Dengue VirusPhase 2NCT00875524

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

A Phase 2 study testing CYD dengue vaccine serotypes (1, 2, 3, 4). and Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide in people with Dengue Virus and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children. Read more about this study

Who is it for?: Ages 2 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever
What is being tested?: CYD dengue vaccine serotypes (1, 2, 3, 4). and Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteVietnam
Study dates: Mar 2009to Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 45 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Aged 2 to 45 years on the day of inclusion.
Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants <18 years).
Participant (and parent/guardian for participants <18 years) able to attend all scheduled visits and to comply with all trial procedures.
For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
Participant in good health, based on medical history, physical examination and laboratory parameters.

Who cannot join

Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
Breast-feeding female participant.
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.

Show all 19Show fewer

Planned participation in another clinical trial during the first year of the study.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy.
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening.
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
Familial atopy medical history (parents, brothers, or sisters).
Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.
History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Sanofi Pasteur Investigational Site
Long Xuyen, An Giang

Other trials in Vietnam

About this study

Official title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

This trial evaluated the use of a tetravalent vaccine against dengue.

Primary objectives:

To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

Read the detailed description

Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Disease
Being tested: CYD dengue vaccine serotypes (1, 2, 3, 4)., Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Keywords: Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases, Dengue vaccine
Medical subject headings: Dengue, Severe Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CYD dengue vaccine serotypes (1, 2, 3, 4).Biological
Also called ChimeriVax™
0.5 mL, Subcutaneous
Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharideBiological
Also called Meningococcal Polysaccharide Vaccine A+C, NaCl, Typhim Vi®
Each at 0.5 mL, Subcutaneous, respectively

Study groups in NCT00875524
Study group	Role	What they receive
CYD Dengue Vaccine Group	Experimental	Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection. Receives: Biological: CYD dengue vaccine serotypes (1, 2, 3, 4).
Control Vaccine Group	Sham comparator	Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection. Receives: Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Measured: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Measured: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Measured: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Measured: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >= 5 cm.
Measured: 7 days post-each injection
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: >=37.5 degree Celsius (°C) to <=38.0°C, Grade 2: >38.0°C to <=39.0°C, Grade 3: >39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Measured: 14 days post-each injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Dec 2014

First posted3 Apr 2009 (estimated)
Study startMar 2009
Primary completionAug 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dengue VirusStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875524
Sponsor's protocol ID: CYD22
Other IDs: 2014-001709-41, 2014
Status last verified: Mar 2022
First submitted: 2 Apr 2009
Last updated: 5 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs
RecruitingObservational study
Immune Responses to Dengue and Sepsis
Dengue, Sepsis

All Dengue Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
ClinicalTrials.gov ID: NCT00875524
Acronym / sponsor ID: CYD22
Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Disease
Keywords: Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases, Dengue vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2009 (actual)
Primary completion: Aug 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 24 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial evaluated the use of a tetravalent vaccine against dengue.

Primary objectives:

To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CYD Dengue Vaccine Group	Experimental	Biological: CYD dengue vaccine serotypes (1, 2, 3, 4).Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Control Vaccine Group	Sham comparator	Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharideParticipants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.

Who may qualify

Ages: 2 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Aged 2 to 45 years on the day of inclusion.
Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants <18 years).
Participant (and parent/guardian for participants <18 years) able to attend all scheduled visits and to comply with all trial procedures.
For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
Participant in good health, based on medical history, physical examination and laboratory parameters.

Key exclusion criteria (19 listed)

Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
Breast-feeding female participant.
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CYD dengue vaccine serotypes (1, 2, 3, 4).Also: ChimeriVax™0.5 mL, Subcutaneous	Biological	CYD Dengue Vaccine Group
Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharideAlso: Meningococcal Polysaccharide Vaccine A+C, NaCl, Typhim Vi®Each at 0.5 mL, Subcutaneous, respectively	Biological	Control Vaccine Group

Primary outcome

Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine
Time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Time frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine
Time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period
Time frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Time frame: 7 days post-each injection
Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >= 5 cm.
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Time frame: 14 days post-each injection
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: >=37.5 degree Celsius (°C) to <=38.0°C, Grade 2: >38.0°C to <=39.0°C, Grade 3: >39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.

