Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02623725
Collaborator
(none)
251
5
2
30.5
50.2
1.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
251 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Latin America
Actual Study Start Date
:
Apr 14, 2016
Actual Primary Completion Date
:
Nov 23, 2016
Actual Study Completion Date
:
Oct 28, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Biological: CYD Dengue Vaccine (5-dose formulation)
0.5 mL, Subcutaneous
|
| Experimental: 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). |
Biological: Placebo, NaCl 0.9%
0.5 mL, Subcutaneous
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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).
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
to 22 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number 001 | Vitoria | Brazil | 29040-091 | |
| 2 | Investigational Site Number 002 | Bucaramanga | Colombia | ||
| 3 | Investigational Site Number 003 | Tegucigalpa | Honduras | ||
| 4 | Investigational Site Number 004 | Temixco | Mexico | 62587 | |
| 5 | Investigational Site Number 005 | Carolina | Puerto Rico | 984 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT02623725
Other Study ID Numbers:
- CYD64
- U1111-1161-2855
First Posted:
Dec 8, 2015
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
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 Detail | 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). |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Period Title: Overall Study | ||
| STARTED | 187 | 64 |
| COMPLETED | 171 | 58 |
| NOT COMPLETED | 16 | 6 |
Baseline Characteristics
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group | Total |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | Total of all reporting groups |
| Overall Participants | 187 | 64 | 251 |
| Age (Count of Participants) | |||
| <=18 years |
63
33.7%
|
19
29.7%
|
82
32.7%
|
| Between 18 and 65 years |
124
66.3%
|
45
70.3%
|
169
67.3%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
19.2
(2.14)
|
19.0
(1.99)
|
19.1
(2.10)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
89
47.6%
|
27
42.2%
|
116
46.2%
|
| Male |
98
52.4%
|
37
57.8%
|
135
53.8%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Arm/Group Description | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64). | 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). |
| Measure Participants | 177 | 177 |
| Dengue Virus Serotype 1 |
316
|
560
|
| Dengue Virus Serotype 2 |
356
|
657
|
| Dengue Virus Serotype 3 |
640
|
671
|
| Dengue Virus Serotype 4 |
243
|
344
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 1 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (>) 1/2 for each serotype. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.66 | |
| Confidence Interval |
(2-Sided) 95% 1.33 to 2.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 2 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was >1/2 for each serotype. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.82 | |
| Confidence Interval |
(2-Sided) 95% 1.43 to 2.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 3 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was >1/2 for each serotype. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.841 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 4 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was >1/2 for each serotype. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.32 | |
| Confidence Interval |
