Phase 2 Trial of a Haemophilus Influenzae Serotype a (Hia) Glycoconjugate Vaccine (NCT07743008) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Trial of a Haemophilus Influenzae Serotype a (Hia) Glycoconjugate Vaccine
Canada47 participantsStarted 2026-04-29
Plain-language summary
This study is testing a vaccine designed to protect against Haemophilus influenzae type a (Hia), a bacterium that can cause serious infections.This is a phase 2 trial.
The study will include healthy adults between the ages of 18 and 65. Participants will be randomly assigned to receive either the Hia vaccine or a placebo.
The main goals of the study are to determine safety and measure immune response as it relates to protection against Hia.
Who can participate
Age range
18 Years – 65 Years
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
. The participant must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; the participant must agree to complete study-related procedures and communicate with the study staff at visits and by phone during the study;
. Participants must have a body mass index (BMI) ≤ 32 kg/m2 (https://www.cdc.gov/healthyweight/bmi/calculator.html).
. The participant is considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
. Participants must be between 18 and 65 years of age at the Vaccination visit (Day 0);
. Participants must be in stable health and with no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Principal Investigator or Sub-Investigator (thereafter referred to as Investigator) and determined by medical history, physical examination, and vital signs; Note: Participants with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination.
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
Immediate Adverse Events Following Immunization
Timeframe: 30 minutes post-vaccination
2
Solicited local and systemic adverse events
Timeframe: From vaccination to day 7 post first vaccination
3
Solicited local and systemic adverse events
Timeframe: From vaccination to day 7 post second vaccination
4
Unsolicited Adverse Events
Timeframe: From vaccination to 28 days post first dose of vaccine
5
Unsolicited Adverse Events
Timeframe: From vaccination to 28 days post second dose
6
Serious Adverse Events and Medically Attended Adverse Events
Timeframe: From vaccination up to 240 days after dose 2
. Participants of childbearing potential must have a negative urine pregnancy test result at the Screening and Vaccination visits (Days 0 \& 60) and must not be lactating. Non-childbearing is defined as:
. Participants of childbearing potential and who are sexually active must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, participants must have no plan to become pregnant for at least two months post-vaccination. Abstinent participants who are ovulating should be asked what method(s) they would use should their circumstances change, and participants without a well-defined plan should be excluded. The following methods of contraception are considered to be effective:
Exclusion criteria
. According to the Investigator's opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness. "Evolving" is defined as:
. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse that would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting, including methadone (methadone as treatment for opioid dependence may be acceptable if the participant has been otherwise opioid-free for at least three years);
. A history of neurologic disorders or seizures;
. Any history of autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, type 1 diabetes, and inflammatory bowel disease) or any confirmed or suspected congenital or acquired immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), hepatitis B or C infection, tested for at the screening. Very little investigator discretion will be permitted with this exclusion criterion but rare participants may still be eligible to participate with appropriate written justification in the source document (e.g., documented HBV carrier status with no evidence of active liver disease, cured HCV with documented clearance of virus, very mild psoriasis \[i.e., a small number of minor plaques requiring no treatment\], etc.);
. Any hematologic or biochemical laboratory abnormalities, as defined by lab normal ranges. To exclude transient abnormalities, the Investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. Grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the Investigator.
. Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years (one or more episodes per year);
. Administration or planned administration of any vaccine (including routine vaccines) within 30 days prior to Hia immunization and up to 30 days post-second dose of vaccine. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
. Administration of any investigational vaccine or other product during the period starting 30 days prior to randomization through to completion of the study. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;