The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
302
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, Philippines
De La Salle University Medical Center
Dasmariñas, Philippines
Philippine General Hospital
Manila, Philippines
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Number of participants with solicited local and systemic AEs will be determined up to 7 days after first vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Time frame: 7 days after first vaccination
Number of Participants with Solicited Local and Systemic AEs
Number of participants with solicited local and systemic AEs will be determined up to 7 days after second vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Time frame: 7 days after second vaccination
Number of Participants with Solicited Local and Systemic AEs
Number of participants with solicited local and systemic AEs will be determined up to 7 days after third vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Time frame: 7 days after third vaccination
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be determined up to 28 days after first vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
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Time frame: 28 days after first vaccination
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be determined up to 28 days after second vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Time frame: 28 days after second vaccination
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be determined up to 28 days after third vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Time frame: 28 days after third vaccination
Number of Participants with Serious Adverse Events (SAEs)
Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Approximately up to 36 weeks
Number of Participants Discontinued due to AEs
Number of participants discontinued from vaccinations or from the study due to AEs will be reported.
Time frame: Approximately up to 36 weeks
Percentage of Participants with Seroprotection
Percentage of participants with seroprotection will be reported. Seroprotection is defined as having a poliovirus neutralizing antibody (NAb) titer greater than or equal to (\>=)8 at 28 days after the third vaccination for each poliovirus strain against Salk virus neutralization assay (VNA).
Time frame: 28 days after the third vaccination
Percentage of Participants with Seroconversion
Percentage of participants with seroconversion will be reported. Seroconversion is defined as: 1) Pre-vaccination poliovirus NAb titer less than (\<)8 and post-vaccination NAb \>=8 at 28 days after the third vaccination for each poliovirus strain against Salk VNA, or 2) Pre-vaccination poliovirus NAb titer \>=8 and post vaccination \>=4 fold increase in poliovirus NAb titer (with correction for maternal-antibody decline at Week 18, with a half-life of maternal antibodies of 1 month), at 28 days after the third vaccination for each poliovirus strain against Salk VNA.
Time frame: 28 days after the third vaccination
Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses
Poliovirus NAb titers will be determined against the wild-type Salk strains (Type 1 \[Mahoney\], Type 2 \[MEF-1\] and Type 3 \[Saukett\]) as well as against the Sabin strains (Types 1, 2 and 3), in accordance with the World Health Organization (WHO) recommendations for immunogenicity assessment of inactivated poliovirus vaccine (IPV).
Time frame: 28 days after the third vaccination