(2-Sided) 95% 1.01 to 1.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Arm/Group Description | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64). | 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). |
| Measure Participants | 184 | 184 |
| Dengue Virus Serotype 1 |
304
|
538
|
| Dengue Virus Serotype 2 |
338
|
648
|
| Dengue Virus Serotype 3 |
617
|
660
|
| Dengue Virus Serotype 4 |
241
|
341
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 1 | |
| Type of Statistical Test | Superiority | |
| Comments | The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.66 | |
| Confidence Interval |
(2-Sided) 95% 1.34 to 2.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 2 | |
| Type of Statistical Test | Superiority | |
| Comments | The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.89 | |
| Confidence Interval |
(2-Sided) 95% 1.49 to 2.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 3 | |
| Type of Statistical Test | Superiority | |
| Comments | The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.860 to 1.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 |
|---|---|---|
| Comments | Dengue Virus Serotype 4 | |
| Type of Statistical Test | Superiority | |
| Comments | The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean of titer ratio |
| Estimated Value | 1.33 | |
| Confidence Interval |
(2-Sided) 95% 1.02 to 1.73 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1: Pre-booster Inj. |
325
|
349
|
| Dengue Virus Serotype 1: 28 days Post-booster Inj. |
560
|
297
|
| Dengue Virus Serotype 2: Pre-booster Inj. |
360
|
323
|
| Dengue Virus Serotype 2: 28 days Post-booster Inj. |
657
|
354
|
| Dengue Virus Serotype 3: Pre-booster Inj. |
357
|
442
|
| Dengue Virus Serotype 3: 28 days Post-booster Inj. |
671
|
432
|
| Dengue Virus Serotype 4: Pre-booster Inj. |
162
|
161
|
| Dengue Virus Serotype 4: 28 days Post-booster Inj. |
344
|
161
|
| Title | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1 |
1.59
|
0.798
|
| Dengue Virus Serotype 2 |
1.70
|
1.03
|
| Dengue Virus Serotype 3 |
1.78
|
0.946
|
| Dengue Virus Serotype 4 |
2.09
|
0.946
|
| Title | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1: Pre-booster Inj. |
88.1
47.1%
|
90.6
141.6%
|
| Dengue Virus Serotype 1: 28 days Post-booster Inj. |
96.0
51.3%
|
84.4
131.9%
|
| Dengue Virus Serotype 2: Pre-booster Inj. |
89.8
48%
|
90.6
141.6%
|
| Dengue Virus Serotype 2: 28 days Post-booster Inj. |
98.9
52.9%
|
87.5
136.7%
|
| Dengue Virus Serotype 3: Pre-booster Inj. |
92.1
49.3%
|
95.3
148.9%
|
| Dengue Virus Serotype 3: 28 days Post-booster Inj. |
99.4
53.2%
|
95.3
148.9%
|
| Dengue Virus Serotype 4: Pre-booster Inj. |
97.2
52%
|
92.2
144.1%
|
| Dengue Virus Serotype 4: 28 days Post-booster Inj. |
100.0
53.5%
|
93.8
146.6%
|
| Title | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 184 | 64 |
| Dengue Virus Serotype 1 |
17.9
9.6%
|
3.1
4.8%
|
| Dengue Virus Serotype 2 |
20.1
10.7%
|
17.2
26.9%
|
| Dengue Virus Serotype 3 |
21.2
11.3%
|
4.7
7.3%
|
| Dengue Virus Serotype 4 |
20.7
11.1%
|
6.3
9.8%
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1: 28 days Post-dose 3 |
316
|
232
|
| Dengue Virus Serotype 1: Pre-booster Inj. |
325
|
349
|
| Dengue Virus Serotype 2: 28 days Post-dose 3 |
356
|
303
|
| Dengue Virus Serotype 2: Pre-booster Inj. |
360
|
323
|
| Dengue Virus Serotype 3: 28 days Post-dose 3 |
640
|
541
|
| Dengue Virus Serotype 3: Pre-booster Inj. |
357
|
442
|
| Dengue Virus Serotype 4: 28 days Post-dose 3 |
243
|
255
|
| Dengue Virus Serotype 4: Pre-booster Inj. |
162
|
161
