Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Hemorrhagic Fever, Dengue Virus, CYD Dengue Vaccine
Brief summary
The aim of the study was to assess and describe the booster effect of a tetravalent CYD dengue vaccine dose administered about 5 years or more after the completion of a 3-dose vaccination schedule in Singapore. Primary Objective: * To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GMTRs) of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). Secondary Objectives: * If the primary objective of non-inferiority achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD28 trial (participants from Group 1 only). * To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in participants who received three doses of the CYD dengue vaccine in the CYD28 trial in all participants. * To describe the neutralizing antibody levels of each dengue serotype Post Dose 3 (CYD28 participants) and immediately prior to booster or placebo injection in all participants. * To describe the neutralizing antibody persistence 6 months, 1 year and 2 years post booster or placebo injection in all study participants. * To evaluate the safety of booster vaccination with CYD dengue vaccine in all participants.
Detailed description
Healthy adolescents and adults received 3 doses of the tetravalent dengue vaccine 5-6 years earlier in a previous CYD dengue vaccine trial (CYD28 - NCT00880893) received either a booster injection of CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination.
Interventions
BIOLOGICALCYD Dengue Vaccine (5 dose formulation)
0.5 mL, Subcutaneous
BIOLOGICALPlacebo, NaCl 0.9%
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
An observer-blind procedure was followed for the injection of CYD dengue vaccine or placebo. Neither the blind-observer Investigator nor the participants (and/or participants' parent(s)/legally acceptable representative(s) for participants aged \< 21 years) knew which product was administered.
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Had been identified as a potential participant by the Sponsor, and was included in the list provided to the investigator (i.e., aged 9 to 45 years on the day of first injection of CYD dengue vaccine in CYD28, had received 3 doses of CYD dengue vaccine in the CYD28 trial, and had a post-dose 3 serum sample available). * Participants with good health, based on medical history and physical examination. * Informed consent form (ICF) had been signed and dated by participant (based on local regulations), and ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations). * Participant and parent(s)/legally acceptable representative(s) was able to attend all scheduled visits to comply with all trial procedures.
Exclusion criteria
* Participant who received any other dengue vaccination that was not part of CYD28. * Participant was pregnant, or lactating, or of childbearing potential (considered of non childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination). * Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63 | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Pre-booster injection (Day 0) and 28 days post-booster injection | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection. |
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Pre-booster injection (Day 0) and 28 days post-booster injection | Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | 28 days post-booster injection | Seroconversion rates for each serotypes were defined as the percentages of participants with either a pre-booster titer \< 10 (1/dilution) and a post-booster titer \>= 40 (1/dilution), or a pre-booster titer \>=10 (1/dilution) and a \>= 4-fold increase in post-booster titer as determined by PRNT. |
| GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD 63 | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. |
| GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD63 | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. GMTRs were calculated as the ratio of GMTs post-dose 3 in CYD28 and pre-booster injection in CYD63. |
| GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Pre-booster injection (Day 0) and 28 days post-booster injection | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. |
| GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | 6 months, 12 months, and 24 months post-booster injection | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. |
| GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Pre-booster injection (Day 0) and 6 months, 12 months, 24 months post-booster injection | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection. |
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | 6 months, 12 months, and 24 months post-booster injection | Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers \>=10 (1/dilution). |
| Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Within 7 days after booster injection | Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 injection site reactions: Pain: significant; prevents daily activity; Erythema and Swelling: \>100 millimeter. |
| Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Within 14 days after booster injection | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: \>=39 degree Celsius; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity. |
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63 | Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers \>=10 (1/dilution). |
Countries
Singapore
Participant flow
Recruitment details
Study participants were enrolled from 01 July 2016 to 18 February 2017 at 3 sites in Singapore.
Pre-assignment details
A total of 118 participants who received 3 doses of CYD dengue vaccine in study CYD28 (NCT00880893) were enrolled and randomized in this study (CYD63).
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Booster Group Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63). | 89 |
| Placebo Group Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63). | 29 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Non-compliance with the protocol | 5 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Booster Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 0 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 29 Participants | 107 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 11.18 | 28.2 years STANDARD_DEVIATION 9.18 | 28.2 years STANDARD_DEVIATION 10.69 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 15 Participants | 58 Participants |
| Sex: Female, Male Male | 46 Participants | 14 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 29 |
| other Total, other adverse events | 47 / 89 | 10 / 29 |
| serious Total, serious adverse events | 5 / 89 | 0 / 29 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).
