Measles-Mumps-RubellaPhase 3NCT06399003
Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months
A Phase 3 study testing SIBP MMR Vaccine, GSK MMR Vaccine (PRIORIX) and Yellow Fever Vaccine (Stamaril) in people with Measles-Mumps-Rubella, run by Shanghai Institute Of Biological Products at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles-Mumps-Rubella
- What is being tested?
- SIBP MMR Vaccine, GSK MMR Vaccine (PRIORIX) and Yellow Fever Vaccine (Stamaril)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteKenya
- Study dates
- 28 Jun 2024to 10 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male and female child as established by medical history and clinical examination at enrollment.
- Age: 9-11 months (inclusive) at the time of enrollment
- 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.
- 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.
Who cannot join
- Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusion until recovery)
- Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery)
- Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)
- Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study
- Presence of severe malnutrition (weight-for-height z-score < -3SD median)
- Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis
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- Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological (including severe anemia), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol.
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Prior receipt or intent to receive measles, mumps, rubella, or yellow fever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center.
- Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of the day of study vaccination or intent to receive any within 6 weeks after study vaccination.
- Receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period
- Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as ≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg) will be exclusionary for the study. Children on inhaled or topical steroids may be permitted to participate in the study.
- Evidence of a clinically significant major congenital anomaly or genetic defect as judged by the investigator.
- Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
- History of any neurologic disorders including encephalopathy, epilepsy, and other progressive neurological diseases
- A known or suspected sensitivity or allergy to any components of the investigational product including egg, chicken protein and the antibiotic gentamycin.
- History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- Any medical condition in the parent/LAR or child which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent(s)'/LAR's ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age
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.
Read the detailed description
This study is designed as a phase III, multi-center, randomized, observer blind active controlled non-inferiority study, enrolling 1200 healthy African children between the ages of 9-11 months. The enrolled children will be randomized to three groups in the ratio of 1:1:1 (400 children in each group) receiving a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed YF vaccine alone at 2nd dose on D43 (Group 1, MMR1YF2) or a single dose of GSK MMR vaccine alone at D1 (Group 2, GSK MMR1) or a single dose of SIBP MMR vaccine co-administered with YF vaccine on D1 (Group 3, MMR1YF1). This study will have an observer-blinded phase for Group 1 and Group 2 followed by an open label phase from Day 43. Group 3 will remain an open label arm throughout the period of the study.
- Conditions
- Measles-Mumps-Rubella
- Being tested
- SIBP MMR Vaccine, GSK MMR Vaccine (PRIORIX), Yellow Fever Vaccine (Stamaril)
- Keywords
- Measles, Mumps and Rubella, Immunogenicity, Safety, 9-11 months of Age
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP MMR VaccineBiological
This is a live attenuated measles, mumps, and rubella combined vaccine (Shanghai MMR) in a freeze-dried powder form, developed and manufactured by Shanghai Institute of Biological Products. A single dose of 0.5 mL, containing not less than 3.0 log CCID50 of both live measles virus and rubella virus and 4.3 log CCID50 of live mumps virus. 0.5ml per dose.
GSK MMR Vaccine (PRIORIX)Biological
PRIORIX (combined measles, mumps and rubella vaccine, live, attenuated) is a lyophilized mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella). 0.5ml per dose.
Yellow Fever Vaccine (Stamaril)Biological
This is a live, attenuated, lyophilized yellow fever vaccine manufactured by Sanofi Pasteur Europe, Lyon, France. A single dose of 0.5 mL contains with not less than 1000 IU of yellow fever virus 17D-204 strain. 0.5ml per dose.
| Study group | Role | What they receive |
|---|---|---|
| SIBP MMR vaccine group | Experimental | Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43. Receives: Biological: SIBP MMR Vaccine; Biological: Yellow Fever Vaccine (Stamaril) |
| GSK MMR vaccine group | Active comparator | Received a single dose of GSK MMR vaccine alone at D1. Receives: Biological: GSK MMR Vaccine (PRIORIX) |
| Joint vaccination group | Experimental | Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1. Receives: Biological: SIBP MMR Vaccine; Biological: Yellow Fever Vaccine (Stamaril) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of seropositivity rate
An evaluation of seropositivity rate to Measles, Mumps and Rubella viruses of SIBP MMR vaccine versus GSK MMR vaccine when measured 42 days after vaccination in seronegative children at baseline.
Measured: 42 days
Secondary outcomes (12)
The percentage of immediate adverse events (AEs)
The percentage of any adverse events in subjects within 30 minutes after each vaccination.
Measured: 30 minutes
The percentage of solicited local reactogenicity
The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination.
Measured: 7 days
The percentage of solicited systemic reactogenicity
The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination.
Measured: 14 days
The percentage of unsolicited AEs
The percentage of unsolicited AEs in subjects through 42 days after each vaccination.
Measured: 42 days
The percentage of serious adverse events (SAEs)
The percentage of SAEs reported up to 42 days and up to 6 months after first vaccination.
Measured: 42 days
Geometric mean titer (GMT) of Yellow Fever
Geometric mean titer (GMT) for anti-yellow fever virus neutralizing antibodies at baseline and 42 days after vaccination.
Measured: 42 days
Geometric mean concentration (GMC) of Measles
Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination.
