Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Fever, Dengue virus, Dengue Hemorrhagic Fever, CYD Dengue Vaccine
Brief summary
The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule. 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 CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only). Secondary Objectives: * If the primary objective of non-inferiority was 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 CYD13 and CYD30 trials. * To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants. * To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 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 participants. * To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.
Detailed description
Healthy adolescents and adults who received 3 doses of the tetravalent dengue vaccine 4 to 5 years earlier in previous CYD dengue vaccine trials (CYD13 and CYD30) received either a booster dose 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
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An observer-blind procedure was followed for the injection of the CYD Dengue Vaccine booster or placebo. Neither the observer Investigator, nor the Sponsor, nor the participant/participants' parent(s)/legally acceptable representative(s) knew which product was administered.
Eligibility
Sex/Gender
ALL
Age
13 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
* Had been identified as a potential participant by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available \[at least 400 microliters of serum\]). * Participants were in good health, based on medical history and physical examination. * Assent form or informed consent form (ICF) had been signed and dated by the 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) attended all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participant who received any other dengue vaccination that was not part of the CYD13 or CYD30 trials. * Participant was pregnant, or lactating, or of childbearing potential (to be 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, was 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 of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 | Geometric Mean Titers (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 |
|---|---|---|
| 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. |
| 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 greater than or equal to (\>=)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 for each serotype was defined as the percentage 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 CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64 | 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 CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64 | 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 pre-booster injection and post-dose injection. |
| GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 | 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 in CYD64 | 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), 6 months, 12 months, and 24 months post-booster injection in CYD64 | 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 in CYD64 | 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 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: \>100 millimeters (mm). |
| 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°C; 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 CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 | 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
Brazil, Colombia, Honduras, Mexico, Puerto Rico
Participant flow
Recruitment details
Study participants were enrolled from 14 April 2016 to 19 October 2016 at 5 sites, one each in Brazil, Colombia, Honduras, Mexico, and Puerto Rico.
Pre-assignment details
A total of 251 participants who received 3 doses of CYD dengue vaccine in previous studies CYD13 (NCT00993447) and CYD30 (NCT01187433) were enrolled and randomized in this study (CYD64).
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Booster Group Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | 187 |
| Placebo Group Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). | 64 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non compliance with protocol | 9 | 3 |
| Overall Study | Serious adverse event | 0 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 1 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Booster Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 63 Participants | 19 Participants | 82 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants | 45 Participants | 169 Participants |
| Age, Continuous | 19.2 years STANDARD_DEVIATION 2.14 | 19.0 years STANDARD_DEVIATION 1.99 | 19.1 years STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 89 Participants | 27 Participants | 116 Participants |
| Sex: Female, Male Male | 98 Participants | 37 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 187 | 2 / 64 |
| other Total, other adverse events | 115 / 187 | 31 / 64 |
| serious Total, serious adverse events | 19 / 187 | 5 / 64 |
Outcome results
Primary
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group
Geometric Mean Titers (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 CYD13 or CYD30 and 28 days post-booster injection in CYD64
Population: Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD64). 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 CYD13 or CYD30 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 1 | 316 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 2 | 356 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 3 | 640 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 4 | 243 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 4 | 344 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 1 | 560 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 3 | 671 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 2 | 657 titers (1/dilution) |
Comparison: Dengue Virus Serotype 195% CI: [1.33, 2.06]
Comparison: Dengue Virus Serotype 295% CI: [1.43, 2.31]
Comparison: Dengue Virus Serotype 395% CI: [0.841, 1.27]
Comparison: Dengue Virus Serotype 495% CI: [1.01, 1.74]
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 CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 1.70 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 1.78 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 1.59 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 2.09 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.946 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 1.03 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 0.798 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.946 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), 6 months, 12 months, and 24 months post-booster injection in CYD64
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 CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Month 12/Day 0 | 0.722 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Month 6/Day 0 | 1.14 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Month 12/Day 0 | 0.651 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Month 12/Day 0 | 0.786 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Month 24/Day 0 | 0.579 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Month 24/Day 0 | 0.878 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Month 6/Day 0 | 1.42 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Month 24/Day 0 | 0.642 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Month 12/Day 0 | 1.02 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Month 6/Day 0 | 0.763 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Month 24/Day 0 | 0.890 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Month 6/Day 0 | 1.34 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Month 24/Day 0 | 0.684 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Month 24/Day 0 | 0.509 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Month 24/Day 0 | 0.548 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Month 6/Day 0 | 0.957 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Month 24/Day 0 | 0.682 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Month 6/Day 0 | 0.502 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Month 6/Day 0 | 0.998 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Month 12/Day 0 | 0.630 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Month 12/Day 0 | 0.667 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Month 6/Day 0 | 0.912 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Month 12/Day 0 | 0.709 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Month 12/Day 0 | 0.483 ratio |
Secondary
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, 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 pre-booster injection and post-dose injection.
