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

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00993447
Collaborator
(none)
600
Enrollment
4
Locations
2
Arms
29
Duration (Months)
150
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CYD Dengue Vaccine
  • Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: CYD Dengue Vaccine Group

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

Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, 6 and 12 months
Other Names:
  • Dengvaxia®

    		•
    Sham Comparator: Control Vaccine Group

    Biological: Tetanus 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
    Other Names:
  • ADACEL®
  • NaCl

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [Day 0 (pre-each vaccination) and Day 28 post-each vaccination]

      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).

    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 [Day 0 (pre-each vaccination) and Day 28 post-each vaccination]

      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.

    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 [Day 0 (pre-each vaccination) and Day 28 post-each vaccination]

      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.

    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 [Day 0 (before each vaccination) and Day 28 post each vaccination]

      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).

    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 [Day 0 (before each vaccination) and Day 28 post each vaccination]

      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).

    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 [Day 0 (before each vaccination) and Day 28 post each vaccination]

      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).

    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 [Day 0 (before each vaccination) and Day 28 post-each vaccination]

      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).

    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 [Day 0 (before each vaccination) and Day 28 post each vaccination]

      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.

    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 [Day 0 (before each vaccination) and Day 28 post each vaccination]

      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.

    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 [Day 0 (pre each vaccination) and Day 28 post each vaccination]

      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.

    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 [Day 0 (pre-each vaccination) and Day 28 post-each vaccination]

      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.

    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 [Day 0 (pre-each vaccination) and Day 28 post-each vaccination]

      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.

    13. Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine [Day 0 up to Day 14 post-each vaccination]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 :

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bucaramanga Colombia
    2 Tegucigalpa Honduras
    3 Cuernavaca Mexico
    4 San Juan Puerto Rico

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00993447
    Other Study ID Numbers:
    • CYD13
    • UTN: U1111-1111-5511
    First Posted:
    Oct 12, 2009
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Dengue
    Dengue hemorrhagic fever
    Dengue virus
    Dengue fever
    Sanofi pasteur's CYD Dengue vaccine
    Additional relevant MeSH terms:
    Dengue
    Hemorrhagic Fevers, Viral
    Severe Dengue
    Fever
    Hyperthermia

    Study Results

    Participant Flow

    Recruitment Details 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.
    Pre-assignment Detail A total of 600 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Period Title: Overall Study
    STARTED 401 199
    COMPLETED 364 180
    NOT COMPLETED 37 19

    Baseline Characteristics

    Arm/Group Title Dengue Vaccine Group Control Group Total
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection. Total of all reporting groups
    Overall Participants 401 199 600
    Age (Count of Participants)
    <=18 years
    401
    100%
    199
    100%
    600
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    12.6
    (2.1)
    12.5
    (2.1)
    12.55
    (2.1)
    Sex: Female, Male (Count of Participants)
    Female
    204
    50.9%
    108
    54.3%
    312
    52%
    Male
    197
    49.1%
    91
    45.7%
    288
    48%
    Region of Enrollment (Number) [Number]
    Colombia
    105
    26.2%
    54
    27.1%
    159
    26.5%
    Honduras
    106
    26.4%
    52
    26.1%
    158
    26.3%
    Mexico
    119
    29.7%
    58
    29.1%
    177
    29.5%
    Puerto Rico
    71
    17.7%
    35
    17.6%
    106
    17.7%

