A study to check the immunogenicity and safety of two doses of SII-MMR vaccine in healthy infants in India

A phase IV, double blind, randomized, active control clinical study comparing safety and immunogenicity of SII-Measles-Mumps- Rubella vaccine with PRIORIX (GSK) in healthy infants in India - MMR01/23

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077318

Enrollment

429

Registered

2024-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SII MMR vaccine: SII-MMR vaccine is a live attenuated and is prepared from live attenuated strains of Edmonston- Zagreb Measles virus propagated on human diploid cell culture, Leningrad

Eligibility

Inclusion criteria

Inclusion criteria: 1) Healthy male and female infants between 9 months and 11 months old 2) Parent of study participant willing to give written informed consent. 3) Free of obvious health problems as established by medical history and screening evaluation including clinical examination.

Exclusion criteria

Exclusion criteria: 1. Acute illness 2. Congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3. History of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances 4. Acute or chronic, clinically significant systemic disorder/disease 5. History of measles, mumps, or rubella infection 6. Previous history of Measles/Rubella/MR/MMR vaccination. 7. History of allergy to eggs, milk, neomycin or gelatin.

Design outcomes

Primary

Measure	Time frame
Proportion of study participants with seropositivity for measles, mumps and rubellaTimepoint: 41 days after the second dose of the study vaccine	—

Secondary

Measure	Time frame
Geometric Mean titers (GMT) for anti-measles, anti-mumps and anti-rubella antibodies mumps and rubella 41 and 179 days after the first dose of the study vaccineTimepoint: At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine ;Proportion of study participants with seropositivity for measles, mumps and rubellaTimepoint: 41 and 179 days after the first dose of study vaccine;Proportion of study participants with seroconversion for measles, mumps and rubellaTimepoint: At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine;Proportion of study participants with seroresponse for measles, mumps and rubellaTimepoint: At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine;Solicited adverse eventsTimepoint: through 14 days following each dose of the study vaccine.;Unsolicited adverse eventsTimepoint: through 41 days following each dose of the study vaccine;Serious adverse eventsTimepoint: Throughout study participation	—

Measure

Time frame

Geometric Mean titers (GMT) for anti-measles, anti-mumps and anti-rubella antibodies mumps and rubella 41 and 179 days after the first dose of the study vaccineTimepoint: At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine ;Proportion of study participants with seropositivity for measles, mumps and rubellaTimepoint: 41 and 179 days after the first dose of study vaccine;Proportion of study participants with seroconversion for measles, mumps and rubellaTimepoint: At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine;Proportion of study participants with seroresponse for measles, mumps and rubellaTimepoint: At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine;Solicited adverse eventsTimepoint: through 14 days following each dose of the study vaccine.;Unsolicited adverse eventsTimepoint: through 41 days following each dose of the study vaccine;Serious adverse eventsTimepoint: Throughout study participation

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Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Pvt Ltd. Pune India

drpsk@seruminstitute.com02071946820

Outcome results