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Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01550289
Collaborator
(none)
189
Enrollment
5
Locations
2
Arms
23.1
Duration (Months)
37.8
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.

Primary Objectives:

  • To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects.

  • To describe the safety of the CYD dengue vaccine after each dose in all subjects.

Secondary Objective:
  • To detect symptomatic dengue cases occurring at any time in the trial.
Condition or Disease Intervention/Treatment Phase
  • Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
  • Biological: Placebo: NaCl 0.9% solution
 Phase 2

Detailed Description

Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
189 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: CYD dengue vaccine

Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.

Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Other Names:
  • CYD Dengue vaccine

    		•
    Placebo Comparator: Group 2: Placebo

    Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively

    Biological: Placebo: NaCl 0.9% solution
    0.5 ml, Subcutaneous

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

    2. Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

    3. Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

    4. Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

    5. Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo [Day 0 up to Day 14 post each injection]

      Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.

    Secondary Outcome Measures

    1. Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.

    2. Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.

    3. Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.

    4. Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.

    5. Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.

    6. Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.

    7. Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.

    8. Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)]

      Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged 18 to 45 years on the day of inclusion

    • Informed consent form has been signed and dated by the subject (and by an independent witness, if applicable)

    • Subject is able to attend all scheduled visits and to comply with all trial procedures

    • Subject in good health, based on medical history and physical examination

    Exclusion Criteria:

    • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)

    • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination

    • Planned participation in another clinical trial during the present trial period

    • Planned receipt of any vaccine in the 4 weeks following any trial vaccination

    • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

    • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

    • Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C reported by the subject

    • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances

    • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

    • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

    • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

    • Identified as an Investigator or employee of the Investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bangalore Karnataka India 560054
    2 Ludhiana Punjab India 141008
    3 Kolkata West Bengal India 700073
    4 New Delhi India 110002
    5 Pune India 411018

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur India Pvt Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT01550289
    Other Study ID Numbers:
    • CYD47
    • UTN: U1111-1114-7909
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Apr 5, 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 Fever
    Dengue Hemorrhagic Fever
    CYD Dengue Vaccine
    Dengue Virus
    Flavivirus
    Additional relevant MeSH terms:
    Dengue
    Hemorrhagic Fevers, Viral
    Severe Dengue
    Fever
    Hyperthermia
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.
    Pre-assignment Detail A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Period Title: Overall Study
    STARTED 128 61
    COMPLETED 115 57
    NOT COMPLETED 13 4