    Outcome Measures

    1. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 401 199
    Serotype 1; Pre-inj. 1 (N=379,191)
    64.9
    16.2%
    68.1
    34.2%
    Serotype 1; Post-inj. 1 (N=379,191)
    73.1
    18.2%
    67.0
    33.7%
    Serotype 1; Pre-inj. 2 (N=353,174)
    75.6
    18.9%
    67.8
    34.1%
    Serotype 1; Post-inj. 2 (N=353,174)
    85.0
    21.2%
    69.0
    34.7%
    Serotype 1; Pre-inj. 3 (N=335,163)
    79.7
    19.9%
    73.6
    37%
    Serotype 1; Post-inj. 3 (N=335,163)
    94.6
    23.6%
    75.5
    37.9%
    Serotype 2; Pre-inj. 1 (N=379,191)
    69.9
    17.4%
    74.3
    37.3%
    Serotype 2; Post-inj. 1 (N=379,191)
    85.2
    21.2%
    72.8
    36.6%
    Serotype 2; Pre-inj. 2 (N=353,174)
    87.3
    21.8%
    71.8
    36.1%
    Serotype 2; Post-inj. 2 (N=353,174)
    96.9
    24.2%
    73.0
    36.7%
    Serotype 2; Pre-inj. 3 (N=335,163)
    91.9
    22.9%
    76.7
    38.5%
    Serotype 2; Post-inj. 3 (N=335,163)
    99.1
    24.7%
    78.5
    39.4%
    Serotype 3; Pre-inj. 1 (N=379,191)
    69.9
    17.4%
    73.3
    36.8%
    Serotype 3; Post-inj. 1 (N=379,191)
    90.8
    22.6%
    74.3
    37.3%
    Serotype 3; Pre-inj. 2 (N=353,174)
    90.9
    22.7%
    72.4
    36.4%
    Serotype 3; Post-inj. 2 (N=353,174)
    98.6
    24.6%
    73.6
    37%
    Serotype 3; Pre-inj. 3 (N=335,163)
    96.4
    24%
    74.8
    37.6%
    Serotype 3; Post-inj. 3 (N=335,163)
    100.0
    24.9%
    76.7
    38.5%
    Serotype 4; Pre-inj. 1 (N=379,191)
    63.1
    15.7%
    68.1
    34.2%
    Serotype 4; Post-inj. 1 (N=379,191)
    92.6
    23.1%
    62.3
    31.3%
    Serotype 4; Pre-inj. 2 (N=353,174)
    92.4
    23%
    66.7
    33.5%
    Serotype 4; Post-inj. 2 (N=353,174)
    96.6
    24.1%
    70.1
    35.2%
    Serotype 4; Pre-inj. 3 (N=335,163)
    95.8
    23.9%
    69.9
    35.1%
    Serotype 4; Post-inj. 3 (N=335,163)
    98.8
    24.6%
    69.3
    34.8%
    2. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 316 160
    Serotype 1; Pre-inj. 1 (N=316,160)
    81.3
    20.3%
    84.4
    42.4%
    Serotype 1; Post-inj. 1 (N=305,158)
    90.8
    22.6%
    82.3
    41.4%
    Serotype 1; Pre-inj. 2 (N=295,148)
    90.5
    22.6%
    82.4
    41.4%
    Serotype 1; Post-inj. 2 (N=293,147)
    95.6
    23.8%
    84.4
    42.4%
    Serotype 1; Pre-inj. 3 (N=288,143)
    92.0
    22.9%
    87.4
    43.9%
    Serotype 1; Post-inj. 3 (N=287,143)
    97.6
    24.3%
    88.8
    44.6%
    Serotype 2; Pre-inj. 1 (N=316,160)
    88.0
    21.9%
    91.9
    46.2%
    Serotype 2; Post-inj. 1 (N=305,158)
    96.4
    24%
    89.9
    45.2%
    Serotype 2; Pre-inj. 2 (N=295,148)
    96.6
    24.1%
    89.2
    44.8%
    Serotype 2; Post-inj. 2 (N=293,147)
    98.6
    24.6%
    90.5
    45.5%
    Serotype 2; Pre-inj. 3 (N=288,143)
    96.5
    24.1%
    90.9
    45.7%
    Serotype 2; Post-inj. 3 (N=287,143)
    99.7
    24.9%
    92.3
    46.4%
    Serotype 3; Pre-inj. 1 (N=316,160)
    88.3
    22%
    90.6
    45.5%
    Serotype 3; Post-inj. 1 (N=305,158)
    96.7
    24.1%
    89.9
    45.2%
    Serotype 3; Pre-inj. 2 (N=295,148)
    96.6
    24.1%
    87.8
    44.1%
    Serotype 3; Post-inj. 2 (N=293,147)
    99.0
    24.7%
    88.4
    44.4%
    Serotype 3; Pre-inj. 3 (N=288,143)
    97.9
    24.4%
    89.5
    45%
    Serotype 3; Post-inj. 3 (N=287,143)
    100.0
    24.9%
    89.5
    45%
    Serotype 4; Pre-inj. 1 (N=316,160)
    79.4
    19.8%
    84.4
    42.4%
    Serotype 4; Post-inj. 1 (N=305,158)
    97.4
    24.3%
    76.6
    38.5%
    Serotype 4; Pre-inj. 2 (N=295,148)
    96.9
    24.2%
    81.1
    40.8%
    Serotype 4; Post-inj. 2 (N=293,147)
    98.0
    24.4%
    84.4
    42.4%
    Serotype 4; Pre-inj. 3 (N=288,143)
    99.3
    24.8%
    84.6
    42.5%
    Serotype 4; Post-inj. 3 (N=287,143)
    100.0
    24.9%
    84.6
    42.5%
    3. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 85 38
    Serotype 1; Pre-inj. 1 (N=85,38)
    0.0
    0%
    0.0
    0%
    Serotype 1; Post-inj. 1 (N=84,37)
    7.1
    1.8%
    2.7
    1.4%
    Serotype 1; Pre-inj. 2 (N=78,36)
    17.9
    4.5%
    5.6
    2.8%
    Serotype 1; Post-inj. 2 (N=78,36)
    44.9
    11.2%
    5.6
    2.8%
    Serotype 1; Pre-inj. 3 (N=77,36)
    33.8
    8.4%
    16.7
    8.4%
    Serotype 1; Post-inj. 3 (N=77,36)
    81.8
    20.4%
    19.4
    9.7%
