Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01488890
Collaborator
(none)
390
7
4
21.7
55.7
2.6
Study Details
Study Description
Brief Summary
The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations.
Primary Objectives:
-
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month [M] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered.
-
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered.
Secondary Objective:
-
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered.
-
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120).
-
To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3.
-
To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants were randomized to 4 different groups to receive either CYD dengue vaccine and/or YF vaccine. Participants who already received YF vaccine prior to enrolment were randomized to one of the 2 groups receiving CYD dengue vaccine alone. Participants were evaluated for immunogenicity, antibody persistence, reactogenicity and safety.
Study Design
Study Type:
Interventional
Actual Enrollment
:
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.
Actual Study Start Date
:
Dec 6, 2011
Actual Primary Completion Date
:
Sep 27, 2013
Actual Study Completion Date
:
Sep 27, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CYD Dengue vaccine: Group 1 Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. |
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL, Subcutaneous
Other Names:
|
| Experimental: CYD Dengue vaccine: Group 2 Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL, Subcutaneous
Other Names:
|
| Experimental: CYD Dengue and Yellow Fever vaccine: Group 3 Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL, Subcutaneous
Other Names:
Biological: Yellow Fever
0.5 mL, Subcutaneous
Other Names:
|
| Active Comparator: Yellow Fever vaccine: Group 4 Participants received single dose of YF vaccine at Day 0. |
Biological: Yellow Fever
0.5 mL, Subcutaneous
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 [Pre-injection 1, 28 days and 6 months post-injection 3]
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
- Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 [Pre-injection 1, 28 days and 6 months post-injection 3]
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Secondary Outcome Measures
- Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 [Pre-injection 1 and 2 and 28 days post-injection 1 and 2]
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
- Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 [Pre-injection 1 and 2 and 28 days post-injection 1 and 2]
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
- Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3 [Pre-injection 1 and 28 days post-injection 1]
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution).
- Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3 [Pre-injection 1 and 28 days post-injection 1]
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution).
- Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) [Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3]
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result).
- Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) [Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3]
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
- Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) [Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3]
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result).
- Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) [Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3]
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
- Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine [Within 7 days after any injection]
Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm.
- Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine [Within 14 days after any injection]
