Dengue, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Fever
Conditions
Keywords
Dengue, Dengue hemorrhagic fever, Dengue virus, Dengue fever, Sanofi pasteur's CYD Dengue vaccine
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.
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.
Interventions
BIOLOGICALCYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, 6 and 12 months
BIOLOGICALTetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Colombia, Honduras, Mexico, Puerto Rico
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 details
A total of 600 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Dengue Vaccine Group 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. | 401 |
| Control Group 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. | 199 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Protocol Violation | 12 | 8 |
| Overall Study | Withdrawal by Subject | 23 | 8 |
Baseline characteristics
| Characteristic | Dengue Vaccine Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 401 Participants | 199 Participants | 600 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.6 Years STANDARD_DEVIATION 2.1 | 12.5 Years STANDARD_DEVIATION 2.1 | 12.55 Years STANDARD_DEVIATION 2.1 |
| Region of Enrollment Colombia | 105 Participants | 54 Participants | 159 Participants |
| Region of Enrollment Honduras | 106 Participants | 52 Participants | 158 Participants |
| Region of Enrollment Mexico | 119 Participants | 58 Participants | 177 Participants |
| Region of Enrollment Puerto Rico | 71 Participants | 35 Participants | 106 Participants |
| Sex: Female, Male Female | 204 Participants | 108 Participants | 312 Participants |
| Sex: Female, Male Male | 197 Participants | 91 Participants | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 237 / 401 | 132 / 199 |
| serious Total, serious adverse events | 10 / 401 | 15 / 199 |
Outcome results
Primary
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Time frame: Day 0 up to Day 14 post-each vaccination
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Post-dose 2; N=373,185) | 8 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Any dose; N=392,198) | 0 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Pain (Any dose; N=392,198) | 13 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Any dose; N=392,198) | 26 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Any dose; N=392,198) | 192 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Any dose; N=392,198) | 20 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Any dose; N=392,198) | 1 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Post-dose 1; N=392,196) | 121 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Pain (Post-dose 1; N=392,196) | 6 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Post-dose 1; N=390,196) | 11 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Post-dose 1; N=390,196) | 0 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Post-dose 1; N=391,196) | 8 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Post-dose 1; N=391,196) | 1 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Post-dose 2; N=373,185) | 101 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade Pain (Post-dose 2; N=373,185) | 7 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Post-dose 2; N=373,185) | 12 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Post-dose 2; N=373,185) | 0 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Post-dose 2; N=373,185) | 1 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Post-dose 3; N=364,180) | 88 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Pain (Post-dose 3; N=364,180) | 2 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Post-dose 3; N=364,180) | 8 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Post-dose 3; N=364,180) | 0 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Post-dose 3; N=364,180) | 6 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Post-dose 3; N=364,180) | 0 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Any dose; N=392;197) | 84 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Any dose; N=392;197) | 13 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Any dose; N=391;198) | 237 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Any dose; N=391;198) | 40 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Any dose; N=390;198) | 157 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Any dose; N=390;198) | 21 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Any dose; N=390;198) | 171 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Any dose; N=390;198) | 22 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Any dose; N=390;198) | 119 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Any dose; N=390;198) | 14 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Post-dose 1; N=392;193) | 43 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Post dose 1; N=392;193) | 11 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Post-dose 1; N=391;197) | 173 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Post-dose 1; N=391;197) | 26 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Post-dose 1; N=390;197) | 102 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Post-dose 1; N=390;197) | 14 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Post-dose 1; N=390;197) | 121 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Post-dose 1; N=390;197) | 15 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Post-dose 1; N=390;197) | 77 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Post dose 1; N=390;197) | 7 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Post-dose 2; N=371;184) | 29 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Post-dose 2; N=371;184) | 2 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Post-dose 2; N=373;185) | 131 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Post-dose 2; N=373;185) | 14 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Post-dose 2; N=373;185) | 68 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Post-dose 2; N=373;185) | 6 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Post dose 2; N=373;185) | 80 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Post-dose 2; N=373;185) | 8 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Post-dose 2; N=373;185) | 51 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Post-dose 2; N=373;185) | 5 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Post-dose 3; N=362;180) | 17 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Post-dose 3; N=362;180) | 0 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Post-dose 3; N=364;180) | 106 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Post-dose 3; N=364;180) | 10 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Post-dose 3; N=364;180) | 60 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Post-dose 3; N=364;180) | 2 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Post-dose 3; N=364;180) | 66 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Post-dose 3; N=364;180) | 3 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Post-dose 3; N=364;180) | 42 Participants |
