801 to 1.94)
Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)4.92 (3.71 to 6.52)1.36 (0.797 to 2.31)
Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)1.07 (0.828 to 1.39)0.793 (0.508 to 1.24)
Serotype 1; Post -nj. 3 / Pre-Inj. 3 (n=89, 46)1.48 (1.25 to 1.74)0.706 (0.607 to 0.821)
Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)4.15 (3.07 to 5.59)0.733 (0.639 to 0.84)
Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)6.80 (5.46 to 8.45)1.75 (0.956 to 3.21)
Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)1.97 (1.56 to 2.50)0.981 (0.66 to 1.46)
Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)6.21 (4.96 to 7.78)1.68 (1.06 to 2.66)
Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)1.78 (1.39 to 2.28)0.944 (0.646 to 1.38)
Serotype 2; Post-Inj. 3 / Pre-Inj. 3 (n=89, 46)1.40 (1.16 to 1.69)0.851 (0.734 to 0.986)
Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)6.50 (5.01 to 8.45)0.916 (0.673 to 1.25)
Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)8.57 (6.79 to 10.8)1.85 (1.03 to 3.32)
Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)2.03 (1.58 to 2.61)1.02 (0.701 to 1.47)
Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)6.26 (4.82 to 8.13)1.24 (0.815 to 1.9)
Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)1.46 (1.11 to 1.91)0.673 (0.489 to 0.925)
Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46)1.53 (1.27 to 1.86)0.8 (0.681 to 0.94)
Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48)17.7 (12.1 to 26.0)0.806 (0.665 to 0.976)
Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)15.4 (12.3 to 19.2)1.27 (0.795 to 2.04)
Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)1.84 (1.50 to 2.26)0.835 (0.587 to 1.19)
Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)20.2 (15.4 to 26.3)1.4 (0.939 to 2.1)
Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)2.26 (1.74 to 2.93)0.912 (0.606 to 1.37)
Serotype 4; Post -nj. 3 / Pre-Inj. 3 (n=87, 46)1.68 (1.38 to 2.05)0.723 (0.564 to 0.927)
PrimaryGeometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

Time frame:
Before and 28 days after each injection
Reported as:
Geometric mean · Titers (1/dilutions)
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Titers (1/dilutions)CYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Injection 1 (n=99, 49)41.4 (27.7 to 62.1)47.2 (26.9 to 82.7)
Serotype 1; Post-Injection 1 (n=99, 49)256 (151 to 433)50.7 (29.5 to 87.3)
Serotype 1; Pre-Injection 2 (n=94, 47)230 (138 to 384)86 (43.8 to 169)
Serotype 1; Post-Injection 2 (n=94, 47)436 (287 to 662)130 (59.7 to 283)
Serotype 1; Pre-Injection 3 (n=90, 46)162 (99.8 to 262)90.8 (46.6 to 177)
Serotype 1; Post-Injection 3 (n=89, 46)267 (181 to 394)79.2 (42.4 to 148)
Serotype 2; Pre-Injection 1 (n=99, 49)67.0 (44.0 to 102)68.3 (36.3 to 129)
Serotype 2; Post-Injection 1 (n=99, 49)352 (210 to 592)62.8 (33.9 to 116)
Serotype 2; Pre-Injection 2 (n=94, 47)287 (173 to 475)117 (57.6 to 238)
Serotype 2; Post-Injection 2 (n=94, 47)647 (449 to 932)137 (61.4 to 306)
Serotype 2; Pre-Injection 3 (n=90, 46)360 (219 to 592)131 (65.7 to 262)
Serotype 2; Post-Injection 3 (n=89, 46)544 (378 to 782)132 (67 to 259)
Serotype 3; Pre-Injection 1 (n=99, 49)81.9 (49.3 to 136)94.7 (43.6 to 206)
Serotype 3; Post-Injection 1 (n=99, 49)690 (423 to 1125)110 (50.3 to 242)
Serotype 3; Pre-Injection 2 (n=94, 47)471 (282 to 787)184 (80.3 to 424)
Serotype 3; Post-Injection 2 (n=94, 47)1031 (704 to 1512)227 (92.8 to 556)
Serotype 3; Pre-Injection 3 (n=89, 46)481 (300 to 772)144 (65.8 to 316)
Serotype 3; Post-Injection 3 (n=89, 46)741 (516 to 1062)140 (66 to 298)
Serotype 4; Pre-Injection 1 (n=99, 49)15.0 (11.6 to 19.4)17.5 (11.9 to 25.8)
Serotype 4; Post-Injection 1 (n=99, 48)383 (262 to 559)19.2 (13.3 to 27.7)
Serotype 4; Pre-Injection 2 (n=94, 47)178 (134 to 238)27.8 (16.9 to 45.8)
Serotype 4; Post-Injection 2 (n=94, 47)346 (281 to 425)31.2 (18.1 to 53.7)
Serotype 4; Pre-Injection 3 (n=88, 46)258 (192 to 347)37.4 (22.6 to 62.1)
Serotype 4; Post-Injection 3 (n=89, 46)432 (335 to 556)33.4 (21.5 to 51.9)
PrimaryGeometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

