A Phase 2 interventional study of LR20062 and DTaP-HepB-IPV-Hib vaccine in Diphtheria, Tetanus and Pertussis, sponsored by LG Chem. Not yet recruiting. Open to participants aged 50 Days to 70 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by LG Chem · Phase 2, Interventional, and Prevention
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.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 336 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:
Medical conditions:
Had a recent febrile illness, defined as axillary temperature ≥38.0℃ [≥100.4℉] occurring at or within 72 hours prior to receipt of study vaccine.
Prior/concomitant therapy:
Meets one or more of the following systemic exclusion criteria:
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
Control hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine
Seroprotection/vaccine-response rate
* Proportion of subjects achieving seroprotection to each antigenic components * Proportion of subjects with vaccine response for pertussis antigens
Time frame: 1 month after the third dose primary series
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
Time frame: 1 month after the third dose primary series
Seroconversion rate
Proportion of subjects achieving seroconversion to pertussis and poliovirus
Time frame: 1 month after the third dose primary series
Long-term seroprotection rate
Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
Time frame: 1 month after the third dose primary series
Solicited adverse event
Expected local or systemic side effects after vaccination
Time frame: 7 days after each vaccination
Unsolicited adverse event
Any AEs other than solicited AEs
Time frame: 1 month after each vaccinations
Immediate reactions after vaccination
Any AEs that occur within 30 minutes after the study vaccine administration
Time frame: 30 minutes after each vaccination
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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