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Tdap · 1 trial · 2 indications
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
| Arm | Type | Description |
|---|---|---|
| 3ABCWY | EXPERIMENTAL | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study |
| 2ABCWY | EXPERIMENTAL | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study |
| 3ABx2CWY | EXPERIMENTAL | two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study |
| 2ABx2CWY | EXPERIMENTAL | two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study |
| 3ABCWY+OMV | EXPERIMENTAL | Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study |
| 2ABCWY+OMV | EXPERIMENTAL | Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study |
| 3ABCWYqOMV | EXPERIMENTAL | Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study |
| 2ABCWYqOMV | EXPERIMENTAL | Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study |
| 3B | ACTIVE_COMPARATOR | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study |
| 2B | ACTIVE_COMPARATOR | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study |
| 1ACWY | ACTIVE_COMPARATOR | One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study |
| Name | Type | Description |
|---|---|---|
| Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine | BIOLOGICAL | The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine |
| Meningococcal (group B) multicomponent recombinant adsorbed vaccine | BIOLOGICAL | Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine |
| Tdap | BIOLOGICAL | Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection |
Inclusion Criteria: Individuals eligible to be enrolled into this study were male or female who completed study V102\_02 (primary study), and: 1. who were 11 to 18 years at the time of enrollment in primary study; 2. who had given their written consent at the time of enrollment; 3. who were availa...
Tdap is an investigational vaccine being studied for the prevention of meningococcal disease and meningococcal meningitis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Tdap is being developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Tdap is in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. One Phase 2 trial has been completed, and the vaccine remains under study.
Tdap has one completed Phase 2 clinical trial, identified as NCT01367158. This study evaluated the safety, tolerability, and immunogenicity of a third dose of a combination vaccine in adolescents who had previously received the same study vaccines.
No, Tdap is not a monoclonal antibody. Although the modality is listed as a monoclonal antibody, Tdap is a vaccine designed to elicit an immune response against meningococcal disease. It is being studied in a randomized, active-controlled trial.
The completed Phase 2 clinical trial for Tdap, NCT01367158, enrolled 440 participants. The study was conducted in Chile, Colombia, and Panama, and included healthy volunteers aged 11 years and older.