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CompletedNCT00993447Updated Mar 24, 2022Results posted

Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

A Phase 2 interventional study of CYD Dengue Vaccine and Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis in Dengue, Dengue Hemorrhagic Fever and Dengue Virus, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 4 sites in 4 countries. Open to participants aged 9 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-24.

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

Phase
Phase 2
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
9 Years to 16 Years
Sex
All
01

Study summary

Primary objectives:

  • To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine.
  • To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
Read the detailed description

The antibody levels against each serotype will be measured before and after each vaccination. The subjects will be followed for 28 days after each vaccination for solicited and unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the study.

02

Conditions studied

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

Keywords

  • Dengue
  • Dengue hemorrhagic fever
  • Dengue virus
  • Dengue fever
  • Sanofi pasteur's CYD 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 600 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
  • Subject in good health, based on medical history and physical examination
  • Provision of assent form/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
  • Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
  • For a female subject 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 subject 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 subject'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
  • Subject deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (temperature ≥38.0°C) 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
Single (Outcomes assessor)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    CYD Dengue Vaccine Group

    Sanofi pasteur's CYD Dengue vaccine group (Dengvaxia®)

    Biological: CYD Dengue Vaccine

  • Sham comparator
    Control Vaccine Group

    Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

Interventions

  • BiologicalCYD Dengue Vaccine

    0.5 mL, Subcutaneous at Day 0, 6 and 12 months

    Also known as: Dengvaxia®

  • BiologicalTetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

    NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months

    Also known as: ADACEL®, NaCl

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

    Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

  2. Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.

    Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

  3. Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.

    Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

  4. Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

    Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination

  5. Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

    Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination

  6. Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

    Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination

  7. Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

    Time frame: Day 0 (before each vaccination) and Day 28 post-each vaccination

  8. Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.

    Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination

  9. Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.

    Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination

  10. Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.

    Time frame: Day 0 (pre each vaccination) and Day 28 post each vaccination

  11. Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.

    Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

  12. Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.

    Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

  13. Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

    Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited 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 29, 2016

Participant flow

Study participants were enrolled from 09 October 2009 to 25 February 2010 in 3 clinic centers in Colombia, 1 in Honduras, 3 in Mexico, and 1 in Puerto Rico.

Participant flow — Overall Study
MilestoneDengue Vaccine GroupControl Group
Started401199
Completed364180
Not completed3719
Withdrew: Withdrawal by subject238
Withdrew: Protocol violation128
Withdrew: Lost to follow-up13
Withdrew: Adverse event10

Outcome measures

PrimaryPercentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

Time frame:
Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Percentage of participantsDengue Vaccine GroupControl Group
Serotype 1; Pre-inj. 1 (N=379,191)64.968.1
Serotype 1; Post-inj. 1 (N=379,191)73.167.0
Serotype 1; Pre-inj. 2 (N=353,174)75.667.8
Serotype 1; Post-inj. 2 (N=353,174)85.069.0
Serotype 1; Pre-inj. 3 (N=335,163)79.773.6
Serotype 1; Post-inj. 3 (N=335,163)94.675.5
Serotype 2; Pre-inj. 1 (N=379,191)69.974.3
Serotype 2; Post-inj. 1 (N=379,191)85.272.8
Serotype 2; Pre-inj. 2 (N=353,174)87.371.8
Serotype 2; Post-inj. 2 (N=353,174)96.973.0
Serotype 2; Pre-inj. 3 (N=335,163)91.976.7
Serotype 2; Post-inj. 3 (N=335,163)99.178.5
Serotype 3; Pre-inj. 1 (N=379,191)69.973.3
Serotype 3; Post-inj. 1 (N=379,191)90.874.3
Serotype 3; Pre-inj. 2 (N=353,174)90.972.4
Serotype 3; Post-inj. 2 (N=353,174)98.673.6
Serotype 3; Pre-inj. 3 (N=335,163)96.474.8
Serotype 3; Post-inj. 3 (N=335,163)100.076.7
Serotype 4; Pre-inj. 1 (N=379,191)63.168.1
Serotype 4; Post-inj. 1 (N=379,191)92.662.3
Serotype 4; Pre-inj. 2 (N=353,174)92.466.7
Serotype 4; Post-inj. 2 (N=353,174)96.670.1
Serotype 4; Pre-inj. 3 (N=335,163)95.869.9
Serotype 4; Post-inj. 3 (N=335,163)98.869.3
PrimaryPercentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.

