DenguePhase 2NCT01187433

Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

A Phase 2 study testing Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9% and Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed in people with Dengue and Dengue Hemorrhagic Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in Brazil.

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 purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. Read more about this study

Who is it for?: Ages 9 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Dengue, Dengue Hemorrhagic Fever
What is being tested?: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9% and Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteBrazil
Study dates: Aug 2010to Dec 2012
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 9 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 9 to 16 years on the day of inclusion
Participant in good health, based on medical history and physical examination
Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
Participant and parent(s)/legally acceptable representative(s) 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 first vaccination until at least 4 weeks after the last vaccination

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 urine pregnancy test at Visit 1
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Breast-feeding woman
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

Show all 16Show fewer

Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of 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 preceding 3 months that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Study site
Vitória, ES, 29040-091

Other trials in Brazil

About this study

Official title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.

Primary Objectives:

To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
To evaluate the safety of each vaccination with CYD dengue vaccine.

Read the detailed description

Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.

Conditions: Dengue, Dengue Hemorrhagic Fever
Being tested: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9%, Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed, Meningococcal A+C vaccine
Keywords: Dengue, Dengue hemorrhagic fever, CYD Dengue Vaccines
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 , and 4 virusBiological
Also called CYD Dengue Vaccine
0.5 mL, Subcutaneous (SC)
NaCl 0.9%Biological
0.5 mL, Subcutaneous
Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbedBiological
Also called ADACEL®
0.5 mL, Intramuscular
Meningococcal A+C vaccineBiological
0.5 mL, Intramuscular

Study groups in NCT01187433
Study group	Role	What they receive
Dengue Vaccine Group	Experimental	Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine Receives: Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
Control Group	Placebo comparator	Participants will receive a placebo, NaCl 0.9%. Receives: Biological: NaCl 0.9%; Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed; Biological: Meningococcal A+C vaccine

What is being measured

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

Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Measured: Before and 28 days after each injection
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Measured: Before and 28 days after each injection
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Measured: Before and 28 Days after each injection
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Measured: Before and 28 days after each injection
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Measured: Before and 28 days after each injection
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Measured: Before and 28 days after each injection
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Measured: Before and 28 days after each injection
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Measured: Before and 28 days after each injection
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Measured: Before and 28 days after each injection
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Measured: Before and 28 days after each injection
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Measured: Day 0 up to Day 14 post each vaccination

Timeline

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

Aug 2010Dec 2012

First posted24 Aug 2010 (estimated)
Study startAug 2010
Primary completionOct 2012
Study completionDec 2012

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 (2)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01187433
Sponsor's protocol ID: CYD30
Other IDs: UTN: U1111-1111-6073
Status last verified: Mar 2022
First submitted: 20 Aug 2010
Last updated: 21 Mar 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

Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, Dietze R. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 2013 Nov 4.
PubMed 24189367
Coronel D, Garcia-Rivera EJ, Rivera DM, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Wang H, Pagnon A, Jantet-Blaudez F, Penalosa LAR, Dayan G, Zambrano B, DiazGranados CA, Noriega F. Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4-5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial. Pediatr Infect Dis J. 2020 Oct;39(10):961-968. doi: 10.1097/INF.0000000000002830.
PubMed 32932330

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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All Dengue trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America
ClinicalTrials.gov ID: NCT01187433
Acronym / sponsor ID: CYD30
Conditions: Dengue, Dengue Hemorrhagic Fever
Keywords: Dengue, Dengue hemorrhagic fever, CYD Dengue Vaccines
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Oct 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 24 Aug 2010 (estimated)
Results: Posted 11 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 purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.

Primary Objectives:

To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
To evaluate the safety of each vaccination with CYD dengue vaccine.

Detailed description

Study design

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

Arm	Type	Receives
Dengue Vaccine Group	Experimental	Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virusParticipants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine
Control Group	Placebo comparator	Biological: NaCl 0.9%, Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed, Biological: Meningococcal A+C vaccineParticipants will receive a placebo, NaCl 0.9%.

Who may qualify

Ages: 9 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Aged 9 to 16 years on the day of inclusion
Participant in good health, based on medical history and physical examination
Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
Participant and parent(s)/legally acceptable representative(s) 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 first vaccination until at least 4 weeks after the last vaccination

Key exclusion criteria (16 listed)

Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Breast-feeding woman
Planned participation in another clinical trial during the present trial period

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 , and 4 virusAlso: CYD Dengue Vaccine0.5 mL, Subcutaneous (SC)	Biological	Dengue Vaccine Group
NaCl 0.9%0.5 mL, Subcutaneous	Biological	Control Group
Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbedAlso: ADACEL®0.5 mL, Intramuscular	Biological	Control Group
Meningococcal A+C vaccine0.5 mL, Intramuscular	Biological	Control Group

Primary outcome

Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 Days after each injection
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Time frame: Before and 28 days after each injection
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Time frame: Day 0 up to Day 14 post each vaccination
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.