| Dengue Vaccine Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Post-dose 3; N=364;180) | 2 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Post-dose 3; N=364;180) | 2 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Any dose; N=390;198) | 51 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Post-dose 2; N=373;185) | 36 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Pain (Any dose; N=392,198) | 7 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Any dose; N=390;198) | 5 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Post-dose 3; N=364;180) | 62 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Any dose; N=392,198) | 132 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Any dose; N=392,198) | 1 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Post-dose 1; N=392;193) | 13 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Any dose; N=392,198) | 16 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Post-dose 2; N=373;185) | 4 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Any dose; N=392,198) | 1 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Post dose 1; N=392;193) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Post-dose 1; N=392,196) | 54 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Post-dose 3; N=364;180) | 51 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Pain (Post-dose 1; N=392,196) | 2 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Post-dose 1; N=391;197) | 80 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Post-dose 1; N=390,196) | 6 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Post dose 2; N=373;185) | 45 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Post-dose 1; N=390,196) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Post-dose 1; N=391;197) | 5 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Post-dose 1; N=391,196) | 5 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Post-dose 3; N=364;180) | 4 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Post-dose 1; N=391,196) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Post-dose 1; N=390;197) | 45 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Post-dose 2; N=373,185) | 31 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Post-dose 2; N=373;185) | 3 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade Pain (Post-dose 2; N=373,185) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Post-dose 1; N=390;197) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Post-dose 2; N=373,185) | 5 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Post-dose 3; N=364;180) | 23 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Post-dose 2; N=373,185) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Any dose; N=392,198) | 18 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Post-dose 2; N=373,185) | 2 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Post-dose 1; N=390;197) | 52 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Post-dose 2; N=373,185) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Post-dose 2; N=373;185) | 24 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Pain (Post-dose 3; N=364,180) | 118 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Post-dose 1; N=390;197) | 3 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Pain (Post-dose 3; N=364,180) | 5 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Post-dose 3; N=364;180) | 41 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Erythema (Post-dose 3; N=364,180) | 16 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Asthenia (Post-dose 1; N=390;197) | 30 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Erythema (Post-dose 3; N=364,180) | 1 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Post-dose 2; N=373;185) | 1 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Injection-site Swelling (Post-dose 3; N=364,180) | 14 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Asthenia (Post dose 1; N=390;197) | 2 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Swelling (Post-dose 3; N=364,180) | 1 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Post-dose 3; N=364;180) | 5 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Any dose; N=392;197) | 36 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Post-dose 2; N=371;184) | 16 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Any dose; N=392;197) | 3 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Fever (Post-dose 3; N=362;180) | 14 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Any dose; N=391;198) | 116 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Post-dose 2; N=371;184) | 0 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Any dose; N=391;198) | 11 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Post-dose 3; N=364;180) | 4 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Malaise (Any dose; N=390;198) | 82 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Headache (Post-dose 2; N=373;185) | 69 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Malaise (Any dose; N=390;198) | 8 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Fever (Post-dose 3; N=362;180) | 3 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Myalgia (Any dose; N=390;198) | 90 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Headache (Post-dose 2; N=373;185) | 4 Participants |
| Control Group | Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine | Grade 3 Myalgia (Any dose; N=390;198) | 10 Participants |
Primary
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.
Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 1 (N=316,160) | 88.0 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1 (N=305,158) | 90.8 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 2 (N=295,148) | 90.5 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2 (N=293,147) | 95.6 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 3 (N=288,143) | 92.0 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3 (N=287,143) | 97.6 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 1 (N=316,160) | 81.3 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1 (N=305,158) | 96.4 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 2 (N=295,148) | 96.6 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2 (N=293,147) | 98.6 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 3 (N=288,143) | 96.5 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3 (N=287,143) | 99.7 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 1 (N=316,160) | 88.3 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1 (N=305,158) | 96.7 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 2 (N=295,148) | 96.6 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2 (N=293,147) | 99.0 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 3 (N=288,143) | 97.9 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3 (N=287,143) | 100.0 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 1 (N=316,160) | 79.4 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1 (N=305,158) | 97.4 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 2 (N=295,148) | 96.9 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2 (N=293,147) | 98.0 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 3 (N=288,143) | 99.3 Percentage of Participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3 (N=287,143) | 100.0 Percentage of Participants |
