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Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Concomitant administration of MenC-TT vaccine and PCV7, 170 subjects |
| 2 | ACTIVE_COMPARATOR | PCV7 administration only, 85 subjects |
| 3 | ACTIVE_COMPARATOR | MenC-TT vaccine only, 85 subjects |
| Name | Type | Description |
|---|---|---|
| Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) | BIOLOGICAL | MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle, PCV7 (0.5 ml) to be administered in the right thigh muscle |
| 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) | BIOLOGICAL | PCV7 (0.5 ml) to be administered in the right thigh muscle |
| Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) | BIOLOGICAL | MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle |
Inclusion Criteria: Male and female subjects will be eligible for participation in this study if: * they are toddlers, aged 12 to 18 months * they are clinically healthy (i.e. the physician would have no reservations vaccinating with a MenC conjugate vaccine, and/or PCV7 outside the scope of a cli...
It is a combination vaccine approach studied in toddlers, pairing a Group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine with a 7-valent pneumococcal CRM197-conjugate vaccine. The study evaluated safety and immune response in children who had already been immunized with PCV7, targeting protection against Neisseria meningitidis and invasive pneumococcal disease.
It is used for immunization against Neisseria meningitidis, the bacterium that causes bacterial meningitis, in toddlers. The trial also covered invasive pneumococcal disease as a condition of interest. The vaccine combination was given to children 12 months and older who had previously received PCV7, with the goal of broadening protection against these bacterial infections.
Pfizer, Inc. is the developer of this vaccine combination, traded under the ticker PFE. Pfizer conducted the Phase 3 study evaluating the MenC-TT vaccine alongside the 7-valent pneumococcal CRM197-conjugate vaccine in toddlers. The company holds the development program for both components of this combination immunization approach.
The vaccine combination is in Phase 3 development. One Phase 3 trial has been completed, with no active trials currently listed. The study enrolled 330 participants and was randomized and active-controlled, though not double-blind. It was conducted in Germany among healthy volunteers aged 12 months and older.
The vaccine combination was studied in clinical trial NCT00617760, titled Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar). This Phase 3 trial enrolled 330 participants in Germany, was randomized and active-controlled, and has been completed. It included healthy volunteers aged 12 months and older.