Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
BiologicalIntramuscular injection
Other names: DTacP
NCT Number: NCT05091619
The study will evaluate the safety, immunogenicity,immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts:
PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM),compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence.
PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.
This study is active but is not currently recruiting participants.
Notify Me2 month–3 month
All sexes
Interventional
Phase 3
Neihuang County Center for Disease Control and Prevention, Anyang, Henan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injection
Other names: DTacP
Intramuscular injection
Other names: DTaP
Intramuscular injection
Other names: PENTAXIM
Time frame: 1 month after Dose 3
seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is < protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration.
Time frame: 1 month after Dose 3
As measured at the central laboratory
Time frame: Day 7 post-each dose
As elicited by investigational site staff
Time frame: Day 7 post-each dose
As elicited by investigational site staff
Time frame: within 30 days post-each dose
As elicited by investigational site staff
Time frame: Day 30 post-dose 3
Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration
Time frame: before dose 4 at 18 months old(booster)
As measured at the central laboratory
Time frame: before dose 4 at 18 months old(booster)
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time frame: Day 30 post-dose 4 at 18 months old(booster)
As measured at the central laboratory
Time frame: Day 30 post-dose 4 at 18 months old(booster)
eropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time frame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
As measured at the central laboratory
Time frame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
China National Biotec Group Company Limited
Industry
A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months
Acronym: DTaP
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.
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