Results and safety

Results posted to the registry on 24 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CYD Dengue Vaccine Group	120	112
Control Vaccine Group	60	54

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine

Time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3. Geometric mean (95% Confidence Interval). Unit: Titers (1/dil)

Measure	CYD Dengue Vaccine Group n = 119	Control Vaccine Group n = 60
Dengue Parental Serotype 1; Pre-Inj. 1	32.7 (21.6 to 49.5)	19.6 (12 to 31.8)
Dengue Parental Serotype 1; Post-Inj. 1	70.9 (44.3 to 113)	18.8 (11.4 to 30.8)
Dengue Parental Serotype 1; Pre-Inj. 2	52.2 (33.3 to 81.6)	19.8 (11.4 to 34.3)
Dengue Parental Serotype 1; Post-Inj. 2	100 (65.1 to 155)	20.6 (11.8 to 36.0)
Dengue Parental Serotype 1; Pre-Inj. 3	70.9 (45.5 to 110)	24.6 (13.7 to 44.0)
Dengue Parental Serotype 1; Post-Inj. 3	129 (90.5 to 183)	25.3 (13.7 to 46.8)
Dengue Parental Serotype 2; Pre-Inj. 1	33.1 (22.5 to 48.7)	27.2 (15.3 to 48.1)
Dengue Parental Serotype 2; Post-Inj. 1	92.3 (58.5 to 145)	25.0 (13.8 to 45.4)

Population analysed: Analysis was performed on Per-protocol analysis (PPA) set which included participants who received at least 1 dose of the study vaccine and had no protocol deviations, randomization error, blood sample not taken within the period and forbidden treatments. Here, 'number analyzed' = participants with available data for each specified category.

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period

Time frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection. Geometric mean (95% Confidence Interval). Unit: Titers (1/dil)

Measure	CYD Dengue Vaccine Group n = 120	Control Vaccine Group n = 60
Dengue Parental Serotype 1: Year 1	103 (69.0 to 152)	28.4 (15.5 to 52.3)
Dengue Parental Serotype 1: Year 2	72.9 (48.9 to 109)	25.7 (14.0 to 47.3)
Dengue Parental Serotype 1: Year 3	56.0 (35.9 to 87.4)	29.7 (15.3 to 57.7)
Dengue Parental Serotype 1: Year 4	52.6 (34.0 to 81.2)	30.5 (15.8 to 58.6)
Dengue Parental Serotype 2: Year 1	133 (91.7 to 192)	36.9 (19.6 to 69.4)
Dengue Parental Serotype 2: Year 2	118 (79.3 to 176)	42.6 (22.1 to 82.0)
Dengue Parental Serotype 2: Year 3	78.1 (52.6 to 116)	45.2 (23.7 to 86.1)
Dengue Parental Serotype 2: Year 4	73.7 (49.3 to 110)	50.7 (26.5 to 97.1)

Population analysed: Analysis was performed on Full analysis set which included all the participants present at first vaccination (V01) and received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for each specified category.

Primary outcome: Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine

Time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 119	Control Vaccine Group n = 60
Dengue Parental Serotype 1; Pre-Inj. 1	50.4	43.3
Dengue Parental Serotype 1; Post-Inj. 1	62.2	41.7
Dengue Parental Serotype 1; Pre-Inj. 2	58.3	39.7
Dengue Parental Serotype 1; Post-Inj. 2	79.1	41.4
Dengue Parental Serotype 1; Pre-Inj. 3	68.4	46.6
Dengue Parental Serotype 1; Post-Inj. 3	93.0	41.4
Dengue Parental Serotype 2; Pre-Inj. 1	49.6	41.7
Dengue Parental Serotype 2; Post-Inj. 1	66.4	35.6

Population analysed: Analysis was performed on PPA set. Here, 'number analyzed' = participants with available data for each specified category.

Primary outcome: Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period

Time frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 120	Control Vaccine Group n = 60
Dengue Parental Serotype 1: Year 1	78.8	43.9
Dengue Parental Serotype 1: Year 2	74.1	38.6
Dengue Parental Serotype 1: Year 3	59.8	40.0
Dengue Parental Serotype 1: Year 4	61.6	40.7
Dengue Parental Serotype 2: Year 1	86.7	47.4
Dengue Parental Serotype 2: Year 2	82.1	49.1
Dengue Parental Serotype 2: Year 3	70.5	50.9
Dengue Parental Serotype 2: Year 4	68.8	53.7

Population analysed: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.

Adverse events

Time frame: Serious Adverse Events (SAEs) data were collected throughout the study from Day 0 to Year 4, and non-serious Adverse Events were collected for 28 days after each injection.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine Group	3 of 120 (2.5%)	42 of 120 (35%)	0 of 120
Control Vaccine Group	3 of 60 (5%)	48 of 60 (80%)	0 of 60

Limitations and caveats (from the sponsor): None reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Sanofi Pasteur Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine (time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00875524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.