    Serotype 2; Pre-inj. 1 (N=85,38)
    0.0
    0%
    0.0
    0%
    Serotype 2; Post-inj. 1 (N=84,37)
    42.9
    10.7%
    0.0
    0%
    Serotype 2; Pre-inj. 2 (N=78,36)
    51.3
    12.8%
    2.8
    1.4%
    Serotype 2; Post-inj. 2 (N=78,36)
    89.7
    22.4%
    5.6
    2.8%
    Serotype 2; Pre-inj. 3 (N=77,36)
    70.1
    17.5%
    16.7
    8.4%
    Serotype 2; Post-inj. 3 (N=77,36)
    96.1
    24%
    19.4
    9.7%
    Serotype 3; Pre-inj. 1 (N=85,38)
    0.0
    0%
    0.0
    0%
    Serotype 3; Post-inj. 1 (N=84,37)
    67.9
    16.9%
    10.8
    5.4%
    Serotype 3; Pre-inj. 2 (N=78,36)
    66.7
    16.6%
    8.3
    4.2%
    Serotype 3; Post-inj. 2 (N=78,36)
    94.9
    23.7%
    8.3
    4.2%
    Serotype 3; Pre-inj. 3 (N=77,36)
    89.6
    22.3%
    5.6
    2.8%
    Serotype 3; Post-inj. 3 (N=77,36)
    100.0
    24.9%
    16.7
    8.4%
    Serotype 4; Pre-inj. 1 (N=85,38)
    0.0
    0%
    0.0
    0%
    Serotype 4; Post-inj. 1 (N=84,37)
    73.8
    18.4%
    2.7
    1.4%
    Serotype 4; Pre-inj. 2 (N=78,36)
    73.1
    18.2%
    5.6
    2.8%
    Serotype 4; Post-inj. 2 (N=78,36)
    91.0
    22.7%
    8.3
    4.2%
    Serotype 4; Pre-inj. 3 (N=77,36)
    80.5
    20.1%
    8.3
    4.2%
    Serotype 4; Post-inj. 3 (N=77,36)
    94.8
    23.6%
    5.6
    2.8%
    4. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 401 199
    At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)
    75.1
    18.7%
    77.9
    39.1%
    At Least 1 Serotype; Post-inj. 1 (N=389,196)
    98.2
    24.5%
    78.6
    39.5%
    At Least 1 Serotype; Pre-inj. 2 (N=373,185)
    99.2
    24.7%
    76.2
    38.3%
    At Least 1 Serotype; Post-inj. 2 (N=371,184)
    99.7
    24.9%
    76.6
    38.5%
    At Least 1 Serotype; Pre-inj. 3 (N=365,180)
    100.0
    24.9%
    79.4
    39.9%
    At Least 1 Serotype; Post-inj. 3 (N=364,180)
    100.0
    24.9%
    78.9
    39.6%
    At Least 2 Serotypes; Pre-inj. 1 (N=401,199)
    69.1
    17.2%
    72.9
    36.6%
    At Least 2 Serotypes; Post-inj. 1 (N=389,196)
    91.0
    22.7%
    70.9
    35.6%
    At Least 2 Serotypes; Pre-inj. 2 (N=373,185)
    91.4
    22.8%
    71.9
    36.1%
    At Least 2 Serotypes; Post-inj. 2 (N=371,184)
    98.9
    24.7%
    71.2
    35.8%
    At Least 2 Serotypes; Pre-inj. 3 (N=365,180)
    96.2
    24%
    75.6
    38%
    At Least 2 Serotypes; Post-inj. 3 (N=364,180)
    100.0
    24.9%
    76.7
    38.5%
    At Least 3 Serotypes; Pre-inj. 1 (N=401,199)
    64.6
    16.1%
    69.8
    35.1%
    At Least 3 Serotypes; Post-inj. 1 (N=381,196)
    79.9
    19.9%
    67.3
    33.8%
    At Least 3 Serotypes; Pre-inj. 2 (N=373,185)
    81.8
    20.4%
    68.1
    34.2%
    At Least 3 Serotypes; Post-inj. 2 (N=371,184)
    94.3
    23.5%
    69.0
    34.7%
    At Least 3 Serotypes; Pre-inj. 3 (N=365,180)
    88.2
    22%
    70.6
    35.5%
    At Least 3 Serotypes; Post-inj. 3 (N=364,180)
    98.6
    24.6%
    72.2
    36.3%
    All 4 Serotypes; Pre-inj. 1 (N=401,199)
    56.9
    14.2%
    61.8
    31.1%
    All 4 Serotypes; Post-inj. 1 (N=389,196)
    71.2
    17.8%
    59.2
    29.7%
    All 4 Serotypes; Pre-inj. 2 (N=373,185)
    72.4
    18.1%
    60.5
    30.4%
    All 4 Serotypes; Post-inj. 2 (N=371,184)
    83.3
    20.8%
    66.3
    33.3%
    All 4 Serotypes; Pre-inj. 3 (N=365,180)
    77.8
    19.4%
    64.4
    32.4%
    All 4 Serotypes; Post-inj. 3 (N=364,180)
    93.4
    23.3%
    66.7
    33.5%
    5. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 316 160
    At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)
    95.3
    23.8%
    96.9
    48.7%
    At Least 1 Serotype; Post-inj. 1 (N=389,196)
    99.0
    24.7%
    93.7
    47.1%
    At Least 1 Serotype; Pre-inj. 2 (N=373,185)
    99.7
    24.9%
    91.9
    46.2%
    At Least 1 Serotype; Post-inj. 2 (N=371,184)
    99.7
    24.9%
    93.2
    46.8%
    At Least 1 Serotype; Pre-inj. 3 (N=365,180)
    100.0
    24.9%
    93.7
    47.1%
    At Least 1 Serotype; Post-inj. 3 (N=364,180)
    100.0
    24.9%
    93.0
    46.7%
    At Least 2 Serotypes; Pre-inj. 1 (N=401,199)
    87.7
    21.9%
    90.6
    45.5%
    At Least 2 Serotypes; Post-inj. 1 (N=389,196)
    97.4
    24.3%
    88.0
    44.2%
    At Least 2 Serotypes; Pre-inj. 2 (N=373,185)
    97.3
    24.3%
    89.2
    44.8%
    At Least 2 Serotypes; Post-inj. 2 (N=371,184)
    99.0
    24.7%
    87.8
