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| Name | Class |
|---|---|
| Victoria Biomedical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| GSK MMR vaccine group | Active Comparator | Received a single dose of GSK MMR vaccine alone at D1. |
|
| Joint vaccination group | Experimental | Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIBP MMR Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of immediate adverse events (AEs) | The percentage of any adverse events in subjects within 30 minutes after each vaccination. | 30 minutes |
| The percentage of solicited local reactogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Otieno, Doctor | Victoria Biomedical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Biomedical Research Institute(VIBRI) | Kisumu | Kenya |
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| ID | Term |
|---|---|
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| D022341 | Yellow Fever Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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The enrolled children will be randomized to three groups in the ratio of 1:1:1 receiving different vaccines.
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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.
|
| 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. |
|
The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination.
| 7 days |
| The percentage of solicited systemic reactogenicity | The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination. | 14 days |
| The percentage of unsolicited AEs | The percentage of unsolicited AEs in subjects through 42 days after each vaccination. | 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. | 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. | 42 days |
| Geometric mean concentration (GMC) of Measles | Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination. | 42 days |
| Geometric mean concentration (GMC) of Mumps | Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination. | 42 days |
| Geometric mean concentration (GMC) of Rubella | Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination. | 42 days |
| Seropositivity rate of Measles | Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination. | 42 days |
| Seropositivity rate of Mumps | Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination. | 42 days |
| Seropositivity rate of Rubella | Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination. | 42 days |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |