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First Experience of Concomitant Vaccination Against Dengue and MMR in Toddlers
Denis Crevat1, Job D Brion, Sophia Gailhardou
1From the *Clinical Department, Sanofi Pasteur, Marcy l'Etoile, France; †San Pablo City Health Office, San Pablo, Philippines; ‡Pharmacovigilance Department, Sanofi Pasteur, Lyon, France; §Clinical Department, Sanofi Pasteur, Makati, Philippines; and ¶Research Institute for Tropical Medicine, Muntinlupa City, Philippines.
Insights
This study shows the recombinant dengue vaccine (CYD-TDV) is safe and effective in toddlers. Coadministration with the measles, mumps, and rubella (MMR) vaccine did not impact its immunogenicity.
Area of Science:
- Tropical Medicine
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Dengue poses a significant public health threat to children in dengue-endemic areas.
- A recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) is being developed for dengue control.
- The vaccine is administered on a 3-dose schedule (0-6-12 months).
Purpose of the Study:
- To evaluate the safety and immunogenicity of the CYD-TDV in toddlers.
- To assess the effects of coadministering CYD-TDV with the measles, mumps, and rubella (MMR) vaccine.
Main Methods:
- A controlled phase II trial in 210 toddlers (12-15 months) in the Philippines.
- Participants received CYD-TDV with MMR concomitantly or 1 month prior, or received active control vaccines.
- Safety, reactogenicity, and immunogenicity (dengue and MMR) were assessed post-vaccination.
Main Results:
- CYD-TDV demonstrated an acceptable safety profile with no major safety concerns.
- Fever was more frequent with CYD-TDV and MMR coadministration but reactogenicity did not increase with subsequent doses.
- The vaccine induced a balanced antibody response to all four dengue serotypes and did not affect MMR immunogenicity.
Conclusions:
- The CYD-TDV vaccine is safe and immunogenic in toddlers.
- Coadministration with the MMR vaccine is feasible and does not compromise the immunogenicity of either vaccine.
Background:
Dengue is a major public health concern in pediatric populations in endemic regions. A recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) is under development for the control of dengue with a 3-dose (0-6-12 month) vaccination schedule.
Methods:
In this controlled phase II trial conducted in the Philippines, 210 toddlers aged 12-15 months were randomized to 4 groups: 3 groups received the CYD-TDV vaccination schedule and a measles, mumps and rubella (MMR) vaccine given either concomitantly with the first CYD-TDV dose or 1 month earlier; 1 group received 3 active control vaccines. Safety and reactogenicity were assessed after each dose. Immunogenicity was assessed 30 days after vaccinations using the plaque reduction neutralization test against dengue and enzyme-linked immunosorbent assay methods against MMR antigens.
Results:
Injection site and systemic reactions occurred at similar rates across CYD-TDV groups, except for fever, which was more frequent after CYD-TDV and MMR coadministration (28.8%) compared with other groups (12-20%). Reactogenicity did not increase with subsequent CYD-TDV injections. There were no safety issues with the study vaccine. CYD-TDV achieved a balanced antibody response to all 4 dengue serotypes across the study groups, with geometric mean titers in the range of 105-124, 147-213, 311-387 and 127-160 for serotypes 1, 2, 3 and 4, respectively. CYD-TDV coadministration did not affect MMR immunogenicity (≥95% seroprotection against MMR) and vice versa.
Conclusions:
The CYD-TDV has an acceptable safety and immunogenicity profile in toddlers and when coadministered with MMR.
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