Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: * To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV) * To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group * To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group * To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV * To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™ * To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines
The duration of each participant's active participation in the study will be approximately 14-17 months (416-506 days) in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation 10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131 Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
460
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Oral suspension Route of administration: Oral
Pharmaceutical form:Oral suspension Route of administration: Oral
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Investigational Site Number 7640003
Bangkok, Thailand
Investigational Site Number 7640001
Bangkok, Thailand
Investigational Site Number 7640002
Khon Kaen, Thailand
Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens
Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered
Time frame: 28 days after the third dose (Day 148)
Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens
Ab against pertussis antigens will be measured
Time frame: 28 days after the third dose (Day 148)
Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
Ab titers against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with a vaccine response for pertussis antigens
Pertussis antigens vaccine response Threshold values will be considered
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Pertussis antigens vaccine seroconversion
Ab against pertussis antigens will be measured
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants
Ab concentrations against all the antigens, including anti-rotavirus and anti-S. pneumoniae for a subset of participants, will be measured The ratio calculated will be: (post dose 3/pre-primary)
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants
Ab concentrations against each antigen, including anti rotavirus and anti pneumococcal serotypes for a subset of participants, will be measured
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants
Ab against rotavirus will be measured in a subset of participants Threshold values will be considered
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants
Anti-pneumococcal Ab will be measured in a subset of participants Threshold values will be considered
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
Ab against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Number of participants with a booster response for pertussis antigens
Pertussis antigens booster response Threshold values will be considered
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Pertussis antigens vaccine seroconversion
Ab against pertussis antigens will be measured
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
GMCRs of Ab against all the antigens
Ab concentrations against all the antigens will be measured The ratio calculated will be: (post booster/pre-booster)
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
GMCs of Ab against each antigen
Ab concentrations against each antigen will be measured
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
aGMCs of Ab against pertussis antigens
Ab against pertussis antigens will be measured, adjusted for baseline value
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Number of participants reporting immediate systemic adverse events (AEs)
Unsolicited (spontaneously reported) systemic AEs
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and systemic reactions
Solicited injection site reactions: \- tenderness, erythema and site swelling Solicited systemic reactions: \- fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability
Time frame: Up to 7 days post-vaccination
Number of participants reporting unsolicited non-serious AEs
Unsolicited non-serious AEs
Time frame: Up to 28 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs
Time frame: Up to Day 416-506
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