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Also known as Haemophilus influenzae type b vaccine, Haemophilus influenzae type b (Hib) vaccine
Haemophilus influenzae type b · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Haemophilus influenzae type b (Hib) vaccine | BIOLOGICAL | Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines |
| Haemophilus influenzae type b vaccine | BIOLOGICAL | 3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine |
| Commercial Haemophilus influenzae type b vaccine | BIOLOGICAL | 3 doses one month apart of Haemophilus influenzae type b vaccine. |
| Haemophilus influenzae type b | BIOLOGICAL | 1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months |
Inclusion Criteria: * Infants 365-569 days of age. Exclusion Criteria: * Subjects who already received a booster dose of Hib vaccine. * History of serious reaction(s) following vaccination. * Any vaccination within 7 days of study vaccination. * Known or suspected immune impairment.
Haemophilus influenzae type b vaccine is used to prevent Haemophilus influenzae type b (Hib) infection, a bacterial disease that can cause serious illness in infants and young children. The vaccine is given to healthy infants and children, with clinical studies conducted in children from 2 months of age and older.
Novartis AG, which trades under the ticker NVS, is the developer of this Haemophilus influenzae type b vaccine. The company has sponsored Phase 3 and Phase 1 clinical trials of the vaccine in China, evaluating its immunogenicity, safety, and reactogenicity in healthy infants and children.
The Haemophilus influenzae type b vaccine is in Phase 3 development. Multiple Phase 3 trials have been completed, including studies of a booster dose and comparisons against a tetanus toxoid-conjugated vaccine. It is an investigational product and is not described as approved.
Completed trials include NCT01226953, a Phase 3 booster dose study in 365 to 569 day old infants; NCT01044316, a Phase 3 comparison against a tetanus toxoid-conjugated vaccine in infants 6 to 12 months old; NCT00808392, a Phase 3 safety and immunogenicity study; and NCT00734565, a Phase 1 safety and reactogenicity study.
Yes. Haemophilus influenzae type b vaccine is also known as the Haemophilus influenzae type b (Hib) vaccine. These names refer to the same product, a monovalent glycoprotein-conjugated vaccine developed by Novartis AG for the prevention of Haemophilus influenzae type b infection.
The Haemophilus influenzae type b vaccine trials enrolled a total of 1,330 participants across four completed studies. Enrollment ranged from 40 participants in the Phase 1 study to 916 in a Phase 3 safety and immunogenicity trial, and all studies were conducted in China with healthy volunteers.