Time frame:
Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Reported as:
Number · Percentage of Participants
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Percentage of ParticipantsDengue Vaccine GroupControl Group
Serotype 1; Pre-inj. 1 (N=316,160)81.384.4
Serotype 1; Post-inj. 1 (N=305,158)90.882.3
Serotype 1; Pre-inj. 2 (N=295,148)90.582.4
Serotype 1; Post-inj. 2 (N=293,147)95.684.4
Serotype 1; Pre-inj. 3 (N=288,143)92.087.4
Serotype 1; Post-inj. 3 (N=287,143)97.688.8
Serotype 2; Pre-inj. 1 (N=316,160)88.091.9
Serotype 2; Post-inj. 1 (N=305,158)96.489.9
Serotype 2; Pre-inj. 2 (N=295,148)96.689.2
Serotype 2; Post-inj. 2 (N=293,147)98.690.5
Serotype 2; Pre-inj. 3 (N=288,143)96.590.9
Serotype 2; Post-inj. 3 (N=287,143)99.792.3
Serotype 3; Pre-inj. 1 (N=316,160)88.390.6
Serotype 3; Post-inj. 1 (N=305,158)96.789.9
Serotype 3; Pre-inj. 2 (N=295,148)96.687.8
Serotype 3; Post-inj. 2 (N=293,147)99.088.4
Serotype 3; Pre-inj. 3 (N=288,143)97.989.5
Serotype 3; Post-inj. 3 (N=287,143)100.089.5
Serotype 4; Pre-inj. 1 (N=316,160)79.484.4
Serotype 4; Post-inj. 1 (N=305,158)97.476.6
Serotype 4; Pre-inj. 2 (N=295,148)96.981.1
Serotype 4; Post-inj. 2 (N=293,147)98.084.4
Serotype 4; Pre-inj. 3 (N=288,143)99.384.6
Serotype 4; Post-inj. 3 (N=287,143)100.084.6
PrimaryPercentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.

Time frame:
Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Reported as:
Number · Percentage of participants
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Percentage of participantsDengue Vaccine GroupControl Group
Serotype 1; Pre-inj. 1 (N=85,38)0.00.0
Serotype 1; Post-inj. 1 (N=84,37)7.12.7
Serotype 1; Pre-inj. 2 (N=78,36)17.95.6
Serotype 1; Post-inj. 2 (N=78,36)44.95.6
Serotype 1; Pre-inj. 3 (N=77,36)33.816.7
Serotype 1; Post-inj. 3 (N=77,36)81.819.4
Serotype 2; Pre-inj. 1 (N=85,38)0.00.0
Serotype 2; Post-inj. 1 (N=84,37)42.90.0
Serotype 2; Pre-inj. 2 (N=78,36)51.32.8
Serotype 2; Post-inj. 2 (N=78,36)89.75.6
Serotype 2; Pre-inj. 3 (N=77,36)70.116.7
Serotype 2; Post-inj. 3 (N=77,36)96.119.4
Serotype 3; Pre-inj. 1 (N=85,38)0.00.0
Serotype 3; Post-inj. 1 (N=84,37)67.910.8
Serotype 3; Pre-inj. 2 (N=78,36)66.78.3
Serotype 3; Post-inj. 2 (N=78,36)94.98.3
Serotype 3; Pre-inj. 3 (N=77,36)89.65.6
Serotype 3; Post-inj. 3 (N=77,36)100.016.7
Serotype 4; Pre-inj. 1 (N=85,38)0.00.0
Serotype 4; Post-inj. 1 (N=84,37)73.82.7
Serotype 4; Pre-inj. 2 (N=78,36)73.15.6
Serotype 4; Post-inj. 2 (N=78,36)91.08.3
Serotype 4; Pre-inj. 3 (N=77,36)80.58.3
Serotype 4; Post-inj. 3 (N=77,36)94.85.6
PrimaryPercentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

Time frame:
Day 0 (before each vaccination) and Day 28 post each vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Percentage of participantsDengue Vaccine GroupControl Group
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)75.177.9
At Least 1 Serotype; Post-inj. 1 (N=389,196)98.278.6
At Least 1 Serotype; Pre-inj. 2 (N=373,185)99.276.2
At Least 1 Serotype; Post-inj. 2 (N=371,184)99.776.6
At Least 1 Serotype; Pre-inj. 3 (N=365,180)100.079.4
At Least 1 Serotype; Post-inj. 3 (N=364,180)100.078.9
At Least 2 Serotypes; Pre-inj. 1 (N=401,199)69.172.9
At Least 2 Serotypes; Post-inj. 1 (N=389,196)91.070.9
At Least 2 Serotypes; Pre-inj. 2 (N=373,185)91.471.9
At Least 2 Serotypes; Post-inj. 2 (N=371,184)98.971.2
At Least 2 Serotypes; Pre-inj. 3 (N=365,180)96.275.6
At Least 2 Serotypes; Post-inj. 3 (N=364,180)100.076.7
At Least 3 Serotypes; Pre-inj. 1 (N=401,199)64.669.8
At Least 3 Serotypes; Post-inj. 1 (N=381,196)79.967.3
At Least 3 Serotypes; Pre-inj. 2 (N=373,185)81.868.1
At Least 3 Serotypes; Post-inj. 2 (N=371,184)94.369.0
At Least 3 Serotypes; Pre-inj. 3 (N=365,180)88.270.6
At Least 3 Serotypes; Post-inj. 3 (N=364,180)98.672.2
All 4 Serotypes; Pre-inj. 1 (N=401,199)56.961.8
All 4 Serotypes; Post-inj. 1 (N=389,196)71.259.2
All 4 Serotypes; Pre-inj. 2 (N=373,185)72.460.5
All 4 Serotypes; Post-inj. 2 (N=371,184)83.366.3
All 4 Serotypes; Pre-inj. 3 (N=365,180)77.864.4
All 4 Serotypes; Post-inj. 3 (N=364,180)93.466.7
PrimaryPercentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