    Baseline Characteristics

    Arm/Group Title CYD Dengue Vaccine Group Placebo Group Total
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine. Total of all reporting groups
    Overall Participants 126 61 187
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    126
    100%
    61
    100%
    187
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    29.5
    (7.17)
    29.6
    (6.41)
    29.5
    (6.91)
    Sex: Female, Male (Count of Participants)
    Female
    27
    21.4%
    9
    14.8%
    36
    19.3%
    Male
    99
    78.6%
    52
    85.2%
    151
    80.7%
    Region of Enrollment (Count of Participants)
    India
    126
    100%
    61
    100%
    187
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 126 61
    Serotype 1; Pre-injection 1 (N=126, 61)
    83.3
    66.1%
    80.3
    131.6%
    Serotype 1; Post-injection 1 (N=125, 61)
    91.2
    72.4%
    83.6
    137%
    Serotype 1; Post-injection 2 (N=117, 58)
    94.9
    75.3%
    81.0
    132.8%
    Serotype 1; Post-injection 3 (N=115, 57)
    97.4
    77.3%
    87.7
    143.8%
    Serotype 2; Pre-injection 1 (N=126, 61)
    83.3
    66.1%
    86.9
    142.5%
    Serotype 2; Post-injection 1 (N=126, 61)
    94.4
    74.9%
    88.5
    145.1%
    Serotype 2; Post-injection 2 (N=117, 58)
    99.1
    78.7%
    84.5
    138.5%
    Serotype 2; Post-injection 3 (N=115, 57)
    97.4
    77.3%
    91.2
    149.5%
    Serotype 3; Pre-injection 1 (N=126, 61)
    84.9
    67.4%
    86.9
    142.5%
    Serotype 3; Post-injection 1 (N=126, 61)
    98.4
    78.1%
    90.2
    147.9%
    Serotype 3; Post-injection 2 (N=117, 58)
    98.3
    78%
    84.5
    138.5%
    Serotype 3; Post-injection 3 (N=115, 57)
    99.1
    78.7%
    89.5
    146.7%
    Serotype 4; Pre-injection 1 (N=126, 61)
    77.0
    61.1%
    80.3
    131.6%
    Serotype 4; Post-injection 1 (N=126, 61)
    96.0
    76.2%
    85.2
    139.7%
    Serotype 4; Post-injection 2 (N=117, 57)
    99.1
    78.7%
    78.9
    129.3%
    Serotype 4; Post-injection 3 (N=115, 57)
    100.0
    79.4%
    84.2
    138%
    2. Primary Outcome
    Title Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 126 61
    At least 1 serotype; Pre-injection 1 (N=126, 61)
    86.5
    68.7%
    88.5
    145.1%
    At least 1 serotype; Post-injection 1 (N=126, 61)
    99.2
    78.7%
    90.2
    147.9%
    At least 1 serotype; Post-injection 2 (N=117, 58)
    100.0
    79.4%
    86.2
    141.3%
    At least 1 serotype; Post-injection 3 (N=115, 57)
    100.0
    79.4%
    91.2
    149.5%
    At least 2 serotypes; Pre-injection 1 (N=126, 61)
    84.1
    66.7%
    85.2
    139.7%
    At least 2 serotypes; Post-injection 1 (N=126, 61)
    98.4
    78.1%
    88.5
    145.1%
    At least 2 serotypes; Post-injection 2 (N=117, 58)
    98.3
    78%
    82.8
    135.7%
    At least 2 serotypes; Post-injection 3 (N=115, 57)
    99.1
    78.7%
    89.5
    146.7%
    At least 3 serotypes; Pre-injection 1 (N=126, 61)
    82.5
    65.5%
    83.6
    137%
    At least 3 serotypes; Post-injection 1 (N=126, 61)
    92.1
    73.1%
    88.5
    145.1%
    At least 3 serotypes; Post-injection 2 (N=117, 58)
    98.3
    78%
    81.0
    132.8%
    At least 3 serotypes; Post-injection 3 (N=115, 57)
    97.4
    77.3%
    87.7
    143.8%
    All 4 serotypes; Pre-injection 1 (N=126, 61)
    75.4
    59.8%
    77.0
    126.2%
    All 4 serotypes; Post-injection 1 (N=126, 61)
    89.7
    71.2%
    80.3
    131.6%
    All 4 serotypes; Post-injection 2 (N=117, 58)
    94.9
    75.3%
    77.6
    127.2%
    All 4 serotypes; Post-injection 3 (N=115, 57)
    97.4
    77.3%
    84.2
    138%
    3. Primary Outcome
    Title Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 126 61
    Serotype 1; Pre-injection 1 (N=126, 61)
    184
    234
    Serotype 1; Post-injection 1 (N=125, 61)
    605
    288
    Serotype 1; Post-injection 2 (N=117, 58)
    556
    294
    Serotype 1; Post-injection 3 (N=115, 57)
    461
    268
    Serotype 2; Pre-injection 1 (N=126, 61)
    204
    243
    Serotype 2; Post-injection 1 (N=126, 61)
    720
    300
    Serotype 2; Post-injection 2 (N=117, 58)
    787
    288
    Serotype 2; Post-injection 3 (N=115, 57)
    484
    258
    Serotype 3; Pre-injection 1 (N=126, 61)
    219
    216
    Serotype 3; Post-injection 1 (N=126, 61)
    951
    293
    Serotype 3; Post-injection 2 (N=117, 58)
    846
    249
    Serotype 3; Post-injection 3 (N=115, 57)
    709
    268
    Serotype 4; Pre injection 1 (N=126, 61)
    55.4
    62.0
    Serotype 4; Post-injection 1 (N=126, 61)
    358
    78.7
    Serotype 4; Post-injection 2 (N=117, 57)
    289
    72.8
    Serotype 4; Post-injection 3 (N=115, 57)
    336
    91.9
    4. Primary Outcome
    Title Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 126 61
    Serotype 1; Post-inj. 1/Pre-inj. 1 (N=125,61)
    3.23
    1.23
    Serotype 1; Post-inj. 2/Pre-inj. 1 (N=117,58)
    3.15
    1.26
    Serotype 1; Post-inj. 3/Pre-inj. 1 (N=115,57)
    2.64
    1.18
    Serotype 2; Post-inj. 1/Pre-inj. 1 (N=126,61)
    3.53
    1.23
    Serotype 2; Post-inj. 2/Pre-inj. 1 (N=117,58)
    3.83
    1.17
    Serotype 2; Post-inj. 3/Pre-inj. 1 (N=115,57)
    2.38
    1.05
    Serotype 3; Post-inj. 1/Pre-inj. 1 (N=126,61)
    4.35
    1.36
    Serotype 3; Post-inj. 2/Pre-inj. 1 (N=117,58)
    3.97
    1.13
    Serotype 3; Post-inj. 3/Pre-inj. 1 (N=115,57)
    3.39
    1.22
    Serotype 4; Post-inj. 1/Pre-inj. 1 (N=126,61)
    6.46
    1.27
    Serotype 4; Post-inj. 2/Pre-inj. 1 (N=117,57)
    5.16
    1.15
    Serotype 4; Post-inj. 3/Pre-inj. 1 (N=115,57)
    6.11
    1.44
    5. Primary Outcome
    Title Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
    Description Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
    Time Frame Day 0 up to Day 14 post each injection

