Recent Updates
Recently added Catalysts

Meningococcal group C polysaccharide conjugate vaccine

Phase 3

Neisseria Meningitidis | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: May 21, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment956

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal group C polysaccharide conjugate vaccine · 1 trial · 1 indication

Phase 3 1
NCT01218451NeisVac-C Single Prime Study in InfantsNeisseria Meningitidis
COMPLETED956 Analytics
PHASE3COMPLETED
NeisVac-C Single Prime Study in Infants
Neisseria Meningitidis
NCT01218451956
Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects with seroprotective antibody titers (rSBA titers >= 8) 1 month after completion of the primary vaccination in single-dose groups compared to the two-dose group
1 month
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
6 to 9 months (from 4-6 months of age until 12-13 months of age)
Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose
1 month after booster dose (administered between 12-13 months of age)

Secondary Endpoints

Antibody titers (rSBA) titers one month after completion of the primary vaccination
1 month after primary vaccination
Antibody titers (rSBA titers) prior to the administration of the booster dose
Prior to booster dose
Antibody titers (rSBA titers)one month after the administration of the booster dose
1 month after administration of booster dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALSingle 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 2EXPERIMENTALSingle 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 3ACTIVE_COMPARATORTwo 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

Interventions

NameTypeDescription
Meningococcal group C polysaccharide conjugate vaccineBIOLOGICAL0.5 mL dose, subcutaneous administration in right anterolateral thigh
Pneumococcal 13-valent conjugate vaccineBIOLOGICAL0.5 mL dose, subcutaneous administration in right anterolateral thigh
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccineBIOLOGICAL0.5 mL dose, subcutaneous administration in right anterolateral thigh
Unlock Study Design Details

Eligibility Criteria

Age Range8 Weeks to 11 Weeks
SexALL
Healthy VolunteersYes
Study Sites24

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...

Countries:PolandSpain
Unlock Eligibility Criteria