DenguePhase 2NCT01550289

Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

A Phase 2 study testing Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus in people with Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 5 sites in India.

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

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
What is being tested?: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 189 participants
Where: 5 sitesIndia
Study dates: Mar 2012to Feb 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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18 to 45 years on the day of inclusion
Informed consent form has been signed and dated by the subject (and by an independent witness, if applicable)
Subject is able to attend all scheduled visits and to comply with all trial procedures
Subject in good health, based on medical history and physical examination

Who cannot join

Subject is 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 another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Planned receipt of any vaccine in the 4 weeks following any trial vaccination
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

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Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C reported by the subject
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
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Identified as an Investigator or employee of the Investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

India5 sites

Study site
Bangalore, Karnataka, 560054
Study site
Kolkata, West Bengal, 700073
Study site
Ludhiana, Punjab, 141008
Study site
New Delhi, 110002
Study site
Pune, 411018

Other trials in India

About this study

Official title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.

Primary Objectives:

To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects.
To describe the safety of the CYD dengue vaccine after each dose in all subjects.

Secondary Objective:

To detect symptomatic dengue cases occurring at any time in the trial.

Read the detailed description

Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.

Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Being tested: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus, Placebo: NaCl 0.9% solution
Keywords: Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Dengue Virus, Flavivirus
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.

Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virusBiological
Also called CYD Dengue vaccine
0.5 mL, Subcutaneous
Placebo: NaCl 0.9% solutionBiological
0.5 ml, Subcutaneous

Study groups in NCT01550289
Study group	Role	What they receive
Group 1: CYD dengue vaccine	Experimental	Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively. Receives: Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
Group 2: Placebo	Placebo comparator	Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively Receives: Biological: Placebo: NaCl 0.9% solution

What is being measured

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

Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
Measured: Day 0 up to Day 14 post each injection

Secondary outcomes (8)

Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Measured: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

Timeline

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

Mar 2012Feb 2014

First posted9 Mar 2012 (estimated)
Study startMar 2012
Primary completionDec 2013
Study completionFeb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DengueStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 189 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01550289
Sponsor's protocol ID: CYD47
Other IDs: UTN: U1111-1114-7909
Status last verified: Mar 2022
First submitted: 7 Mar 2012
Last updated: 5 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Publications

Dubey AP, Agarkhedkar S, Chhatwal J, Narayan A, Ganguly S, Wartel TA, Bouckenooghe A, Menezes J. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial. Hum Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598.
PubMed 26291554

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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Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
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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

All Dengue 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 a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.
ClinicalTrials.gov ID: NCT01550289
Acronym / sponsor ID: CYD47
Conditions: Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Keywords: Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Dengue Virus, Flavivirus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 189 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Dec 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 9 Mar 2012 (estimated)
Results: Posted 3 Nov 2016

Clinical summary

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

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.

Primary Objectives:

To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects.
To describe the safety of the CYD dengue vaccine after each dose in all subjects.

Secondary Objective:

To detect symptomatic dengue cases occurring at any time in the trial.

Detailed description

Study design

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

Arm	Type	Receives
Group 1: CYD dengue vaccine	Experimental	Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virusSubjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.
Group 2: Placebo	Placebo comparator	Biological: Placebo: NaCl 0.9% solutionSubjects will receive a dose of placebo at 0, 6, and 12 months, respectively

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Aged 18 to 45 years on the day of inclusion
Informed consent form has been signed and dated by the subject (and by an independent witness, if applicable)
Subject is able to attend all scheduled visits and to comply with all trial procedures
Subject in good health, based on medical history and physical examination

Key exclusion criteria (12 listed)

Subject is 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 another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Planned receipt of any vaccine in the 4 weeks following any trial vaccination
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

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
Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virusAlso: CYD Dengue vaccine0.5 mL, Subcutaneous	Biological	Group 1: CYD dengue vaccine
Placebo: NaCl 0.9% solution0.5 ml, Subcutaneous	Biological	Group 2: Placebo

Primary outcome

Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Time frame: Day 0 up to Day 14 post each injection
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.