Time frame: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63
Population: Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD63). Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 1 | 20.3 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 2 | 85.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 3 | 102 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 4 | 92.8 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 4 | 123 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 1 | 37.7 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 3 | 105 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 2 | 56.2 titers (1/dilution) |
Comparison: Dengue Virus Serotype 195% CI: [0.998, 1.79]
Comparison: Dengue Virus Serotype 295% CI: [0.439, 0.829]
Comparison: Dengue Virus Serotype 395% CI: [0.746, 1.28]
Comparison: Dengue Virus Serotype 495% CI: [0.918, 1.75]
Secondary
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.
Time frame: Pre-booster injection (Day 0) and 28 days post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 1.74 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 2.04 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 3.52 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 3.58 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.822 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 0.676 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.669 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 0.624 ratio |
Secondary
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.
Time frame: Pre-booster injection (Day 0) and 6 months, 12 months, 24 months post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 6 months/Day 0 | 1.19 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 12 months/Day 0 | 0.983 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 24 months/Day 0 | 0.658 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 6 months/Day 0 | 1.60 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 12 months/Day 0 | 1.42 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 24 months/Day 0 | 1.43 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 6 months/Day 0 | 2.14 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 12 months/Day 0 | 1.76 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 24 months/Day 0 | 1.11 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 6 months/Day 0 | 2.17 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 12 months/Day 0 | 1.70 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 24 months/Day 0 | 1.35 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 12 months/Day 0 | 0.710 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 6 months/Day 0 | 0.646 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 6 months/Day 0 | 0.797 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 12 months/Day 0 | 0.660 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 6 months/Day 0 | 0.743 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 24 months/Day 0 | 0.594 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 12 months/Day 0 | 0.614 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 6 months/Day 0 | 0.634 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 24 months/Day 0 | 0.529 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 12 months/Day 0 | 0.687 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 24 months/Day 0 | 0.479 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 24 months/Day 0 | 0.646 ratio |
Secondary
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. GMTRs were calculated as the ratio of GMTs post-dose 3 in CYD28 and pre-booster injection in CYD63.
Time frame: 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD63
Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 0.487 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 0.199 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.207 ratio |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.291 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.474 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 0.441 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.267 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 0.313 ratio |
Secondary
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
Time frame: Pre-booster injection (Day 0) and 28 days post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Pre-booster Inj. | 13.5 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 37.7 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Pre-booster Inj. | 18.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 56.2 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Pre-booster Inj. | 22.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 105 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Pre-booster Inj. | 28.0 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 123 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 39.8 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Pre-booster Inj. | 16.7 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Pre-booster Inj. | 27.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 18.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Pre-booster Inj. | 44.9 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Pre-booster Inj. | 23.2 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 24.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 21.5 titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
Time frame: 6 months, 12 months, and 24 months post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3:6 months Post-booster Inj. | 65.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2:6 months Post-booster Inj. | 44.3 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:12 months Post-booster Inj. | 54.8 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:12 months Post-booster Inj. | 20.9 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:24 months Post-booster Inj. | 36.5 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:12 months Post-booster Inj. | 39.3 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4:6 months Post-booster Inj. | 75.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1:6 months Post-booster Inj. | 25.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:12 months Post-booster Inj. | 61.9 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:24 months Post-booster Inj. | 41.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:24 months Post-booster Inj. | 50.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:24 months Post-booster Inj. | 14.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:24 months Post-booster Inj. | 24.5 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1:6 months Post-booster Inj. | 14.3 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:12 months Post-booster Inj. | 14.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2:6 months Post-booster Inj. | 20.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:12 months Post-booster Inj. | 22.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:24 months Post-booster Inj. | 21.7 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3:6 months Post-booster Inj. | 26.7 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:12 months Post-booster Inj. | 20.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:24 months Post-booster Inj. | 16.8 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4:6 months Post-booster Inj. | 34.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:12 months Post-booster Inj. | 33.1 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:24 months Post-booster Inj. | 13.6 titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.
