This study will be conducted among 1530 healthy infants of 9 to 12 months of age residing in the Dakshinkhan and Uttarkhan area which is located in Dhaka North City Corporation (DNCC) to enroll the required number of participants. Only infants who have not previously received the MR and YF vaccines will be enrolled. The findings of this study are likely to have a significant impact on vaccine co-administration strategies for campaign and routine immunization programs. The participants will be assigned to one of the three groups by the central computer-generated randomization schedule. The numbers are defined for each arm (Table 1) based on the sample size calculation. A list of infants who did not receive MR and Yellow fever vaccine will be prepared before enrollment by trained study staff (TSS). The TSSs will visit households in the defined study area and ask if the parents/guardians of infants aged 9-12 months are willing to participate in the study. If they show a willingness to participate, the TSSs will check their vaccination cards (if available) and prepare the list of potentially eligible infants who have not received MR and Yellow fever vaccines based on their vaccination card status. The investigators will collect blood specimens (4-5 ml) at the time of screening (visit-1), to evaluate serological markers of dengue and Japanese Encephalitis infection and for baseline (pre-vaccination) immunological assessment. The investigators will vaccinate seronegative, eligible participants within 24 hours of blood collection. There will be additional three follow-up visits after enrollment and will collect around 3-4 ml blood from each participant during visit 4 (week 6), and visit 5 (week 26) for immunological assessment. Diary cards will be used to collect adverse events (AEs) following immunization (AEFI) data for vaccinated participants (up to 14 days for solicited and 6 weeks for unsolicited AEs). Medically attended adverse events (MAAEs) and data on serious adverse events (SAEs) will be reported during the study. All study updates including AEs and SAEs will be reported to the data safety and monitoring board (DSMB) and sponsor.
Healthy infant participants of either gender aged* 9 to 12 months at the time of enrollment
Participants should be in good health as determined by the medical history and physical examination based on the clinical judgment of the investigator
No previous history of vaccination against measles, rubella, or Yellow fever
Written informed consent from the participant's parent/guardian
Participants positive for serological markers against Dengue and/or Japanese Encephalitis infections
History of hypersensitivity reaction to any component of the study vaccines including egg and chicken proteins
History of hypersensitivity reaction to neomycin
History of laboratory-confirmed or suspected measles, rubella, or Yellow fever in the past
Parallel
Measles-Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd
Biological/VaccineLive attenuated vaccine
Yellow fever Vaccine (WHO prequalified)
Biological/VaccineLive attenuated vaccine
Seropositivity
Equivalence for seropositivity rate for anti-measles, anti-rubella, and anti-YF IgG antibodies at 6 weeks post-vaccination
Immunogenicity
* Seropositivity rate for anti-measles (≥9 NovaTec Units), anti-rubella (≥10 IU/ml), and anti-YF IgG (Plaque Reduction Neutralization Test titre of ≥1:10) antibodies at 26 weeks post-vaccination * Seroconversion rate for anti-measles (≥9 NovaTec Units), anti-rubella (≥10 IU/ml), and anti-YF IgG (Plaque Reduction Neutralization Test titre of ≥1:10) antibodies at 6 weeks and 26 weeks post-vaccination * Geometric mean titre of anti-measles, anti-rubella, and anti-YF IgG antibodies at 6 weeks and 26 weeks after vaccination
Safety reporting
* Number of solicited local and systemic adverse events reported during the study * Number of unsolicited adverse events reported during the study * Number of medically attended adverse events reported during the study * Number of serious adverse events reported during the study
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International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Zydus Lifesciences Limited
Collaborator
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