| Control Group | 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 | Serotype 4; Pre-inj. 3 (N=288,143) | 84.6 Percentage of Participants |
| Control Group | 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 | Serotype 1; Pre-inj. 1 (N=316,160) | 84.4 Percentage of Participants |
| Control Group | 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 | Serotype 3; Pre-inj. 1 (N=316,160) | 90.6 Percentage of Participants |
| Control Group | 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 | Serotype 1; Post-inj. 1 (N=305,158) | 82.3 Percentage of Participants |
| Control Group | 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 | Serotype 4; Pre-inj. 1 (N=316,160) | 84.4 Percentage of Participants |
| Control Group | 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 | Serotype 1; Pre-inj. 2 (N=295,148) | 82.4 Percentage of Participants |
| Control Group | 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 | Serotype 3; Post-inj. 1 (N=305,158) | 89.9 Percentage of Participants |
| Control Group | 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 | Serotype 1; Post-inj. 2 (N=293,147) | 84.4 Percentage of Participants |
| Control Group | 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 | Serotype 4; Post-inj. 2 (N=293,147) | 84.4 Percentage of Participants |
| Control Group | 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 | Serotype 1; Pre-inj. 3 (N=288,143) | 87.4 Percentage of Participants |
| Control Group | 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 | Serotype 3; Pre-inj. 2 (N=295,148) | 87.8 Percentage of Participants |
| Control Group | 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 | Serotype 1; Post-inj. 3 (N=287,143) | 88.8 Percentage of Participants |
| Control Group | 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 | Serotype 4; Post-inj. 1 (N=305,158) | 76.6 Percentage of Participants |
| Control Group | 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 | Serotype 2; Pre-inj. 1 (N=316,160) | 91.9 Percentage of Participants |
| Control Group | 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 | Serotype 3; Post-inj. 2 (N=293,147) | 88.4 Percentage of Participants |
| Control Group | 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 | Serotype 2; Post-inj. 1 (N=305,158) | 89.9 Percentage of Participants |
| Control Group | 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 | Serotype 4; Post-inj. 3 (N=287,143) | 84.6 Percentage of Participants |
| Control Group | 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 | Serotype 2; Pre-inj. 2 (N=295,148) | 89.2 Percentage of Participants |
| Control Group | 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 | Serotype 3; Pre-inj. 3 (N=288,143) | 89.5 Percentage of Participants |
| Control Group | 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 | Serotype 2; Post-inj. 2 (N=293,147) | 90.5 Percentage of Participants |
| Control Group | 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 | Serotype 4; Pre-inj. 2 (N=295,148) | 81.1 Percentage of Participants |
| Control Group | 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 | Serotype 2; Pre-inj. 3 (N=288,143) | 90.9 Percentage of Participants |
| Control Group | 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 | Serotype 3; Post-inj. 3 (N=287,143) | 89.5 Percentage of Participants |
| Control Group | 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 | Serotype 2; Post-inj. 3 (N=287,143) | 92.3 Percentage of Participants |
Primary
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 1 (N=401,199) | 87.7 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 1 (N=389,196) | 99.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj. 2 (N=373,185) | 99.7 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 2 (N=371,184) | 99.7 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj. 3 (N=365,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 3 (N=364,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) | 95.3 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 1 (N=389,196) | 97.4 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 2 (N=373,185) | 97.3 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 2 (N=371,184) | 99.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 3 (N=365,180) | 98.6 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 3 (N=364,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 1 (N=401,199) | 92.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 1 (N=381,196) | 95.1 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 2 (N=373,185) | 94.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 2 (N=371,184) | 98.3 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 3 (N=365,180) | 96.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 3 (N=364,180) | 99.7 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 1 (N=401,199) | 72.2 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 1 (N=389,196) | 89.8 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 2 (N=373,185) | 89.5 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 2 (N=371,184) | 94.2 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 3 (N=365,180) | 91.0 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 3 (N=364,180) | 97.6 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 3 (N=365,180) | 80.4 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) | 96.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 1 (N=401,199) | 86.9 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 1 (N=389,196) | 93.7 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 1 (N=401,199) | 76.9 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj. 2 (N=373,185) | 91.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 1 (N=381,196) | 83.5 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 2 (N=371,184) | 93.2 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 2 (N=371,184) | 81.6 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj. 3 (N=365,180) | 93.7 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 2 (N=373,185) | 84.5 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 3 (N=364,180) | 93.0 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 1 (N=389,196) | 73.4 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 1 (N=401,199) | 90.6 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 2 (N=371,184) | 85.0 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 1 (N=389,196) | 88.0 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 3 (N=364,180) | 82.5 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 2 (N=373,185) | 89.2 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 3 (N=365,180) | 86.7 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 2 (N=371,184) | 87.8 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 2 (N=373,185) | 75.0 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 3 (N=365,180) | 91.6 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 3 (N=364,180) | 87.4 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 3 (N=364,180) | 92.3 Percentage of participants |
Primary
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.
Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1 (N=84,37) | 7.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 2 (N=78,36) | 17.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2 (N=78,36) | 44.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 3 (N=77,36) | 33.8 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3 (N=77,36) | 81.8 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1 (N=84,37) | 42.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 2 (N=78,36) | 51.3 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2 (N=78,36) | 89.7 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 3 (N=77,36) | 70.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3 (N=77,36) | 96.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1 (N=84,37) | 67.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 2 (N=78,36) | 66.7 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2 (N=78,36) | 94.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 3 (N=77,36) | 89.6 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3 (N=77,36) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1 (N=84,37) | 73.8 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 2 (N=78,36) | 73.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2 (N=78,36) | 91.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 3 (N=77,36) | 80.5 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3 (N=77,36) | 94.8 Percentage of participants |
| Control Group | 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 | Serotype 4; Pre-inj. 3 (N=77,36) | 8.3 Percentage of participants |
| Control Group | 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 | Serotype 1; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Control Group | 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 | Serotype 3; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Control Group | 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 | Serotype 1; Post-inj. 1 (N=84,37) | 2.7 Percentage of participants |
| Control Group | 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 | Serotype 4; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Control Group | 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 | Serotype 1; Pre-inj. 2 (N=78,36) | 5.6 Percentage of participants |
| Control Group | 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 | Serotype 3; Post-inj. 1 (N=84,37) | 10.8 Percentage of participants |
| Control Group | 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 | Serotype 1; Post-inj. 2 (N=78,36) | 5.6 Percentage of participants |
| Control Group | 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 | Serotype 4; Post-inj. 2 (N=78,36) | 8.3 Percentage of participants |
| Control Group | 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 | Serotype 1; Pre-inj. 3 (N=77,36) | 16.7 Percentage of participants |
| Control Group | 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 | Serotype 3; Pre-inj. 2 (N=78,36) | 8.3 Percentage of participants |
| Control Group | 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 | Serotype 1; Post-inj. 3 (N=77,36) | 19.4 Percentage of participants |
| Control Group | 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 | Serotype 4; Post-inj. 1 (N=84,37) | 2.7 Percentage of participants |
| Control Group | 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 | Serotype 2; Pre-inj. 1 (N=85,38) | 0.0 Percentage of participants |
| Control Group | 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 | Serotype 3; Post-inj. 2 (N=78,36) | 8.3 Percentage of participants |
| Control Group | 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 | Serotype 2; Post-inj. 1 (N=84,37) | 0.0 Percentage of participants |
| Control Group | 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 | Serotype 4; Post-inj. 3 (N=77,36) | 5.6 Percentage of participants |
| Control Group | 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 | Serotype 2; Pre-inj. 2 (N=78,36) | 2.8 Percentage of participants |
| Control Group | 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 | Serotype 3; Pre-inj. 3 (N=77,36) | 5.6 Percentage of participants |
| Control Group | 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 | Serotype 2; Post-inj. 2 (N=78,36) | 5.6 Percentage of participants |
| Control Group | 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 | Serotype 4; Pre-inj. 2 (N=78,36) | 5.6 Percentage of participants |
| Control Group | 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 | Serotype 2; Pre-inj. 3 (N=77,36) | 16.7 Percentage of participants |
| Control Group | 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 | Serotype 3; Post-inj. 3 (N=77,36) | 16.7 Percentage of participants |
| Control Group | 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 | Serotype 2; Post-inj. 3 (N=77,36) | 19.4 Percentage of participants |
Primary
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 1 (N=401,199) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 1 (N=389,196) | 95.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj. 2 (N=373,185) | 97.4 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 2 (N=371,184) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj. 3 (N=365,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 3 (N=364,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 1 (N=389,196) | 67.9 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 2 (N=373,185) | 69.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 2 (N=371,184) | 98.7 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 3 (N=365,180) | 87.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 3 (N=364,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 1 (N=401,199) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 1 (N=381,196) | 25.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 2 (N=373,185) | 34.6 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 2 (N=371,184) | 79.5 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 3 (N=365,180) | 58.4 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 3 (N=364,180) | 94.8 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 1 (N=401,199) | 0.0 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 1 (N=389,196) | 3.6 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 2 (N=373,185) | 7.7 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 2 (N=371,184) | 42.3 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 3 (N=365,180) | 28.6 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 3 (N=364,180) | 77.9 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 3 (N=365,180) | 2.8 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) | 0.0 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 1 (N=401,199) | 0.0 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 1 (N=389,196) | 16.2 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 1 (N=401,199) | 0.0 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj. 2 (N=373,185) | 13.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 1 (N=381,196) | 0.0 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 2 (N=371,184) | 11.1 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 2 (N=371,184) | 5.6 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj. 3 (N=365,180) | 22.2 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 2 (N=373,185) | 2.8 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 3 (N=364,180) | 25.0 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 1 (N=389,196) | 0.0 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 1 (N=401,199) | 0.0 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 2 (N=371,184) | 5.6 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 1 (N=389,196) | 0.0 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 3 (N=364,180) | 5.6 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 2 (N=373,185) | 2.8 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 3 (N=365,180) | 8.3 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 2 (N=371,184) | 5.6 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 2 (N=373,185) | 2.8 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 3 (N=365,180) | 13.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 3 (N=364,180) | 13.9 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 3 (N=364,180) | 16.7 Percentage of participants |
Primary