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Aged >= 18 to <= 45 years on the day of inclusion
-
Informed consent form had been signed and dated
-
Able to attend all scheduled visits and complied with all trial procedures
-
For participants classified as YF positive (+) to be included in Groups 1 and 2, previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable documentation.
Exclusion Criteria:
-
Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be 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 the first vaccination and until at least 4 weeks after the last vaccination)
-
Participation in the 4 weeks preceding the first 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination
-
For all participants classified as YF negative (-), any previous vaccination against Flavivirus (FV) diseases (including Japanese Encephalitis [JE], tick-borne encephalitis, and YF)
-
For participants classified as YF+, previous vaccination against FV diseases except YF (including JE and tick-borne encephalitis)
-
For all participants, any FV vaccination planned during the trial period outside the study protocol
-
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)
-
Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
-
Self-reported history of FV infection (e.g., JE, Dengue, YF, West Nile), confirmed either clinically or serologically
-
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including dry natural latex
-
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
-
Current alcohol abuse or drug addiction
-
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
-
Identified as an 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 employee or the Investigator
-
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C [>=100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
-
Previous residence (> 12 months) in, or travel in the last 30 days to FV endemic regions
-
History of thymic pathology (thymoma), thymectomy, or myasthenia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabaster | Alabama | United States | 35007 | |
| 2 | Sacramento | California | United States | 95816 | |
| 3 | Jacksonville | Florida | United States | 32216 | |
| 4 | Silver Spring | Maryland | United States | 20910 | |
| 5 | Springfield | Missouri | United States | 65802 | |
| 6 | Las Vegas | Nevada | United States | 89104 | |
| 7 | West Jordan | Utah | United States | 84088 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01488890
Other Study ID Numbers:
- CYD51
- U1111-1122-1892
First Posted:
Dec 8, 2011
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 06 December 2011 to 22 March 2012 in the United States. |
|---|---|
| Pre-assignment Detail | A total of 390 participants were enrolled and randomized in the study. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever (YF) Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. | Participants received single dose of YF vaccine at Day 0. |
| Period Title: Overall Study | ||||
| STARTED | 120 | 120 | 120 | 30 |
| Treated | 120 | 120 | 119 | 30 |
| COMPLETED | 88 | 100 | 85 | 25 |
| NOT COMPLETED | 32 | 20 | 35 | 5 |
Baseline Characteristics
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. | Participants received single dose of YF vaccine at Day 0. | Total of all reporting groups |
| Overall Participants | 120 | 120 | 120 | 30 | 390 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
120
100%
|
120
100%
|
120
100%
|
30
100%
|
390
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
31.6
(7.63)
|
32.6
(7.32)
|
32.6
(7.52)
|
34.8
(8.63)
|
32.5
(7.59)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
57
47.5%
|
61
50.8%
|
60
50%
|
17
56.7%
|
195
50%
|
| Male |
63
52.5%
|
59
49.2%
|
60
50%
|
13
43.3%
|
195
50%
|
Outcome Measures
| Title | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT). |
