Comparison Study of Immunogenicity and Safety of SIBP’s Measles, Mumps and Rubella (MMR) Vaccine versus WHO prequalified GSK Measles, Mumps and Rubella (MMR) Vaccine

A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.’s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9- 11 Months of Age.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202405741158761

Enrollment

1200

Registered

2024-05-23

Start date

2024-06-17

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Measles, Mumps and Rubella MMR Vaccine

Interventions

SIBP MMR vaccine followed by licensed Yellow Fever Vaccine

GSK MMR vaccine

SIBP MMR vaccine and Yellow Fever vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male and female child as established by medical history and clinical examination at enrollment. 2. Age: 9-11 months (inclusive) at the time of enrollment 3. Parent’s/legally acceptable representative’s (LAR) ability to read and willingness to provide written informed consent as per the ethical and regulatory requirements of the site. 4. Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff.

Exclusion criteria

Exclusion criteria: 1. Presence of fever (defined as axillary temperature = 37.5°C) (temporary exclusion until recovery) 2. Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery) 3. Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery) 4. Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study 5. Presence of severe malnutrition (weight-for-height z-score 10 kg) will be exclusionary for the study. Children o

Design outcomes

Primary

Measure	Time frame
Immunogenicity To demonstrate non-inferiority of SIBP MMR vaccine compared to GSK MMR vaccine when administered individually based on immunogenicity as measured at baseline and 42 days after vaccination.	—

Secondary

Measure	Time frame
Safety -To assess the safety of SIBP MMR vaccine compared with the GSK MMR vaccine when administered alone in terms of immediate post-vaccination reactogenicity events, solicited adverse events, unsolicited adverse events and serious adverse events. -To assess the safety of the SIBP MMR vaccine co-administered with YF vaccine compared with SIBP MMR vaccine when administered separately from YF vaccine in terms of immediate post- vaccination reactogenicity events, solicited adverse events, unsolicited adverse events, and serious adverse events. Immunogenicity -To evaluate the immunological interference of SIBP MMR vaccine and a licensed YF vaccine when co-administered compared to the immunogenicity when administered alone, in terms of seropositivity rate as measured at baseline and 42 days after vaccination in seronegative children, 9-11 months of age.	—

Measure

Time frame

Safety -To assess the safety of SIBP MMR vaccine compared with the GSK MMR vaccine when administered alone in terms of immediate post-vaccination reactogenicity events, solicited adverse events, unsolicited adverse events and serious adverse events. -To assess the safety of the SIBP MMR vaccine co-administered with YF vaccine compared with SIBP MMR vaccine when administered separately from YF vaccine in terms of immediate post- vaccination reactogenicity events, solicited adverse events, unsolicited adverse events, and serious adverse events. Immunogenicity -To evaluate the immunological interference of SIBP MMR vaccine and a licensed YF vaccine when co-administered compared to the immunogenicity when administered alone, in terms of seropositivity rate as measured at baseline and 42 days after vaccination in seronegative children, 9-11 months of age.

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Countries

Kenya

Contacts

Public ContactWalter Otieno

Public Inqueries

wotieno@vibriafrica.org+254714481488

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026