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Also known as NeisVac-C
Meningococcal group C polysaccharide conjugate vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age |
| Group 2 | EXPERIMENTAL | Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age |
| Group 3 | ACTIVE_COMPARATOR | Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age |
| Name | Type | Description |
|---|---|---|
| Meningococcal group C polysaccharide conjugate vaccine | BIOLOGICAL | 0.5 mL dose, subcutaneous administration in right anterolateral thigh |
| Pneumococcal 13-valent conjugate vaccine | BIOLOGICAL | 0.5 mL dose, subcutaneous administration in right anterolateral thigh |
| Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine | BIOLOGICAL | 0.5 mL dose, subcutaneous administration in right anterolateral thigh |
Inclusion Criteria: * Subject is an infant aged 8 to 11 weeks at the time of first vaccination * Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination * Subject was born at full term of pregnancy (\>= 37 we...
It is used to protect against Neisseria meningitidis, the bacterium that causes meningococcal disease. The vaccine targets group C meningococcal infection and is given to infants and other at-risk groups. It is a conjugate vaccine, meaning the polysaccharide is linked to a carrier protein to improve the immune response.
Pfizer, Inc. is the developer of this meningococcal group C polysaccharide conjugate vaccine. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company conducted the clinical development program for the vaccine, including a Phase 3 study in infants.
The meningococcal group C polysaccharide conjugate vaccine has completed a Phase 3 clinical trial. It is an investigational vaccine that has been studied in late-stage clinical development. The Phase 3 trial, NCT01218451, has been completed, and no active trials are currently listed for this asset.
The vaccine was evaluated in a single Phase 3 trial, NCT01218451, titled NeisVac-C Single Prime Study in Infants. The trial enrolled 956 healthy infants aged 8 weeks and older in Poland and Spain. It was randomized and active-controlled, and the study has been completed.
The vaccine is a conjugate vaccine that presents Neisseria meningitidis group C polysaccharide linked to a carrier protein. This design helps generate a stronger and more durable immune response against group C meningococcal bacteria, particularly in infants, compared with plain polysaccharide vaccines.