| Time Frame | Pre-injection 1, 28 days and 6 months post-injection 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set included participants who received at least 1 Inj. of CYD dengue or/ YF vaccine, had at least 1 blood sample drawn and valid post-Inj. serology result. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| Measure Participants | 117 | 119 |
| Dengue Virus Serotype 1: Pre-injection 1 |
5.38
|
5.13
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
14.8
|
15.9
|
| Dengue Virus Serotype 1: 6 months Post-injection 3 |
13.3
|
9.01
|
| Dengue Virus Serotype 2: Pre-injection 1 |
5.19
|
5.22
|
| Dengue Virus Serotype 2: 28 days Post-injection 3 |
51.2
|
59.9
|
| Dengue Virus Serotype 2: 6 months Post-injection 3 |
45.6
|
38.7
|
| Dengue Virus Serotype 3: Pre-injection |
5.32
|
5.28
|
| Dengue Virus Serotype 3: 28 days Post-injection 3 |
45.7
|
59.3
|
| Dengue Virus Serotype 3: 6 months Post-injection 3 |
30.2
|
34.5
|
| Dengue Virus Serotype 4: Pre-injection 1 |
5.78
|
5.11
|
| Dengue Virus Serotype 4: Post-injection 3 |
66.8
|
83.1
|
| Dengue Virus Serotype 4: 6 months Post-injection 3 |
74.8
|
41.7
|
| Title | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 |
|---|---|
| Description | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). |
| Time Frame | Pre-injection 1, 28 days and 6 months post-injection 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| Measure Participants | 117 | 119 |
| Dengue Virus Serotype 1: Pre-injection 1 |
1.7
1.4%
|
2.5
2.1%
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
52.7
43.9%
|
56.5
47.1%
|
| Dengue Virus Serotype 1: 6 months Post-injection 3 |
47.7
39.8%
|
32.7
27.3%
|
| Dengue Virus Serotype 2: Pre-injection 1 |
0.9
0.8%
|
2.5
2.1%
|
| Dengue Virus Serotype 2: 28 days Post-injection 3 |
84.0
70%
|
88.0
73.3%
|
| Dengue Virus Serotype 2: 6 months Post-injection 3 |
75.0
62.5%
|
80.8
67.3%
|
| Dengue Virus Serotype 3: Pre-injection 1 |
2.6
2.2%
|
4.2
3.5%
|
| Dengue Virus Serotype 3: 28 days Post-injection 3 |
85.1
70.9%
|
90.7
75.6%
|
| Dengue Virus Serotype 3: 6 months Post-injection 3 |
79.5
66.3%
|
80.8
67.3%
|
| Dengue Virus Serotype 4: Pre-injection 1 |
6.8
5.7%
|
0.8
0.7%
|
| Dengue Virus Serotype 4: 28 days Post-injection 3 |
88.3
73.6%
|
86.0
71.7%
|
| Dengue Virus Serotype 4: 6 months Post-injection 3 |
86.4
72%
|
74.0
61.7%
|
| Title | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. |
| Time Frame | Pre-injection 1 and 2 and 28 days post-injection 1 and 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full 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 Group 3 and 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| Measure Participants | 117 | 119 |
| Dengue Virus Serotype 1: Pre-injection 1 |
5.38
|
5.13
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
10.3
|
8.75
|
| Dengue Virus Serotype 1: Pre-injection 2 |
11.2
|
11.5
|
| Dengue Virus Serotype 1: 28 days Post-injection 2 |
18.9
|
14.9
|
| Dengue Virus Serotype 2: Pre-injection 1 |
5.19
|
5.22
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
30.9
|
24.2
|
| Dengue Virus Serotype 2: Pre-injection 2 |
38.4
|
40.0
|
| Dengue Virus Serotype 2: 28 days Post-injection 2 |
64.1
|
66.9
|
| Dengue Virus Serotype 3: Pre-injection 1 |
5.32
|
5.28
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
32.5
|
31.0
|
| Dengue Virus Serotype 3: Pre-injection 2 |
26.2
|
34.5
|
| Dengue Virus Serotype 3: 28 days Post-injection 2 |
47.9
|
62.0
|
| Dengue Virus Serotype 4: Pre-injection 1 |
5.78
|
5.11
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
121
|
126
|
| Dengue Virus Serotype 4: Pre-injection 2 |
60.2
|
89.8
|
| Dengue Virus Serotype 4: 28 days Post-injection 2 |
104
|
111
|
| Title | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 |
|---|---|
| Description | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). |
| Time Frame | Pre-injection 1 and 2 and 28 days post-injection 1 and 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full 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 Group 3 and 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| Measure Participants | 117 | 119 |