Time frame:
Before and 28 days after each injection
Reported as:
Geometric mean · Titers (1/dilutions)
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Titers (1/dilutions)CYD Dengue Vaccine GroupControl Group
Serotype 1; Pre-Injection 1 (n=80, 41)68.5 (44.5 to 105)73.1 (40.9 to 131)
Serotype 1; Post-Injection 1 (n=80, 41)549 (328 to 918)79.8 (46.1 to 138)
Serotype 1; Pre-Injection 2 (n=78, 39)430 (261 to 709)154 (78.5 to 303)
Serotype 1; Post-Injection 2 (n=78, 39)661 (442 to 987)253 (116 to 553)
Serotype 1; Pre-Injection 3 (n=74, 38)268 (164 to 435)143 (73.7 to 278)
Serotype 1; Post-Injection 3 (n=73, 38)381 (256 to 566)126 (67.6 to 236)
Serotype 2; Pre-Injection 1 (n=80, 41)124 (81.9 to 188)114 (59.7 to 217)
Serotype 2; Post-Injection 1 (n=80, 41)816 (517 to 1290)103 (54.8 to 193)
Serotype 2; Pre-Injection 2 (n=78, 39)591 (376 to 928)224 (112 to 446)
Serotype 2; Post-Injection 2 (n=78, 39)978 (697 to 1374)271 (120 to 610)
Serotype 2; Pre-Injection 3 (n=74, 38)648 (400 to 1048)240 (122 to 471)
Serotype 2; Post-Injection 3 (n=73, 38)835 (584 to 1193)242 (126 to 463)
Serotype 3; Pre-Injection 1 (n=80, 41)159 (93.5 to 271)168 (74.3 to 380)
Serotype 3; Post-Injection 1 (n=80, 41)1263 (764 to 2088)202 (89.3 to 455)
Serotype 3; Pre-Injection 2 (n=78, 39)879 (531 to 1455)387 (170 to 878)
Serotype 3; Post-Injection 2 (n=78, 39)1426 (950 to 2141)497 (204 to 1210)
Serotype 3; Pre-Injection 3 (n=74, 38)776 (481 to 1251)272 (122 to 606)
Serotype 3; Post-Injection 3 (n=73, 38)1031 (700 to 1519)266 (125 to 566)
Serotype 4; Pre-Injection 1 (n=80, 41)19.5 (14.6 to 26.1)22.4 (14.6 to 34.3)
Serotype 4; Post-Injection 1 (n=80, 40)467 (325 to 672)25.2 (17.1 to 37.1)
Serotype 4; Pre-Injection 2 (n=78, 39)220 (164 to 295)39.5 (23.1 to 67.6)
Serotype 4; Post-Injection 2 (n=78, 39)377 (303 to 470)45.3 (25.1 to 81.8)
Serotype 4; Pre-Injection 3 (n=73, 38)313 (231 to 424)53.9 (31.7 to 91.8)
Serotype 4; Post-Injection 3 (n=73, 38)485 (374 to 628)46.5 (29.3 to 73.6)
PrimaryGeometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

Time frame:
Before and 28 days after each injection
Reported as:
Geometric mean · Titer ratio
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Titer ratioCYD Dengue Vaccine GroupControl Group
Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)1.03 (0.639 to 1.67)0.5 (0.5 to 0.5)
Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)5.73 (1.89 to 17.3)0.5 (0.5 to 0.5)
Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)3.25 (1.18 to 8.93)0.5 (0.5 to 0.5)
Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)5.34 (2.25 to 12.7)0.861 (0.238 to 3.11)
Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)3.03 (1.35 to 6.80)0.861 (0.238 to 3.11)
Serotype 1; Post-Inj. 3 / Pre-Inj. 3 (n=16, 8)2.19 (1.37 to 3.48)0.446 (0.342 to 0.584)
Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)1.02 (0.527 to 1.99)0.5 (0.5 to 0.5)
Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)8.62 (3.49 to 21.3)0.5 (0.5 to 0.5)
Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)6.02 (2.37 to 15.3)0.5 (0.5 to 0.5)
Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)7.67 (4.19 to 14.0)0.737 (0.294 to 1.85)
Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)5.36 (2.73 to 10.5)0.737 (0.294 to 1.85)
Serotype 2; Post -nj. 3 / Pre-Inj. 3 (n=16, 8)2.37 (1.35 to 4.17)0.538 (0.453 to 0.639)
Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)5.41 (2.80 to 10.5)0.5 (0.5 to 0.5)
Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)21.2 (10.5 to 42.9)0.5 (0.5 to 0.5)
Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)7.58 (3.12 to 18.4)0.5 (0.5 to 0.5)
Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)16.3 (9.65 to 27.7)0.678 (0.33 to 1.39)
Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)5.83 (3.17 to 10.7)0.678 (0.33 to 1.39)
Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8)3.35 (1.92 to 5.84)0.524 (0.469 to 0.587)
Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)16.5 (4.58 to 59.1)0.5 (0.5 to 0.5)
Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)22.7 (12.8 to 40.3)0.5 (0.5 to 0.5)
Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)3.15 (1.63 to 6.09)0.5 (0.5 to 0.5)
Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)25.5 (11.6 to 55.9)0.701 (0.414 to 1.19)
Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)3.53 (1.71 to 7.26)0.701 (0.414 to 1.19)
Serotype 4; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8)2.55 (1.37 to 4.75)0.578 (0.401 to 0.832)
PrimaryPercentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo

Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.

Time frame:
Day 0 up to Day 14 post each vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Percentage of participantsCYD Dengue Vaccine GroupControl Group
Injection-site Pain; Post-Any Injection (N=100,49)4040.8
Grade 3 Inj.-site Pain; Post-Any Inj. (N=100,49)04.1
Inj.-site Erythema; Post-Any Inj. (N=100,49)4.02
Gr 3 Inj.-site Erythema; Post-Any Inj. (N=100,49)00
Inj.-site Swelling; Post-Any Inj. (N=100,49)5.04.1
Gr 3 Inj.-site Swelling; Post-Any Inj. (N=100,49)00
Injection-site Pain; Post-Injection 1 (N=99,49)26.330.6
Gr 3 Inj.-site Pain; Post-Inj. 1 (N=99,49)02
Inj.-site Erythema; Post-Inj. 1 (N=99,49)1.02
Gr 3 Inj.-site Erythema; Post-Inj. 1 (N=99,49)00
Inj.-site Swelling; Post-Inj. 1 (N=99,49)2.04.1
Gr 3 Inj.-site Swelling; Post-Inj. 1 (N=99,49)00
Injection-site Pain; Post-Injection 2 (N=93,47)21.514.9
Gr 3 Inj.-site Pain; Post-Inj. 2 (N=93,47)02.1
Inj.-site Erythema; Post-Inj. 2 (N=93,47)3.20
Gr 3 Inj.-site Erythema; Post-Inj. 2 (N=93,47)00
Inj.-site Swelling; Post-Inj. 2 (N=93,47)2.20
Gr 3 Inj.-site Swelling; Post-Inj. 2 (N=93,47)00
Injection-site Pain; Post-Injection 3 (N=89,45)16.915.6
Gr 3 Inj.-site Pain; Post-Inj. 3 (N=89,45)02.2
Inj.-site Erythema; Post-Inj. 3 (N=89,45)00
Gr 3 Inj.-site Erythema; Post-Inj. 3 (N=89,45)00
Inj.-site Swelling; Post-Inj. 3 (N=89,45)1.10
Gr 3 Inj.-site Swelling; Post-Inj. 3 (N=89,45)00
Fever; Post-Any Injection (N=100, 49)30.018.4
Grade 3 Fever; Post-Any Injection (N=100, 49)8.06.1
Headache; Post-Any Injection (N=100, 49)61.051
Grade 3 Headache; Post-Any Injection (N=100, 49)15.020.4
Malaise; Post-Any Injection (N=100, 49)40.032.7
Grade 3 Malaise; Post-Any Injection (N=100, 49)11.06.1
Myalgia; Post-Any Injection (N=100, 49)42.042.9
Grade 3 Myalgia; Post-Any Injection (N=100, 49)6.08.2
Asthenia; Post-Any Injection (N=100, 49)35.020.4
Grade 3 Asthenia; Post-Any Injection (N=100, 49)8.04.1
Fever; Post-Injection 1 (N=98, 48)15.310.4
Grade 3 Fever; Post-Injection 1 (N=98, 48)3.12.1
Headache; Post-Injection 1 (N=99, 49)48.540.8
Grade 3 Headache; Post-Injection 1 (N=99, 49)8.110.2
Malaise; Post-Injection 1 (N=99, 49)31.318.4
Grade 3 Malaise; Post-Injection 1 (N=99, 49)3.02
Myalgia; Post-Injection 1 (N=99, 49)32.330.6
Grade 3 Myalgia; Post-Injection 1 (N=99, 49)2.06.1
Asthenia; Post-Injection 1 (N=99, 49)22.210.2
Grade 3 Asthenia; Post-Injection 1 (N=99, 49)4.04.1
Fever; Post-Injection 2 (N=92, 47)8.74.3
Grade 3 Fever; Post-Injection 2 (N=92, 47)2.20
Headache; Post-Injection 2 (N=94, 47)28.734
Grade 3 Headache; Post-Injection 2 (N=94, 47)5.36.4
Malaise; Post-Injection 2 (N=94, 47)18.117
Grade 3 Malaise; Post-Injection 2 (N=94, 47)6.44.3
Myalgia; Post-Injection 2 (N=94, 47)20.221.3
Grade 3 Myalgia; Post-Injection 2 (N=94, 47)3.24.3
Asthenia; Post-Injection 2 (N=94, 47)12.814.9
Grade 3 Asthenia; Post-Injection 2 (N=94, 47)3.20
Fever; Post-Injection 3 (N=82, 43)11.07
Grade 3 Fever; Post-Injection 3 (N=82, 43)3.77
Headache; Post-Injection 3 (N=89, 45)27.020
Grade 3 Headache; Post-Injection 3 (N=89, 45)5.68.9
Malaise; Post-Injection 3 (N=89, 45)15.711.1
Grade 3 Malaise; Post-Injection 3 (N=89, 45)2.20
Myalgia; Post-Injection 3 (N=89, 45)20.211.1
Grade 3 Myalgia; Post-Injection 3 (N=89, 45)2.20
Asthenia; Post-Injection 3 (N=89, 45)14.64.4
Grade 3 Asthenia; Post-Injection 3 (N=89, 45)2.20

