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Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec

Phase 3

Poliomyelitis | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jan 6, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment480

FDA Designations

No designations recorded

Clinical trial landscape

Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec · 1 trial · 5 indications

Phase 3 1
NCT00352963Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).Poliomyelitis
COMPLETED480 Analytics
PHASE3COMPLETED
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
Poliomyelitis
NCT00352963480
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Study Endpoints

Primary Endpoints

At M7: Antibodies to PRP, MenC HBsAg

Secondary Endpoints

At M7: Abs. to all vaccine antigens
At M6: Abs. to PRP & MenC
Solicited (D0-3); unsol. events (D0-30); SAEs (full study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Study vaccines: IH+Hib-MenC/NVC; Control: IH+MeningitecBIOLOGICAL -
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Eligibility Criteria

Age RangeN/A to 7 Days
SexALL
Healthy VolunteersYes
Study Sites22

Inclusion Criteria: * Healthy male or female infant between, \& including, 0 \& 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 \& 42 weeks). * Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: * Use of any ...

Countries:Spain
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