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
Recruiting
Phase 2
Phase 3
Interventional Study
Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type b
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 6 Weeks – 8 Weeks
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,186 (estimated)
- Sponsor
- LG Chem · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
Inclusion 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)
Exclusion Criteria:
* Known history of Hib infection, HepB, diphth…
Contacts