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DTwP-HepB-Hib-IPV hexavalent vaccine · 1 trial · 8 indications
Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered
Ab against pertussis antigens will be measured
| Arm | Type | Description |
|---|---|---|
| Group A - Intervention regimen | EXPERIMENTAL | SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine \[PCV\] \[Prevnar 13®\] and oral rotavirus vaccine \[ORV-1\] \[Rotarix™\] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months |
| Group B - Control regimen | ACTIVE_COMPARATOR | SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine \[IPV\] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age |
| Name | Type | Description |
|---|---|---|
| DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus) | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b) | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Inactivated Poliomyelitis Vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Poliomyelitis Vaccine bivalent types 1 and 3 | BIOLOGICAL | Pharmaceutical form:Oral suspension Route of administration: Oral |
| Human Rotavirus, live attenuated | BIOLOGICAL | Pharmaceutical form:Oral suspension Route of administration: Oral |
| Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
Inclusion criteria : * Aged ≥ 2 months (age range of 8 weeks \<12 weeks) on the day of the first vaccination * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or medically stable prematurely born infants (born after a gestational period of 27-36 weeks) * Infants who hav...