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed'=participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1 |
0.952
|
1.41
|
| Dengue Virus Serotype 2 |
0.986
|
1.04
|
| Dengue Virus Serotype 3 |
0.536
|
0.818
|
| Dengue Virus Serotype 4 |
0.618
|
0.613
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1: 28 days Post-dose 3 |
90.9
48.6%
|
90.6
141.6%
|
| Dengue Virus Serotype 1: 28 days Post-booster Inj. |
96.0
51.3%
|
84.4
131.9%
|
| Dengue Virus Serotype 2: 28 days Post-dose 3 |
95.4
51%
|
96.9
151.4%
|
| Dengue Virus Serotype 2: 28 days Post-booster Inj. |
98.9
52.9%
|
87.5
136.7%
|
| Dengue Virus Serotype 3: 28 days Post-dose 3 |
100.0
53.5%
|
100.0
156.3%
|
| Dengue Virus Serotype 3: 28 days Post-booster Inj. |
99.4
53.2%
|
95.3
148.9%
|
| Dengue Virus Serotype 4: 28 days Post-dose 3 |
92.0
49.2%
|
96.8
151.3%
|
| Dengue Virus Serotype 4: 28 days Post-booster Inj. |
100.0
53.5%
|
93.8
146.6%
|
| Title | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1:6 months Post-booster Inj. |
270
|
192
|
| Dengue Virus Serotype1:12 months Post-booster Inj. |
270
|
185
|
| Dengue Virus Serotype1:24 months Post-booster Inj. |
241
|
182
|
| Dengue Virus Serotype 2:6 months Post-booster Inj. |
442
|
335
|
| Dengue Virus Serotype2:12 months Post-booster Inj. |
269
|
225
|
| Dengue Virus Serotype2:24 months Post-booster Inj. |
246
|
187
|
| Dengue Virus Serotype 3:6 months Post-booster Inj. |
503
|
447
|
| Dengue Virus Serotype3:12 months Post-booster Inj. |
303
|
328
|
| Dengue Virus Serotype3:24 months Post-booster Inj. |
341
|
309
|
| Dengue Virus Serotype 4:6 months Post-booster Inj. |
233
|
156
|
| Dengue Virus Serotype4:12 months Post-booster Inj. |
169
|
127
|
| Dengue Virus Serotype4:24 months Post-booster Inj. |
150
|
114
|
| Title | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1: Month 6/Day 0 |
0.763
|
0.502
|
| Dengue Virus Serotype 1: Month 12/Day 0 |
0.722
|
0.483
|
| Dengue Virus Serotype 1: Month 24/Day 0 |
0.642
|
0.509
|
| Dengue Virus Serotype 2: Month 6/Day 0 |
1.14
|
0.998
|
| Dengue Virus Serotype 2: Month 12/Day 0 |
0.651
|
0.630
|
| Dengue Virus Serotype 2: Month 24/Day 0 |
0.579
|
0.548
|
| Dengue Virus Serotype 3: Month 6/Day 0 |
1.34
|
0.957
|
| Dengue Virus Serotype 3: Month 12/Day 0 |
0.786
|
0.667
|
| Dengue Virus Serotype 3: Month 24/Day 0 |
0.878
|
0.682
|
| Dengue Virus Serotype 4: Month 6/Day 0 |
1.42
|
0.912
|
| Dengue Virus Serotype 4: Month 12/Day 0 |
1.02
|
0.709
|
| Dengue Virus Serotype 4: Month 24/Day 0 |
0.890
|
0.684
|
| Title | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 177 | 64 |
| Dengue Virus Serotype 1:6 months Post-booster Inj. |
91.4
48.9%
|
85.7
133.9%
|
| Dengue Virus Serotype1:12 months Post-booster Inj. |
92.9
49.7%
|
88.7
138.6%
|
| Dengue Virus Serotype1:24 months Post-booster Inj. |
87.2
46.6%
|
89.7
140.2%
|
| Dengue Virus Serotype 2:6 months Post-booster Inj. |
98.9
52.9%
|
92.1
143.9%
|
| Dengue Virus Serotype2:12 months Post-booster Inj. |
96.5
51.6%
|
91.9
143.6%
|
| Dengue Virus Serotype2:24 months Post-booster Inj. |
93.3
49.9%
|
91.4
142.8%
|
| Dengue Virus Serotype 3:6 months Post-booster Inj. |
97.7
52.2%
|
95.2
148.8%
|
| Dengue Virus Serotype3:12 months Post-booster Inj. |
97.1
51.9%
|
96.8
151.3%
|
| Dengue Virus Serotype3:24 months Post-booster Inj. |
99.4
53.2%
|
94.8
148.1%
|
| Dengue Virus Serotype 4:6 months Post-booster Inj. |
98.9
52.9%
|
95.2
148.8%
|
| Dengue Virus Serotype4:12 months Post-booster Inj. |
97.6
52.2%
|
95.2
148.8%
|
| Dengue Virus Serotype4:24 months Post-booster Inj. |
98.8
52.8%
|
94.8
148.1%
|
