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Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) | BIOLOGICAL | a single dose was administered |
| Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) | BIOLOGICAL | a single dose was administered |
Inclusion Criteria: * Infants 13-59 months of age. Exclusion Criteria: * Prior Hib vaccine administration. * History of serious reaction(s) following vaccination. * Any vaccination within 7 days of study vaccination. * Known or suspected immune impairment. * Premature (before 37th week of gestati...
It is a vaccine intended to prevent Haemophilus influenzae type b (Hib) infection. Hib is a bacterial pathogen that can cause serious invasive disease, particularly in young children. This vaccine candidate is designed for use in healthy children aged 13 to 59 months, and it is being developed by Novartis AG.
Novartis AG, which trades under the ticker NVS, is the developer of the monovalent glyco-conjugated vaccine against Haemophilus influenzae type b. The vaccine is being studied for the prevention of Hib infection in children, and Novartis is the company associated with its clinical development program.
The monovalent glyco-conjugated vaccine against Haemophilus influenzae type b is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine remains investigational and is not described as approved by the FDA.
The vaccine has been evaluated in one completed Phase 3 trial, NCT01125527, titled Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diphtheria Toxin-CRM197) Hib Vaccine in 13-59 Months Old Healthy Children. The trial enrolled 700 participants in China, was randomized, and used an active-controlled design.
Yes, the monovalent glyco-conjugated vaccine against Haemophilus influenzae type b is also known as the monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib). The Hib abbreviation refers to Haemophilus influenzae type b, the bacterial infection this vaccine candidate is designed to prevent.