    44.1%
    At Least 2 Serotypes; Pre-inj. 3 (N=365,180)
    98.6
    24.6%
    91.6
    46%
    At Least 2 Serotypes; Post-inj. 3 (N=364,180)
    100.0
    24.9%
    92.3
    46.4%
    At Least 3 Serotypes; Pre-inj. 1 (N=401,199)
    92.0
    22.9%
    86.9
    43.7%
    At Least 3 Serotypes; Post-inj. 1 (N=381,196)
    95.1
    23.7%
    83.5
    42%
    At Least 3 Serotypes; Pre-inj. 2 (N=373,185)
    94.2
    23.5%
    84.5
    42.5%
    At Least 3 Serotypes; Post-inj. 2 (N=371,184)
    98.3
    24.5%
    85.0
    42.7%
    At Least 3 Serotypes; Pre-inj. 3 (N=365,180)
    96.2
    24%
    86.7
    43.6%
    At Least 3 Serotypes; Post-inj. 3 (N=364,180)
    99.7
    24.9%
    87.4
    43.9%
    All 4 Serotypes; Pre-inj. 1 (N=401,199)
    72.2
    18%
    76.9
    38.6%
    All 4 Serotypes; Post-inj. 1 (N=389,196)
    89.8
    22.4%
    73.4
    36.9%
    All 4 Serotypes; Pre-inj. 2 (N=373,185)
    89.5
    22.3%
    75.0
    37.7%
    All 4 Serotypes; Post-inj. 2 (N=371,184)
    94.2
    23.5%
    81.6
    41%
    All 4 Serotypes; Pre-inj. 3 (N=365,180)
    91.0
    22.7%
    80.4
    40.4%
    All 4 Serotypes; Post-inj. 3 (N=364,180)
    97.6
    24.3%
    82.5
    41.5%
    6. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 85 38
    At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)
    0.0
    0%
    0.0
    0%
    At Least 1 Serotype; Post-inj. 1 (N=389,196)
    95.0
    23.7%
    16.2
    8.1%
    At Least 1 Serotype; Pre-inj. 2 (N=373,185)
    97.4
    24.3%
    13.9
    7%
    At Least 1 Serotype; Post-inj. 2 (N=371,184)
    100.0
    24.9%
    11.1
    5.6%
    At Least 1 Serotype; Pre-inj. 3 (N=365,180)
    100.0
    24.9%
    22.2
    11.2%
    At Least 1 Serotype; Post-inj. 3 (N=364,180)
    100.0
    24.9%
    25.0
    12.6%
    At Least 2 Serotypes; Pre-inj. 1 (N=401,199)
    0.0
    0%
    0.0
    0%
    At Least 2 Serotypes; Post-inj. 1 (N=389,196)
    67.9
    16.9%
    0.0
    0%
    At Least 2 Serotypes; Pre-inj. 2 (N=373,185)
    69.2
    17.3%
    2.8
    1.4%
    At Least 2 Serotypes; Post-inj. 2 (N=371,184)
    98.7
    24.6%
    5.6
    2.8%
    At Least 2 Serotypes; Pre-inj. 3 (N=365,180)
    87.0
    21.7%
    13.9
    7%
    At Least 2 Serotypes; Post-inj. 3 (N=364,180)
    100.0
    24.9%
    16.7
    8.4%
    At Least 3 Serotypes; Pre-inj. 1 (N=401,199)
    0.0
    0%
    0.0
    0%
    At Least 3 Serotypes; Post-inj. 1 (N=381,196)
    25.0
    6.2%
    0.0
    0%
    At Least 3 Serotypes; Pre-inj. 2 (N=373,185)
    34.6
    8.6%
    2.8
    1.4%
    At Least 3 Serotypes; Post-inj. 2 (N=371,184)
    79.5
    19.8%
    5.6
    2.8%
    At Least 3 Serotypes; Pre-inj. 3 (N=365,180)
    58.4
    14.6%
    8.3
    4.2%
    At Least 3 Serotypes; Post-inj. 3 (N=364,180)
    94.8
    23.6%
    13.9
    7%
    All 4 Serotypes; Pre-inj. 1 (N=401,199)
    0.0
    0%
    0.0
    0%
    All 4 Serotypes; Post-inj. 1 (N=389,196)
    3.6
    0.9%
    0.0
    0%
    All 4 Serotypes; Pre-inj. 2 (N=373,185)
    7.7
    1.9%
    2.8
    1.4%
    All 4 Serotypes; Post-inj. 2 (N=371,184)
    42.3
    10.5%
    5.6
    2.8%
    All 4 Serotypes; Pre-inj. 3 (N=365,180)
    28.6
    7.1%
    2.8
    1.4%
    All 4 Serotypes; Post-inj. 3 (N=364,180)
    77.9
    19.4%
    5.6
    2.8%
    7. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 401 199
    Serotype 1; Pre-inj. 1 (N=401,199)
    74.2
    81.9
    Serotype 1; Post-inj. 1 (N=389,196)
    221
    77.1
    Serotype 1; Pre-inj. 2 (N=373,185)
    193
    96.6
    Serotype 1; Post-inj. 2 (N=371,184)
    276
    102
    Serotype 1; Pre-inj. 3 (N=365,180)
    204
    113
    Serotype 1; Post-inj. 3 (N=364,180)
    320
    106
    Serotype 2; Pre-inj. 1 (N=401,199)
    92.6
    100
    Serotype 2; Post-inj. 1 (N=389,196)
    409
    90.4
    Serotype 2; Pre-inj. 2 (N=373,185)
    326
    117
    Serotype 2; Post-inj. 2 (N=371,184)
    504
    114
    Serotype 2; Pre-inj. 3 (N=365,180)
    300
    133
    Serotype 2; Post-inj. 3 (N=364,180)
    486
    133
    Serotype 3; Pre-inj. 1 (N=401,199)
    85.0
    88.8
    Serotype 3; Post-inj. 1 (N=389,196)
    442
    93.2
    Serotype 3; Pre-inj. 2 (N=372,185)
    301
    107
    Serotype 3; Post-inj. 2 (N=371,184)
    502
    108
    Serotype 3; Pre-inj. 3 (N=365,180)
    379
    123
    Serotype 3; Post-inj. 3 (N=364,180)
    594
    121
    Serotype 4; Pre-inj. 1 (N=401,199)