Time frame:
Day 0 (before each vaccination) and Day 28 post each vaccination
Reported as:
Number · Percentage of participants
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Percentage of participantsDengue Vaccine GroupControl Group
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)95.396.9
At Least 1 Serotype; Post-inj. 1 (N=389,196)99.093.7
At Least 1 Serotype; Pre-inj. 2 (N=373,185)99.791.9
At Least 1 Serotype; Post-inj. 2 (N=371,184)99.793.2
At Least 1 Serotype; Pre-inj. 3 (N=365,180)100.093.7
At Least 1 Serotype; Post-inj. 3 (N=364,180)100.093.0
At Least 2 Serotypes; Pre-inj. 1 (N=401,199)87.790.6
At Least 2 Serotypes; Post-inj. 1 (N=389,196)97.488.0
At Least 2 Serotypes; Pre-inj. 2 (N=373,185)97.389.2
At Least 2 Serotypes; Post-inj. 2 (N=371,184)99.087.8
At Least 2 Serotypes; Pre-inj. 3 (N=365,180)98.691.6
At Least 2 Serotypes; Post-inj. 3 (N=364,180)100.092.3
At Least 3 Serotypes; Pre-inj. 1 (N=401,199)92.086.9
At Least 3 Serotypes; Post-inj. 1 (N=381,196)95.183.5
At Least 3 Serotypes; Pre-inj. 2 (N=373,185)94.284.5
At Least 3 Serotypes; Post-inj. 2 (N=371,184)98.385.0
At Least 3 Serotypes; Pre-inj. 3 (N=365,180)96.286.7
At Least 3 Serotypes; Post-inj. 3 (N=364,180)99.787.4
All 4 Serotypes; Pre-inj. 1 (N=401,199)72.276.9
All 4 Serotypes; Post-inj. 1 (N=389,196)89.873.4
All 4 Serotypes; Pre-inj. 2 (N=373,185)89.575.0
All 4 Serotypes; Post-inj. 2 (N=371,184)94.281.6
All 4 Serotypes; Pre-inj. 3 (N=365,180)91.080.4
All 4 Serotypes; Post-inj. 3 (N=364,180)97.682.5
PrimaryPercentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

Time frame:
Day 0 (before each vaccination) and Day 28 post each vaccination
Reported as:
Number · Percentage of participants
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Percentage of participantsDengue Vaccine GroupControl Group
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)0.00.0
At Least 1 Serotype; Post-inj. 1 (N=389,196)95.016.2
At Least 1 Serotype; Pre-inj. 2 (N=373,185)97.413.9
At Least 1 Serotype; Post-inj. 2 (N=371,184)100.011.1
At Least 1 Serotype; Pre-inj. 3 (N=365,180)100.022.2
At Least 1 Serotype; Post-inj. 3 (N=364,180)100.025.0
At Least 2 Serotypes; Pre-inj. 1 (N=401,199)0.00.0
At Least 2 Serotypes; Post-inj. 1 (N=389,196)67.90.0
At Least 2 Serotypes; Pre-inj. 2 (N=373,185)69.22.8
At Least 2 Serotypes; Post-inj. 2 (N=371,184)98.75.6
At Least 2 Serotypes; Pre-inj. 3 (N=365,180)87.013.9
At Least 2 Serotypes; Post-inj. 3 (N=364,180)100.016.7
At Least 3 Serotypes; Pre-inj. 1 (N=401,199)0.00.0
At Least 3 Serotypes; Post-inj. 1 (N=381,196)25.00.0
At Least 3 Serotypes; Pre-inj. 2 (N=373,185)34.62.8
At Least 3 Serotypes; Post-inj. 2 (N=371,184)79.55.6
At Least 3 Serotypes; Pre-inj. 3 (N=365,180)58.48.3
At Least 3 Serotypes; Post-inj. 3 (N=364,180)94.813.9
All 4 Serotypes; Pre-inj. 1 (N=401,199)0.00.0
All 4 Serotypes; Post-inj. 1 (N=389,196)3.60.0
All 4 Serotypes; Pre-inj. 2 (N=373,185)7.72.8
All 4 Serotypes; Post-inj. 2 (N=371,184)42.35.6
All 4 Serotypes; Pre-inj. 3 (N=365,180)28.62.8
All 4 Serotypes; Post-inj. 3 (N=364,180)77.95.6
PrimarySummary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