    Outcome Measure Data

    Analysis Population Description
    Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 127 61
    Injection-site Pain; Post-Any inj. (N=126, 61)
    9.5
    7.5%
    4.9
    8%
    Grade 3 Inj.-site Pain; Post-Any inj. (N=126, 61)
    0.0
    0%
    0.0
    0%
    Injection-site Erythema; Post-Any inj. (N=126, 61)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Erythema;Post-Any inj (N=126,61)
    0.0
    0%
    0.0
    0%
    Injection-site Swelling; Post-Any inj. (N=126, 61)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Swelling;PostAny inj (N=126,61)
    0.0
    0%
    0.0
    0%
    Injection-site Pain; Post-inj. 1 (N=126, 61)
    6.3
    5%
    4.9
    8%
    Grade 3 Inj.-site Pain; Post-inj. 1 (N=126, 61)
    0.0
    0%
    0.0
    0%
    Injection-site Erythema; Post-inj. 1 (N=126, 61)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Erythema; Post-inj 1 (N=126,61)
    0.0
    0%
    0.0
    0%
    Injection-site Swelling; Post-inj. 1 (N=126, 61)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Swelling; Post-inj. 1 (N=126,61)
    0.0
    0%
    0.0
    0%
    Injection-site Pain; Post-inj. 2 (N=117, 58)
    1.7
    1.3%
    3.4
    5.6%
    Grade 3 Inj.-site Pain; Post-inj. 2 (N=117, 58)
    0.0
    0%
    0.0
    0%
    Injection-site Erythema; Post-inj. 2 (N=117, 58)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Erythema; Post-inj 2 (N=117,58)
    0.0
    0%
    0.0
    0%
    Injection-site Swelling; Post-inj. 2 (N=117, 58)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Swelling; Post-inj. 2 (N=117,58)
    0.0
    0%
    0.0
    0%
    Injection-site Pain; Post-inj. 3 (N=115, 57)
    2.6
    2.1%
    0.0
    0%
    Grade 3 Inj.-site Pain; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Injection-site Erythema; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Erythema; Post-inj 3 (N=115,57)
    0.0
    0%
    0.0
    0%
    Injection-site Swelling; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Grade 3 Inj.-site Swelling; Post-inj. 3 (N=115,57)
    0.0
    0%
    0.0
    0%
    Fever; Post-Any inj. (N=126, 61)
    5.6
    4.4%
    1.6
    2.6%
    Grade 3 Fever; Post-Any inj. (N=126, 61)
    0.8
    0.6%
    0.0
    0%
    Headache; Post Any\-inj. (N=126, 61)
    7.9
    6.3%
    4.9
    8%
    Grade 3 Headache; Post-Any inj. (N=126, 61)
    1.6
    1.3%
    1.6
    2.6%
    Malaise; Post-Any inj. (N=126, 61)
    8.7
    6.9%
    4.9
    8%
    Grade 3 Malaise; Post-Any inj. (N=126, 61)
    0.8
    0.6%
    0.0
    0%
    Myalgia; Post Any inj. (N=126, 61)
    9.5
    7.5%
    4.9
    8%
    Grade 3 Myalgia; Post-Any inj. (N=126, 61)
    0.0
    0%
    1.6
    2.6%
    Asthenia; Post-Any inj. (N=126, 61)
    11.1
    8.8%
    4.9
    8%
    Grade 3 Asthenia; Post-Any inj. (N=126, 61)
    0.8
    0.6%
    0.0
    0%
    Fever; Post-inj. 1 (N=125, 60)
    4.8
    3.8%
    0.0
    0%
    Grade 3 Fever; Post-inj. 1 (N=125, 60)
    0.8
    0.6%
    0.0
    0%
    Headache; Post-inj. 1 (N=126, 61)
    5.6
    4.4%
    4.9
    8%
    Grade 3 Headache; Post-inj. 1 (N=126, 61)
    1.6
    1.3%
    1.6
    2.6%
    Malaise; Post-inj. 1 (N=126, 61)
    7.1
    5.6%
    4.9
    8%
    Grade 3 Malaise; Post-inj. 1 (N=126, 61)
    0.0
    0%
    0.0
    0%
    Myalgia; Post-inj. 1 (N=126, 61)
    7.9
    6.3%
    4.9
    8%
    Grade 3 Myalgia; Post inj. 1 (N=126, 61)
    0
    0%
    1.6
    2.6%
    Asthenia; Post-inj. 1 (N=126, 61)
    9.5
    7.5%
    4.9
    8%
    Grade 3 Asthenia; Post inj. 1 (N=126, 61)
    0.0
    0%
    0.0
    0%
    Fever; Post-inj. 2 (N=117, 58)
    0.9
    0.7%
    1.7
    2.8%
    Grade 3 Fever; Post-inj. 2 (N=117, 58)
    0.0
    0%
    0.0
    0%
    Headache; Post-inj. 2 (N=117, 58)
    1.7
    1.3%
    0.0
    0%
