DenguePhase 3NCT01436396
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
A Phase 3 study testing Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Yellow fever vaccine and Measles, mumps, and rubella (MMR) vaccine in people with Dengue and Dengue Hemorrhagic Fever, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.
Trial summary
The study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration. Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Dengue, Dengue Hemorrhagic Fever, Yellow Fever
- What is being tested?
- Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Yellow fever vaccine and Measles, mumps, and rubella (MMR) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 792 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Sep 2011to 2 Sep 2013
- Phase
- Phase 3
- 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 12 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12 to 13 months on the day of inclusion.
- Born at full term of pregnancy (>=37 weeks) and with a birth weight >=2.5 kg as reported by the parent/legally acceptable representative.
- Participant in good health, based on medical history and physical examination.
- Participant had completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively.
- Informed consent form had been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations).
- Participant and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- 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 first trial vaccination.
- Previous vaccination against YF, hepatitis A, or measles, mumps and rubella.
- 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 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
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- Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative.
- History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative.
- Personal history of YF or dengue infection/disease as reported by the parent/legally acceptable representative.
- Known systemic hypersensitivity to any of the vaccine components of the vaccines that were used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances.
- History of contraindication to receipt of vaccines containing components of Stamaril® (yellow fever vaccine), measles, mumps and rubella vaccine, hepatitis A vaccine, pneumococcal conjugated vaccine or of diphtheria (D) toxoid, tetanus (T) toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio or other diphtheria, tetanus and pertussis vaccine (e.g., DTwP).
- Thrombocytopenia, as reported by the parent/legally acceptable representative.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular (IM) vaccination.
- History of central nervous system disorder or disease, including seizures.
- Personal history of thymic pathology (e.g., thymoma), and/or thymectomy.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- Identified as a child (adopted or natural) of the Investigator or of employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru
The study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration.
Primary Objective:
Read more
- To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to participants receiving one dose of Stamaril vaccine concomitantly with placebo.
Secondary Objectives:
- To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of participants at baseline.
- To describe the YF immune response 28 days post-Stamaril vaccination in both groups.
- To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD dengue vaccine (Visit [V] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2 from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect of YF vaccination).
- To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.
- To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.
- To describe the safety of the CYD dengue vaccine in all participants after each dose.
Read the detailed description
All participants received a total of 9 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies was performed in a randomized subset of participants. All participants were followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.
- Conditions
- Dengue, Dengue Hemorrhagic Fever, Yellow Fever
- Being tested
- Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Yellow fever vaccine, Measles, mumps, and rubella (MMR) vaccine, Pneumococcal Conjugated Vaccine, Hepatitis A Pediatric Vaccine
- Keywords
- Dengue, Dengue Hemorrhagic Fever, CYD Dengue Vaccines, Yellow Fever, Stamaril®, Flavivirus Infections
- Medical subject headings
- Dengue, Severe Dengue, Yellow Fever, Flavivirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live, attenuated dengue serotype 1, 2, 3, and 4 virusBiological
Also called CYD Dengue Vaccine
0.5 mL, subcutaneous at age 12, 18, and 24 months
Yellow fever vaccineBiological
Also called Stamaril®
0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
Measles, mumps, and rubella (MMR) vaccineBiological
Also called MMR vaccine
0.5 mL, subcutaneous at age 12 to 13 months.
Pneumococcal Conjugated VaccineBiological
0.5 mL, intramuscular at age 13 to 14 months
Hepatitis A Pediatric VaccineBiological
0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccineBiological
Also called DTaP IPV//Hib Vaccine
0.5 mL, intramuscular at age 19 to 20 months
Live, attenuated dengue serotype 1, 2, 3, and 4 virusBiological
Also called CYD dengue vaccine
0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months
Yellow Fever VaccineBiological
Also called Stamaril®
0.5 mL, subcutaneous at age 12 to 13 months
Placebo (NaCl)Biological
Also called NaCl 0.9%
0.5 mL, subcutaneous at age 12 to 13 months
Measles, mumps, and rubella vaccineBiological
Also called MMR vaccine
0.5 mL, subcutaneous at age 13 to 14 months
Pneumococcal Conjugated VaccineBiological
0.5 mL, intramuscular at age 13 to 14 months
Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccineBiological
Also called DTaP IPV//Hib Vaccine
0.5 mL, intramuscular at age 19 to 20 months
Hepatitis A Pediatric VaccineBiological
0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
| Study group | Role | What they receive |
|---|---|---|
| CYD Dengue Vaccine Group | Experimental | Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (Month [M] 0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP-IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). Receives: Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus; Biological: Yellow fever vaccine; Biological: Measles, mumps, and rubella (MMR) vaccine; Biological: Pneumococcal Conjugated Vaccine; Biological: Hepatitis A Pediatric Vaccine; Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine |
| Placebo Group | Experimental | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). Receives: Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus; Biological: Yellow Fever Vaccine; Biological: Placebo (NaCl); Biological: Measles, mumps, and rubella vaccine; Biological: Pneumococcal Conjugated Vaccine; Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine; Biological: Hepatitis A Pediatric Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dilution [dil]) in flavivirus non-immune participants (defined as those with YF antibodies <10 [1/dil] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).
Measured: 28 days Post-Injection 1
Secondary outcomes (13)
Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline.
Measured: 28 days Post-Injection 1
Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Measured: Pre-Injection 1 and 28-days Post-Injection 1
Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Measured: Pre-Injection 1 and 28- days Post-Injection 1
Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dil) regardless of the flavivirus status of participants at baseline.