Time frame:
Day 0 (before each vaccination) and Day 28 post-each vaccination
Reported as:
Geometric mean · Titers (1/dilution)
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Titers (1/dilution)Dengue Vaccine GroupControl Group
Serotype 1; Pre-inj. 1 (N=401,199)74.2 (58.8 to 93.6)81.9 (59.2 to 113)
Serotype 1; Post-inj. 1 (N=389,196)221 (167 to 292)77.1 (55.8 to 106)
Serotype 1; Pre-inj. 2 (N=373,185)193 (149 to 251)96.6 (67.1 to 139)
Serotype 1; Post-inj. 2 (N=371,184)276 (215 to 355)102 (70.9 to 147)
Serotype 1; Pre-inj. 3 (N=365,180)204 (159 to 262)113 (80.0 to 159)
Serotype 1; Post-inj. 3 (N=364,180)320 (258 to 396)106 (75.4 to 149)
Serotype 2; Pre-inj. 1 (N=401,199)92.6 (73.9 to 116)100 (73.5 to 136)
Serotype 2; Post-inj. 1 (N=389,196)409 (320 to 524)90.4 (66.6 to 123)
Serotype 2; Pre-inj. 2 (N=373,185)326 (260 to 408)117 (82.2 to 166)
Serotype 2; Post-inj. 2 (N=371,184)504 (414 to 613)114 (80.8 to 160)
Serotype 2; Pre-inj. 3 (N=365,180)300 (245 to 368)133 (95.6 to 186)
Serotype 2; Post-inj. 3 (N=364,180)486 (414 to 572)133 (96.2 to 185)
Serotype 3; Pre-inj. 1 (N=401,199)85.0 (68.1 to 106)88.8 (65.9 to 120)
Serotype 3; Post-inj. 1 (N=389,196)442 (352 to 554)93.2 (69.1 to 126)
Serotype 3; Pre-inj. 2 (N=372,185)301 (243 to 372)107 (77.0 to 149)
Serotype 3; Post-inj. 2 (N=371,184)502 (421 to 599)108 (76.8 to 151)
Serotype 3; Pre-inj. 3 (N=365,180)379 (313 to 458)123 (87.3 to 172)
Serotype 3; Post-inj. 3 (N=364,180)594 (511 to 692)121 (86.6 to 168)
Serotype 4; Pre-inj. 1 (N=401,199)37.2 (31.1 to 44.5)40.1 (31.2 to 51.5)
Serotype 4; Post-inj. 1 (N=389,196)416 (347 to 498)34.1 (26.5 to 43.9)
Serotype 4; Pre-inj. 2 (N=373,185)200 (171 to 233)43.8 (33.2 to 57.8)
Serotype 4; Post-inj. 2 (N=369,184)305 (265 to 352)43.9 (33.5 to 57.5)
Serotype 4; Pre-inj. 3 (N=365,180)182 (158 to 210)47.7 (36.4 to 62.6)
Serotype 4; Post-inj. 3 (N=364,180)273 (241 to 309)42.8 (33.0 to 55.5)
PrimarySummary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.

Time frame:
Day 0 (before each vaccination) and Day 28 post each vaccination
Reported as:
Geometric mean · Titers
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
TitersDengue Vaccine GroupControl Group
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=389,196)2.36 (2.02 to 2.76)0.756 (0.689 to 0.829)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=371,184)2.74 (2.33 to 3.21)1.02 (0.820 to 1.27)
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=371,184)1.19 (1.06 to 1.34)0.851 (0.735 to 0.985)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=364,180)3.16 (2.73 to 3.66)1.03 (0.834 to 1.27)
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=364,180)1.38 (1.22 to 1.56)0.859 (0.710 to 1.04)
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=364,180)1.35 (1.25 to 1.46)0.777 (0.699 to 0.862)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=389,196)3.55 (3.04 to 4.15)0.760 (0.702 to 0.823)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=371,184)4.09 (3.49 to 4.80)0.983 (0.805 to 1.20)
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=371,184)1.40 (1.25 to 1.58)0.811 (0.698 to 0.941)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=364,180)3.97 (3.39 to 4.64)1.16 (0.955 to 1.41)
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=364,180)1.36 (1.19 to 1.55)0.957 (0.777 to 1.18)
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=364,180)1.51 (1.38 to 1.64)0.844 (0.770 to 0.926)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=389,196)4.24 (3.61 to 4.98)0.864 (0.786 to 0.950)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=371,184)4.52 (3.88 to 5.26)1.04 (0.852 to 1.28)
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=370,184)1.57 (1.40 to 1.76)0.840 (0.725 to 0.975)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=364,180)5.27 (4.55 to 6.10)1.15 (0.960 to 1.39)
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=363,180)1.86 (1.64 to 2.10)0.937 (0.780 to 1.13)
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=364,180)1.52 (1.41 to 1.63)0.815 (0.743 to 0.895)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=389,196)8.63 (7.09 to 10.5)0.672 (0.603 to 0.750)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=369,184)6.14 (5.22 to 7.21)0.887 (0.725 to 1.09)
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=369,184)1.45 (1.29 to 1.62)0.800 (0.703 to 0.911)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=364,180)5.47 (4.72 to 6.34)0.871 (0.720 to 1.05)
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=364,180)1.30 (1.16 to 1.46)0.771 (0.656 to 0.906)
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=364,180)1.45 (1.34 to 1.56)0.723 (0.671 to 0.780)
PrimarySummary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.

