A Phase IV Study to Assess the Safety of EupentaTM Inj (NCT04056728) | Clinical Trial Compass
UnknownPhase 4
A Phase IV Study to Assess the Safety of EupentaTM Inj
3,000 participantsStarted 2019-09-23
Plain-language summary
A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA \[recombinant-deoxyribonucleic acid\])-Haemophilus influenzae type b conjugate vaccine}
Who can participate
Age range
6 Weeks – 8 Weeks
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
. Written informed consent obtained from the parents or legally acceptable representatives (LARs) of the subject who have been informed of the purpose, method, effects, etc., of the study
. A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination
. In good health as determined by medical history, physical examination, and judgment by the Investigator
. Body weight 3.2 kg and over at the time of screening
. Subjects for whom the Investigator believed that their parent(s)/LAR(s) could comply with the requirements of the protocol (e.g., completion of the Subject Diary Cards, return for site visits)
Exclusion criteria
. Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases
. Any history of allergy to any of the components or excipients of EupentaTM Inj., including aluminum hydroxide, sodium hydrogen phosphate heptahydrate, monobasic sodium phosphate dihydrate, polysorbate and thimerosal
. Any medical condition which can compromise the infant's safety, as per Investigator's discretion
. History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality
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
Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination
Timeframe: first 30 minutes after each study vaccination
2
Incidence of solicited local and systemic adverse events (AEs)
Timeframe: baseline(pre-vaccination) up to 7 days after each vaccination
3
Incidence of any unsolicited AEs during the entire study
Timeframe: through study completion, an average of 1 year
4
Incidence of SAEs during the entire study period
Timeframe: through study completion, an average of 1 year
. Household contact and/or intimate exposure with a confirmed case of diphtheria, pertussis, HB, polio and/or Hib diseases within in 30 days prior to screening
. History of fever ≥ 38°C/ 100.4°F within 3 days prior to screening and/or intake of anti-pyretic/analgesic medication. Subjects who meet this criterion will be rescreened to check the temperature after the temporary condition has resolved and if they are within the window period for age of first vaccination at the time of re-scheduled visit
. History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses