NCT05457946

Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

About the study

The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine 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 and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Infants in stable health
Male or female 6 to 8 weeks of age
Signed informed consent by the infant's parent(s) or legally acceptable representative(s)

EXCLUSION CRITERIA

Exclusion Criteria:

Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration
Known or suspected immunodeficiency
Previous use of blood or blood-derived products
Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
Any history of allergy (hypersensitivity) to any of the vaccine components
Participation in another interventional clinical trial simultaneously