Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Lot Consistency
Brief summary
The purpose of this study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses. Primary Objective * To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes. Secondary Objectives: * To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes. * To describe the safety of the CYD dengue vaccine in all participants after each dose.
Detailed description
All participants received 3 doses of their assigned vaccine or placebo and provided blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Safety data were collected in all participants after each dose and throughout the study.
Interventions
BIOLOGICALLive, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)
BIOLOGICALPlacebo: NaCl 0.9%
0.5 ml, SC
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
An observer-blind procedure was followed for the three injections with CYD dengue vaccine or placebo. Neither the observer, Investigator, Sponsor, nor the participant knew which product was administered.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 60 years on the day of inclusion. * Informed consent form was signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman of childbearing potential, use of an effective method of contraception, or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination (i.e., for 14 months).
Exclusion criteria
* Known pregnancy, or a positive urine pregnancy test. * History of flavivirus infection or vaccination or prolonged habitation in a dengue endemic area. * Currently breastfeeding a child. * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for pandemic influenza vaccination. * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Self-reported seropositivity for human immunodeficiency virus (HIV). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | 28 days post-injection 3 | GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | 28 days post-Injection 3 | GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine. |
| Number of Participants With Solicited Injection Site Reactions After Any Vaccination | 7 days post any vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: \> 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported. |
| Number of Participants With Solicited Systemic Reactions After Any Vaccination | 14 days post any vaccination | Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: \>=39.0°C (\>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported. |
Countries
Australia
Participant flow
Recruitment details
Study participants were enrolled from 05 October 2010 to 26 November 2010 at 8 study sites in Australia.
Pre-assignment details
A total of 715 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Phase III Lot 1 Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. | 163 |
| CYD Dengue Vaccine Phase III Lot 2 Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. | 162 |
| CYD Dengue Vaccine Phase III Lot 3 Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. | 163 |
| CYD Dengue Vaccine Phase II Lot Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months, subcutaneously. | 167 |
| Placebo Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. | 57 |
| Total | 712 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Enrolled, but not treated | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 | 5 | 3 | 1 |
| Overall Study | Other adverse event | 1 | 2 | 5 | 3 | 0 |
| Overall Study | Protocol Violation | 8 | 7 | 2 | 4 | 2 |
| Overall Study | Serious adverse event | 2 | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 6 | 16 | 7 | 5 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Phase III Lot 1 | CYD Dengue Vaccine Phase III Lot 2 | CYD Dengue Vaccine Phase III Lot 3 | CYD Dengue Vaccine Phase II Lot | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 13.3 | 39.4 Years STANDARD_DEVIATION 12.9 | 38.7 Years STANDARD_DEVIATION 14.1 | 38.4 Years STANDARD_DEVIATION 13.2 | 39.7 Years STANDARD_DEVIATION 13.5 | 39.0 Years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 103 Participants | 87 Participants | 84 Participants | 84 Participants | 33 Participants | 391 Participants |
| Sex: Female, Male Male | 60 Participants | 75 Participants | 79 Participants | 83 Participants | 24 Participants | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 163 | 0 / 161 | 0 / 164 | 0 / 167 | 0 / 57 |
| other Total, other adverse events | 136 / 163 | 131 / 161 | 135 / 164 | 140 / 167 | 41 / 57 |
| serious Total, serious adverse events | 10 / 163 | 9 / 161 | 5 / 164 | 9 / 167 | 1 / 57 |
Outcome results
Primary
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
Time frame: 28 days post-injection 3
Population: Analysis was performed on Per-protocol analysis set which included participants who received at least 1 dose of the study vaccine or placebo and had no protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Phase II Lot and placebo.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Phase III Lot 1 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 1 | 20.6 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 1 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 2 | 65.9 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 1 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 3 | 74.2 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 1 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 4 | 131.8 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 4 | 94.6 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 1 | 18.1 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 3 | 65 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 2 | 44.1 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 3 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 4 | 108.5 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 3 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 2 | 58.1 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 3 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 3 | 71.6 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 3 | Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine | Dengue Virus Serotype 1 | 17.1 Titer (1/dilution) |
Comparison: Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 295% CI: [-0.067, 0.178]
Comparison: Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 395% CI: [-0.102, 0.151]
Comparison: Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 195% CI: [-0.204, 0.045]
Comparison: Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 295% CI: [0.009, 0.34]
Comparison: Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 395% CI: [-0.297, 0.056]
Comparison: Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 195% CI: [-0.225, 0.117]
Comparison: Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 295% CI: [-0.068, 0.184]
Comparison: Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 395% CI: [-0.167, 0.082]
Comparison: Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 195% CI: [-0.144, 0.113]
Comparison: Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 295% CI: [-0.006, 0.295]
Comparison: Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 395% CI: [-0.207, 0.088]
Comparison: Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 195% CI: [-0.242, 0.073]
Secondary
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.
Time frame: 28 days post-Injection 3
Population: Analysis was performed on Per Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Phase III Lot 1 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 1 | 18.6 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 1 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 2 | 55.4 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 1 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 3 | 70.2 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 1 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 4 | 110.9 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 4 | 115.4 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 1 | 15.1 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 3 | 83.6 Titer (1/dilution) |
| CYD Dengue Vaccine Phase III Lot 2 | Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine | Dengue Virus Serotype 2 | 25.7 Titer (1/dilution) |
Comparison: Dengue Virus Serotype 195% CI: [-0.009, 0.192]
Comparison: Dengue Virus Serotype 295% CI: [0.202, 0.466]
Comparison: Dengue Virus Serotype 395% CI: [-0.173, 0.021]
Comparison: Dengue Virus Serotype 495% CI: [-0.137, 0.103]
Secondary
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: \> 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Time frame: 7 days post any vaccination
Population: Analysis was performed on Safety Analysis Set which included all participants who received the study dose, and participants were analyzed according to the treatment received. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Any | 8 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Any | 22 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Any | 73 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Any | 15 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Any | 4 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Any | 74 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Any | 25 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Any | 73 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Any | 2 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Any | 78 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Any | 24 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Any | 5 Participants |
| Placebo | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Any | 0 Participants |
| Placebo | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Any | 1 Participants |
| Placebo | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Any | 11 Participants |
Secondary
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: \>=39.0°C (\>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Time frame: 14 days post any vaccination
Population: Analysis was performed on Safety Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Any | 70 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Any | 72 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 10 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 3 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Any | 5 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Any | 49 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 4 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Any | 100 Participants |
| CYD Dengue Vaccine Phase III Lot 1 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 8 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 9 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Any | 8 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 22 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Any | 51 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Any | 69 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Any | 75 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Any | 96 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 17 Participants |
| CYD Dengue Vaccine Phase III Lot 2 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 10 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 19 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Any | 57 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 17 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Any | 8 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Any | 71 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 11 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Any | 108 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Any | 97 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 1 Participants |
| CYD Dengue Vaccine Phase III Lot 3 | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 11 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Any | 84 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 9 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Any | 69 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Any | 5 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Any | 104 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 14 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Any | 90 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 13 Participants |
| CYD Dengue Vaccine Phase II Lot | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 13 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 3 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 4 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Any | 28 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Any | 21 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Any | 1 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 2 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Any | 20 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Any | 26 Participants |
| Placebo | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 3 Participants |