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 1 (N=401,199) | 69.1 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 1 (N=389,196) | 98.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj. 2 (N=373,185) | 99.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 2 (N=371,184) | 99.7 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj. 3 (N=365,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Post-inj. 3 (N=364,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) | 75.1 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 1 (N=389,196) | 91.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 2 (N=373,185) | 91.4 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 2 (N=371,184) | 98.9 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Pre-inj. 3 (N=365,180) | 96.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 2 Serotypes; Post-inj. 3 (N=364,180) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 1 (N=401,199) | 64.6 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 1 (N=381,196) | 79.9 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 2 (N=373,185) | 81.8 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 2 (N=371,184) | 94.3 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Pre-inj. 3 (N=365,180) | 88.2 Percentage of participants |
| Dengue Vaccine Group | 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 | At Least 3 Serotypes; Post-inj. 3 (N=364,180) | 98.6 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 1 (N=401,199) | 56.9 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 1 (N=389,196) | 71.2 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 2 (N=373,185) | 72.4 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 2 (N=371,184) | 83.3 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Pre-inj. 3 (N=365,180) | 77.8 Percentage of participants |
| Dengue Vaccine Group | 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 | All 4 Serotypes; Post-inj. 3 (N=364,180) | 93.4 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 3 (N=365,180) | 64.4 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) | 77.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 1 (N=401,199) | 69.8 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 1 (N=389,196) | 78.6 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 1 (N=401,199) | 61.8 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj. 2 (N=373,185) | 76.2 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 1 (N=381,196) | 67.3 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 2 (N=371,184) | 76.6 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 2 (N=371,184) | 66.3 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Pre-inj. 3 (N=365,180) | 79.4 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 2 (N=373,185) | 68.1 Percentage of participants |
| Control Group | 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 | At Least 1 Serotype; Post-inj. 3 (N=364,180) | 78.9 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 1 (N=389,196) | 59.2 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 1 (N=401,199) | 72.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 2 (N=371,184) | 69.0 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 1 (N=389,196) | 70.9 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Post-inj. 3 (N=364,180) | 66.7 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 2 (N=373,185) | 71.9 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Pre-inj. 3 (N=365,180) | 70.6 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 2 (N=371,184) | 71.2 Percentage of participants |
| Control Group | 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 | All 4 Serotypes; Pre-inj. 2 (N=373,185) | 60.5 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Pre-inj. 3 (N=365,180) | 75.6 Percentage of participants |
| Control Group | 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 | At Least 3 Serotypes; Post-inj. 3 (N=364,180) | 72.2 Percentage of participants |
| Control Group | 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 | At Least 2 Serotypes; Post-inj. 3 (N=364,180) | 76.7 Percentage of participants |
Primary
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 1 (N=379,191) | 69.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1 (N=379,191) | 73.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 2 (N=353,174) | 75.6 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2 (N=353,174) | 85.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 3 (N=335,163) | 79.7 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3 (N=335,163) | 94.6 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 1 (N=379,191) | 64.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1 (N=379,191) | 85.2 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 2 (N=353,174) | 87.3 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2 (N=353,174) | 96.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 3 (N=335,163) | 91.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3 (N=335,163) | 99.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 1 (N=379,191) | 69.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1 (N=379,191) | 90.8 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 2 (N=353,174) | 90.9 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2 (N=353,174) | 98.6 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 3 (N=335,163) | 96.4 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3 (N=335,163) | 100.0 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 1 (N=379,191) | 63.1 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1 (N=379,191) | 92.6 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 2 (N=353,174) | 92.4 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2 (N=353,174) | 96.6 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 3 (N=335,163) | 95.8 Percentage of participants |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3 (N=335,163) | 98.8 Percentage of participants |
| Control Group | 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 | Serotype 4; Pre-inj. 3 (N=335,163) | 69.9 Percentage of participants |
| Control Group | 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 | Serotype 1; Pre-inj. 1 (N=379,191) | 68.1 Percentage of participants |
| Control Group | 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 | Serotype 3; Pre-inj. 1 (N=379,191) | 73.3 Percentage of participants |
| Control Group | 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 | Serotype 1; Post-inj. 1 (N=379,191) | 67.0 Percentage of participants |
| Control Group | 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 | Serotype 4; Pre-inj. 1 (N=379,191) | 68.1 Percentage of participants |
| Control Group | 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 | Serotype 1; Pre-inj. 2 (N=353,174) | 67.8 Percentage of participants |
| Control Group | 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 | Serotype 3; Post-inj. 1 (N=379,191) | 74.3 Percentage of participants |
| Control Group | 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 | Serotype 1; Post-inj. 2 (N=353,174) | 69.0 Percentage of participants |
| Control Group | 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 | Serotype 4; Post-inj. 2 (N=353,174) | 70.1 Percentage of participants |
| Control Group | 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 | Serotype 1; Pre-inj. 3 (N=335,163) | 73.6 Percentage of participants |
| Control Group | 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 | Serotype 3; Pre-inj. 2 (N=353,174) | 72.4 Percentage of participants |
| Control Group | 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 | Serotype 1; Post-inj. 3 (N=335,163) | 75.5 Percentage of participants |
| Control Group | 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 | Serotype 4; Post-inj. 1 (N=379,191) | 62.3 Percentage of participants |
| Control Group | 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 | Serotype 2; Pre-inj. 1 (N=379,191) | 74.3 Percentage of participants |
| Control Group | 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 | Serotype 3; Post-inj. 2 (N=353,174) | 73.6 Percentage of participants |
| Control Group | 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 | Serotype 2; Post-inj. 1 (N=379,191) | 72.8 Percentage of participants |
