A Phase 1 interventional study of DTaP-HepB-IPV-Hib vaccine and DTaP-HepB-IPV-Hib vaccine in Diphtheria, Tetanus and Pertussis, sponsored by LG Chem. Not yet recruiting. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by LG Chem · Phase 1, Interventional, and Prevention
This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 42 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DTaP-HepB-IPV-Hib vaccine
Biological: DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Biological: DTaP-HepB-IPV-Hib vaccine
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)
Number of subjects with immediate reactions
Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.
Time frame: For 30 minutes after the vaccination
Number of subjects with solicited adverse events
Solicited adverse events are classified into the local(pain, tenderness, erythema/redness, induration/swelling, pruritus) and systemic(fever, fatigue, chills/shivering, myalgia, headache, arthralgia, decreased appetite, diarrhea, nausea/vomiting, hypersensitivity) signs and symptoms.
Time frame: For 7 days after the vaccination [Day 1-8]
Number of subjects with unsolicited adverse events
Unsolicited adverse events mean all the adverse events excluding the solicited adverse events that occur after the ICF is obtained until 28 days after vaccination.
Time frame: For 28 days (+7 days of window period) after the vaccination [Day 1-29]
Number of subjects with serious adverse events
serious adverse events that occur after the ICF is obtained until 6 months after vaccination.
Time frame: For 181 days (+7 days of window period) after the vaccination [Day 1-181]
Proportions of the subjects who meet seroprotection/vaccine-response to each antigen and the subjects who have shown seroconversion 28 days post-vaccination with the study vaccine (Day 29) compared to pre-vaccination.
Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acellular Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b)
Time frame: Day 29 (+7 days window period)
Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN
①If the antibody concentration is \< 4 X LLOQ before the administration of the investigational vaccine: The antibody concentration is ≥ 4 X LLOQ 29 days after the administration of the investigational vaccine ②If the antibody concentration is ≥ 4 X LLOQ before the administration of the investigational vaccine: The antibody concentration 29 days after the administration of the investigational vaccine is ≥ the antibody concentration before the administration
Time frame: Day 29 (+7 days window period)
GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)
Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acelluar Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b
Time frame: Day 29 (+7 days window period)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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