Measured: 42 days
Geometric mean concentration (GMC) of Mumps
Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination.
Measured: 42 days
Geometric mean concentration (GMC) of Rubella
Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination.
Measured: 42 days
Seropositivity rate of Measles
Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination.
Measured: 42 days
Seropositivity rate of Mumps
Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination.
Measured: 42 days
Seropositivity rate of Rubella
Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start28 Jun 2024
- Primary completion15 Sep 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measles-Mumps-RubellaStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The enrolled children will be randomized to three groups in the ratio of 1:1:1 receiving different vaccines.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Victoria Biomedical Research Institute
- Responsible party
- Sponsor
- Investigators
- Walter Otieno, Doctor, Principal investigator, Victoria Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399003
- Sponsor's protocol ID
- SIBP-MMR-02
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age
- ClinicalTrials.gov ID
- NCT06399003
- Acronym / sponsor ID
- SIBP-MMR-02
- Conditions
- Measles-Mumps-Rubella
- Keywords
- Measles, Mumps and Rubella, Immunogenicity, Safety, 9-11 months of Age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Victoria Biomedical Research Institute
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed as a phase III, multi-center, randomized, observer blind active controlled non-inferiority study, enrolling 1200 healthy African children between the ages of 9-11 months. The enrolled children will be randomized to three groups in the ratio of 1:1:1 (400 children in each group) receiving a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed YF vaccine alone at 2nd dose on D43 (Group 1, MMR1YF2) or a single dose of GSK MMR vaccine alone at D1 (Group 2, GSK MMR1) or a single dose of SIBP MMR vaccine co-administered with YF vaccine on D1 (Group 3, MMR1YF1). This study will have an observer-blinded phase for Group 1 and Group 2 followed by an open label phase from Day 43. Group 3 will remain an open label arm throughout the period of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The enrolled children will be randomized to three groups in the ratio of 1:1:1 receiving different vaccines.
| Arm | Type | Receives |
|---|---|---|
| SIBP MMR vaccine group | Experimental | Biological: SIBP MMR Vaccine, Biological: Yellow Fever Vaccine (Stamaril)Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43. |
| GSK MMR vaccine group | Active comparator | Biological: GSK MMR Vaccine (PRIORIX)Received a single dose of GSK MMR vaccine alone at D1. |
| Joint vaccination group | Experimental | Biological: SIBP MMR Vaccine, Biological: Yellow Fever Vaccine (Stamaril)Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1. |
Who may qualify
- Ages
- 9 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy male and female child as established by medical history and clinical examination at enrollment.
- Age: 9-11 months (inclusive) at the time of enrollment
- 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.
- 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.
Key exclusion criteria (18 listed)
- Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusion until recovery)
- Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery)
- Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)
- Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study
- Presence of severe malnutrition (weight-for-height z-score < -3SD median)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIBP MMR VaccineThis is a live attenuated measles, mumps, and rubella combined vaccine (Shanghai MMR) in a freeze-dried powder form, developed and manufactured by Shanghai Institute of Biological Products. A single dose of 0.5 mL, containing not less than 3.0 log CCID50 of both live measles virus and rubella virus and 4.3 log CCID50 of live mumps virus. 0.5ml per dose. | Biological | Joint vaccination group, SIBP MMR vaccine group |
| GSK MMR Vaccine (PRIORIX)PRIORIX (combined measles, mumps and rubella vaccine, live, attenuated) is a lyophilized mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella). 0.5ml per dose. | Biological | GSK MMR vaccine group |
| Yellow Fever Vaccine (Stamaril)This is a live, attenuated, lyophilized yellow fever vaccine manufactured by Sanofi Pasteur Europe, Lyon, France. A single dose of 0.5 mL contains with not less than 1000 IU of yellow fever virus 17D-204 strain. 0.5ml per dose. | Biological | Joint vaccination group, SIBP MMR vaccine group |
Primary outcome
Difference of seropositivity rate
Time frame: 42 days
An evaluation of seropositivity rate to Measles, Mumps and Rubella viruses of SIBP MMR vaccine versus GSK MMR vaccine when measured 42 days after vaccination in seronegative children at baseline.
12 secondary outcomes
The percentage of immediate adverse events (AEs)
Time frame: 30 minutes
The percentage of solicited local reactogenicity
Time frame: 7 days
The percentage of solicited systemic reactogenicity
Time frame: 14 days
The percentage of unsolicited AEs
Time frame: 42 days
The percentage of serious adverse events (SAEs)
Time frame: 42 days
Geometric mean titer (GMT) of Yellow Fever
Time frame: 42 days
Geometric mean concentration (GMC) of Measles
Time frame: 42 days
Geometric mean concentration (GMC) of Mumps
Time frame: 42 days
Geometric mean concentration (GMC) of Rubella
Time frame: 42 days
Seropositivity rate of Measles
Time frame: 42 days
Seropositivity rate of Mumps
Time frame: 42 days
Seropositivity rate of Rubella
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Otieno, Doctor principal investigator
Victoria Biomedical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIBP MMR Vaccine, GSK MMR Vaccine (PRIORIX) and Yellow Fever Vaccine (Stamaril) in people with Measles-Mumps-Rubella, run by Shanghai Institute Of Biological Products at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of seropositivity rate (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.