Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscul… (NCT06618196) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age
336 participantsStarted 2024-10-02
Plain-language summary
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.
Who can participate
Age range
50 Days – 70 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.
Exclusion criteria
. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
. Has a known SARS-CoV-2 infection at Screening.
. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
. 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.
. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
. Meets one or more of the following systemic corticosteroid exclusion criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seroprotection/vaccine-response rate
Timeframe: 1 month after the third dose primary series