Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01943825
Collaborator
United States Department of Defense (U.S. Fed)
90
1
4
24.6
3.7
Study Details
Study Description
Brief Summary
The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese encephalitis (JE) vaccine.
Primary Objectives:
-
To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.
-
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine had been previously administered.
Secondary Objectives:
-
To describe the safety profile after each injection of CYD dengue vaccine.
-
To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine in Groups 3 and 4.
-
To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months post-dose 3 in Groups 1 and 3 with the compressed schedule.
-
To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD vaccine dose administered in Groups 1-4.
-
To describe the JE humoral immune response at baseline and 28 days after each injection of CYD dengue vaccine in Groups 3 and 4.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Study participants were randomly assigned to one of the four groups to receive assigned study vaccine and were evaluated for neutralizing antibody titers; markers of cell-mediated immunity.
Study Design
Study Type:
Interventional
Actual Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Exploration of Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity Following Various Administration Schedules With CYD Tetravalent Dengue Vaccine
Actual Study Start Date
:
Nov 5, 2013
Actual Primary Completion Date
:
Nov 25, 2015
Actual Study Completion Date
:
Nov 25, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CYD Dengue Vaccine: Group 1 Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. |
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous
|
| Experimental: CYD Dengue Vaccine: Group 2 Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. |
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous
|
| Experimental: CYD Dengue and JE Vaccine: Group 3 Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. |
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous
Biological: Japanese Encephalitis Vaccine
0.5 mL, Intramuscular
Other Names:
|
| Experimental: CYD Dengue and JE Vaccine: Group 4 Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous
Biological: Japanese Encephalitis Vaccine
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains [Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3]
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
- Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains [Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3]
Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Secondary Outcome Measures
- Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 [Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3]
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution).
- Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains [6 months and 12 months post-injection 3]
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
- Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia [3, 5, 7 and 14 days post-injection 1, 2 and 3]
Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine.
- Number of Participants With Detectable Serotype-Specific Vaccine Viremia [3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3]
Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes.
- Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 [Pre-injection 1, and 28 days post-injection 1, 2 and 3]
GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution).
- Number of Participants With Solicited Injection Site Reactions [Within 7 days after any CYD dengue vaccine and/or JE vaccine]
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling.
- Number of Participants With Solicited Systemic Reactions [Within 14 days after any CYD dengue vaccine and/or JE vaccine]
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Aged greater than or equal to (>=)18 to less than or equal 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.
-
Participant was in good health, based on medical history and physical examination.
Exclusion Criteria:
-
Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female had to be post- menopausal for at least 1 year, surgically sterile, or used 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 or planned receipt of any vaccine, outside the study protocol in the 4 weeks preceded or followed trial vaccinations. (If influenza activity warranted vaccination of healthy young adults, influenza vaccination was encouraged and did not lead to study exclusion).
-
Any history of FV vaccination, or planned FV vaccination during the trial period.
-
Previous residence (greater than [>]12 months) in, or travel in the last 30 days to dengue endemic regions.
-
Receipt of immune globulins, blood or blood-derived products in the 3 months prior to first vaccination or planned use during the study period.
-
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceded 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 (including protamine sulfate), 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.
-
Excessive alcohol consumption or drug addiction.
-
Chronic illness that, in the opinion of the Investigator, was 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.
-
Temporary Exclusion Criteria: Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>= 100.4 degree fahrenheit]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided. If the delay for the febrile illness exceeded the window between screening and vaccination, or if deemed necessary by the Investigator, a prospective participant might be re-screened once the fever had resolved.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Syracuse | New York | United States | 13210 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
- United States Department of Defense
Investigators
- Study Director: Medical Director, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01943825
Other Study ID Numbers:
- CYD56
- U1111-1143-8391
First Posted:
Sep 17, 2013
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were involved in the study from 05 November 2013 to 25 November 2015 in the United States. |
|---|---|
| Pre-assignment Detail | A total of 90 participants were enrolled and randomized in the study. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and Japanese Encephalitis (JE) Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Period Title: Overall Study | ||||
| STARTED | 25 | 15 | 25 | 25 |
| COMPLETED | 15 | 11 | 10 | 14 |
| NOT COMPLETED | 10 | 4 | 15 | 11 |
Baseline Characteristics
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. | Total of all reporting groups |
| Overall Participants | 25 | 15 | 25 | 25 | 90 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
31.0
(6.7)
|
26.8
(5.6)
|
28.5
(6.5)
|
30.4
(6.2)
|
29.4
(6.4)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
12
48%
|
6
40%
|
7
28%
|
12
48%
|
37
41.1%
|
| Male |
13
52%
|
9
60%
|
18
72%
|
13
52%
|
53
58.9%
|
Outcome Measures
| Title | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution). |
| Time Frame | Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on full analysis set which included participants who received at least one injection of CYD dengue vaccine or JE vaccine and had at least one blood sample drawn and valid post-injection serology result. 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 JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 15 | 25 | 25 |
| Serotype 1: Pre-injection 1 |
NA
|
NA
|
NA
|
NA
|
| Serotype 1: 28 days Post-injection 1 |
6.1
|
5.5
|
6.8
|
7.4
|
| Serotype 1: Pre-injection 2 |
6.5
|
5.4
|
6.7
|
7.2
|
| Serotype 1: 28 days Post-injection 2 |
8.5
|
6.2
|
10.8
|
10.8
|
| Serotype 1: Pre-injection 3 |
7.1
|
6.3
|
8.3
|
6.5
|
| Serotype 1: 28 days Post-injection 3 |
9.1
|
9.9
|
12.0
|
12.9
|
| Serotype 1: 6 months Post-injection 3 |
5.8
|
6.6
|
8.6
|
7.3
|
| Serotype 2: Pre-injection 1 |
NA
|
NA
|
NA
|
NA
|
| Serotype 2: 28 days Post-injection 1 |
9.2
|
7.4
|
8.8
|
35.5
|
| Serotype 2: Pre-injection 2 |
12.1
|
9.6
|
8.8
|
44.5
|
| Serotype 2: 28 days Post-injection 2 |
19.0
|
10.7
|
17.3
|
61.5
|
| Serotype 2: Pre-injection 3 |
13.3
|
9.8
|
12.2
|
37.4
|
| Serotype 2: 28 days Post-injection 3 |
32.5
|
25.5
|
19.3
|
48.2
|
| Serotype 2: 6 months Post-injection 3 |
13.9
|
7.9
|
10.9
|
21.0
|
| Serotype 3: Pre-injection 1 |
NA
|
NA
|
5.2
|
NA
|
| Serotype 3: 28 days Post-injection 1 |
22.1
|
24.9
|
19.7
|
49.3
|
| Serotype 3: Pre-injection 2 |
24.5
|
15.4
|
23.8
|
49.0
|
| Serotype 3: 28 days Post-injection 2 |
31.0
|
40.8
|
28.5
|
68.8
|
| Serotype 3: Pre-injection 3 |
22.9
|
31.7
|
20.5
|
35.6
|
| Serotype 3: 28 days Post-injection 3 |
45.5
|
79.9
|
32.2
|
