Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to… (NCT01855945) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.
United States627 participantsStarted 2013-05
Plain-language summary
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.
Who can participate
Age range
3 Years – 92 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
. Males and females 3 years of age and older
. Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent
. Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
. Individuals who can comply with study procedures and are available for follow-up
Exclusion criteria
. Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study
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
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
Timeframe: Day 1 through Day 7 after each vaccination
2
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Timeframe: Day 1 through Day 7 after each vaccination
3
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Timeframe: Day 1 through Day 7 after each vaccination
4
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Timeframe: Day 1 through Day 7 after each vaccination
5
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Timeframe: Day 1 through Day 366
6
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
. Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
. Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study
. Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study
. Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
. Individuals with known or suspected impairment of the immune system including, but not limited to:
. Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
. If female, "of childbearing potential", sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry
Timeframe: Day 22, Day 43 post vaccination
7
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.