| Control Group | 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 | Serotype 4; Post-inj. 3 (N=335,163) | 69.3 Percentage of participants |
| Control Group | 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 | Serotype 2; Pre-inj. 2 (N=353,174) | 71.8 Percentage of participants |
| Control Group | 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 | Serotype 3; Pre-inj. 3 (N=335,163) | 74.8 Percentage of participants |
| Control Group | 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 | Serotype 2; Post-inj. 2 (N=353,174) | 73.0 Percentage of participants |
| Control Group | 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 | Serotype 4; Pre-inj. 2 (N=353,174) | 66.7 Percentage of participants |
| Control Group | 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 | Serotype 2; Pre-inj. 3 (N=335,163) | 76.7 Percentage of participants |
| Control Group | 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 | Serotype 3; Post-inj. 3 (N=335,163) | 76.7 Percentage of participants |
| Control Group | 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 | Serotype 2; Post-inj. 3 (N=335,163) | 78.5 Percentage of participants |
Primary
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.
Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=84,37) | 1.59 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=78,36) | 1.43 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 2 (N=78,36) | 0.990 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=77,36) | 3.46 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 2 (N=77,36) | 2.39 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 3 (N=77,36) | 1.83 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=84,37) | 0.572 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=78,36) | 6.00 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 2 (N=78,36) | 2.04 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=77,36) | 10.1 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 2 (N=77,36) | 3.40 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 3 (N=77,36) | 2.73 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=84,37) | 3.88 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=78,36) | 9.49 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 2 (N=77,36) | 2.67 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=77,36) | 17.4 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 2 (N=76,36) | 4.90 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 3 (N=77,36) | 2.61 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=84,37) | 15.1 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=78,36) | 11.7 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 2 (N=78,36) | 1.69 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=77,36) | 11.9 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 2 (N=77,36) | 1.75 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 3 (N=77,36) | 2.15 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 2 (N=77,36) | 0.533 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=84,37) | 0.515 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=84,37) | 0.610 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=78,36) | 0.729 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=84,37) | 0.530 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 2 (N=78,36) | 0.613 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=78,36) | 0.707 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=77,36) | 0.836 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=77,36) | 0.563 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 2 (N=77,36) | 0.703 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 2 (N=77,36) | 0.627 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 3 (N=77,36) | 0.592 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=78,36) | 0.677 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=84,37) | 0.500 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=77,36) | 0.753 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=78,36) | 0.679 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 3 (N=77,36) | 0.499 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 2 (N=78,36) | 0.630 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 2 (N=76,36) | 0.668 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=77,36) | 0.945 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 2 (N=78,36) | 0.642 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 2 (N=77,36) | 0.876 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 3 (N=77,36) | 0.633 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 3 (N=77,36) | 0.559 Titers |
Primary
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time frame: Day 0 (before each vaccination) and Day 28 post-each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 1 (N=401,199) | 92.6 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1 (N=389,196) | 221 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 2 (N=373,185) | 193 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2 (N=371,184) | 276 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 3 (N=365,180) | 204 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3 (N=364,180) | 320 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 1 (N=401,199) | 74.2 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1 (N=389,196) | 409 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 2 (N=373,185) | 326 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2 (N=371,184) | 504 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 3 (N=365,180) | 300 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3 (N=364,180) | 486 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 1 (N=401,199) | 85.0 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1 (N=389,196) | 442 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 2 (N=372,185) | 301 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2 (N=371,184) | 502 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 3 (N=365,180) | 379 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3 (N=364,180) | 594 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 1 (N=401,199) | 37.2 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1 (N=389,196) | 416 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 2 (N=373,185) | 200 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2 (N=369,184) | 305 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 3 (N=365,180) | 182 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3 (N=364,180) | 273 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 3 (N=365,180) | 47.7 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 1 (N=401,199) | 81.9 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 1 (N=401,199) | 88.8 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 1 (N=389,196) | 77.1 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 1 (N=401,199) | 40.1 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 2 (N=373,185) | 96.6 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 1 (N=389,196) | 93.2 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 2 (N=371,184) | 102 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 2 (N=369,184) | 43.9 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 3 (N=365,180) | 113 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 2 (N=372,185) | 107 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 3 (N=364,180) | 106 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 1 (N=389,196) | 34.1 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 1 (N=401,199) | 100 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 2 (N=371,184) | 108 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 1 (N=389,196) | 90.4 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 3 (N=364,180) | 42.8 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 2 (N=373,185) | 117 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 3 (N=365,180) | 123 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 2 (N=371,184) | 114 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 2 (N=373,185) | 43.8 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 3 (N=365,180) | 133 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 3 (N=364,180) | 121 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 3 (N=364,180) | 133 Titers (1/dilution) |
Primary
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.
Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 1 (N=316,160) | 203 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1 (N=305,158) | 604 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 2 (N=295,148) | 447 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2 (N=293,147) | 607 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 3 (N=288,143) | 435 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3 (N=287,143) | 580 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 1 (N=316,160) | 153 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1 (N=305,158) | 1001 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 2 (N=295,148) | 673 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2 (N=293,147) | 888 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 3 (N=288,143) | 554 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3 (N=287,143) | 741 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 1 (N=316,160) | 182 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1 (N=305,158) | 863 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 2 (N=295,148) | 556 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2 (N=293,147) | 782 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 3 (N=288,143) | 615 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3 (N=287,143) | 827 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 1 (N=316,160) | 63.8 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1 (N=305,158) | 549 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 2 (N=295,148) | 278 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2 (N=291,147) | 395 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 3 (N=288,143) | 259 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3 (N=287,143) | 341 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 3 (N=288,143) | 81.8 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 1 (N=316,160) | 162 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 1 (N=316,160) | 179 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 1 (N=305,158) | 148 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 1 (N=316,160) | 66.5 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 2 (N=295,148) | 192 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 1 (N=305,158) | 180 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 2 (N=293,147) | 199 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 2 (N=291,147) | 70.4 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 3 (N=288,143) | 225 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 2 (N=295,148) | 221 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 3 (N=287,143) | 205 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 1 (N=305,158) | 53.4 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 1 (N=316,160) | 207 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 2 (N=293,147) | 215 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 1 (N=305,158) | 181 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 3 (N=287,143) | 72.5 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 2 (N=295,148) | 251 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 3 (N=288,143) | 265 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 2 (N=293,147) | 232 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 2 (N=295,148) | 73.7 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 3 (N=288,143) | 265 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 3 (N=287,143) | 248 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 3 (N=287,143) | 266 Titers (1/dilution) |
Primary
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.
Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1 (N=84,37) | 5.72 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 2 (N=78,36) | 8.16 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2 (N=78,36) | 14.3 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 3 (N=77,36) | 12.0 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3 (N=77,36) | 34.6 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 1; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1 (N=84,37) | 15.9 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 2 (N=78,36) | 21.0 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2 (N=78,36) | 60.0 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Pre-inj. 3 (N=77,36) | 30.3 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3 (N=77,36) | 101 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1 (N=84,37) | 38.8 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 2 (N=77,36) | 28.6 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2 (N=78,36) | 94.9 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Pre-inj. 3 (N=77,36) | 61.9 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3 (N=77,36) | 174 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1 (N=84,37) | 151 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 2 (N=78,36) | 57.5 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2 (N=78,36) | 117 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Pre-inj. 3 (N=77,36) | 48.3 Titers (1/dilution) |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3 (N=77,36) | 119 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 3 (N=77,36) | 5.97 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 1 (N=84,37) | 5.15 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 2 (N=78,36) | 6.18 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 1 (N=84,37) | 6.10 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 2 (N=78,36) | 7.29 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 2 (N=78,36) | 6.77 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Pre-inj. 3 (N=77,36) | 7.93 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 2 (N=77,36) | 5.97 Titers (1/dilution) |
| Control Group | 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 | Serotype 1; Post-inj. 3 (N=77,36) | 8.36 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 1 (N=84,37) | 5.30 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 1 (N=85,38) | 5.00 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 2 (N=78,36) | 7.07 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 1 (N=84,37) | 5.00 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Post-inj. 3 (N=77,36) | 5.63 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 2 (N=78,36) | 5.50 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Pre-inj. 3 (N=77,36) | 6.18 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 2 (N=78,36) | 6.79 Titers (1/dilution) |
| Control Group | 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 | Serotype 4; Pre-inj. 2 (N=78,36) | 5.48 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Pre-inj. 3 (N=77,36) | 9.48 Titers (1/dilution) |
| Control Group | 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 | Serotype 3; Post-inj. 3 (N=77,36) | 7.53 Titers (1/dilution) |
| Control Group | 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 | Serotype 2; Post-inj. 3 (N=77,36) | 9.45 Titers (1/dilution) |
Primary
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.
