LR20062
BiologicalDTaP-HepB-IPV-Hib vaccine
NCT Number: NCT06618196
This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.
Trial opening soon.
Get Notified50 day–70 day
All sexes
Interventional
Phase 2
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medical conditions:
Prior/concomitant therapy:
Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.
Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.
DTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine
Time frame: 1 month after the third dose primary series
Time frame: 1 month after the third dose primary series
GMC or GMT and their ratio of all types of antibodies
Time frame: 1 month after the third dose primary series
Proportion of subjects achieving seroconversion to pertussis and poliovirus
Time frame: 1 month after the third dose primary series
Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
Time frame: 7 days after each vaccination
Expected local or systemic side effects after vaccination
Time frame: 1 month after each vaccinations
Any AEs other than solicited AEs
Time frame: 30 minutes after each vaccination
Any AEs that occur within 30 minutes after the study vaccine administration
Contact information is provided by the study sponsor or research team.
LG Chem
Industry
A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03208101
Actinomycetales Infections, Bacterial Infections
Seoul, South Korea
View Trial DetailsNCT02094833
Actinomycetales Infections, Bacterial Infections
Daejeon, South Korea
View Trial DetailsNCT00654901
Actinomycetales Infections, Bacterial Infections
Estado de México, Mexico
View Trial DetailsNCT06947499
Actinomycetales Infections, Bacterial Infections
Dasmariñas, Cavite, Philippines
View Trial Details