- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046227
Antibody Titer Analysis After H1N1 Vaccination in Pediatric Haemato-oncology Patients
January 8, 2010 updated by: National Taiwan University Hospital
Antibody Titer Analysis Afer Monovalent Vaccination in Pediatric Haemato-oncology Patients
The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza infection than general population, and they are strongly recommended to receive novel H1N1 vaccination.
However, there is no previous data to answer how the efficacy and effectiveness of novel H1N1 vaccination is in patients of pediatric haemato-oncology.
This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients.
Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI).
A HAI titer with a 4-fold rise or greater is defined as seroconversion.
Study subjects with seroconversion are regarded as responsiveness to the vaccination.
Meanwhile, if the patient presents influenza-like symptoms, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis.
After the study, we will be able to know whether or not current novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric haemato-oncology patients.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
The emergence of novel H1N1 influenza in 2009 has a great impact to the societies in Taiwan and worldwide.
The patients of pediatric haemato-oncology have a higher risk for novel H1N1 influenza infection than general population, and they are strongly recommended to receive novel H1N1 vaccination.
However, there is no previous data to answer how the efficacy and effectiveness of novel H1N1 vaccination is in patients of pediatric haemato-oncology.
This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients.
Thus two blood samples will be drawn.
The first sample will be collected before the vaccination and the second one will be collected three weeks after the vaccination (If the patient is younger than 9 years old, the third sample will be collected three weeks after the booster vaccination).
Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI).
A HAI titer with a 4-fold rise or greater is defined as seroconversion.
Study subjects with seroconversion are regarded as responsiveness to the vaccination.
We will analyze seroconversion rate as well.
Meanwhile, if the patient presents influenza-like symptoms, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis.
After the study, we will be able to know whether or not current novel H1N1 influenza vaccination schedule is adequate and efficient for pediatric haemato-oncology patients.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luan-Yin Chang, MD
- Phone Number: 75128 886-23123456
- Email: ly7077@tpts6.seed.net.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Luan-Yin Chang, MD
- Phone Number: 71528 886-2-23123456
- Email: ly7077@tpts6.seed.net.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.
Description
Inclusion Criteria:
- Boys or girls aged ≧ 6 months old to 18 years old on the day of first vaccination;
- Subject and/or parents(s)/legal guardian(s) was willing to comply with planned study procedures and be available for all study visits;
- Subject was ever treated at pediatric haemato-oncology ward
- Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
Exclusion Criteria:
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication (AdimFlu-S (A/H1N1));
- Personal or family history of Guillain-Barré Syndrome;
- An acute febrile illness within the last 72 hours prior to vaccination;
- Subject with bleeding disorder or has any coagulation disorder that needs receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection;
- Subjects with influenza-like illness as defined by the presence of fever (temperature ≧38.5℃ ) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
- Underlying condition in the investigator's opinion may be inappropriate for vaccination;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Serology after Novel H1N1 vaccination
This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.
|
Serology study before and after Influenza A (2009) monovalent vaccine, inactivated
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in these patients. Titer of H1N1 influenza virus antibodies will be determined by hemagglutinin inhibition assay (HAI).
Time Frame: Dec, 2009 - Feb, 2010
|
Dec, 2009 - Feb, 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
If the patient presents influenza-like symptoms during the six month follow up period, we will perform throat swab or nasal swab for influenza rapid test, viral isolation, and novel H1N1 influenza PCR to confirm the diagnosis.
Time Frame: Dec, 2009 - Jun, 2010
|
Dec, 2009 - Jun, 2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luan-Yin Chang, MD, National Taiwan University Hospital, Taipei, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
February 1, 2010
Study Completion (Anticipated)
June 1, 2010
Study Registration Dates
First Submitted
January 8, 2010
First Submitted That Met QC Criteria
January 8, 2010
First Posted (Estimate)
January 11, 2010
Study Record Updates
Last Update Posted (Estimate)
January 11, 2010
Last Update Submitted That Met QC Criteria
January 8, 2010
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200912031R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Serology Analysis
-
Indiana UniversityCompletedSARS-CoV-2 | Students | SerologyUnited States
-
Medacta International SAActive, not recruiting
-
PepsiCo Global R&DCompleted
-
University of South FloridaCompleted
-
University GhentHasselt University; Maastricht UniversityRecruitingGait Analysis | ReproducibilityNetherlands, Belgium
-
Hospital for Special Surgery, New YorkCompletedBlood Volume AnalysisUnited States
-
University of California, Los AngelesOlive View-UCLA Education & Research InstituteUnknown
-
Keimyung University Dongsan Medical CenterCompletedAnalysis, Event History
Clinical Trials on Influenza A (H1N1) 2009 monovalent vaccine, inactivated
-
University of RochesterNational Institutes of Health (NIH)Withdrawn2009 H1N1 InfluenzaUnited States
-
Adimmune CorporationCompleted
-
Adimmune CorporationCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | H1N1 Influenza VirusUnited States, Puerto Rico
-
University of RochesterCompleted
-
University of RochesterNational Institutes of Health (NIH)Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
University of RochesterCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | H1N1 Influenza VirusUnited States, Puerto Rico