Time frame: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64
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 CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 0.952 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 0.986 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.536 ratio |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.618 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 0.613 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 1.41 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 0.818 ratio |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 1.04 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 CYD13 or CYD30 | 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. | 162 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 657 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 560 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 357 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 344 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 671 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 360 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 325 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 161 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 161 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 349 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 297 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 323 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 354 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 442 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 432 titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group
GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
Time frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64
Population: Analysis was performed on Full analysis set which included all participants who received either CYD Dengue Vaccine or placebo and had blood sample drawn and valid post-injection serology results. 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 CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 4 | 241 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 3 | 617 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 1 | 304 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 2 | 338 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 2 | 648 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 1 | 538 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 3 | 660 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Dengue Virus Serotype 4 | 341 titers (1/dilution) |
Comparison: Dengue Virus Serotype 195% CI: [1.34, 2.05]
Comparison: Dengue Virus Serotype 295% CI: [1.49, 2.41]
Comparison: Dengue Virus Serotype 395% CI: [0.86, 1.3]
Comparison: Dengue Virus Serotype 495% CI: [1.02, 1.73]
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 in CYD64
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 CYD13 or CYD30 | 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. | 270 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 270 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 241 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 246 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 503 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 303 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 341 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 150 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 442 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 269 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 233 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 169 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 225 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 192 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 309 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 185 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 114 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 182 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 127 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 187 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 335 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 447 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 156 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 328 titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, 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.
Time frame: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64
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 CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-dose 3 | 316 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Pre-booster Inj. | 325 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-dose 3 | 356 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Pre-booster Inj. | 360 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-dose 3 | 640 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Pre-booster Inj. | 357 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-dose 3 | 243 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Pre-booster Inj. | 162 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: Pre-booster Inj. | 161 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-dose 3 | 232 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-dose 3 | 541 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: Pre-booster Inj. | 349 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-dose 3 | 255 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-dose 3 | 303 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: Pre-booster Inj. | 442 titers (1/dilution) |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: Pre-booster Inj. | 323 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 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: \>100 millimeters (mm).
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 CYD13 or CYD30 | 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 CYD13 or CYD30 | 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 CYD13 or CYD30 | 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 | 46 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 Dose 3 in CYD13 or CYD30 | 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 Booster Dose in CYD64 | 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 in CYD64 | 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 in CYD64 | 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 | 12 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 in CYD64 | 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 |
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°C; 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 CYD13 or CYD30 | 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 | 2 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 1 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 3 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 87 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 52 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 47 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 5 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 13 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 60 Participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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 | 11 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 19 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 2 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 19 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 2 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 14 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 1 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 6 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 1 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 | 22 Participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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 |
Secondary
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Seroconversion for each serotype was defined as the percentage 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 Full 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 CYD13 or CYD30 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 17.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 20.1 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 21.2 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 20.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4 | 6.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1 | 3.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3 | 4.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2 | 17.2 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 greater than or equal to (\>=)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 CYD13 or CYD30 | 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. | 96.0 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 99.4 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 98.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 97.2 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 89.8 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 100.0 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 92.1 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 88.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 93.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 90.6 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 90.6 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 87.5 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 95.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 95.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 92.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 84.4 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 in CYD64
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 CYD13 or CYD30 | 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. | 97.6 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 96.5 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 92.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 93.3 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 98.8 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 97.1 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 87.2 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 99.4 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 91.4 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 98.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 98.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | 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. | 97.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 94.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 95.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 95.2 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 85.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 88.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 89.7 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 92.1 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 91.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 91.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 96.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 94.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | 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. | 95.2 percentage of participants |
Secondary
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, 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 CYD13 or CYD30 and 28 days post-booster injection in CYD64
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 CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 98.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-dose 3 | 92.0 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-dose 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 96.0 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 99.4 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-dose 3 | 90.9 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 100.0 percentage of participants |
| CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-dose 3 | 95.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-booster Inj. | 93.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-booster Inj. | 84.4 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 4: 28 days Post-dose 3 | 96.8 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-dose 3 | 96.9 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 2: 28 days Post-booster Inj. | 87.5 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-dose 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 3: 28 days Post-booster Inj. | 95.3 percentage of participants |
| CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Dengue Virus Serotype 1: 28 days Post-dose 3 | 90.6 percentage of participants |