| Dengue Virus Serotype 1: Pre-injection 1 |
1.7
1.4%
|
2.5
2.1%
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
34.2
28.5%
|
24.6
20.5%
|
| Dengue Virus Serotype 1: Pre-injection 2 |
35.5
29.6%
|
35.6
29.7%
|
| Dengue Virus Serotype 1: 28 days Post-injection 2 |
58.4
48.7%
|
52.6
43.8%
|
| Dengue Virus Serotype 2: Pre-injection 1 |
0.9
0.8%
|
2.5
2.1%
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
65.0
54.2%
|
56.3
46.9%
|
| Dengue Virus Serotype 2: Pre-injection 2 |
61.3
51.1%
|
68.6
57.2%
|
| Dengue Virus Serotype 2: 28 days Post-injection 2 |
86.1
71.8%
|
87.9
73.3%
|
| Dengue Virus Serotype 3: Pre-injection 1 |
2.6
2.2%
|
4.2
3.5%
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
63.2
52.7%
|
64.1
53.4%
|
| Dengue Virus Serotype 3: Pre-injection 2 |
61.7
51.4%
|
66.1
55.1%
|
| Dengue Virus Serotype 3: 28 days Post-injection 2 |
80.2
66.8%
|
84.5
70.4%
|
| Dengue Virus Serotype 4: Pre-injection 1 |
6.8
5.7%
|
0.8
0.7%
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
67.8
56.5%
|
67.5
56.3%
|
| Dengue Virus Serotype 4: Pre-injection 2 |
71.7
59.8%
|
67.5
56.3%
|
| Dengue Virus Serotype 4: 28 days Post-injection 2 |
84.2
70.2%
|
80.5
67.1%
|
| Title | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3 |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution). |
| Time Frame | Pre-injection 1 and 28 days post-injection 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, "Overall number of participants analyzed = participants evaluable for this outcome measure" and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4. |
| Arm/Group Title | CYD Dengue Vaccine Group 1 and 2: Pooled | CYD Dengue and Yellow Fever Vaccine: Group 3 |
|---|---|---|
| Arm/Group Description | All Participants who received 3 doses of CYD dengue vaccine in Group 1 and 2. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Measure Participants | 116 | 108 |
| Dengue Virus Serotype 1: Pre-injection 1 |
5.19
|
5.00
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
8.71
|
7.68
|
| Dengue Virus Serotype 2: Pre-injection 1 |
5.06
|
5.06
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
18.8
|
10.8
|
| Dengue Virus Serotype 3: Pre-injection 1 |
5.21
|
5.28
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
28.5
|
8.88
|
| Dengue Virus Serotype 4: Pre-injection 1 |
5.43
|
5.26
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
229
|
22.6
|
| Title | Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3 |
|---|---|
| Description | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution). |
| Time Frame | Pre-injection 1 and 28 days post-injection 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, "Overall number of participants analyzed = participants evaluable for this outcome measure" and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4. |
| Arm/Group Title | CYD Dengue Vaccine Group 1 and Group 2: Pooled | CYD Dengue and Yellow Fever Vaccine: Group 3 |
|---|---|---|
| Arm/Group Description | All participants who received 3 doses of CYD dengue vaccine in Group 1 and Group 2. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Measure Participants | 116 | 108 |
| Dengue Virus Serotype 1: Pre-injection 1 |
1.7
1.4%
|
0.0
0%
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
23.3
19.4%
|
20.4
17%
|
| Dengue Virus Serotype 2: Pre-injection 1 |
0.9
0.8%
|
0.9
0.8%
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
46.6
38.8%
|
35.2
29.3%
|
| Dengue Virus Serotype 3: Pre-injection 1 |
2.6
2.2%
|
2.8
2.3%
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
57.9
48.3%
|
25.0
20.8%
|
| Dengue Virus Serotype 4: Pre-injection 1 |
3.4
2.8%
|
1.9
1.6%
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
74.6
62.2%
|
48.6
40.5%
|
| Title | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result). |
| Time Frame | Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 |
