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Pediarix TM, Infanrix penta TM

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 7, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Pediarix TM, Infanrix penta TM · 1 trial · 5 indications

Phase 3 1
NCT00879827Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy InfantsDiphtheria
COMPLETED60 Analytics
PHASE3COMPLETED
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
DiphtheriaUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-PT, anti-FHA and anti-PRN antibody titers.
One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
One month after the 3rd dose of the primary vaccination course

Secondary Endpoints

Occurrence of solicited adverse events
During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events
During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events
Over the course of the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Single GroupEXPERIMENTAL -

Interventions

NameTypeDescription
Pediarix TM, Infanrix penta TMBIOLOGICALThe vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Hiberix TMBIOLOGICALThe vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
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Eligibility Criteria

Age Range6 Weeks to 8 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female infant between 6 and 8 weeks of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guard...

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Frequently asked questions about Pediarix TM, Infanrix penta TM

What is Pediarix TM, Infanrix penta TM used for?

Pediarix TM, Infanrix penta TM is a combination vaccine used for immunization against diphtheria, poliomyelitis, hepatitis B, tetanus, and acellular pertussis in infants. It is being developed by GSK plc for the prevention of these infectious diseases.

Who makes Pediarix TM, Infanrix penta TM?

Pediarix TM, Infanrix penta TM is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is intended for use in infants to protect against multiple infectious diseases.

What phase is Pediarix TM, Infanrix penta TM in?

Pediarix TM, Infanrix penta TM is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under clinical investigation.

What clinical trials is Pediarix TM, Infanrix penta TM in?

Pediarix TM, Infanrix penta TM has one completed Phase 3 clinical trial, identified as NCT00879827. This trial evaluated the immunogenicity and reactogenicity of the vaccine when coadministered to healthy infants aged 6 weeks and older.

Is Pediarix TM the same as Infanrix penta TM?

Yes, Pediarix TM and Infanrix penta TM are alternative names for the same vaccine product developed by GSK plc. The vaccine is designed to protect against diphtheria, poliomyelitis, hepatitis B, tetanus, and acellular pertussis.