    37.2
    40.1
    Serotype 4; Post-inj. 1 (N=389,196)
    416
    34.1
    Serotype 4; Pre-inj. 2 (N=373,185)
    200
    43.8
    Serotype 4; Post-inj. 2 (N=369,184)
    305
    43.9
    Serotype 4; Pre-inj. 3 (N=365,180)
    182
    47.7
    Serotype 4; Post-inj. 3 (N=364,180)
    273
    42.8
    8. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 401 199
    Serotype 1; Post-inj. 1/Pre-inj. 1 (N=389,196)
    2.36
    0.756
    Serotype 1; Post-inj. 2/Pre-inj. 1 (N=371,184)
    2.74
    1.02
    Serotype 1; Post-inj. 2/Pre-inj. 2 (N=371,184)
    1.19
    0.851
    Serotype 1; Post-inj. 3/Pre-inj. 1 (N=364,180)
    3.16
    1.03
    Serotype 1; Post-inj. 3/Pre-inj. 2 (N=364,180)
    1.38
    0.859
    Serotype 1; Post-inj. 3/Pre-inj. 3 (N=364,180)
    1.35
    0.777
    Serotype 2; Post-inj. 1/Pre-inj. 1 (N=389,196)
    3.55
    0.760
    Serotype 2; Post-inj. 2/Pre-inj. 1 (N=371,184)
    4.09
    0.983
    Serotype 2; Post-inj. 2/Pre-inj. 2 (N=371,184)
    1.40
    0.811
    Serotype 2; Post-inj. 3/Pre-inj. 1 (N=364,180)
    3.97
    1.16
    Serotype 2; Post-inj. 3/Pre-inj. 2 (N=364,180)
    1.36
    0.957
    Serotype 2; Post-inj. 3/Pre-inj. 3 (N=364,180)
    1.51
    0.844
    Serotype 3; Post-inj. 1/Pre-inj. 1 (N=389,196)
    4.24
    0.864
    Serotype 3; Post-inj. 2/Pre-inj. 1 (N=371,184)
    4.52
    1.04
    Serotype 3; Post-inj. 2/Pre-inj. 2 (N=370,184)
    1.57
    0.840
    Serotype 3; Post-inj. 3/Pre-inj. 1 (N=364,180)
    5.27
    1.15
    Serotype 3; Post-inj. 3/Pre-inj. 2 (N=363,180)
    1.86
    0.937
    Serotype 3; Post-inj. 3/Pre-inj. 3 (N=364,180)
    1.52
    0.815
    Serotype 4; Post-inj. 1/Pre-inj. 1 (N=389,196)
    8.63
    0.672
    Serotype 4; Post-inj. 2/Pre-inj. 1 (N=369,184)
    6.14
    0.887
    Serotype 4; Post-inj. 2/Pre-inj. 2 (N=369,184)
    1.45
    0.800
    Serotype 4; Post-inj. 3/Pre-inj. 1 (N=364,180)
    5.47
    0.871
    Serotype 4; Post-inj. 3/Pre-inj. 2 (N=364,180)
    1.30
    0.771
    Serotype 4; Post-inj. 3/Pre-inj. 3 (N=364,180)
    1.45
    0.723
    9. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 316 160
    Serotype 1; Pre-inj. 1 (N=316,160)
    153
    162
    Serotype 1; Post-inj. 1 (N=305,158)
    604
    148
    Serotype 1; Pre-inj. 2 (N=295,148)
    447
    192
    Serotype 1; Post-inj. 2 (N=293,147)
    607
    199
    Serotype 1; Pre-inj. 3 (N=288,143)
    435
    225
    Serotype 1; Post-inj. 3 (N=287,143)
    580
    205
    Serotype 2; Pre-inj. 1 (N=316,160)
    203
    207
    Serotype 2; Post-inj. 1 (N=305,158)
    1001
    181
    Serotype 2; Pre-inj. 2 (N=295,148)
    673
    251
    Serotype 2; Post-inj. 2 (N=293,147)
    888
    232
    Serotype 2; Pre-inj. 3 (N=288,143)
    554
    265
    Serotype 2; Post-inj. 3 (N=287,143)
    741
    266
    Serotype 3; Pre-inj. 1 (N=316,160)
    182
    179
    Serotype 3; Post-inj. 1 (N=305,158)
    863
    180
    Serotype 3; Pre-inj. 2 (N=295,148)
    556
    221
    Serotype 3; Post-inj. 2 (N=293,147)
    782
    215
    Serotype 3; Pre-inj. 3 (N=288,143)
    615
    265
    Serotype 3; Post-inj. 3 (N=287,143)
    827
    248
    Serotype 4; Pre-inj. 1 (N=316,160)
    63.8
    66.5
    Serotype 4; Post-inj. 1 (N=305,158)
    549
    53.4
    Serotype 4; Pre-inj. 2 (N=295,148)
    278
    73.7
    Serotype 4; Post-inj. 2 (N=291,147)
    395
    70.4
    Serotype 4; Pre-inj. 3 (N=288,143)
    259
    81.8
    Serotype 4; Post-inj. 3 (N=287,143)
    341
    72.5
    10. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 316 160
    Serotype 1; Post-inj. 1/Pre-inj. 1 (N=305,158)
    3.49
    0.829
    Serotype 1; Post-inj. 2/Pre-inj. 1 (N=293,147)
    3.25
    1.11
    Serotype 1; Post-inj. 2/Pre-inj. 2 (N=293,147)
    1.25
    0.925
    Serotype 1; Post-inj. 3/Pre-inj. 1 (N=287,143)
    3.08
    1.09
    Serotype 1; Post-inj. 3/Pre-inj. 2 (N=287,143)
    1.19
    0.907
    Serotype 1; Post-inj. 3/Pre-inj. 3 (N=287,143)
    1.24
    0.834
    Serotype 2; Post-inj. 1/Pre-inj. 1 (N=305,158)
    4.43
    0.840
    Serotype 2; Post-inj. 2/Pre-inj. 1 (N=293,147)
    3.70
    1.08
    Serotype 2; Post-inj. 2/Pre-inj. 2 (N=293,147)
    1.27
    0.865
    Serotype 2; Post-inj. 3/Pre-inj. 1 (N=287,143)
    3.08
    1.23
    Serotype 2; Post-inj. 3/Pre-inj. 2 (N=287,143)
    1.06
    0.982
    Serotype 2; Post-inj. 3/Pre-inj. 3 (N=287,143)
    1.29
    0.940