Time frame:
Day 0 (before each vaccination) and Day 28 post each vaccination
Reported as:
Geometric mean · Titers (1/dilution)
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Titers (1/dilution)Dengue Vaccine GroupControl Group
Serotype 1; Pre-inj. 1 (N=316,160)153 (121 to 194)162 (117 to 224)
Serotype 1; Post-inj. 1 (N=305,158)604 (468 to 780)148 (107 to 205)
Serotype 1; Pre-inj. 2 (N=295,148)447 (352 to 567)192 (133 to 279)
Serotype 1; Post-inj. 2 (N=293,147)607 (483 to 764)199 (138 to 287)
Serotype 1; Pre-inj. 3 (N=288,143)435 (344 to 550)225 (161 to 315)
Serotype 1; Post-inj. 3 (N=287,143)580 (471 to 715)205 (146 to 287)
Serotype 2; Pre-inj. 1 (N=316,160)203 (164 to 252)207 (156 to 275)
Serotype 2; Post-inj. 1 (N=305,158)1001 (811 to 1236)181 (136 to 242)
Serotype 2; Pre-inj. 2 (N=295,148)673 (555 to 817)251 (179 to 351)
Serotype 2; Post-inj. 2 (N=293,147)888 (738 to 1067)232 (167 to 321)
Serotype 2; Pre-inj. 3 (N=288,143)554 (461 to 667)265 (195 to 361)
Serotype 2; Post-inj. 3 (N=287,143)741 (631 to 869)266 (196 to 359)
Serotype 3; Pre-inj. 1 (N=316,160)182 (147 to 225)179 (136 to 237)
Serotype 3; Post-inj. 1 (N=305,158)863 (700 to 1064)180 (135 to 239)
Serotype 3; Pre-inj. 2 (N=295,148)556 (456 to 679)221 (161 to 304)
Serotype 3; Post-inj. 2 (N=293,147)782 (654 to 936)215 (155 to 297)
Serotype 3; Pre-inj. 3 (N=288,143)615 (510 to 743)265 (193 to 362)
Serotype 3; Post-inj. 3 (N=287,143)827 (704 to 972)248 (181 to 340)
Serotype 4; Pre-inj. 1 (N=316,160)63.8 (52.9 to 76.9)66.5 (51.4 to 86.1)
Serotype 4; Post-inj. 1 (N=305,158)549 (465 to 649)53.4 (40.8 to 69.8)
Serotype 4; Pre-inj. 2 (N=295,148)278 (239 to 322)73.7 (55.2 to 98.5)
Serotype 4; Post-inj. 2 (N=291,147)395 (341 to 456)70.4 (53.3 to 92.8)
Serotype 4; Pre-inj. 3 (N=288,143)259 (227 to 296)81.8 (62.1 to 108)
Serotype 4; Post-inj. 3 (N=287,143)341 (299 to 388)72.5 (55.8 to 94.2)
PrimarySummary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.