Results and safety

Results posted to the registry on 11 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	100	89
Control Group	50	46

Primary outcome: Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Time frame: Before and 28 days after each injection. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 99	Control Group n = 49
Serotype 1; Pre-Injection 1 (n=99, 49)	59.6	63.3
Serotype 1; Post-Injection 1 (n=99, 49)	79.8	69.4
Serotype 1; Pre-Injection 2 (n=94, 47)	80.9	72.3
Serotype 1; Post Injection 2 (n=94, 47)	95.7	72.3
Serotype 1; Pre-Injection 3 (n=90, 46)	78.9	69.6
Serotype 1; Post-Injection 3 (n=89, 46)	96.6	69.6
Serotype 2; Pre-Injection 1 (n=99, 49)	65.7	67.3
Serotype 2; Post-Injection 1 (n=99, 49)	80.8	67.3

Population analysed: Seropositivity was assessed in the Full Analysis Set.

Primary outcome: Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Time frame: Before and 28 days after each injection. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 80	Control Group n = 41
Serotype 1; Pre-Injection 1 (n=80, 41)	73.8	75.6
Serotype 1; Post-Injection 1 (n=80, 41)	88.8	82.9
Serotype 1; Pre-Injection 2 (n=78, 39)	91.0	87.2
Serotype 1; Post-Injection 2 (n=78, 39)	100.0	87.2
Serotype 1; Pre-Injection 3 (n=74, 38)	87.8	81.6
Serotype 1; Post-Injection 3 (n=73, 38)	98.6	81.6
Serotype 2; Pre-Injection 1 (n=80, 41)	81.3	80.5
Serotype 2; Post-Injection 1 (n=80, 41)	93.8	80.5

Population analysed: Seropositivity was assessed in the Full Analysis Set.

Primary outcome: Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Time frame: Before and 28 Days after each injection. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 19	Control Group n = 8
Serotype 1; Pre-Injection 1 (n=19, 8)	0.0	0
Serotype 1; Post-Injection 1 (n=19, 8)	42.1	0
Serotype 1; Pre-Injection 2 (n=16, 8)	31.3	0
Serotype 1; Post-Injection 2 (n=16, 8)	75.0	0
Serotype 1; Pre-Injection 3 (n=16, 8)	37.5	12.5
Serotype 1; Post-Injection 3 (n=16, 8)	87.5	12.5
Serotype 2; Pre-Injection 1 (n=19, 8)	0.0	0
Serotype 2; Post-Injection 1 (n=19, 8)	26.3	0

Population analysed: Seropositivity was assessed in the Full Analysis Set.

Primary outcome: Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo

Time frame: Before and 28 days after each injection. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 99	Control Group n = 49
At least 1 serotype; Pre-Injection 1 (n=99, 49)	68.7	71.4
At least 1 serotype; Post-Injection 1 (n=99, 49)	97.0	71.4
At least 1 serotype; Pre-Injection 2 (n=94, 47)	94.7	74.5
At least 1 serotype; Post-Injection 2 (n=94, 47)	100.0	74.5
At least 1 serotype; Pre-Injection 3 (n=90, 46)	98.9	78.3
At least 1 serotype; Post-Injection 3 (n=89, 46)	100.0	78.3
At least 2 serotypes; Pre-Injection 1 (n=99, 49)	62.6	67.3
At least 2 serotypes; Post-Injection 1 (n=99, 49)	91.9	71.4

Population analysed: Seropositivity was assessed in the Full Analysis Set.

Adverse events

Time frame: Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine Group	5 of 100 (5%)	61 of 100 (61%)	Not reported
Control Group	3 of 50 (6%)	25 of 50 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24189367Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, Dietze R. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 2013 Nov 4.
Derived from this study: PubMed 32932330Coronel D, Garcia-Rivera EJ, Rivera DM, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Wang H, Pagnon A, Jantet-Blaudez F, Penalosa LAR, Dayan G, Zambrano B, DiazGranados CA, Noriega F. Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4-5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial. Pediatr Infect Dis J. 2020 Oct;39(10):961-968. doi: 10.1097/INF.0000000000002830.
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 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 16 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 21 Mar 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 Brazil. 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 11 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 Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo (time frame: Before and 28 days after each injection). The study lists 11 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 NCT01187433, which also lists 2 linked publications.

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 21 Mar 2022.