    Serotype 3; Post-inj. 1/Pre-inj. 1 (N=305,158)
    4.35
    0.941
    Serotype 3; Post-inj. 2/Pre-inj. 1 (N=293,147)
    3.71
    1.16
    Serotype 3; Post-inj. 2/Pre-inj. 2 (N=293,147)
    1.36
    0.906
    Serotype 3; Post-inj. 3/Pre-inj. 1 (N=287,143)
    3.82
    1.29
    Serotype 3; Post-inj. 3/Pre-inj. 2 (N=287,143)
    1.43
    1.03
    Serotype 3; Post-inj. 3/Pre-inj. 3 (N=287,143)
    1.31
    0.872
    Serotype 4; Post-inj. 1/Pre-inj. 1 (N=305,158)
    7.40
    0.712
    Serotype 4; Post-inj. 2/Pre-inj. 1 (N=291,147)
    5.16
    0.952
    Serotype 4; Post-inj. 2/Pre-inj. 2 (N=291,147)
    1.39
    0.847
    Serotype 4; Post-inj. 3/Pre-inj. 1 (N=287,143)
    4.45
    0.976
    Serotype 4; Post-inj. 3/Pre-inj. 2 (N=287,143)
    1.20
    0.849
    Serotype 4; Post-inj. 3/Pre-inj. 3 (N=287,143)
    1.30
    0.796
    11. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 85 38
    Serotype 1; Pre-inj. 1 (N=85,38)
    5.00
    5.00
    Serotype 1; Post-inj. 1 (N=84,37)
    5.72
    5.15
    Serotype 1; Pre-inj. 2 (N=78,36)
    8.16
    6.18
    Serotype 1; Post-inj. 2 (N=78,36)
    14.3
    7.29
    Serotype 1; Pre-inj. 3 (N=77,36)
    12.0
    7.93
    Serotype 1; Post-inj. 3 (N=77,36)
    34.6
    8.36
    Serotype 2; Pre-inj. 1 (N=85,38)
    5.00
    5.00
    Serotype 2; Post-inj. 1 (N=84,37)
    15.9
    5.00
    Serotype 2; Pre-inj. 2 (N=78,36)
    21.0
    5.50
    Serotype 2; Post-inj. 2 (N=78,36)
    60.0
    6.79
    Serotype 2; Pre-inj. 3 (N=77,36)
    30.3
    9.48
    Serotype 2; Post-inj. 3 (N=77,36)
    101
    9.45
    Serotype 3; Pre-inj. 1 (N=85,38)
    5.00
    5.00
    Serotype 3; Post-inj. 1 (N=84,37)
    38.8
    6.10
    Serotype 3; Pre-inj. 2 (N=77,36)
    28.6
    5.97
    Serotype 3; Post-inj. 2 (N=78,36)
    94.9
    7.07
    Serotype 3; Pre-inj. 3 (N=77,36)
    61.9
    6.18
    Serotype 3; Post-inj. 3 (N=77,36)
    174
    7.53
    Serotype 4; Pre-inj. 1 (N=85,38)
    5.00
    5.00
    Serotype 4; Post-inj. 1 (N=84,37)
    151
    5.30
    Serotype 4; Pre-inj. 2 (N=78,36)
    57.5
    5.48
    Serotype 4; Post-inj. 2 (N=78,36)
    117
    6.77
    Serotype 4; Pre-inj. 3 (N=77,36)
    48.3
    5.97
    Serotype 4; Post-inj. 3 (N=77,36)
    119
    5.63
    12. Primary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 85 38
    Serotype 1; Post-inj. 1/Pre-inj. 1 (N=84,37)
    0.572
    0.515
    Serotype 1; Post-inj. 2/Pre-inj. 1 (N=78,36)
    1.43
    0.729
    Serotype 1; Post-inj. 2/Pre-inj. 2 (N=78,36)
    0.990
    0.613
    Serotype 1; Post-inj. 3/Pre-inj. 1 (N=77,36)
    3.46
    0.836
    Serotype 1; Post-inj. 3/Pre-inj. 2 (N=77,36)
    2.39
    0.703
    Serotype 1; Post-inj. 3/Pre-inj. 3 (N=77,36)
    1.83
    0.592
    Serotype 2; Post-inj. 1/Pre-inj. 1 (N=84,37)
    1.59
    0.500
    Serotype 2; Post-inj. 2/Pre-inj. 1 (N=78,36)
    6.00
    0.679
    Serotype 2; Post-inj. 2/Pre-inj. 2 (N=78,36)
    2.04
    0.630
    Serotype 2; Post-inj. 3/Pre-inj. 1 (N=77,36)
    10.1
    0.945
    Serotype 2; Post-inj. 3/Pre-inj. 2 (N=77,36)
    3.40
    0.876
    Serotype 2; Post-inj. 3/Pre-inj. 3 (N=77,36)
    2.73
    0.559
    Serotype 3; Post-inj. 1/Pre-inj. 1 (N=84,37)
    3.88
    0.610
    Serotype 3; Post-inj. 2/Pre-inj. 1 (N=78,36)
    9.49
    0.707
    Serotype 3; Post-inj. 2/Pre-inj. 2 (N=77,36)
    2.67
    0.627
    Serotype 3; Post-inj. 3/Pre-inj. 1 (N=77,36)
    17.4
    0.753
    Serotype 3; Post-inj. 3/Pre-inj. 2 (N=76,36)
    4.90
    0.668
    Serotype 3; Post-inj. 3/Pre-inj. 3 (N=77,36)
    2.61
    0.633
    Serotype 4; Post-inj. 1/Pre-inj. 1 (N=84,37)
    15.1
    0.530
    Serotype 4; Post-inj. 2/Pre-inj. 1 (N=78,36)
    11.7
    0.677
    Serotype 4; Post-inj. 2/Pre-inj. 2 (N=78,36)
    1.69
    0.642
    Serotype 4; Post-inj. 3/Pre-inj. 1 (N=77,36)
    11.9
    0.563
    Serotype 4; Post-inj. 3/Pre-inj. 2 (N=77,36)
    1.75
    0.533
    Serotype 4; Post-inj. 3/Pre-inj. 3 (N=77,36)
    2.15
    0.499
    13. Primary Outcome
    Title Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    Measure Participants 401 199
    Injection-site Pain (Any dose; N=392,198)
    192
    47.9%
    132
    66.3%
    Grade 3 Pain (Any dose; N=392,198)
    13
    3.2%
    7
    3.5%
    Injection-site Erythema (Any dose; N=392,198)
    26
    6.5%
    18
    9%
    Grade 3 Erythema (Any dose; N=392,198)
    0
    0%
    1
    0.5%
    Injection-site Swelling (Any dose; N=392,198)
