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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...
DTwP-HepB-Hib-IPV hexavalent vaccine is a combination vaccine designed to protect against six diseases in a single product: diphtheria, tetanus, whole cell pertussis, hepatitis B, Haemophilus influenzae type b, and poliovirus. It is being developed by Sanofi (ticker SNY) for pertussis immunisation and related pediatric infectious disease indications.
DTwP-HepB-Hib-IPV hexavalent vaccine is intended for pediatric immunisation against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and polio. Its lead indication is pertussis immunisation, and the clinical program has studied it in healthy infants and toddlers, including concomitant use with routine pediatric vaccines.
Sanofi, which trades under the ticker SNY, is the developer of the DTwP-HepB-Hib-IPV hexavalent vaccine. The vaccine also appears in its clinical program under the name SHAN6.
DTwP-HepB-Hib-IPV hexavalent vaccine is in Phase 3 development. It is an investigational combination vaccine and is not described as approved. One Phase 3 trial has been completed, and no trials are currently listed as active.
DTwP-HepB-Hib-IPV hexavalent vaccine has been evaluated in one completed Phase 3 trial, NCT04429295. That study enrolled 460 healthy infants and toddlers in Thailand, starting at 8 weeks of age, and examined the vaccine given concomitantly with routine pediatric vaccines. It was randomized and active-controlled.
Yes. SHAN6 is the name used for the DTwP-HepB-Hib-IPV hexavalent vaccine in its clinical trial, NCT04429295. The full name describes its six components: diphtheria toxoid, tetanus toxoid, whole cell pertussis, hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, and inactivated poliovirus.