61.8
|
| Serotype 3: 6 months Post-injection 3 |
19.3
|
33.9
|
19.3
|
24.8
|
| Serotype 4: Pre-injection 1 |
NA
|
NA
|
NA
|
NA
|
| Serotype 4: 28 days Post-injection 1 |
425.8
|
669.7
|
177.6
|
325.4
|
| Serotype 4: Pre-injection 2 |
296.2
|
100.3
|
89.9
|
300.9
|
| Serotype 4: 28 days Post-injection 2 |
166.6
|
147.1
|
68.0
|
211.3
|
| Serotype 4: Pre-injection 3 |
108.9
|
89.8
|
47.7
|
139.5
|
| Serotype 4: 28 days Post-injection 3 |
120.4
|
124.5
|
55.4
|
152.5
|
| Serotype 4: 6 months Post-injection 3 |
105.3
|
106.7
|
43.8
|
92.6
|
| Title | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains |
|---|---|
| Description | Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. |
| Time Frame | Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; 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. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccines at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 15 | 25 | 25 |
| Serotype 1: Pre-injection 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 1: 28 days Post-injection 1 |
3
12%
|
1
6.7%
|
3
12%
|
6
24%
|
| Serotype 1: Pre-injection 2 |
3
12%
|
1
6.7%
|
2
8%
|
4
16%
|
| Serotype 1: 28 days Post-injection 2 |
6
24%
|
2
13.3%
|
5
20%
|
8
32%
|
| Serotype 1: Pre-injection 3 |
3
12%
|
2
13.3%
|
3
12%
|
3
12%
|
| Serotype 1: 28 days Post-injection 3 |
5
20%
|
6
40%
|
5
20%
|
9
36%
|
| Serotype 1: 6 months Post-injection 3 |
2
8%
|
2
13.3%
|
2
8%
|
4
16%
|
| Serotype 2: Pre-injection 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 2: 28 days Post-injection 1 |
5
20%
|
2
13.3%
|
4
16%
|
16
64%
|
| Serotype 2: Pre-injection 2 |
5
20%
|
7
46.7%
|
4
16%
|
15
60%
|
| Serotype 2: 28 days Post-injection 2 |
9
36%
|
5
33.3%
|
7
28%
|
16
64%
|
| Serotype 2: Pre-injection 3 |
8
32%
|
4
26.7%
|
7
28%
|
13
52%
|
| Serotype 2: 28 days Post-injection 3 |
12
48%
|
9
60%
|
9
36%
|
15
60%
|
| Serotype 2: 6 months Post-injection 3 |
7
28%
|
3
20%
|
4
16%
|
9
36%
|
| Serotype 3: Pre-injection 1 |
0
0%
|
0
0%
|
1
4%
|
0
0%
|
| Serotype 3: 28 days Post-injection 1 |
15
60%
|
7
46.7%
|
10
40%
|
16
64%
|
| Serotype 3: Pre-injection 2 |
11
44%
|
7
46.7%
|
10
40%
|
14
56%
|
| Serotype 3: 28 days Post-injection 2 |
12
48%
|
9
60%
|
10
40%
|
16
64%
|
| Serotype 3: Pre-injection 3 |
12
48%
|
10
66.7%
|
9
36%
|
12
48%
|
| Serotype 3: 28 days Post-injection 3 |
14
56%
|
12
80%
|
9
36%
|
16
64%
|
| Serotype 3: 6 months Post-injection 3 |
10
40%
|
9
60%
|
6
24%
|
10
40%
|
| Serotype 4: Pre-injection 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 4: 28 days Post-injection 1 |
21
84%
|
13
86.7%
|
16
64%
|
18
72%
|
| Serotype 4: Pre-injection 2 |
21
84%
|
13
86.7%
|
11
44%
|
18
72%
|
| Serotype 4: 28 days Post-injection 2 |
17
68%
|
13
86.7%
|
11
44%
|
18
72%
|
| Serotype 4: Pre-injection 3 |
17
68%
|
12
80%
|
11
44%
|
16
64%
|
| Serotype 4: 28 days Post-injection 3 |
16
64%
|
12
80%
|
11
44%
|
16
64%
|
| Serotype 4: 6 months Post-injection 3 |
15
60%
|
11
73.3%
|
7
28%
|
14
56%
|
| Title | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution). |
| 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, 'Number analyzed' = participants with available data for each specified category. |
| Arm/Group Title | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 25 |
| Serotype 1: Pre-injection 1 |
NA
|
NA
|
| Serotype 1: 28 days Post-injection 1 |
6.8
|
7.4
|
| Serotype 1: Pre-injection 2 |
6.7
|
7.2
|
| Serotype 1: 28 days Post-injection 2 |
