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DTPw-HBV/Hib-MenAC conjugate vaccine

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,525

FDA Designations

No designations recorded

Clinical trial landscape

DTPw-HBV/Hib-MenAC conjugate vaccine · 5 trials · 9 indications

Phase 3 3Phase 2 2
NCT00317122Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at BirthDiphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
COMPLETED192 Analytics
NCT00317161Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.Diphtheria
COMPLETED1,000 Analytics
NCT00290303Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy InfantsHaemophilus Influenzae Type b
COMPLETED996 Analytics
PHASE3COMPLETED
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
NCT00317122192
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PHASE3COMPLETED
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
Diphtheria
NCT003171611,000
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PHASE3COMPLETED
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
Haemophilus Influenzae Type b
NCT00290303996
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Study Endpoints

Primary Endpoints

One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
Post-dose 3, bactericidal titers & antibody levels to meningococcal serogroups A & C; & PRP; & antibody levels to HBs, diphtheria, tetanus & BPT (subset of subjects).
Immunogenicity: One month post-dose 3, measurement of serum bactericidal titers against meningococcal serogroups A & C (SBA-MenA; SBA-MenC), anti-PRP, anti-HBs & anti-diphtheria concentrations; & in some subjects anti-tetanus & anti-BPT concentrations.
Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.
One month after the third dose of the primary vaccination course, measurement of serum bactericidal titers against meningococcal serogroups A and C (SBA-MenA; SBA-MenC) and anti-PRP antibody concentration.

Secondary Endpoints

Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.
Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"
Solicited events (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study). Pre-dose 1, antibody levels to Men(A&C) & PRP; & in some subjects anti-BPT antibody levels Seropositivity/seroprotection/vaccine response & antibody levels
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
DTPw-HBV/Hib-MenAC conjugate vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range4 Days to 10 Days
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion criteria: * Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria: * Known exposure to diphtheria, tetanus, pertu...

Countries:South AfricaThailandPhilippines
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Frequently asked questions about DTPw-HBV/Hib-MenAC conjugate vaccine

What is DTPw-HBV/Hib used for?

DTPw-HBV/Hib is an investigational combination vaccine studied for preventing diphtheria, tetanus, whole cell pertussis, hepatitis B, and Haemophilus influenzae type b disease in infants. It is being developed by GSK plc (GSK) and has completed Phase 3 clinical trials.

Who makes DTPw-HBV/Hib?

DTPw-HBV/Hib is developed by GSK plc, traded as GSK on the stock exchange. The vaccine is intended for pediatric immunization against multiple infectious diseases including diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b.

What phase is DTPw-HBV/Hib in?

DTPw-HBV/Hib is in Phase 3 clinical development. It is investigational and not yet approved. Two Phase 3 trials have been completed, along with one Phase 2 trial, all with healthy infant participants.

What clinical trials is DTPw-HBV/Hib in?

DTPw-HBV/Hib has completed trials NCT00317122 and NCT00317161, both Phase 3 studies in infants. NCT00317122 enrolled 192 participants in South Africa, while NCT00317161 enrolled 1,000 participants in Thailand. A Phase 2 trial NCT00291967 enrolled 525 infants in the Philippines.

Is DTPw-HBV/Hib the same as Tritanrix-HepB/Hiberix?

DTPw-HBV/Hib is being compared to Tritanrix-HepB/Hiberix in clinical trials. In NCT00317122, the immune response following primary vaccination with Tritanrix-HepB/Hib-MenAC was compared to Tritanrix-HepB/Hiberix in infants.

What is the enrollment and design of DTPw-HBV/Hib trials?

DTPw-HBV/Hib trials enrolled a total of 1,525 participants across two completed studies. The trials were randomized, double-blind, and actively controlled, involving healthy infants aged from 4 days to 56 days in countries including South Africa, Thailand, and the Philippines.