    Grade 3 Headache; Post-inj. 2 (N=117, 58)
    0.0
    0%
    0.0
    0%
    Malaise; Post-inj. 2 (N=117, 58)
    0.9
    0.7%
    0.0
    0%
    Grade 3 Malaise; Post-inj. 2 (N=117, 58)
    0.9
    0.7%
    0.0
    0%
    Myalgia; Post-inj. 2 (N=117, 58)
    1.7
    1.3%
    0.0
    0%
    Grade 3 Myalgia; Post-inj. 2 (N=117, 58)
    0.0
    0%
    0.0
    0%
    Asthenia; Post-inj. 2 (N=117, 58)
    2.6
    2.1%
    0.0
    0%
    Grade 3 Asthenia; Post-inj. 2 (N=117, 58)
    0.9
    0.7%
    0.0
    0%
    Fever; Post-inj. 3 (N=113, 57)
    0.0
    0%
    0.0
    0%
    Grade 3 Fever; Post inj. 3 (N=113, 57)
    0.0
    0%
    0.0
    0%
    Headache; Post-inj. 3 (N=115, 57)
    0.9
    0.7%
    0.0
    0%
    Grade 3 Headache; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Malaise; Post-inj. 3 (N=115, 57)
    0.9
    0.7%
    0.0
    0%
    Grade 3 Malaise; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Myalgia; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Grade 3 Myalgia; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Asthenia; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    Grade 3 Asthenia; Post-inj. 3 (N=115, 57)
    0.0
    0%
    0.0
    0%
    6. Secondary Outcome
    Title Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 113 56
    Serotype 1; Pre-injection 1 (N=113, 56)
    92.9
    73.7%
    87.5
    143.4%
    Serotype 1; Post-injection 1 (N=112, 56)
    96.4
    76.5%
    89.3
    146.4%
    Serotype 1; Post-injection 2 (N=104, 53)
    99.0
    78.6%
    88.7
    145.4%
    Serotype 1; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    94.2
    154.4%
    Serotype 2; Pre-injection 1 (N=113, 56)
    92.9
    73.7%
    94.6
    155.1%
    Serotype 2; Post-injection 1 (N=113, 56)
    98.2
    77.9%
    94.6
    155.1%
    Serotype 2; Post-injection 2 (N=104, 53)
    100.0
    79.4%
    92.5
    151.6%
    Serotype 2; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    98.1
    160.8%
    Serotype 3; Pre-injection 1 (N=113, 56)
    94.7
    75.2%
    94.6
    155.1%
    Serotype 3; Post-injection 1 (N=113, 56)
    100.0
    79.4%
    96.4
    158%
    Serotype 3; Post-injection 2 (N=104, 53)
    100.0
    79.4%
    92.5
    151.6%
    Serotype 3; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    96.2
    157.7%
    Serotype 4; Pre-injection 1 (N=113, 56)
    85.8
    68.1%
    87.5
    143.4%
    Serotype 4; Post-injection 1 (N=113, 56)
    98.2
    77.9%
    91.1
    149.3%
    Serotype 4; Post-injection 2 (N=104, 52)
    100.0
    79.4%
    86.5
    141.8%
    Serotype 4; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    90.4
    148.2%
    7. Secondary Outcome
    Title Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 13 5
    Serotype 1; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    Serotype 1; Post-injection 1 (N=13, 5)
    46.2
    36.7%
    20.0
    32.8%
    Serotype 1; Post-injection 2 (N=13, 5)
    61.5
    48.8%
    0.0
    0%
    Serotype 1; Post-injection 3 (N=13, 5)
    76.9
    61%
    20.0
    32.8%
    Serotype 2; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    Serotype 2; Post-injection 1 (N=13, 5)
    61.5
    48.8%
    20.0
    32.8%
    Serotype 2; Post-injection 2 (N=13, 5)
    92.3
    73.3%
    0.0
    0%
    Serotype 2; Post injection 3 (N=13, 5)
    76.9
    61%
    20.0
    32.8%
    Serotype 3; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    Serotype 3; Post-injection 1 (N=13, 5)
    84.6
    67.1%
    20.0
    32.8%
    Serotype 3; Post-injection 2 (N=13, 5)
    84.6
    67.1%
    0.0
    0%
    Serotype 3; Post-injection 3 (N=13, 5)
    92.3
    73.3%
    20.0
    32.8%
    Serotype 4; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    Serotype 4; Post-injection 1 (N=13, 5)
    76.9
    61%
    20.0
    32.8%
