The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® \[Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)\] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study.
In this open label, prospective, bridging study, 300 healthy infants and toddlers will be recruited into the study three pre-defined age groups: Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months Study subjects will be vaccinated PNEUMOSIL® with the primary doses: Age group 1 with 3 doses, Age group 2 and Age group 3 with 2 doses. Immunogenicity blood sample for Immunoglobulin G (IgG) will be taken in 35 subjects who completed primary dose series.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Study subjects will be vaccinated PNEUMOSIL® with the primary doses as described below: Group 1: 3 doses, 4 to 8 week interval Group 2: 2 doses, dose interval \> 1 month Group 3: 2 doses, dose interval \> 2 months
Percent of participants with immediate solicited adverse events (AEs), serious adverse events (SAEs) at least 30 minutes after each study vaccine administration.
The incidence and severity of immediate solicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.
Time frame: 30 minutes after each vaccination
Percent of participants with solicited AEs, SAEs within 7 days after each study vaccine administration.
The incidence and severity of solicited local and systemic AEs, SAEs within 7 days after each dose of the study vaccine.
Time frame: within 7 days after each vaccination
Percent of participants with solicited AEs, SAEs within 28 days after each dose of the study vaccine.
The incidence and severity of solicited local and systemic AEs, SAEs within 28 days after each dose of the study vaccine
Time frame: within 28 days after each vaccination
Percent of participants with immediate unsolicited AEs, SAEs at least 30 minutes after each study vaccine administration.
The incidence and severity of immediate unsolicited local and systemic AEs, SAEs at least 30 minutes observation after each dose of the study vaccine.
Time frame: 30 minutes after each vaccination
Percent of participants with unsolicited AEs, SAEs until 28 days after the last primary dose.
Percent of participants with unsolicited local and systemic AEs, SAEs from the first primary dose to 28 days after the last primary dose vaccination.
Time frame: From the first primary dose to 28 days after the last primary dose vaccination.
Geometric mean (μg/mL) of IgG concentration for each serotype at 28 days after the last primary dose.
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Time frame: at 28 days after the last primary dose.
Proportion of patients achieving seroconversion with IgG > 0.35 μg/mL as defined by WHO at 28 days after the last primary dose.
Time frame: at 28 days after the last primary dose.