Time frame: Day 0 (before each vaccination) and Day 28 post each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=389,196) | 3.55 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=371,184) | 2.74 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 2 (N=371,184) | 1.19 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=364,180) | 3.16 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 2 (N=364,180) | 1.38 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 3 (N=364,180) | 1.35 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=389,196) | 2.36 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=371,184) | 4.09 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 2 (N=371,184) | 1.40 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=364,180) | 3.97 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 2 (N=364,180) | 1.36 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 3 (N=364,180) | 1.51 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=389,196) | 4.24 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=371,184) | 4.52 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 2 (N=370,184) | 1.57 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=364,180) | 5.27 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 2 (N=363,180) | 1.86 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 3 (N=364,180) | 1.52 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=389,196) | 8.63 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=369,184) | 6.14 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 2 (N=369,184) | 1.45 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=364,180) | 5.47 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 2 (N=364,180) | 1.30 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 3 (N=364,180) | 1.45 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 2 (N=364,180) | 0.771 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=389,196) | 0.756 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=389,196) | 0.864 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=371,184) | 1.02 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=389,196) | 0.672 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 2 (N=371,184) | 0.851 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=371,184) | 1.04 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=364,180) | 1.03 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=364,180) | 0.871 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 2 (N=364,180) | 0.859 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 2 (N=370,184) | 0.840 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 3 (N=364,180) | 0.777 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=369,184) | 0.887 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=389,196) | 0.760 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=364,180) | 1.15 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=371,184) | 0.983 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 3 (N=364,180) | 0.723 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 2 (N=371,184) | 0.811 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 2 (N=363,180) | 0.937 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=364,180) | 1.16 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 2 (N=369,184) | 0.800 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 2 (N=364,180) | 0.957 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 3 (N=364,180) | 0.815 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 3 (N=364,180) | 0.844 Titers |
Primary
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.
Time frame: Day 0 (pre each vaccination) and Day 28 post each vaccination
Population: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=305,158) | 4.43 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=293,147) | 3.25 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 2 (N=293,147) | 1.25 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=287,143) | 3.08 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 2 (N=287,143) | 1.19 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 3 (N=287,143) | 1.24 Titers |
| Dengue Vaccine Group | 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 | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=305,158) | 3.49 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=293,147) | 3.70 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 2 (N=293,147) | 1.27 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=287,143) | 3.08 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 2 (N=287,143) | 1.06 Titers |
| Dengue Vaccine Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 3 (N=287,143) | 1.29 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=305,158) | 4.35 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=293,147) | 3.71 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 2 (N=293,147) | 1.36 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=287,143) | 3.82 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 2 (N=287,143) | 1.43 Titers |
| Dengue Vaccine Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 3 (N=287,143) | 1.31 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=305,158) | 7.40 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=291,147) | 5.16 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 2 (N=291,147) | 1.39 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=287,143) | 4.45 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 2 (N=287,143) | 1.20 Titers |
| Dengue Vaccine Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 3 (N=287,143) | 1.30 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 2 (N=287,143) | 0.849 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=305,158) | 0.829 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=305,158) | 0.941 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=293,147) | 1.11 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=305,158) | 0.712 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 2/Pre-inj. 2 (N=293,147) | 0.925 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=293,147) | 1.16 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=287,143) | 1.09 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=287,143) | 0.976 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 2 (N=287,143) | 0.907 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 2/Pre-inj. 2 (N=293,147) | 0.906 Titers |
| Control Group | 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 | Serotype 1; Post-inj. 3/Pre-inj. 3 (N=287,143) | 0.834 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=291,147) | 0.952 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=305,158) | 0.840 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=287,143) | 1.29 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=293,147) | 1.08 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 3/Pre-inj. 3 (N=287,143) | 0.796 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 2/Pre-inj. 2 (N=293,147) | 0.865 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 2 (N=287,143) | 1.03 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=287,143) | 1.23 Titers |
| Control Group | 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 | Serotype 4; Post-inj. 2/Pre-inj. 2 (N=291,147) | 0.847 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 2 (N=287,143) | 0.982 Titers |
| Control Group | 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 | Serotype 3; Post-inj. 3/Pre-inj. 3 (N=287,143) | 0.872 Titers |
| Control Group | 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 | Serotype 2; Post-inj. 3/Pre-inj. 3 (N=287,143) | 0.940 Titers |