    Serotype 4; Post-injection 2 (N=13, 5)
    92.3
    73.3%
    0.0
    0%
    Serotype 4; Post-injection 3 (N=13, 5)
    100.0
    79.4%
    20.0
    32.8%
    8. Secondary Outcome
    Title Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 113 56
    At least 1 serotype; Pre-injection 1 (N=113, 56)
    96.5
    76.6%
    96.4
    158%
    At least 1 serotype; Post-injection 1 (N=113, 56)
    100.0
    79.4%
    96.4
    158%
    At least 1 serotype; Post-injection 2 (N=104, 53)
    100.0
    79.4%
    94.3
    154.6%
    At least 1 serotype; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    98.1
    160.8%
    At least 2 serotypes; Pre-injection 1 (N=113, 56)
    93.8
    74.4%
    92.9
    152.3%
    At least 2 serotypes; Post-injection 1 (N=113, 56)
    100.0
    79.4%
    94.6
    155.1%
    At least 2 serotypes; Post-injection 2 (N=104, 53)
    100.0
    79.4%
    90.6
    148.5%
    At least 2 serotypes; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    96.2
    157.7%
    At least 3 serotypes; Pre-injection 1 (N=113, 56)
    92.0
    73%
    91.1
    149.3%
    At least 3 serotypes; Post-injection 1 (N=113, 56)
    96.5
    76.6%
    94.6
    155.1%
    At least 3 serotypes; Post-injection 2 (N=104, 53)
    100.0
    79.4%
    88.7
    145.4%
    At least 3 serotypes; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    94.2
    154.4%
    All 4 serotypes; Pre-injection 1 (N=113, 56)
    84.1
    66.7%
    83.9
    137.5%
    All 4 serotypes; Post-injection 1 (N=113, 56)
    95.6
    75.9%
    85.7
    140.5%
    All 4 serotypes; Post-injection 2 (N=104, 53)
    99.0
    78.6%
    84.9
    139.2%
    All 4 serotypes; Post-injection 3 (N=102, 52)
    100.0
    79.4%
    90.4
    148.2%
    9. Secondary Outcome
    Title Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 13 5
    At least 1 serotype; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    At least 1 serotype; Post-injection 1 (N=13, 5)
    92.3
    73.3%
    20.0
    32.8%
    At least 1 serotype; Post-injection 2 (N=13, 5)
    100.0
    79.4%
    0.0
    0%
    At least 1 serotype; Post-injection 3 (N=13, 5)
    100.0
    79.4%
    20.0
    32.8%
    At least 2 serotypes; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    At least 2 serotypes; Post-injection 1 (N=13, 5)
    84.6
    67.1%
    20.0
    32.8%
    At least 2 serotypes; Post-injection 2 (N=13, 5)
    84.6
    67.1%
    0.0
    0%
    At least 2 serotypes; Post-injection 3 (N=13, 5)
    92.3
    73.3%
    20.0
    32.8%
    At least 3 serotypes; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    At least 3 serotypes; Post-injection 1 (N=13, 5)
    53.8
    42.7%
    20.0
    32.8%
    At least 3 serotypes; Post-injection 2 (N=13, 5)
    84.6
    67.1%
    0.0
    0%
    At least 3 serotypes; Post-injection 3 (N=13, 5)
    76.9
    61%
    20.0
    32.8%
    All 4 serotypes; Pre-injection 1 (N=13, 5)
    0.0
    0%
    0.0
    0%
    All 4 serotypes; Post-injection 1 (N=13, 5)
    38.5
    30.6%
    20.0
    32.8%
    All 4 serotypes; Post-injection 2 (N=13, 5)
    61.5
    48.8%
    0.0
    0%
    All 4 serotypes; Post-injection 3 (N=13, 5)
    76.9
    61%
    20.0
    32.8%
    10. Secondary Outcome
    Title Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants who received 3 vaccinations of placebo vaccine.
    Measure Participants 113 56
    Serotype 1; Pre-injection 1 (N=113, 56)
    279
    329
    Serotype 1; Post-injection 1 (N=112, 56)
    925
    401
    Serotype 1; Post-injection 2 (N=104, 53)
    807
    432
    Serotype 1; Post-injection 3 (N=102, 52)
    636
    362
    Serotype 2; Pre-injection 1 (N=113, 56)
    312
    344
    Serotype 2; Post-injection 1 (N=113, 56)
    1030
    413
    Serotype 2; Post-injection 2 (N=104, 53)
    1010
    422
