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Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib

Phase 2

Hib Disease | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 30, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib · 1 trial · 5 indications

Phase 2 1
NCT00158808Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 MthsHib Disease
COMPLETED175 Analytics
PHASE2COMPLETED
Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths
Hib DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine).

Secondary Endpoints

Immunology
At the time of the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
One month after the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Diphteria, tetanus, whole-cell pertussis, hepatitis B & HibBIOLOGICAL -
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Eligibility Criteria

Age Range15 Months to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if ...

Countries:Philippines
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Frequently asked questions about Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib

What is Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib used for?

Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib is a combination vaccine formulation studied for protection against Hib disease along with diphtheria, tetanus, pertussis, and hepatitis B. It is being developed by GSK plc as a pediatric vaccine candidate intended for prophylactic immunization in young children.

Who makes Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib?

GSK plc, which trades under the ticker GSK, is the developer of the Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib vaccine formulation. The company sponsored the clinical trial evaluating this combination vaccine candidate.

What phase is Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib in?

Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib is in Phase 2 development. It is an investigational combination vaccine candidate and is not described as approved. The Phase 2 trial evaluating this formulation has been completed.

What clinical trials is Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib in?

Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib was evaluated in one completed Phase 2 trial, NCT00158808. The study enrolled 175 healthy volunteers aged 15 months and older in the Philippines and assessed immune memory and reactogenicity of a booster dose given at 15 to 18 months.

How was the Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib trial designed?

The Phase 2 trial NCT00158808 was a randomized study with 175 healthy volunteers aged 15 months and older in the Philippines. It was an uncontrolled trial, meaning it did not use a comparator control arm, and it evaluated a booster dose administered at 15 to 18 months of age.