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Tests treatment safety and results for Diphtheria
Official title A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
ClinicalTrials.gov ID: NCT06947499
What this study is testing
What is LBVD?
LBVD is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for diphtheria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 8. Healthy volunteers may be eligible.
You may be able to join if
- healthy infants from 6 weeks to 8 weeks of age (both inclusive)
- body weight ≥ 3.2 kg
- born at full term pregnancy (≥ 37 weeks)
- signed informed consent by parent(s) or legally acceptable representative(s)
You likely can't join if
- Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
- Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to...
- Known history of SARS-CoV-2 infection
- Participant's mother is HepB antigen or HIV positive
- Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment
- Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette...
See the full eligibility criteria
- healthy infants from 6 weeks to 8 weeks of age (both inclusive)
- body weight ≥ 3.2 kg
- born at full term pregnancy (≥ 37 weeks)
- signed informed consent by parent(s) or legally acceptable representative(s)
- Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
- Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
- Known history of SARS-CoV-2 infection
- Participant's mother is HepB antigen or HIV positive
- Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment
- Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)
- Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
- Received immunosuppressive agents or other immune-modifying drugs
- Previous use of blood or blood-derived products
- Any history of allergy (hypersensitivity) to any of the vaccine components
- Participation in another treatment clinical trial within 4 weeks of expected first vaccination
The study team makes the final eligibility decision.
Where it's taking place
- Dasmariñas, Cavite, Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 weeks to 8 weeks. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dasmariñas, Cavite, Philippines. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.