Recent Updates
Recently added Catalysts

Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine

Phase 3

Neisseria Meningitidis (Bacterial Meningitis) | 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 Enrollment330

FDA Designations

No designations recorded

Clinical trial landscape

Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine · 1 trial · 2 indications

Phase 3 1
NCT00617760Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)Neisseria Meningitidis (Bacterial Meningitis)
COMPLETED330 Analytics
PHASE3COMPLETED
Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)
Neisseria Meningitidis (Bacterial Meningitis)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects achieving PCV7-specific (elicited by each vaccine pneumococcal serotype) antibody concentrations of at least 0.2 mg/mL 1 month after a booster vaccination with PCV7
1 month after booster vaccination with PCV7
Number of subjects achieving sero-protective levels of meningococcal serogroup C (MenC) specific serum bactericidal activity (SBA), defined as titer >=1:8, 1 month after administration of MenC-TT vaccine
1 month after administration of MenC-TT vaccine
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALConcomitant administration of MenC-TT vaccine and PCV7, 170 subjects
2ACTIVE_COMPARATORPCV7 administration only, 85 subjects
3ACTIVE_COMPARATORMenC-TT vaccine only, 85 subjects

Interventions

NameTypeDescription
Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)BIOLOGICALMenC-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)BIOLOGICALPCV7 (0.5 ml) to be administered in the right thigh muscle
Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)BIOLOGICALMenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle
Unlock Study Design Details

Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites27

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...

Countries:Germany
Unlock Eligibility Criteria