    20
    5%
    16
    8%
    Grade 3 Swelling (Any dose; N=392,198)
    1
    0.2%
    1
    0.5%
    Injection-site Pain (Post-dose 1; N=392,196)
    121
    30.2%
    54
    27.1%
    Grade 3 Pain (Post-dose 1; N=392,196)
    6
    1.5%
    2
    1%
    Injection-site Erythema (Post-dose 1; N=390,196)
    11
    2.7%
    6
    3%
    Grade 3 Erythema (Post-dose 1; N=390,196)
    0
    0%
    0
    0%
    Injection-site Swelling (Post-dose 1; N=391,196)
    8
    2%
    5
    2.5%
    Grade 3 Swelling (Post-dose 1; N=391,196)
    1
    0.2%
    0
    0%
    Injection-site Pain (Post-dose 2; N=373,185)
    101
    25.2%
    31
    15.6%
    Grade Pain (Post-dose 2; N=373,185)
    7
    1.7%
    0
    0%
    Injection-site Erythema (Post-dose 2; N=373,185)
    12
    3%
    5
    2.5%
    Grade 3 Erythema (Post-dose 2; N=373,185)
    0
    0%
    0
    0%
    Injection-site Swelling (Post-dose 2; N=373,185)
    8
    2%
    2
    1%
    Grade 3 Swelling (Post-dose 2; N=373,185)
    1
    0.2%
    0
    0%
    Injection-site Pain (Post-dose 3; N=364,180)
    88
    21.9%
    118
    59.3%
    Grade 3 Pain (Post-dose 3; N=364,180)
    2
    0.5%
    5
    2.5%
    Injection-site Erythema (Post-dose 3; N=364,180)
    8
    2%
    16
    8%
    Grade 3 Erythema (Post-dose 3; N=364,180)
    0
    0%
    1
    0.5%
    Injection-site Swelling (Post-dose 3; N=364,180)
    6
    1.5%
    14
    7%
    Grade 3 Swelling (Post-dose 3; N=364,180)
    0
    0%
    1
    0.5%
    Fever (Any dose; N=392;197)
    84
    20.9%
    36
    18.1%
    Grade 3 Fever (Any dose; N=392;197)
    13
    3.2%
    3
    1.5%
    Headache (Any dose; N=391;198)
    237
    59.1%
    116
    58.3%
    Grade 3 Headache (Any dose; N=391;198)
    40
    10%
    11
    5.5%
    Malaise (Any dose; N=390;198)
    157
    39.2%
    82
    41.2%
    Grade 3 Malaise (Any dose; N=390;198)
    21
    5.2%
    8
    4%
    Myalgia (Any dose; N=390;198)
    171
    42.6%
    90
    45.2%
    Grade 3 Myalgia (Any dose; N=390;198)
    22
    5.5%
    10
    5%
    Asthenia (Any dose; N=390;198)
    119
    29.7%
    51
    25.6%
    Grade 3 Asthenia (Any dose; N=390;198)
    14
    3.5%
    5
    2.5%
    Fever (Post-dose 1; N=392;193)
    43
    10.7%
    13
    6.5%
    Grade 3 Fever (Post dose 1; N=392;193)
    11
    2.7%
    0
    0%
    Headache (Post-dose 1; N=391;197)
    173
    43.1%
    80
    40.2%
    Grade 3 Headache (Post-dose 1; N=391;197)
    26
    6.5%
    5
    2.5%
    Malaise (Post-dose 1; N=390;197)
    102
    25.4%
    45
    22.6%
    Grade 3 Malaise (Post-dose 1; N=390;197)
    14
    3.5%
    0
    0%
    Myalgia (Post-dose 1; N=390;197)
    121
    30.2%
    52
    26.1%
    Grade 3 Myalgia (Post-dose 1; N=390;197)
    15
    3.7%
    3
    1.5%
    Asthenia (Post-dose 1; N=390;197)
    77
    19.2%
    30
    15.1%
    Grade 3 Asthenia (Post dose 1; N=390;197)
    7
    1.7%
    2
    1%
    Fever (Post-dose 2; N=371;184)
    29
    7.2%
    16
    8%
    Grade 3 Fever (Post-dose 2; N=371;184)
    2
    0.5%
    0
    0%
    Headache (Post-dose 2; N=373;185)
    131
    32.7%
    69
    34.7%
    Grade 3 Headache (Post-dose 2; N=373;185)
    14
    3.5%
    4
    2%
    Malaise (Post-dose 2; N=373;185)
    68
    17%
    36
    18.1%
    Grade 3 Malaise (Post-dose 2; N=373;185)
    6
    1.5%
    4
    2%
    Myalgia (Post dose 2; N=373;185)
    80
    20%
    45
    22.6%
    Grade 3 Myalgia (Post-dose 2; N=373;185)
    8
    2%
    3
    1.5%
    Asthenia (Post-dose 2; N=373;185)
    51
    12.7%
    24
    12.1%
    Grade 3 Asthenia (Post-dose 2; N=373;185)
    5
    1.2%
    1
    0.5%
    Fever (Post-dose 3; N=362;180)
    17
    4.2%
    14
    7%
    Grade 3 Fever (Post-dose 3; N=362;180)
    0
    0%
    3
    1.5%
    Headache (Post-dose 3; N=364;180)
    106
    26.4%
    62
    31.2%
    Grade 3 Headache (Post-dose 3; N=364;180)
    10
    2.5%
    4
    2%
    Malaise (Post-dose 3; N=364;180)
    60
    15%
    41
    20.6%
    Grade 3 Malaise (Post-dose 3; N=364;180)
    2
    0.5%
    4
    2%
    Myalgia (Post-dose 3; N=364;180)
    66
    16.5%
    51
    25.6%
    Grade 3 Myalgia (Post-dose 3; N=364;180)
    3
    0.7%
    5
    2.5%
    Asthenia (Post-dose 3; N=364;180)
    42
    10.5%
    23
    11.6%
    Grade 3 Asthenia (Post-dose 3; N=364;180)
    2
    0.5%
    2
    1%