Measured: Pre-Injection 1 and 28-days Post-Injection 1
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay.
Measured: Pre-Injection 1 and 28-days Post-Injections 2 and 3
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Measured: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers >= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains.
Measured: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Measured: Pre-Injection 1 and 28 days Post-Injections 2 and 3
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus.
Measured: Pre-Injection 1 and 28 days Post-Injections 2 and 3
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.
Measured: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus.
Measured: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.
Measured: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >39.5°celsius; Vomiting: >= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine.
Measured: Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study start7 Sep 2011
- Primary completionSep 2013
- Study completion2 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436396
- Sponsor's protocol ID
- CYD29
- Other IDs
- U1111-1116-4913, 2014-001714-26, 2014
- Status last verified
- Mar 2022
- First submitted
- 7 Sep 2011
- Last updated
- 25 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru
- ClinicalTrials.gov ID
- NCT01436396
- Acronym / sponsor ID
- CYD29
- Conditions
- Dengue, Dengue Hemorrhagic Fever, Yellow Fever
- Keywords
- Dengue, Dengue Hemorrhagic Fever, CYD Dengue Vaccines, Yellow Fever, Stamaril®, Flavivirus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2011 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- 2 Sep 2013 (actual)
- First posted
- 19 Sep 2011 (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 study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration.
Primary Objective:
- To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to participants receiving one dose of Stamaril vaccine concomitantly with placebo.
Secondary Objectives:
- To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of participants at baseline.
- To describe the YF immune response 28 days post-Stamaril vaccination in both groups.
- To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD dengue vaccine (Visit [V] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2 from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect of YF vaccination).
- To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.
- To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.
- To describe the safety of the CYD dengue vaccine in all participants after each dose.
Detailed description
All participants received a total of 9 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies was performed in a randomized subset of participants. All participants were followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYD Dengue Vaccine Group | Experimental | Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Biological: Yellow fever vaccine, Biological: Measles, mumps, and rubella (MMR) vaccine, Biological: Pneumococcal Conjugated Vaccine, Biological: Hepatitis A Pediatric Vaccine, Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccineParticipants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (Month [M] 0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP-IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| Placebo Group | Experimental | Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Biological: Yellow Fever Vaccine, Biological: Placebo (NaCl), Biological: Measles, mumps, and rubella vaccine, Biological: Pneumococcal Conjugated Vaccine, Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine, Biological: Hepatitis A Pediatric VaccineParticipants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 12 to 13 months on the day of inclusion.
- Born at full term of pregnancy (>=37 weeks) and with a birth weight >=2.5 kg as reported by the parent/legally acceptable representative.
- Participant in good health, based on medical history and physical examination.
- Participant had completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively.
- Informed consent form had been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations).
Key exclusion criteria (17 listed)
- 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 first trial vaccination.
- Previous vaccination against YF, hepatitis A, or measles, mumps and rubella.
- 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 dengue serotype 1, 2, 3, and 4 virusAlso: CYD Dengue Vaccine0.5 mL, subcutaneous at age 12, 18, and 24 months | Biological | CYD Dengue Vaccine Group |
| Yellow fever vaccineAlso: Stamaril®0.5 mL subcutaneous in the deltoid at age 12 to 13 months. | Biological | CYD Dengue Vaccine Group |
| Measles, mumps, and rubella (MMR) vaccineAlso: MMR vaccine0.5 mL, subcutaneous at age 12 to 13 months. | Biological | CYD Dengue Vaccine Group |
| Pneumococcal Conjugated Vaccine0.5 mL, intramuscular at age 13 to 14 months | Biological | CYD Dengue Vaccine Group |
| Hepatitis A Pediatric Vaccine0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months | Biological | CYD Dengue Vaccine Group |
| Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccineAlso: DTaP IPV//Hib Vaccine0.5 mL, intramuscular at age 19 to 20 months | Biological | CYD Dengue Vaccine Group |
| Live, attenuated dengue serotype 1, 2, 3, and 4 virusAlso: CYD dengue vaccine0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months | Biological | Placebo Group |
| Yellow Fever VaccineAlso: Stamaril®0.5 mL, subcutaneous at age 12 to 13 months | Biological | Placebo Group |
| Placebo (NaCl)Also: NaCl 0.9%0.5 mL, subcutaneous at age 12 to 13 months | Biological | Placebo Group |
| Measles, mumps, and rubella vaccineAlso: MMR vaccine0.5 mL, subcutaneous at age 13 to 14 months | Biological | Placebo Group |
| Pneumococcal Conjugated Vaccine0.5 mL, intramuscular at age 13 to 14 months | Biological | Placebo Group |
| Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccineAlso: DTaP IPV//Hib Vaccine0.5 mL, intramuscular at age 19 to 20 months | Biological | Placebo Group |
| Hepatitis A Pediatric Vaccine0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months | Biological | Placebo Group |
Primary outcome
Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: 28 days Post-Injection 1
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dilution [dil]) in flavivirus non-immune participants (defined as those with YF antibodies <10 [1/dil] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).
13 secondary outcomes
Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: 28 days Post-Injection 1
Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28-days Post-Injection 1
Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28- days Post-Injection 1
Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28-days Post-Injection 1
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28-days Post-Injections 2 and 3
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Time frame: Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Live, attenuated dengue serotype 1, 2, 3, and 4 virus, Yellow fever vaccine and Measles, mumps, and rubella (MMR) vaccine in people with Dengue and Dengue Hemorrhagic Fever, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.
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 17 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 25 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 2 sites in Colombia, 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo (time frame: 28 days Post-Injection 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.