10.8
|
10.8
|
| Serotype 1: Pre-injection 3 |
8.3
|
6.5
|
| Serotype 1: 28 days Post-injection 3 |
12.0
|
12.9
|
| Serotype 2: Pre-injection 1 |
NA
|
NA
|
| Serotype 2: 28 days Post-injection 1 |
8.8
|
35.5
|
| Serotype 2: Pre-injection 2 |
8.8
|
44.5
|
| Serotype 2: 28 days Post-injection 2 |
17.3
|
61.5
|
| Serotype 2: Pre-injection 3 |
12.2
|
37.4
|
| Serotype 2: 28 days Post-injection 3 |
19.3
|
48.2
|
| Serotype 3: Pre-injection 1 |
5.2
|
NA
|
| Serotype 3: 28 days Post-injection 1 |
19.7
|
49.3
|
| Serotype 3: Pre-injection 2 |
23.8
|
49.0
|
| Serotype 3: 28 days Post-injection 2 |
28.5
|
68.8
|
| Serotype 3: Pre-injection 3 |
20.5
|
35.6
|
| Serotype 3: 28 days Post-injection 3 |
32.2
|
61.8
|
| Serotype 4: Pre-injection 1 |
NA
|
NA
|
| Serotype 4: 28 days Post-injection 1 |
177.6
|
325.4
|
| Serotype 4: Pre-injection 2 |
89.9
|
300.9
|
| Serotype 4: 28 days Post-injection 2 |
68.0
|
211.3
|
| Serotype 4: Pre-injection 3 |
47.7
|
139.5
|
| Serotype 4: 28 days Post-injection 3 |
55.4
|
152.5
|
| Title | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains |
|---|---|
| Description | GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. |
| Time Frame | 6 months and 12 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 was not planned to be collected and analyzed for Groups 2 and 4 for 12 months post-injection 3 time point. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 15 | 25 | 25 |
| Serotype 1: 6 months Post-injection 3 |
5.8
|
6.6
|
8.6
|
7.3
|
| Serotype 2: 6 months Post-injection 3 |
13.9
|
7.9
|
10.9
|
21.0
|
| Serotype 3: 6 months Post-injection 3 |
19.3
|
33.9
|
19.3
|
24.8
|
| Serotype 4: 6 months Post-injection 3 |
105.3
|
106.7
|
43.8
|
92.6
|
| Serotype 1: 12 months Post-injection 3 |
5.3
|
7.8
|
||
| Serotype 2: 12 months Post-injection 3 |
11.5
|
7.6
|
||
| Serotype 3: 12 months Post-injection 3 |
18.3
|
16.2
|
||
| Serotype 4: 12 months Post-injection 3 |
144.8
|
23.9
|
| Title | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia |
|---|---|
| Description | Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine. |
| Time Frame | 3, 5, 7 and 14 days post-injection 1, 2 and 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. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 15 | 25 | 25 |
| 3 days Post-Injection 1 |
0
0%
|
0
0%
|
0
0%
|
1
4%
|
| 5 days Post-Injection 1 |
7
28%
|
5
33.3%
|
1
4%
|
3
12%
|
| 7 days Post-Injection 1 |
16
64%
|
9
60%
|
8
32%
|
9
36%
|
| 14 days Post-Injection 1 |
12
48%
|
4
26.7%
|
3
12%
|
6
24%
|
| 3 days Post-Injection 2 |
0
0%
|
0
0%
|
0
0%
|
1
4%
|
| 5 days Post-Injection 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 7 days Post-Injection 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 14 days Post-Injection 2 |
1
4%
|
1
6.7%
|
0
0%
|
0
0%
|
| 3 days Post-Injection 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 5 days Post-Injection 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 7 days Post-Injection 3 |
1
4%
|
0
0%
|
0
0%
|
0
0%
|
| 14 days Post-Injection 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Detectable Serotype-Specific Vaccine Viremia |
|---|---|
| Description | Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes. |
| Time Frame | 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days 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. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 15 | 25 | 25 |
| Serotype 1: 3 days Post-Injection 1 |
0
0%