|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Measure Participants | 63 | 65 | 11 |
| Dengue Virus Serotype 1: Pre-injection 1 |
5.73
|
5.23
|
14.3
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
13.9
|
9.25
|
27.2
|
| Dengue Virus Serotype 1: Pre-injection 2 |
18.0
|
12.8
|
36.1
|
| Dengue Virus Serotype 1: 28 days Post-injection 2 |
25.0
|
16.7
|
31.4
|
| Dengue Virus Serotype 1: Pre-injection 3 |
12.7
|
10.6
|
36.3
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
15.6
|
17.2
|
79.0
|
| Dengue Virus Serotype 2: Pre-injection 1 |
5.35
|
5.42
|
13.5
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
48.1
|
34.4
|
66.3
|
| Dengue Virus Serotype 2: Pre-injection 2 |
72.3
|
45.0
|
70.2
|
| Dengue Virus Serotype 2: 28 days Post-injection 2 |
83.7
|
74.6
|
122
|
| Dengue Virus Serotype 2: Pre-injection 3 |
43.0
|
62.3
|
63.6
|
| Dengue Virus Serotype 2: 28 days Post-injection 3 |
60.0
|
68.1
|
133
|
| Dengue Virus Serotype 3: Pre-injection 1 |
5.61
|
5.53
|
21.5
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
45.1
|
31.2
|
98.0
|
| Dengue Virus Serotype 3: Pre-injection 2 |
47.8
|
41.1
|
105
|
| Dengue Virus Serotype 3: 28 days Post-injection 2 |
72.5
|
69.6
|
158
|
| Dengue Virus Serotype 3: Pre-injection 3 |
29.9
|
48.3
|
106
|
| Dengue Virus Serotype 3: 28 days Post-injection 3 |
44.8
|
71.2
|
130
|
| Dengue Virus Serotype 4: Pre-injection 1 |
6.55
|
5.20
|
15.6
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
78.2
|
77.9
|
215
|
| Dengue Virus Serotype 4: Pre-injection 2 |
65.9
|
65.0
|
235
|
| Dengue Virus Serotype 4: 28 days Post-injection 2 |
89.6
|
88.8
|
223
|
| Dengue Virus Serotype 4: Pre-injection 3 |
40.0
|
68.3
|
146
|
| Dengue Virus Serotype 4: 28 days Post-injection 3 |
51.7
|
78.5
|
182
|
| Title | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result). |
| Time Frame | Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 |
|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Measure Participants | 54 | 54 | 103 |
| Dengue Virus Serotype 1: Pre-injection 1 |
5.00
|
5.00
|
5.00
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
7.31
|
8.18
|
7.50
|
| Dengue Virus Serotype 1: Pre-injection 2 |
6.73
|
10.1
|
7.76
|
| Dengue Virus Serotype 1: 28 days Post-injection 2 |
13.9
|
13.0
|
10.9
|
| Dengue Virus Serotype 1: Pre-injection 3 |
6.71
|
8.97
|
10.8
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
13.9
|
14.4
|
18.5
|
| Dengue Virus Serotype 2: Pre-injection 1 |
5.00
|
5.00
|
5.00
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
18.5
|
15.8
|
10.3
|
| Dengue Virus Serotype 2: Pre-injection 2 |
18.9
|
34.6
|
11.6
|
| Dengue Virus Serotype 2: 28 days Post-injection 2 |
47.8
|
58.8
|
30.8
|
| Dengue Virus Serotype 2: Pre-injection 3 |
18.2
|
32.4
|
23.1
|
| Dengue Virus Serotype 2: 28 days Post-injection 3 |
42.1
|
51.4
|
46.4
|
| Dengue Virus Serotype 3: Pre-injection 1 |
5.00
|
5.00
|
5.00
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
22.2
|
30.7
|
8.00
|
| Dengue Virus Serotype 3: Pre-injection 2 |
13.5
|
27.8
|
9.06
|
| Dengue Virus Serotype 3: 28 days Post-injection 2 |
30.3
|
54.1
|
18.5
|
| Dengue Virus Serotype 3: Pre-injection 3 |
19.8
|
27.2
|
17.5
|
| Dengue Virus Serotype 3: 28 days Post-injection 3 |
46.9
|
47.3
|
30.2
|
| Dengue Virus Serotype 4: Pre-injection 1 |
5.00
|
5.00
|
5.00
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
197
|
229
|
20.5
|
| Dengue Virus Serotype 4: Pre-injection 2 |
54.4
|
135
|
18.2
|
| Dengue Virus Serotype 4: 28 days Post-injection 2 |
122
|
145
|
42.8
|
| Dengue Virus Serotype 4: Pre-injection 3 |
62.8
|
82.9
|
47.8
|
| Dengue Virus Serotype 4: 28 days Post-injection 3 |
91.8
|
89.2
|
71.2
|
| Title | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) |
|---|---|
| Description | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result). |
| Time Frame | Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 |
