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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,200
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.
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.
Victoria Biomedical Research Institute(VIBRI)
Kisumu, Kenya
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.
Time frame: 42 days
The percentage of immediate adverse events (AEs)
The percentage of any adverse events in subjects within 30 minutes after each vaccination.
Time frame: 30 minutes
The percentage of solicited local reactogenicity
The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination.
Time frame: 7 days
The percentage of solicited systemic reactogenicity
The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination.
Time frame: 14 days
The percentage of unsolicited AEs
The percentage of unsolicited AEs in subjects through 42 days after each vaccination.
Time frame: 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.
Time frame: 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.
Time frame: 42 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Geometric mean concentration (GMC) of Measles
Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination.
Time frame: 42 days
Geometric mean concentration (GMC) of Mumps
Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination.
Time frame: 42 days
Geometric mean concentration (GMC) of Rubella
Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination.
Time frame: 42 days
Seropositivity rate of Measles
Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination.
Time frame: 42 days
Seropositivity rate of Mumps
Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination.
Time frame: 42 days
Seropositivity rate of Rubella
Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination.
Time frame: 42 days