|
|||
| Serotype 1: 5 days Post-Injection 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 1: 7 days Post-Injection 1 |
0
0%
|
1
6.7%
|
0
0%
|
0
0%
|
| Serotype 1: 14 days Post-Injection 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 1: 3 days Post-Injection 2 |
0
0%
|
|||
| Serotype 1: 14 days Post-Injection 2 |
0
0%
|
0
0%
|
||
| Serotype 1: 7 days Post-Injection 3 |
0
0%
|
|||
| Serotype 2: 3 days Post-Injection 1 |
0
0%
|
|||
| Serotype 2: 5 days Post-Injection 1 |
2
8%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 2: 7 days Post-Injection 1 |
2
8%
|
1
6.7%
|
1
4%
|
0
0%
|
| Serotype 2: 14 days Post-Injection 1 |
1
4%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 2: 3 days Post-Injection 2 |
0
0%
|
|||
| Serotype 2: 14 days Post-Injection 2 |
0
0%
|
0
0%
|
||
| Serotype 2: 7 days Post-Injection 3 |
0
0%
|
|||
| Serotype 3: 3 days Post-Injection 1 |
0
0%
|
|||
| Serotype 3: 5 days Post-Injection 1 |
1
4%
|
0
0%
|
0
0%
|
0
0%
|
| Serotype 3: 7 days Post-Injection 1 |
5
20%
|
2
13.3%
|
1
4%
|
4
16%
|
| Serotype 3: 14 days Post-Injection 1 |
1
4%
|
1
6.7%
|
0
0%
|
1
4%
|
| Serotype 3: 3 days Post-Injection 2 |
0
0%
|
|||
| Serotype 3: 14 days Post-Injection 2 |
0
0%
|
0
0%
|
||
| Serotype 3: 7 days Post-Injection 3 |
1
4%
|
|||
| Serotype 4: 3 days Post-Injection 1 |
0
0%
|
|||
| Serotype 4: 5 days Post-Injection 1 |
6
24%
|
3
20%
|
1
4%
|
2
8%
|
| Serotype 4: 7 days Post-Injection 1 |
13
52%
|
7
46.7%
|
5
20%
|
7
28%
|
| Serotype 4: 14 days Post-Injection 1 |
8
32%
|
2
13.3%
|
2
8%
|
4
16%
|
| Serotype 4: 3 days Post-Injection 2 |
0
0%
|
|||
| Serotype 4: 14 days Post-Injection 2 |
0
0%
|
0
0%
|
||
| Serotype 4: 7 days Post-Injection 3 |
0
0%
|
| Title | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 |
|---|---|
| Description | GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution). |
| Time Frame | Pre-injection 1, and 28 days post-injection 1, 2 and 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. |
| Arm/Group Title | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 25 | 25 |
| Pre-injection 1 |
NA
|
22.9
|
| 28 days Post-injection 1 |
132.3
|
620.9
|
| 28 days Post-injection 2 |
382.7
|
501.8
|
| 28 days Post-injection 3 |
82.3
|
157.4
|
| Title | Number of Participants With Solicited Injection Site Reactions |
|---|---|
| Description | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling. |
| Time Frame | Within 7 days after any CYD dengue vaccine and/or JE vaccine |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 24 | 15 | 22 | 19 |
| Injection site Pain |
7
28%
|
6
40%
|
3
12%
|
6
24%
|
| Injection site Erythema |
7
28%
|
4
26.7%
|
2
8%
|
2
8%
|
| Injection site Swelling |
3
12%
|
2
13.3%
|
0
0%
|
1
4%
|
| Title | Number of Participants With Solicited Systemic Reactions |
|---|---|
| Description | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia. |
| Time Frame | Within 14 days after any CYD dengue vaccine and/or JE vaccine |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. |
| Arm/Group Title | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccines at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccines at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. |
| Measure Participants | 24 | 15 | 22 | 19 |
| Fever |
2
8%
|
2
13.3%
|
3
12%
|
1
4%
|
| Headache |
10
40%
|
11
73.3%
|
12
48%
|
11
44%
|
| Malaise |
9
36%
|
10
66.7%
|
11
44%
|
6
24%
|
| Myalgia |
8
32%
|
6
40%
|
10
40%
|
7
28%
|
| Asthenia |
6
24%
|
7
46.7%
|
7
28%
|
3
12%
|
Adverse Events
| Time Frame | Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE 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 for Groups 1, 2 and 3 and 19 months for Group 4). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (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 JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 | ||||
| Arm/Group Description | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. | ||||
All Cause Mortality |
||||||||
| CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/15 (0%) | 0/25 (0%) | 0/25 (0%) | ||||
Serious Adverse Events |
||||||||
| CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/25 (12%) | 0/15 (0%) | 0/25 (0%) | 1/25 (4%) | ||||
| Gastrointestinal disorders | ||||||||
| Alcoholic pancreatitis | 1/25 (4%) | 1 | 0/15 (0%) | 0 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Infections and infestations | ||||||||
| Cellulitis | 1/25 (4%) | 1 | 0/15 (0%) | 0 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Jaw fracture | 1/25 (4%) | 1 | 0/15 (0%) | 0 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Drug dependence | 0/25 (0%) | 0 | 0/15 (0%) | 0 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/25 (72%) | 15/15 (100%) | 17/25 (68%) | 20/25 (80%) | ||||
| Gastrointestinal disorders | ||||||||
| Dental caries | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Diarrhoea | 0/25 (0%) | 0 | 0/15 (0%) | 0 | 1/25 (4%) | 1 | 2/25 (8%) | 4 |
| Enteritis | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Nausea | 2/25 (8%) | 2 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
| Vomiting | 3/25 (12%) | 3 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 2/25 (8%) | 2 |
| General disorders | ||||||||
| Asthenia | 6/25 (24%) | 12 | 7/15 (46.7%) | 11 | 7/25 (28%) | 13 | 8/25 (32%) | 14 |
| Fatigue | 0/25 (0%) | 0 | 2/15 (13.3%) | 2 | 1/25 (4%) | 1 | 0/25 (0%) | 0 |
| Injection site erythema | 7/25 (28%) | 11 | 4/15 (26.7%) | 6 | 2/25 (8%) | 2 | 2/25 (8%) | 2 |
| Injection site pain | 7/25 (28%) | 8 | 6/15 (40%) | 8 | 8/25 (32%) | 13 | 13/25 (52%) | 25 |
| Injection site pruritus | 1/25 (4%) | 1 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Injection site swelling | 3/25 (12%) | 3 | 2/15 (13.3%) | 3 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
| Injection site warmth | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Malaise | 9/25 (36%) | 16 | 10/15 (66.7%) | 12 | 11/25 (44%) | 22 | 11/25 (44%) | 23 |
| Pyrexia | 2/25 (8%) | 3 | 2/15 (13.3%) | 2 | 3/25 (12%) | 3 | 2/25 (8%) | 3 |
| Immune system disorders | ||||||||
| Seasonal allergy | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchitis | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Gastroenteritis | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 1/25 (4%) | 1 | 1/25 (4%) | 1 |
| Gastroenteritis viral | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
| Influenza | 0/25 (0%) | 0 | 0/15 (0%) | 0 | 0/25 (0%) | 0 | 2/25 (8%) | 2 |
| Lice infestation | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Nasopharyngitis | 4/25 (16%) | 7 | 2/15 (13.3%) | 3 | 2/25 (8%) | 2 | 6/25 (24%) | 7 |
| Oral infection | 1/25 (4%) | 1 | 0/15 (0%) | 0 | 2/25 (8%) | 2 | 0/25 (0%) | 0 |
| Sinusitis | 2/25 (8%) | 2 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 3/25 (12%) | 3 |
| Trichomoniasis | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Upper respiratory tract infection | 7/25 (28%) | 7 | 7/15 (46.7%) | 7 | 3/25 (12%) | 3 | 7/25 (28%) | 7 |