    Serotype 2; Post-injection 3 (N=102, 52)
    624
    357
    Serotype 3; Pre-injection 1 (N=113, 56)
    338
    302
    Serotype 3; Post-injection 1 (N=113, 56)
    1324
    405
    Serotype 3; Post-injection 2 (N=104, 53)
    1131
    361
    Serotype 3; Post-injection 3 (N=102, 52)
    912
    368
    Serotype 4; Pre-injection 1 (N=113, 56)
    73.1
    77.6
    Serotype 4; Post-injection 1 (N=113, 56)
    424
    99.1
    Serotype 4; Post-injection 2 (N=104, 52)
    346
    94.2
    Serotype 4; Post-injection 3 (N=102, 52)
    387
    117
    11. Secondary Outcome
    Title Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants who received 3 vaccinations of placebo vaccine.
    Measure Participants 113 56
    Serotype 1; Post-inj. 1/Pre-inj. 1 (N=112,56)
    3.24
    1.22
    Serotype 1; Post-inj. 2/Pre-inj. 1 (N=104,53)
    2.93
    1.29
    Serotype 1; Post-inj. 3/Pre-inj. 1 (N=102,52)
    2.31
    1.10
    Serotype 2; Post-inj. 1/Pre-inj. 1 (N=113,56)
    3.30
    1.20
    Serotype 2; Post-inj. 2/Pre-inj. 1 (N=104,53)
    3.09
    1.19
    Serotype 2; Post-inj. 3/Pre-inj. 1 (N=102,52)
    1.91
    1.00
    Serotype 3; Post-inj. 1/Pre-inj. 1 (N=113,56)
    3.92
    1.34
    Serotype 3; Post-inj. 2/Pre-inj. 1 (N=104,53)
    3.32
    1.15
    Serotype 3; Post-inj. 3/Pre-inj. 1 (N=102,52)
    2.71
    1.17
    Serotype 4; Post-inj. 1/Pre-inj. 1 (N=113,56)
    5.80
    1.28
    Serotype 4; Post-inj. 2/Pre-inj. 1 (N=104,52)
    4.86
    1.17
    Serotype 4; Post-inj. 3/Pre-inj. 1 (N=102,52)
    5.18
    1.43
    12. Secondary Outcome
    Title Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    Measure Participants 13 5
    Serotype 1; Pre-injection 1 (N=13, 5)
    5.00
    5.00
    Serotype 1; Post-injection 1 (N=13, 5)
    15.5
    7.01
    Serotype 1; Post-injection 2 (N=13, 5)
    28.2
    5.00
    Serotype 1; Post-injection 3 (N=13, 5)
    37.1
    11.8
    Serotype 2; Pre-injection 1 (N=13, 5)
    5.00
    5.00
    Serotype 2; Post-injection 1 (N=13, 5)
    32.1
    8.27
    Serotype 2; Post-injection 2 (N=13, 5)
    107
    5.00
    Serotype 2; Post-injection 3 (N=13, 5)
    66.8
    8.93
    Serotype 3; Pre-injection 1 (N=13, 5)
    5.00
    5.00
    Serotype 3; Post-injection 1 (N=13, 5)
    53.8
    5.96
    Serotype 3; Post-injection 2 (N=13, 5)
    83.1
    5.00
    Serotype 3; Post-injection 3 (N=13, 5)
    98.6
    9.72
    Serotype 4; Pre-injection 1 (N=13, 5)
    5.00
    5.00
    Serotype 4; Post-injection 1 (N=13, 5)
    81.8
    5.96
    Serotype 4; Post-injection 2 (N=13, 5)
    68.4
    5.00
    Serotype 4; Post-injection 3 (N=13, 5)
    111
    7.29
    13. Secondary Outcome
    Title Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
    Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (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 Japanese encephalitis (JE) virus.
    Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants who received 3 vaccinations of placebo vaccine.
    Measure Participants 13 5
    Serotype 1; Post-inj. 1/Pre-inj. 1 (N=13,5)
    3.10
    1.40
    Serotype 1; Post-inj. 2/Pre-inj. 1 (N=13,5)
    5.64
    1.00
    Serotype 1; Post-inj. 3/Pre-inj. 1 (N=13,5)
    7.43
    2.35
    Serotype 2; Post-inj. 1/Pre-inj. 1 (N=13,5)
    6.41
    1.65
    Serotype 2; Post-inj. 2/Pre-inj. 1 (N=13,5)
    21.4
    1.00
    Serotype 2; Post-inj. 3/Pre-inj. 1 (N=13,5)
    13.4
    1.79
    Serotype 3; Post-inj. 1/Pre-inj. 1 (N=13,5)
    10.8
    1.58
    Serotype 3; Post-inj. 2/Pre-inj. 1 (N=13,5)
    16.6
    1.00
    Serotype 3; Post-inj. 3/Pre-inj. 1 (N=13,5)
    19.7
    1.94
    Serotype 4; Post-inj. 1/Pre-inj. 1 (N=13,5)
    16.4
    1.19
    Serotype 4; Post-inj. 2/Pre-inj. 1 (N=13,5)
    13.7
    1.00
    Serotype 4; Post-inj. 3/Pre-inj. 1 (N=13,5)
    22.2
    1.46