8 secondary outcomes

Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

Results and safety

Results posted to the registry on 3 Nov 2016, 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	128	115
Placebo Group	61	57

Primary outcome: Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo

Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1). Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 126	Placebo Group n = 61
Serotype 1; Pre-injection 1 (N=126, 61)	83.3	80.3
Serotype 1; Post-injection 1 (N=125, 61)	91.2	83.6
Serotype 1; Post-injection 2 (N=117, 58)	94.9	81.0
Serotype 1; Post-injection 3 (N=115, 57)	97.4	87.7
Serotype 2; Pre-injection 1 (N=126, 61)	83.3	86.9
Serotype 2; Post-injection 1 (N=126, 61)	94.4	88.5
Serotype 2; Post-injection 2 (N=117, 58)	99.1	84.5
Serotype 2; Post-injection 3 (N=115, 57)	97.4	91.2

Population analysed: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.

Primary outcome: Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo

Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1). Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 126	Placebo Group n = 61
At least 1 serotype; Pre-injection 1 (N=126, 61)	86.5	88.5
At least 1 serotype; Post-injection 1 (N=126, 61)	99.2	90.2
At least 1 serotype; Post-injection 2 (N=117, 58)	100.0	86.2
At least 1 serotype; Post-injection 3 (N=115, 57)	100.0	91.2
At least 2 serotypes; Pre-injection 1 (N=126, 61)	84.1	85.2
At least 2 serotypes; Post-injection 1 (N=126, 61)	98.4	88.5
At least 2 serotypes; Post-injection 2 (N=117, 58)	98.3	82.8
At least 2 serotypes; Post-injection 3 (N=115, 57)	99.1	89.5

Population analysed: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.

Primary outcome: Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo

Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1). Geometric mean (95% Confidence Interval). Unit: Titers (1/dilutions)

Measure	CYD Dengue Vaccine Group n = 126	Placebo Group n = 61
Serotype 1; Pre-injection 1 (N=126, 61)	184 (127 to 268)	234 (133 to 409)
Serotype 1; Post-injection 1 (N=125, 61)	605 (410 to 892)	288 (161 to 513)
Serotype 1; Post-injection 2 (N=117, 58)	556 (391 to 790)	294 (159 to 543)
Serotype 1; Post-injection 3 (N=115, 57)	461 (340 to 625)	268 (164 to 438)
Serotype 2; Pre-injection 1 (N=126, 61)	204 (141 to 294)	243 (147 to 403)
Serotype 2; Post-injection 1 (N=126, 61)	720 (510 to 1015)	300 (184 to 489)
Serotype 2; Post-injection 2 (N=117, 58)	787 (592 to 1045)	288 (163 to 509)
Serotype 2; Post-injection 3 (N=115, 57)	484 (370 to 634)	258 (163 to 410)

Population analysed: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.

Primary outcome: Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo

Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1). Geometric mean (95% Confidence Interval). Unit: Titer ratio

Measure	CYD Dengue Vaccine Group n = 126	Placebo Group n = 61
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=125,61)	3.23 (2.49 to 4.18)	1.23 (1.02 to 1.49)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=117,58)	3.15 (2.46 to 4.04)	1.26 (1.01 to 1.58)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=115,57)	2.64 (2.08 to 3.35)	1.18 (0.838 to 1.66)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=126,61)	3.53 (2.76 to 4.52)	1.23 (1.03 to 1.47)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=117,58)	3.83 (2.84 to 5.18)	1.17 (0.951 to 1.45)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=115,57)	2.38 (1.81 to 3.11)	1.05 (0.791 to 1.41)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=126,61)	4.35 (3.34 to 5.68)	1.36 (1.09 to 1.69)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=117,58)	3.97 (2.99 to 5.28)	1.13 (0.888 to 1.44)

Population analysed: Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 0 up to 1 year post injection 1.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine Group	1 of 127 (0.8%)	14 of 127 (11%)	Not reported
Placebo Group	1 of 61 (1.6%)	3 of 61 (4.9%)	Not 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.
Results publication: PubMed 26291554Dubey AP, Agarkhedkar S, Chhatwal J, Narayan A, Ganguly S, Wartel TA, Bouckenooghe A, Menezes J. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial. Hum Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598.
Related InfoLink provided by the sponsor.
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 Director study director

Sanofi Pasteur India Pvt Ltd

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus in people with Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 5 sites in India.

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 4 inclusion and 12 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 5 sites in India. 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 3 Nov 2016). 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?

Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo (time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)). The study lists 5 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 NCT01550289, which also lists 1 linked publication.

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.