| Urinary tract infection | 1/25 (4%) | 1 | 3/15 (20%) | 5 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Vaginal infection | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/25 (0%) | 0 | 0/15 (0%) | 0 | 2/25 (8%) | 2 | 1/25 (4%) | 3 |
| Foot fracture | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
| Ligament sprain | 1/25 (4%) | 1 | 1/15 (6.7%) | 1 | 1/25 (4%) | 1 | 0/25 (0%) | 0 |
| Investigations | ||||||||
| Heart rate decreased | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
| Heart rate increased | 3/25 (12%) | 3 | 1/15 (6.7%) | 1 | 1/25 (4%) | 1 | 2/25 (8%) | 2 |
| Hepatic enzyme increased | 0/25 (0%) | 0 | 1/15 (6.7%) | 2 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Vitamin D deficiency | 1/25 (4%) | 1 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 1/25 (4%) | 1 | 1/15 (6.7%) | 1 | 2/25 (8%) | 2 | 3/25 (12%) | 3 |
| Bunion | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Bursitis | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Enostosis | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Myalgia | 9/25 (36%) | 14 | 6/15 (40%) | 11 | 10/25 (40%) | 22 | 10/25 (40%) | 22 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Haemangioma of liver | 1/25 (4%) | 1 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Nervous system disorders | ||||||||
| Disturbance in attention | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Headache | 9/25 (36%) | 27 | 13/15 (86.7%) | 22 | 12/25 (48%) | 37 | 14/25 (56%) | 46 |
| Migraine | 2/25 (8%) | 5 | 0/15 (0%) | 0 | 1/25 (4%) | 1 | 0/25 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Vomiting in pregnancy | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Attention deficit/hyperactivity disorder | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Insomnia | 2/25 (8%) | 3 | 2/15 (13.3%) | 2 | 0/25 (0%) | 0 | 1/25 (4%) | 1 |
| Post-traumatic stress disorder | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Sleep disorder | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Renal cyst | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Breast tenderness | 0/25 (0%) | 0 | 1/15 (6.7%) | 2 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Dysmenorrhoea | 1/25 (4%) | 1 | 2/15 (13.3%) | 2 | 3/25 (12%) | 3 | 3/25 (12%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 2/25 (8%) | 2 | 0/15 (0%) | 0 | 1/25 (4%) | 2 | 0/25 (0%) | 0 |
| Oropharyngeal pain | 2/25 (8%) | 2 | 1/15 (6.7%) | 1 | 2/25 (8%) | 2 | 2/25 (8%) | 2 |
| Pleuritic pain | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Sinus congestion | 0/25 (0%) | 0 | 2/15 (13.3%) | 2 | 2/25 (8%) | 3 | 2/25 (8%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Rash | 0/25 (0%) | 0 | 0/15 (0%) | 0 | 1/25 (4%) | 1 | 2/25 (8%) | 5 |
| Rash papular | 0/25 (0%) | 0 | 1/15 (6.7%) | 2 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 2/25 (8%) | 2 | 0/15 (0%) | 0 | 1/25 (4%) | 1 | 0/25 (0%) | 0 |
| Hypotension | 0/25 (0%) | 0 | 1/15 (6.7%) | 1 | 0/25 (0%) | 0 | 0/25 (0%) | 0 |
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 | Trial Transparency Team |
|---|---|
| Organization | Sanofi Pasteur |
| Phone | 800-633-1610 ext 1# |
| Contact-US@sanofi.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01943825
Other Study ID Numbers:
- CYD56
- U1111-1143-8391
First Posted:
Sep 17, 2013
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022