Time frame: 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD 63
Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 1: 28 days Post-dose 3 | 20.3 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 1: Pre-booster Inj. | 13.5 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 2: 28 days Post-dose 3 | 85.6 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 2: Pre-booster Inj. | 18.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 3: 28 days Post-dose 3 | 102 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 3: Pre-booster Inj. | 22.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 4: 28 days Post-dose 3 | 92.8 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 4: Pre-booster Inj. | 28.0 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 4: Pre-booster Inj. | 44.9 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 1: 28 days Post-dose 3 | 26.8 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 3: 28 days Post-dose 3 | 107 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 1: Pre-booster Inj. | 16.7 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 4: 28 days Post-dose 3 | 86.5 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 2: 28 days Post-dose 3 | 65.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 3: Pre-booster Inj. | 27.4 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 | Dengue Virus Serotype 2: Pre-booster Inj. | 23.2 titers (1/dilution) |
Secondary
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 injection site reactions: Pain: significant; prevents daily activity; Erythema and Swelling: \>100 millimeter.
Time frame: Within 7 days after booster injection
Population: Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Pain: Any | 29 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Pain: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Erythema: Any | 1 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Swelling: Any | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Swelling: Any | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Pain: Any | 7 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Pain: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Injection-site Erythema: Any | 0 Participants |
Secondary
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: \>=39 degree Celsius; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.
Time frame: Within 14 days after booster injection
Population: Analysis was performed on Safety Analysis Set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Fever: Any Grade | 2 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Headache: Any Grade | 23 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Headache: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Malaise: Any Grade | 11 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Malaise: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Myalgia: Any Grade | 21 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Myalgia: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Asthenia: Any Grade | 15 Participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Asthenia: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Myalgia: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Fever: Any Grade | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Malaise: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Asthenia: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Headache: Any Grade | 3 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Myalgia: Any Grade | 7 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Headache: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Asthenia: Any Grade | 4 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Malaise: Any Grade | 3 Participants |
Secondary
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Seroconversion rates for each serotypes were defined as the percentages of participants with either a pre-booster titer \< 10 (1/dilution) and a post-booster titer \>= 40 (1/dilution), or a pre-booster titer \>=10 (1/dilution) and a \>= 4-fold increase in post-booster titer as determined by PRNT.
Time frame: 28 days post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 29.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 29.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 44.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 38.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 3.6 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-booster injection (Day 0) and 28 days post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Pre-booster Inj. | 32.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 74.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Pre-booster Inj. | 41.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 81.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Pre-booster Inj. | 58.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 96.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Pre-booster Inj. | 70.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 97.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 82.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Pre-booster Inj. | 32.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Pre-booster Inj. | 60.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 35.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Pre-booster Inj. | 89.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Pre-booster Inj. | 42.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 67.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 42.9 percentage of participants |
Secondary
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: 6 months, 12 months, and 24 months post-booster injection
Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1:6 months Post-booster Inj. | 59.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:12 months Post-booster Inj. | 49.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:24 months Post-booster Inj. | 37.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2:6 months Post-booster Inj. | 72.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:12 months Post-booster Inj. | 66.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:24 months Post-booster Inj. | 65.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3:6 months Post-booster Inj. | 88.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:12 months Post-booster Inj. | 89.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:24 months Post-booster Inj. | 76.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4:6 months Post-booster Inj. | 95.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:12 months Post-booster Inj. | 91.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:24 months Post-booster Inj. | 89.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:12 months Post-booster Inj. | 85.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1:6 months Post-booster Inj. | 33.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3:6 months Post-booster Inj. | 70.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:12 months Post-booster Inj. | 33.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4:6 months Post-booster Inj. | 77.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype1:24 months Post-booster Inj. | 34.6 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:12 months Post-booster Inj. | 63.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2:6 months Post-booster Inj. | 40.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype4:24 months Post-booster Inj. | 65.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:12 months Post-booster Inj. | 44.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype3:24 months Post-booster Inj. | 50.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype2:24 months Post-booster Inj. | 42.3 percentage of participants |
Secondary
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63
Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-dose 3 | 52.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 74.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-dose 3 | 89.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 81.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-dose 3 | 97.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 96.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-dose 3 | 95.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 97.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 82.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-dose 3 | 50.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-dose 3 | 96.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 35.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-dose 3 | 88.5 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-dose 3 | 74.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 67.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 42.9 percentage of participants |