|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Measure Participants | 63 | 65 | 11 |
| Dengue Virus Serotype 1: Pre-injection 1 |
3.2
2.7%
|
4.6
3.8%
|
18.2
15.2%
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
47.6
39.7%
|
26.6
22.2%
|
45.5
37.9%
|
| Dengue Virus Serotype 1: Pre-injection 2 |
51.8
43.2%
|
38.5
32.1%
|
54.5
45.4%
|
| Dengue Virus Serotype 1: 28 days Post-injection 2 |
67.9
56.6%
|
61.9
51.6%
|
70.0
58.3%
|
| Dengue Virus Serotype 1: Pre-injection 3 |
45.1
37.6%
|
36.2
30.2%
|
55.6
46.3%
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
54.9
45.8%
|
61.0
50.8%
|
88.9
74.1%
|
| Dengue Virus Serotype 2: Pre-injection 1 |
1.6
1.3%
|
4.6
3.8%
|
27.3
22.8%
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
79.4
66.2%
|
69.2
57.7%
|
81.8
68.2%
|
| Dengue Virus Serotype 2: Pre-injection 2 |
75.0
62.5%
|
75.4
62.8%
|
72.7
60.6%
|
| Dengue Virus Serotype 2: 28 days Post-injection 2 |
88.7
73.9%
|
95.2
79.3%
|
100.0
83.3%
|
| Dengue Virus Serotype 2: Pre-injection 3 |
70.6
58.8%
|
86.7
72.3%
|
88.9
74.1%
|
| Dengue Virus Serotype 2: 28 days Post-injection 3 |
84.6
70.5%
|
94.9
79.1%
|
100.0
83.3%
|
| Dengue Virus Serotype 3: Pre-injection 1 |
4.8
4%
|
7.7
6.4%
|
54.5
45.4%
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
74.6
62.2%
|
66.2
55.2%
|
100.0
83.3%
|
| Dengue Virus Serotype 3: Pre-injection 2 |
80.4
67%
|
70.8
59%
|
81.8
68.2%
|
| Dengue Virus Serotype 3: 28 days Post-injection 2 |
90.6
75.5%
|
92.1
76.8%
|
100.0
83.3%
|
| Dengue Virus Serotype 3: Pre-injection 3 |
74.5
62.1%
|
85.0
70.8%
|
77.8
64.8%
|
| Dengue Virus Serotype 3: 28 days Post-injection 3 |
84.6
70.5%
|
94.9
79.1%
|
88.9
74.1%
|
| Dengue Virus Serotype 4: Pre-injection 1 |
12.7
10.6%
|
1.5
1.3%
|
36.4
30.3%
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
65.6
54.7%
|
61.5
51.3%
|
90.9
75.8%
|
| Dengue Virus Serotype 4: Pre-injection 2 |
76.8
64%
|
63.1
52.6%
|
90.9
75.8%
|
| Dengue Virus Serotype 4: 28 days Post-injection 2 |
81.1
67.6%
|
78.7
65.6%
|
100.0
83.3%
|
| Dengue Virus Serotype 4: Pre-injection 3 |
74.5
62.1%
|
76.7
63.9%
|
88.9
74.1%
|
| Dengue Virus Serotype 4: 28 days Post-injection 3 |
82.7
68.9%
|
88.1
73.4%
|
100.0
83.3%
|
| Title | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) |
|---|---|
| Description | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result). |
| Time Frame | Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full Analysis Set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 |
|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Measure Participants | 54 | 54 | 103 |
| Dengue Virus Serotype 1: Pre-injection 1 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Dengue Virus Serotype 1: 28 days Post-injection 1 |
18.5
15.4%
|
22.2
18.5%
|
19.4
16.2%
|
| Dengue Virus Serotype 1: Pre-injection 2 |
17.6
14.7%
|
32.1
26.8%
|
22.0
18.3%
|
| Dengue Virus Serotype 1: 28 days Post-injection 2 |
47.9
39.9%
|
41.5
34.6%
|
36.7
30.6%
|
| Dengue Virus Serotype 1: Pre-injection 3 |
19.1
15.9%
|
28.0
23.3%
|
39.3
32.8%
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
50.0
41.7%
|
51.0
42.5%
|
59.5
49.6%
|
| Dengue Virus Serotype 2: Pre-injection 1 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Dengue Virus Serotype 2: 28 days Post-injection 1 |
48.1
40.1%
|
40.7
33.9%
|
33.0
27.5%
|
| Dengue Virus Serotype 2: Pre-injection 2 |
46.0
38.3%
|
60.4
50.3%
|
33.0
27.5%
|
| Dengue Virus Serotype 2: 28 days Post-injection 2 |
83.3
69.4%
|
79.2
66%
|
68.9
57.4%
|
| Dengue Virus Serotype 2: Pre-injection 3 |
55.3
46.1%
|
72.5
60.4%
|
57.0
47.5%
|
| Dengue Virus Serotype 2: 28 days Post-injection 3 |
83.3
69.4%
|
79.6
66.3%
|
83.3
69.4%
|
| Dengue Virus Serotype 3: Pre-injection 1 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Dengue Virus Serotype 3: 28 days Post-injection 1 |
50.0
41.7%
|
61.5
51.3%
|
21.4
17.8%
|
| Dengue Virus Serotype 3: Pre-injection 2 |
41.2
34.3%
|
60.4
50.3%
|
26.0
21.7%
|