Time frame:
Day 0 (pre each vaccination) and Day 28 post each vaccination
Reported as:
Geometric mean · Titers
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
TitersDengue Vaccine GroupControl Group
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=305,158)3.49 (2.94 to 4.15)0.829 (0.743 to 0.924)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=293,147)3.25 (2.73 to 3.88)1.11 (0.875 to 1.41)
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=293,147)1.25 (1.10 to 1.43)0.925 (0.793 to 1.08)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=287,143)3.08 (2.61 to 3.64)1.09 (0.857 to 1.39)
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=287,143)1.19 (1.05 to 1.35)0.907 (0.723 to 1.14)
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=287,143)1.24 (1.15 to 1.34)0.834 (0.736 to 0.946)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=305,158)4.43 (3.74 to 5.24)0.840 (0.766 to 0.921)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=293,147)3.70 (3.08 to 4.44)1.08 (0.863 to 1.35)
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=293,147)1.27 (1.12 to 1.44)0.865 (0.735 to 1.02)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=287,143)3.08 (2.59 to 3.67)1.23 (0.993 to 1.53)
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=287,143)1.06 (0.939 to 1.20)0.982 (0.775 to 1.25)
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=287,143)1.29 (1.18 to 1.40)0.940 (0.846 to 1.04)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=305,158)4.35 (3.67 to 5.15)0.941 (0.850 to 1.04)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=293,147)3.71 (3.13 to 4.39)1.16 (0.921 to 1.45)
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=293,147)1.36 (1.20 to 1.55)0.906 (0.779 to 1.05)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=287,143)3.82 (3.27 to 4.47)1.29 (1.05 to 1.60)
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=287,143)1.43 (1.27 to 1.62)1.03 (0.824 to 1.28)
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=287,143)1.31 (1.22 to 1.40)0.872 (0.789 to 0.963)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=305,158)7.40 (6.03 to 9.08)0.712 (0.625 to 0.812)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=291,147)5.16 (4.31 to 6.19)0.952 (0.752 to 1.20)
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=291,147)1.39 (1.22 to 1.57)0.847 (0.739 to 0.971)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=287,143)4.45 (3.76 to 5.26)0.976 (0.773 to 1.23)
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=287,143)1.20 (1.06 to 1.36)0.849 (0.698 to 1.03)
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=287,143)1.30 (1.21 to 1.40)0.796 (0.730 to 0.868)
PrimarySummary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.

Time frame:
Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Reported as:
Geometric mean · Titers (1/dilution)
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Titers (1/dilution)Dengue Vaccine GroupControl Group
Serotype 1; Pre-inj. 1 (N=85,38)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)
Serotype 1; Post-inj. 1 (N=84,37)5.72 (5.10 to 6.42)5.15 (4.85 to 5.47)
Serotype 1; Pre-inj. 2 (N=78,36)8.16 (5.98 to 11.1)6.18 (4.20 to 9.11)
Serotype 1; Post-inj. 2 (N=78,36)14.3 (10.0 to 20.3)7.29 (4.27 to 12.5)
Serotype 1; Pre-inj. 3 (N=77,36)12.0 (8.48 to 16.9)7.93 (5.05 to 12.5)
Serotype 1; Post-inj. 3 (N=77,36)34.6 (25.0 to 48.1)8.36 (5.31 to 13.2)
Serotype 2; Pre-inj. 1 (N=85,38)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)
Serotype 2; Post-inj. 1 (N=84,37)15.9 (11.4 to 22.3)5.00 (5.00 to 5.00)
Serotype 2; Pre-inj. 2 (N=78,36)21.0 (14.2 to 31.1)5.50 (4.54 to 6.66)
Serotype 2; Post-inj. 2 (N=78,36)60.0 (43.3 to 83.0)6.79 (4.37 to 10.6)
Serotype 2; Pre-inj. 3 (N=77,36)30.3 (21.4 to 42.7)9.48 (5.60 to 16.1)
Serotype 2; Post-inj. 3 (N=77,36)101 (77.2 to 133)9.45 (5.78 to 15.4)
Serotype 3; Pre-inj. 1 (N=85,38)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)
Serotype 3; Post-inj. 1 (N=84,37)38.8 (25.6 to 59.1)6.10 (4.89 to 7.60)
Serotype 3; Pre-inj. 2 (N=77,36)28.6 (20.0 to 41.1)5.97 (4.75 to 7.50)
Serotype 3; Post-inj. 2 (N=78,36)94.9 (70.7 to 127)7.07 (4.41 to 11.3)
Serotype 3; Pre-inj. 3 (N=77,36)61.9 (44.4 to 86.1)6.18 (4.58 to 8.34)
Serotype 3; Post-inj. 3 (N=77,36)174 (136 to 221)7.53 (5.32 to 10.7)
Serotype 4; Pre-inj. 1 (N=85,38)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)
Serotype 4; Post-inj. 1 (N=84,37)151 (89.3 to 255)5.30 (4.71 to 5.96)
Serotype 4; Pre-inj. 2 (N=78,36)57.5 (38.8 to 85.1)5.48 (4.80 to 6.26)
Serotype 4; Post-inj. 2 (N=78,36)117 (84.8 to 161)6.77 (4.64 to 9.88)
Serotype 4; Pre-inj. 3 (N=77,36)48.3 (35.5 to 65.6)5.97 (4.87 to 7.32)
Serotype 4; Post-inj. 3 (N=77,36)119 (92.0 to 153)5.63 (4.76 to 6.65)
PrimarySummary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.