    Adverse Events

    Time Frame Adverse event data were collected from Day 0 up to 1 year post injection 1.
    Adverse Event Reporting Description
    Arm/Group Title CYD Dengue Vaccine Group Placebo Group
    Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
    All Cause Mortality
    CYD Dengue Vaccine Group Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    CYD Dengue Vaccine Group Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/127 (0.8%) 1/61 (1.6%)
    Blood and lymphatic system disorders
    Anaemia megaloblastic 1/127 (0.8%) 1 0/61 (0%) 0
    General disorders
    Pyrexia 1/127 (0.8%) 1 0/61 (0%) 0
    Infections and infestations
    Viral upper respiratory tract infection 0/127 (0%) 0 1/61 (1.6%) 1
    Other (Not Including Serious) Adverse Events
    CYD Dengue Vaccine Group Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/127 (11%) 3/61 (4.9%)
    General disorders
    Injection site Pain 12/127 (9.4%) 12 3/61 (4.9%) 3
    Fever 7/126 (5.6%) 7 1/61 (1.6%) 1
    Malaise 11/126 (8.7%) 11 3/61 (4.9%) 3
    Asthenia 14/126 (11.1%) 14 3/61 (4.9%) 3
    Musculoskeletal and connective tissue disorders
    Myalgia 12/126 (9.5%) 12 3/61 (4.9%) 3
    Nervous system disorders
    Headache 10/126 (7.9%) 10 3/61 (4.9%) 3

    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:
    NCT01550289
    Other Study ID Numbers:
    • CYD47
    • UTN: U1111-1114-7909
    First Posted:
    Mar 9, 2012
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022