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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 Disease
NCT00158808175
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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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Competitive Landscape -Alzheimer's Disease 66 trials (matched to "Hib Disease")

Top 20 of 24 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC
Eli Lilly and CompanyLLY12PHASE3Donanemab, Dexamethasone
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Merck & Co., Inc.MRK1PHASE2MK-2214
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, Inc.IGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Denali Therapeutics Inc.DNLI1PHASE1DNL628
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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