| Title | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 187 | 64 |
| Injection-site Pain: Any |
46
24.6%
|
12
18.8%
|
| Injection-site Pain: Grade 3 |
1
0.5%
|
0
0%
|
| Injection-site Erythema: Any |
1
0.5%
|
0
0%
|
| Injection-site Erythema: Grade 3 |
0
0%
|
0
0%
|
| Injection-site Swelling: Any |
0
0%
|
0
0%
|
| Injection-site Swelling: Grade 3 |
0
0%
|
0
0%
|
| Title | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety Analysis Set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 187 | 64 |
| Fever: Any Grade |
13
7%
|
6
9.4%
|
| Fever: Grade 3 |
1
0.5%
|
1
1.6%
|
| Headache: Any Grade |
87
46.5%
|
22
34.4%
|
| Headache: Grade 3 |
11
5.9%
|
2
3.1%
|
| Malaise: Any Grade |
47
25.1%
|
19
29.7%
|
| Malaise: Grade 3 |
5
2.7%
|
0
0%
|
| Myalgia: Any Grade |
60
32.1%
|
19
29.7%
|
| Myalgia: Grade 3 |
2
1.1%
|
2
3.1%
|
| Asthenia: Any Grade |
52
27.8%
|
14
21.9%
|
| Asthenia: Grade 3 |
3
1.6%
|
1
1.6%
|
Adverse Events
| Time Frame | Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. | |||
| Arm/Group Title | CYD Dengue Vaccine Booster Group | Placebo Group | ||
| Arm/Group Description | 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). | 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). | ||
All Cause Mortality |
||||
| CYD Dengue Vaccine Booster Group | Placebo Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/187 (0%) | 2/64 (3.1%) | ||
Serious Adverse Events |
||||
| CYD Dengue Vaccine Booster Group | Placebo Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/187 (10.2%) | 5/64 (7.8%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Infections and infestations | ||||
| Appendicitis | 3/187 (1.6%) | 3 | 1/64 (1.6%) | 1 |
| Cellulitis | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Gastroenteritis | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Gun Shot Wound | 0/187 (0%) | 0 | 1/64 (1.6%) | 1 |
| Intentional Overdose | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Road Traffic Accident | 3/187 (1.6%) | 3 | 0/64 (0%) | 0 |
| Toxicity To Various Agents | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Nervous system disorders | ||||
| Syncope | 1/187 (0.5%) | 1 | 1/64 (1.6%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Abortion Spontaneous | 1/187 (0.5%) | 1 | 1/64 (1.6%) | 1 |
| Ectopic Pregnancy | 2/187 (1.1%) | 2 | 0/64 (0%) | 0 |
| Pre-Eclampsia | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Psychiatric disorders | ||||
| Completed Suicide | 0/187 (0%) | 0 | 1/64 (1.6%) | 1 |
| Suicide Attempt | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
| Surgical and medical procedures | ||||
| Abortion Induced | 1/187 (0.5%) | 1 | 0/64 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| CYD Dengue Vaccine Booster Group | Placebo Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 115/187 (61.5%) | 31/64 (48.4%) | ||
| General disorders | ||||
| Asthenia | 52/187 (27.8%) | 52 | 14/64 (21.9%) | 14 |
| Injection Site Pain | 46/187 (24.6%) | 46 | 12/64 (18.8%) | 12 |
| Malaise | 47/187 (25.1%) | 48 | 19/64 (29.7%) | 19 |
| Pyrexia | 15/187 (8%) | 15 | 6/64 (9.4%) | 6 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 60/187 (32.1%) | 61 | 19/64 (29.7%) | 19 |
| Nervous system disorders | ||||
| Headache | 88/187 (47.1%) | 90 | 22/64 (34.4%) | 23 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur |
| Phone | 800-633-1610 ext ext 1# |
| Contact-US@sanofi.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT02623725
Other Study ID Numbers:
- CYD64
- U1111-1161-2855
First Posted:
Dec 8, 2015
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022