| Dengue Virus Serotype 3: 28 days Post-injection 2 |
68.8
57.3%
|
75.5
62.9%
|
52.2
43.5%
|
| Dengue Virus Serotype 3: Pre-injection 3 |
63.8
53.2%
|
68.0
56.7%
|
50.0
41.7%
|
| Dengue Virus Serotype 3: 28 days Post-injection 3 |
85.7
71.4%
|
85.4
71.2%
|
73.5
61.3%
|
| Dengue Virus Serotype 4: Pre-injection 1 |
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Dengue Virus Serotype 4: 28 days Post-injection 1 |
70.4
58.7%
|
75.0
62.5%
|
46.1
38.4%
|
| Dengue Virus Serotype 4: Pre-injection 2 |
66.0
55%
|
73.1
60.9%
|
41.0
34.2%
|
| Dengue Virus Serotype 4: 28 days Post-injection 2 |
87.5
72.9%
|
82.7
68.9%
|
67.8
56.5%
|
| Dengue Virus Serotype 4: Pre-injection 3 |
80.9
67.4%
|
79.6
66.3%
|
77.6
64.7%
|
| Dengue Virus Serotype 4: 28 days Post-injection 3 |
95.2
79.3%
|
83.3
69.4%
|
84.3
70.3%
|
| Title | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine |
|---|---|
| Description | Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm. |
| Time Frame | Within 7 days after any injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety Analysis set which included participants who received at least one injection of CYD dengue vaccine or YF vaccine. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine ; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. | Participants received single dose of YF vaccine at Day 0. |
| Measure Participants | 118 | 119 | 115 | 27 |
| Any Injection site Pain: CYD Dengue Vaccine |
44
36.7%
|
59
49.2%
|
51
42.5%
|
NA
NaN
|
| Grade 3 Pain: CYD Dengue Vaccine |
0
0%
|
3
2.5%
|
1
0.8%
|
NA
NaN
|
| Any Injection site Pain: Yellow Fever Vaccine |
NA
NaN
|
NA
NaN
|
53
44.2%
|
10
33.3%
|
| Grade 3 Pain: Yellow Fever Vaccine |
NA
NaN
|
NA
NaN
|
1
0.8%
|
0
0%
|
| Any Injection site Erythema: CYD Dengue Vaccine |
5
4.2%
|
10
8.3%
|
1
0.8%
|
NA
NaN
|
| Grade 3 Erythema: CYD Dengue Vaccine |
0
0%
|
0
0%
|
0
0%
|
NA
NaN
|
| Any Injection site Erythema: Yellow Fever Vaccine |
NA
NaN
|
NA
NaN
|
5
4.2%
|
0
0%
|
| Grade 3 Erythema: Yellow Fever Vaccine |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Any Injection site Swelling: CYD Dengue Vaccine |
5
4.2%
|
2
1.7%
|
0
0%
|
NA
NaN
|
| Grade 3 Swelling: CYD Dengue Vaccine |
0
0%
|
0
0%
|
0
0%
|
NA
NaN
|
| Any Injection site Swelling: Yellow Fever Vaccine |
NA
NaN
|
NA
NaN
|
2
1.7%
|
0
0%
|
| Grade 3 Swelling: Yellow Fever Vaccine |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Title | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine |
|---|---|
| Description | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity. |
| Time Frame | Within 14 days after any injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine ; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. | Participants received single dose of YF vaccine at Day 0. |
| Measure Participants | 120 | 120 | 119 | 30 |
| Fever: Any Grade |
7
5.8%
|
5
4.2%
|
4
3.3%
|
1
3.3%
|
| Fever: Grade 3 |
1
0.8%
|
1
0.8%
|
0
0%
|
0
0%
|
| Headache: Any Grade |
59
49.2%
|
60
50%
|
64
53.3%
|
11
36.7%
|
| Headache: Grade 3 |
4
3.3%
|
5
4.2%
|
6
5%
|
1
3.3%
|
| Malaise: Any Grade |
63
52.5%
|
53
44.2%
|
53
44.2%
|
12
40%
|
| Malaise: Grade 3 |
10
8.3%
|
8
6.7%
|
10
8.3%
|
3
10%
|
| Myalgia: Any Grade |
51
42.5%
|
47
39.2%
|
54
45%
|
8
26.7%
|
| Myalgia: Grade 3 |
6
5%
|
3
2.5%
|
9
7.5%
|
2
6.7%
|
| Asthenia: Any Grade |
41
34.2%
|
36
30%
|
40
33.3%
|
9
30%
|
| Asthenia: Grade 3 |
6
5%
|
5
4.2%
|
6
5%
|
2
6.7%
|
Adverse Events
| Time Frame | Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection). | |||||||
|---|---|---|---|---|---|---|---|---|
| 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: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 | ||||
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. | Participants received single dose of YF vaccine at Day 0. | ||||
All Cause Mortality |
||||||||
| CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/120 (0%) | 0/120 (0%) | 0/119 (0%) | 0/30 (0%) | ||||
Serious Adverse Events |