Adverse events

Collected over Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CYD Dengue Vaccine Group—5/100 (5%)61/100 (61%)
Control Group—3/50 (6%)25/50 (50%)
Most frequent serious events
Most frequent serious events
EventCYD Dengue Vaccine GroupControl Group
Multiple injuriesInjury, poisoning and procedural complications0/1001/50
Abdominal painGastrointestinal disorders0/1001/50
AppendicitisInfections and infestations1/1001/50
CellulitisInfections and infestations2/1000/50
GastroenteritisInfections and infestations0/1001/50
Intra uterine deathPregnancy, puerperium and perinatal conditions1/1000/50
Food poisoningGastrointestinal disorders1/1000/50
Abdominal wall abscessInfections and infestations1/1000/50
Most frequent other events
Showing 10 of 19
Most frequent other events
EventCYD Dengue Vaccine GroupControl Group
Headache: Post Any InjectionNervous system disorders61/10025/49
Myalgia; Post-Any InjectionMusculoskeletal and connective tissue disorders42/10021/49
Injection site Pain; Post Any InjectionGeneral disorders40/10020/49
Malaise; Post-Any InjectionGeneral disorders40/10016/49
Asthenia; Post-Any InjectionGeneral disorders35/10010/49
Fever; Post Any InjectionGeneral disorders30/1009/49
Upper respiratory tract infectionInfections and infestations18/1003/50
ConjunctivitisEye disorders11/1007/50
Abdominal painGastrointestinal disorders12/1004/50
NasopharyngitisInfections and infestations12/1006/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CYD Dengue Vaccine GroupControl GroupTotal
<=18 years10050150
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(Years)CYD Dengue Vaccine GroupControl GroupTotal
Age Continuous12.7 ± 2.112.7 ± 2.212.7 ± 2.15
Sex: Female, Male
Sex: Female, Male(Participants)CYD Dengue Vaccine GroupControl GroupTotal
Female592382
Male412768
Region of Enrollment
Region of Enrollment(Participants)CYD Dengue Vaccine GroupControl GroupTotal
Brazil10050150
08

Study locations

1 site
  • Vitória, ES, 29040-091, Brazil
09

References and documents

Publications

  • Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, Dietze R. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 2013 Nov 4. PubMed 24189367 ↗
  • Coronel D, Garcia-Rivera EJ, Rivera DM, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Wang H, Pagnon A, Jantet-Blaudez F, Penalosa LAR, Dayan G, Zambrano B, DiazGranados CA, Noriega F. Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4-5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial. Pediatr Infect Dis J. 2020 Oct;39(10):961-968. doi: 10.1097/INF.0000000000002830. PubMed 32932330 ↗

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01187433
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Aug 24, 2010
Start date
Aug 2010
Primary completion
Oct 2012
Completion
Dec 2012
Results posted
Nov 11, 2016
Last update
Mar 21, 2022

Study contacts

Medical Director
study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dengue →

Other studies from this sponsor

Sanofi Pasteur, a Sanofi Company →

Start the discussion