    Adverse Events

    Time Frame Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
    Adverse Event Reporting Description
    Arm/Group Title Dengue Vaccine Group Control Group
    Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
    All Cause Mortality
    Dengue Vaccine Group Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Dengue Vaccine Group Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/401 (2.5%) 15/199 (7.5%)
    Gastrointestinal disorders
    Gastritis 0/401 (0%) 0 1/199 (0.5%) 1
    Vomiting 0/401 (0%) 0 1/199 (0.5%) 1
    Infections and infestations
    Appendicitis 3/401 (0.7%) 3 2/199 (1%) 2
    Cellulitis 0/401 (0%) 0 2/199 (1%) 2
    Dengue fever 3/401 (0.7%) 3 3/199 (1.5%) 3
    Herpes simplex 0/401 (0%) 0 1/199 (0.5%) 1
    Pneumonia 0/401 (0%) 0 1/199 (0.5%) 1
    Pyelonephritis 1/401 (0.2%) 1 0/199 (0%) 0
    Sinusitis 0/401 (0%) 0 1/199 (0.5%) 1
    Urinary tract infection 1/401 (0.2%) 1 0/199 (0%) 0
    Injury, poisoning and procedural complications
    Accidental poisoning 1/401 (0.2%) 1 0/199 (0%) 0
    Hand fracture 0/401 (0%) 0 1/199 (0.5%) 1
    Head injury 0/401 (0%) 0 1/199 (0.5%) 1
    Intentional overdose 0/401 (0%) 0 1/199 (0.5%) 1
    Nervous system disorders
    Convulsion 0/401 (0%) 0 1/199 (0.5%) 1
    Epilepsy 1/401 (0.2%) 1 0/199 (0%) 0
    Migraine 0/401 (0%) 0 2/199 (1%) 2
    Other (Not Including Serious) Adverse Events
    Dengue Vaccine Group Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 237/401 (59.1%) 132/199 (66.3%)
    Gastrointestinal disorders
    Abdominal pain 17/401 (4.2%) 19 12/199 (6%) 12
    Diarrhoea 30/401 (7.5%) 30 9/199 (4.5%) 10
    General disorders
    Injection site Pain 192/392 (49%) 192 132/198 (66.7%) 132
    Injection site Erythema 26/392 (6.6%) 26 18/198 (9.1%) 18
    Injection site Swelling 20/392 (5.1%) 20 16/198 (8.1%) 16
    Fever 84/392 (21.4%) 84 36/197 (18.3%) 36
    Malaise 157/390 (40.3%) 157 82/198 (41.4%) 82
    Asthenia 119/390 (30.5%) 119 51/198 (25.8%) 51
    Infections and infestations
    Nasopharyngitis 105/401 (26.2%) 124 51/199 (25.6%) 61
    Musculoskeletal and connective tissue disorders
    Myalgia 171/390 (43.8%) 171 90/198 (45.5%) 90
    Nervous system disorders
    Headache 35/401 (8.7%) 40 10/199 (5%) 10
    Headache 237/391 (60.6%) 237 116/198 (58.6%) 116
    Respiratory, thoracic and mediastinal disorders
    Cough 24/401 (6%) 26 23/199 (11.6%) 24
    Rhinitis allergic 14/401 (3.5%) 16 10/199 (5%) 10

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.

    Results Point of Contact

    Name/Title Medical Director
    Organization Sanofi Pasteur Inc.
    Phone
    Email RegistryContactUs@sanofipasteur.com
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00993447
    Other Study ID Numbers:
    • CYD13
    • UTN: U1111-1111-5511
    First Posted:
    Oct 12, 2009
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022