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Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Feb 1, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment1,167

FDA Designations

No designations recorded

Clinical trial landscape

Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar · 1 trial · 5 indications

Phase 3 1
NCT00772928Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™Diphtheria
COMPLETED1,167 Analytics
PHASE3COMPLETED
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
DiphtheriaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
28 to 48 days post-3rd vaccination

Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.

Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
60 Days Post-dose 3

Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Pentacel™ concurrently with Prevnar®EXPERIMENTALParticipants had Pentacel™ concurrently administered with Prevnar®
Pentacel™ staggered schedule with Prevnar®EXPERIMENTALParticipants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).

Interventions

NameTypeDescription
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®BIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range42 Days to 89 Days
SexALL
Healthy VolunteersYes
Study Sites23

Inclusion Criteria : * Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age. * Infants with at least 36 weeks of gestation at delivery. * Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines). * Able to attend the schedul...

Countries:United States
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Frequently asked questions about Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar

What is Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar used for?

Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar is used for diphtheria, tetanus, Haemophilus infection, pertussis, and polio. It is an investigational combination vaccine being studied in the infectious disease therapeutic area. The drug is currently in Phase 3 clinical development.

Who makes Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar?

Sanofi (ticker: SNY) is developing Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar. The company is conducting clinical trials for this vaccine candidate, which is being studied for the prevention of diphtheria, tetanus, Haemophilus infection, pertussis, and polio.

What phase is Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar in?

Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with a total enrollment of 1,167 participants.

What clinical trials is Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar in?

Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar has one completed Phase 3 trial, NCT00772928, titled 'Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™'. The trial enrolled 1,167 participants in the United States, including healthy volunteers aged 42 days and older.

Is Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar the same as Prevnar?

Pentacel: HCPDT-IPV/PRP-T Vaccine and Prevnar is a combination vaccine that includes both Pentacel (HCPDT-IPV/PRP-T) and Prevnar (pneumococcal conjugate vaccine). The clinical trial NCT00772928 studied the effect of Prevnar on the immunogenicity of Pentacel, indicating they are separate vaccine components studied together.