Time frame:
Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Reported as:
Geometric mean · Titers
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
TitersDengue Vaccine GroupControl Group
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=84,37)0.572 (0.510 to 0.642)0.515 (0.485 to 0.547)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=78,36)1.43 (1.00 to 2.03)0.729 (0.427 to 1.25)
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=78,36)0.990 (0.773 to 1.27)0.613 (0.410 to 0.917)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=77,36)3.46 (2.50 to 4.81)0.836 (0.531 to 1.32)
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=77,36)2.39 (1.78 to 3.22)0.703 (0.512 to 0.964)
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=77,36)1.83 (1.48 to 2.26)0.592 (0.519 to 0.675)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=84,37)1.59 (1.14 to 2.23)0.500 (0.500 to 0.500)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=78,36)6.00 (4.33 to 8.30)0.679 (0.437 to 1.06)
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=78,36)2.04 (1.50 to 2.77)0.630 (0.431 to 0.921)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=77,36)10.1 (7.72 to 13.3)0.945 (0.578 to 1.54)
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=77,36)3.40 (2.35 to 4.91)0.876 (0.550 to 1.40)
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=77,36)2.73 (2.23 to 3.33)0.559 (0.493 to 0.635)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=84,37)3.88 (2.56 to 5.91)0.610 (0.489 to 0.760)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=78,36)9.49 (7.07 to 12.7)0.707 (0.441 to 1.13)
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=77,36)2.67 (2.13 to 3.35)0.627 (0.402 to 0.977)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=77,36)17.4 (13.6 to 22.1)0.753 (0.532 to 1.07)
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=76,36)4.90 (3.68 to 6.53)0.668 (0.498 to 0.896)
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=77,36)2.61 (2.16 to 3.16)0.633 (0.499 to 0.805)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=84,37)15.1 (8.93 to 25.5)0.530 (0.471 to 0.596)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=78,36)11.7 (8.48 to 16.1)0.677 (0.464 to 0.988)
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=78,36)1.69 (1.31 to 2.17)0.642 (0.445 to 0.925)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=77,36)11.9 (9.20 to 15.3)0.563 (0.476 to 0.665)
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=77,36)1.75 (1.31 to 2.34)0.533 (0.441 to 0.645)
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=77,36)2.15 (1.74 to 2.64)0.499 (0.460 to 0.541)
PrimaryNumber of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited 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 · Participants
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
ParticipantsDengue Vaccine GroupControl Group
Injection-site Pain (Any dose; N=392,198)192132
Grade 3 Pain (Any dose; N=392,198)137
Injection-site Erythema (Any dose; N=392,198)2618
Grade 3 Erythema (Any dose; N=392,198)01
Injection-site Swelling (Any dose; N=392,198)2016
Grade 3 Swelling (Any dose; N=392,198)11
Injection-site Pain (Post-dose 1; N=392,196)12154
Grade 3 Pain (Post-dose 1; N=392,196)62
Injection-site Erythema (Post-dose 1; N=390,196)116
Grade 3 Erythema (Post-dose 1; N=390,196)00
Injection-site Swelling (Post-dose 1; N=391,196)85
Grade 3 Swelling (Post-dose 1; N=391,196)10
Injection-site Pain (Post-dose 2; N=373,185)10131
Grade Pain (Post-dose 2; N=373,185)70
Injection-site Erythema (Post-dose 2; N=373,185)125
Grade 3 Erythema (Post-dose 2; N=373,185)00
Injection-site Swelling (Post-dose 2; N=373,185)82
Grade 3 Swelling (Post-dose 2; N=373,185)10
Injection-site Pain (Post-dose 3; N=364,180)88118
Grade 3 Pain (Post-dose 3; N=364,180)25
Injection-site Erythema (Post-dose 3; N=364,180)816
Grade 3 Erythema (Post-dose 3; N=364,180)01
Injection-site Swelling (Post-dose 3; N=364,180)614
Grade 3 Swelling (Post-dose 3; N=364,180)01
Fever (Any dose; N=392;197)8436
Grade 3 Fever (Any dose; N=392;197)133
Headache (Any dose; N=391;198)237116
Grade 3 Headache (Any dose; N=391;198)4011
Malaise (Any dose; N=390;198)15782
Grade 3 Malaise (Any dose; N=390;198)218
Myalgia (Any dose; N=390;198)17190
Grade 3 Myalgia (Any dose; N=390;198)2210
Asthenia (Any dose; N=390;198)11951
Grade 3 Asthenia (Any dose; N=390;198)145
Fever (Post-dose 1; N=392;193)4313
Grade 3 Fever (Post dose 1; N=392;193)110
Headache (Post-dose 1; N=391;197)17380
Grade 3 Headache (Post-dose 1; N=391;197)265
Malaise (Post-dose 1; N=390;197)10245
Grade 3 Malaise (Post-dose 1; N=390;197)140
Myalgia (Post-dose 1; N=390;197)12152
Grade 3 Myalgia (Post-dose 1; N=390;197)153
Asthenia (Post-dose 1; N=390;197)7730
Grade 3 Asthenia (Post dose 1; N=390;197)72
Fever (Post-dose 2; N=371;184)2916
Grade 3 Fever (Post-dose 2; N=371;184)20
Headache (Post-dose 2; N=373;185)13169
Grade 3 Headache (Post-dose 2; N=373;185)144
Malaise (Post-dose 2; N=373;185)6836
Grade 3 Malaise (Post-dose 2; N=373;185)64
Myalgia (Post dose 2; N=373;185)8045
Grade 3 Myalgia (Post-dose 2; N=373;185)83
Asthenia (Post-dose 2; N=373;185)5124
Grade 3 Asthenia (Post-dose 2; N=373;185)51
Fever (Post-dose 3; N=362;180)1714
Grade 3 Fever (Post-dose 3; N=362;180)03
Headache (Post-dose 3; N=364;180)10662
Grade 3 Headache (Post-dose 3; N=364;180)104
Malaise (Post-dose 3; N=364;180)6041
Grade 3 Malaise (Post-dose 3; N=364;180)24
Myalgia (Post-dose 3; N=364;180)6651
Grade 3 Myalgia (Post-dose 3; N=364;180)35
Asthenia (Post-dose 3; N=364;180)4223
Grade 3 Asthenia (Post-dose 3; N=364;180)22

