Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
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
3 other identifiers
interventional
792
2 countries
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2011
CompletedStudy Start
First participant enrolled
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2013
CompletedResults Posted
Study results publicly available
July 29, 2019
CompletedMarch 25, 2022
March 1, 2022
2 years
September 7, 2011
April 16, 2019
March 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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
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
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
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
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
Pre-Injection 1 and 28-days Post-Injections 2 and 3
- +8 more secondary outcomes
Study Arms (2)
CYD Dengue Vaccine Group
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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).
Interventions
0.5 mL, subcutaneous at age 12, 18, and 24 months
0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
0.5 mL, subcutaneous at age 12 to 13 months.
0.5 mL, intramuscular at age 13 to 14 months
0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
0.5 mL, intramuscular at age 19 to 20 months
0.5 mL, subcutaneous at age 12 to 13 months
0.5 mL, subcutaneous at age 13 to 14 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Cali, Colombia
Unknown Facility
Lima, Peru
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
None reported
Results Point of Contact
- Title
- Director
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- To ensure that objective safety data were obtained, the trial was designed using an observer-blind methodology since the products were visually different and may be recognized. For first trial vaccination (V01), the person who administered the injections knew which products were administered while either the participant or parent nor the Investigator in charge of safety evaluation knew which products were administered.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 19, 2011
Study Start
September 7, 2011
Primary Completion
September 1, 2013
Study Completion
September 2, 2013
Last Updated
March 25, 2022
Results First Posted
July 29, 2019
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
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