Dengue VirusPhase 2NCT00788151

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

A Phase 2 study testing CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 and Pneumococcal polysaccharide vaccine in people with Dengue Virus and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in Peru.

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 the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously… Read more about this study

Who is it for?: Ages 2 to 11 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, and 4 and Pneumococcal polysaccharide vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 1 sitePeru
Study dates: 26 Sep 2008to 16 Aug 2010
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 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 2 to 11 years on the day of inclusion.
Participant in good health, based on medical history, physical examination and laboratory parameters.
Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
For a female participant of child-bearing potential (girls post-menarche), 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.
Documented receipt of yellow fever vaccine since at least one month before the first vaccination.

Who cannot join

Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test 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 participation in another clinical trial during the trial.
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.

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Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
Receipt of any blood or blood-derived products in the past 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.
Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
Known previous vaccination with pneumococcal polysaccharide vaccine.

Trial locations and contacts

1 site in 1 country.

Peru1 site

Study site
Chulucanas Morropon, Piura

Other trials in Peru

About this study

Official title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru

The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.

Primary Objectives:

To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

Read the detailed description

Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.

Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
Being tested: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4, Pneumococcal polysaccharide vaccine
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, and 4Biological
Also called ChimeriVax™
0.5 mL, Subcutaneous (SC)
Pneumococcal polysaccharide vaccineBiological
Also called Pneumo23®
0.5 mL, SC

Study groups in NCT00788151
Study group	Role	What they receive
CYD Dengue vaccine group	Experimental	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). Receives: Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4
Control group	Placebo comparator	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). Receives: Biological: Pneumococcal polysaccharide vaccine

What is being measured

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

Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Measured: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Measured: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Measured: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

Secondary outcomes (16)

Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Measured: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Measured: Pre-Injection 1 and 28 days Post-Injection 1
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Measured: Pre-Injection 1 and 28 days Post-Injection 1
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Measured: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

Timeline

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

26 Sep 200816 Aug 2010

First posted10 Nov 2008 (estimated)
Study start26 Sep 2008
Primary completion16 Feb 2010
Study completion16 Aug 2010

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 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00788151
Sponsor's protocol ID: CYD24
Other IDs: 2014-001711-40, 2014
Status last verified: Mar 2022
First submitted: 7 Nov 2008
Last updated: 5 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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

Publications

Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.
Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, Saville M, Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012 Sep 7;30(41):5935-41. doi: 10.1016/j.vaccine.2012.07.043. Epub 2012 Jul 31.
PubMed 22863660

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 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 Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru
ClinicalTrials.gov ID: NCT00788151
Acronym / sponsor ID: CYD24
Conditions: Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
Keywords: Dengue virus, Dengue fever, Dengue Hemorrhagic fever, Dengue diseases, Dengue vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 26 Sep 2008 (actual)
Primary completion: 16 Feb 2010 (actual)
Study completion: 16 Aug 2010 (actual)
First posted: 10 Nov 2008 (estimated)
Results: Posted 29 Jul 2019

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 the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.

Primary Objectives:

To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

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
CYD Dengue vaccine group	Experimental	Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Control group	Placebo comparator	Biological: Pneumococcal polysaccharide vaccineParticipants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Who may qualify

Ages: 2 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Aged 2 to 11 years on the day of inclusion.
Participant in good health, based on medical history, physical examination and laboratory parameters.
Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
For a female participant of child-bearing potential (girls post-menarche), 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 (girls post-menarche), known pregnancy.
For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test 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 participation in another clinical trial during the trial.

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, and 4Also: ChimeriVax™0.5 mL, Subcutaneous (SC)	Biological	CYD Dengue vaccine group
Pneumococcal polysaccharide vaccineAlso: Pneumo23®0.5 mL, SC	Biological	Control group

Primary outcome

Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.

16 secondary outcomes

Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injection 1
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injection 1
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

Results and safety

Results posted to the registry on 29 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	200	186
Control Group	100	90

Primary outcome: Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo

Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 199	Control Group n = 99
Inj. site Pain; Post-Inj. 1 (2-11 years)	20.6	17.2
Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years)	0.0	0.0
Inj. site Erythema; Post-Inj. 1 (2-11 years)	7.5	4.0
Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years)	0.0	0.0
Inj. site Swelling; Post-Inj. 1 (2-11 years)	5.5	5.1
Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years)	0.0	0.0
Inj. site Pain; Post-Inj. 2 (2-11 years)	19.7	17.4
Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years)	0.0	1.1

Population analysed: Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, 'number analyzed' = participants with available data for specified category.

Primary outcome: Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 100	Control Group n = 50
Inj. site Pain: Post-Inj.1 (2-5 years)	19.0	16.0
Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years)	0.0	0.0
Inj. site Erythema; Post-Inj. 1 (2-5 years)	11.0	6.0
Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years)	0.0	0.0
Inj. site Swelling; Post-Inj. 1 (2-5 years)	6.0	8.0
Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years)	0.0	0.0
Inj. site Pain; Post-Inj. 2 (2-5 years)	17.4	15.6
Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years)	0.0	2.2

Population analysed: Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.

Primary outcome: Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3. Number. Unit: Percentage of participants

Measure	CYD Dengue Vaccine Group n = 99	Control Group n = 49
Inj. site Pain; Post-Inj.1 (6-11 years)	22.2	18.4
Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years)	0.0	0.0
Inj. site Erythema; Post-Inj. 1 (6-11 years)	4.0	2.0
Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years)	0.0	0.0
Inj. site Swelling; Post-Inj. 1 (6-11 years)	5.1	2.0
Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years)	0.0	0.0
Inj. site Pain; Post-Inj. 2 (6-11 years)	21.9	19.1
Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years)	0.0	0.0

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine Group	2 of 199 (1%)	71 of 199 (35.7%)	0 of 199
Control Group	4 of 99 (4%)	29 of 99 (29.3%)	0 of 99

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.
BackgroundCrevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.
Results publication: PubMed 22863660Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, Saville M, Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012 Sep 7;30(41):5935-41. doi: 10.1016/j.vaccine.2012.07.043. Epub 2012 Jul 31.
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 Monitor study director

Sanofi Pasteur SA

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 6 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 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 Peru. 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 29 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?

Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo (time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3). The study lists 3 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 NCT00788151, 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 5 Apr 2022.