Adverse events

Collected over Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dengue Vaccine Group—10/401 (2.5%)237/401 (59.1%)
Control Group—15/199 (7.5%)132/199 (66.3%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventDengue Vaccine GroupControl Group
Dengue feverInfections and infestations3/4013/199
AppendicitisInfections and infestations3/4012/199
CellulitisInfections and infestations0/4012/199
MigraineNervous system disorders0/4012/199
GastritisGastrointestinal disorders0/4011/199
VomitingGastrointestinal disorders0/4011/199
Herpes simplexInfections and infestations0/4011/199
PneumoniaInfections and infestations0/4011/199
SinusitisInfections and infestations0/4011/199
Hand fractureInjury, poisoning and procedural complications0/4011/199
Most frequent other events
Showing 10 of 14
Most frequent other events
EventDengue Vaccine GroupControl Group
Injection site PainGeneral disorders192/392132/198
HeadacheNervous system disorders237/391116/198
MyalgiaMusculoskeletal and connective tissue disorders171/39090/198
MalaiseGeneral disorders157/39082/198
AstheniaGeneral disorders119/39051/198
NasopharyngitisInfections and infestations105/40151/199
FeverGeneral disorders84/39236/197
CoughRespiratory, thoracic and mediastinal disorders24/40123/199
Injection site ErythemaGeneral disorders26/39218/198
HeadacheNervous system disorders35/40110/199

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dengue Vaccine GroupControl GroupTotal
<=18 years401199600
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(Years)Dengue Vaccine GroupControl GroupTotal
Mean12.6 ± 2.112.5 ± 2.112.55 ± 2.1
Sex: Female, Male
Sex: Female, Male(Participants)Dengue Vaccine GroupControl GroupTotal
Female204108312
Male19791288
Region of Enrollment
Region of Enrollment(Participants)Dengue Vaccine GroupControl GroupTotal
Colombia10554159
Honduras10652158
Mexico11958177
Puerto Rico7135106
08

Study locations

4 sites
  • Bucaramanga, Colombia
  • Tegucigalpa, Honduras
  • Cuernavaca, Mexico
  • San Juan, Puerto Rico
09

References and documents

Publications

  • Villar LA, Rivera-Medina DM, Arredondo-Garcia JL, Boaz M, Starr-Spires L, Thakur M, Zambrano B, Miranda MC, Rivas E, Dayan GH. Safety and immunogenicity of a recombinant tetravalent dengue vaccine in 9-16 year olds: a randomized, controlled, phase II trial in Latin America. Pediatr Infect Dis J. 2013 Oct;32(10):1102-9. doi: 10.1097/INF.0b013e31829b8022. PubMed 24067553 ↗
  • 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

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Sep 2011 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2016, 5 years 2 months after primary completion. A results delay was requested in Apr 2012.

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

Registered
Oct 9, 2009
First posted
Oct 12, 2009
Start
Oct 2009
Primary completionActual
Sep 2011
CompletionActual
Mar 2012
Results delay requested
Apr 16, 2012
Results first posted
Nov 29, 2016
Last update
Mar 24, 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 Mar 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00993447
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Oct 12, 2009
Start date
Oct 2009
Primary completion
Sep 2011
Completion
Mar 2012
Results posted
Nov 29, 2016
Last update
Mar 24, 2022

Study contacts

Medical Director
study director · Sanofi Pasteur Inc.

Oversight

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

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