||||||||
| CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/120 (3.3%) | 4/120 (3.3%) | 5/119 (4.2%) | 0/30 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholecystitis Acute | 1/120 (0.8%) | 1 | 0/120 (0%) | 0 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Infections and infestations | ||||||||
| Abdominal Abscess | 0/120 (0%) | 0 | 1/120 (0.8%) | 1 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Appendicitis | 1/120 (0.8%) | 1 | 0/120 (0%) | 0 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Diverticulitis | 1/120 (0.8%) | 1 | 0/120 (0%) | 0 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Pneumonia | 1/120 (0.8%) | 1 | 0/120 (0%) | 0 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Femur Fracture | 0/120 (0%) | 0 | 0/120 (0%) | 0 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
| Rib Fracture | 0/120 (0%) | 0 | 0/120 (0%) | 0 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
| Toxicity To Various Agents | 0/120 (0%) | 0 | 0/120 (0%) | 0 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Basal Cell Carcinoma | 0/120 (0%) | 0 | 1/120 (0.8%) | 1 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Breast Cancer | 0/120 (0%) | 0 | 0/120 (0%) | 0 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
| Squamous Cell Carcinoma | 0/120 (0%) | 0 | 1/120 (0.8%) | 1 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Vaginal Cancer | 1/120 (0.8%) | 1 | 0/120 (0%) | 0 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Blighted Ovum | 1/120 (0.8%) | 1 | 0/120 (0%) | 0 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Suicidal Ideation | 0/120 (0%) | 0 | 1/120 (0.8%) | 1 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/120 (0%) | 0 | 1/120 (0.8%) | 1 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Atelectasis | 0/120 (0%) | 0 | 1/120 (0.8%) | 1 | 0/119 (0%) | 0 | 0/30 (0%) | 0 |
| Pneumothorax | 0/120 (0%) | 0 | 0/120 (0%) | 0 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
| Vascular disorders | ||||||||
| Thrombosis | 0/120 (0%) | 0 | 0/120 (0%) | 0 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Yellow Fever Vaccine: Group 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 91/120 (75.8%) | 92/120 (76.7%) | 92/119 (77.3%) | 17/30 (56.7%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 4/120 (3.3%) | 5 | 7/120 (5.8%) | 7 | 1/119 (0.8%) | 1 | 0/30 (0%) | 0 |
| General disorders | ||||||||
| Asthenia | 41/120 (34.2%) | 57 | 36/120 (30%) | 61 | 40/119 (33.6%) | 57 | 9/30 (30%) | 9 |
| Fatigue | 1/120 (0.8%) | 1 | 4/120 (3.3%) | 4 | 1/119 (0.8%) | 1 | 2/30 (6.7%) | 2 |
| Injection Site Erythema | 5/120 (4.2%) | 5 | 10/120 (8.3%) | 11 | 5/119 (4.2%) | 6 | 0/30 (0%) | 0 |
| Injection Site Pain | 44/120 (36.7%) | 71 | 59/120 (49.2%) | 97 | 63/119 (52.9%) | 138 | 10/30 (33.3%) | 10 |
| Malaise | 63/120 (52.5%) | 92 | 53/120 (44.2%) | 93 | 53/119 (44.5%) | 77 | 12/30 (40%) | 12 |
| Pyrexia | 7/120 (5.8%) | 7 | 6/120 (5%) | 6 | 5/119 (4.2%) | 5 | 1/30 (3.3%) | 1 |
| Infections and infestations | ||||||||
| Nasopharyngitis | 5/120 (4.2%) | 6 | 7/120 (5.8%) | 8 | 2/119 (1.7%) | 2 | 0/30 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Myalgia | 51/120 (42.5%) | 75 | 47/120 (39.2%) | 78 | 54/119 (45.4%) | 91 | 8/30 (26.7%) | 8 |
| Nervous system disorders | ||||||||
| Headache | 60/120 (50%) | 90 | 61/120 (50.8%) | 110 | 64/119 (53.8%) | 110 | 11/30 (36.7%) | 11 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 2/120 (1.7%) | 2 | 4/120 (3.3%) | 4 | 7/119 (5.9%) | 7 | 0/30 (0%) | 0 |
| Oropharyngeal Pain | 5/120 (4.2%) | 5 | 7/120 (5.8%) | 7 | 4/119 (3.4%) | 4 | 0/30 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject 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 | |
| Contact-US@sanofi.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01488890
Other Study ID Numbers:
- CYD51
- U1111-1122-1892
First Posted:
Dec 8, 2011
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022