Serology AnalysisNCT01046227
Antibody Titer Analysis After H1N1 Vaccination in Pediatric Haemato-oncology Patients
An observational study of Serology Analysis and Novel H1N1 Influenza Vaccination, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Serology Analysis, Novel H1N1 Influenza Vaccination, Pediatric Haemato-oncology Patients
- What is being tested?
- Influenza A (H1N1) 2009 monovalent vaccine, inactivated
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Luan-Yin Chang, MD, 886-2-23123456 ext. 71528, ly7077@tpts6.seed.net.tw
About this study
Official title: 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.
Read the 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.
- Being tested
- Influenza A (H1N1) 2009 monovalent vaccine, inactivated
- Keywords
- Serology, Monovalent inactivated H1N1 vaccine, Pediatric haemato-oncology patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza A (H1N1) 2009 monovalent vaccine, inactivatedBiological
Also called Influenza Virus Vaccine, AdimFlu-S (A/H1N1)
Serology study before and after Influenza A (2009) monovalent vaccine, inactivated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Dec, 2009 - Feb, 2010
Secondary outcomes (1)
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.
Measured: Dec, 2009 - Jun, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serology AnalysisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Luan-Yin Chang, MD, Principal investigator, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046227
- Sponsor's protocol ID
- 200912031R
- Status last verified
- Dec 2009
- First submitted
- 8 Jan 2010
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Titer Analysis Afer Monovalent Vaccination in Pediatric Haemato-oncology Patients
- ClinicalTrials.gov ID
- NCT01046227
- Acronym / sponsor ID
- 200912031R
- Keywords
- Serology, Monovalent inactivated H1N1 vaccine, Pediatric haemato-oncology patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serology after Novel H1N1 vaccination | – | Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivatedThis study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study is designed to investigate the antibodies titers before and after the novel H1N1 influenza vaccination in pediatric haemato-oncology patients.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza A (H1N1) 2009 monovalent vaccine, inactivatedAlso: Influenza Virus Vaccine, AdimFlu-S (A/H1N1)Serology study before and after Influenza A (2009) monovalent vaccine, inactivated | Biological | Serology after Novel H1N1 vaccination |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luan-Yin Chang, MD principal investigator
National Taiwan University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serology Analysis and Novel H1N1 Influenza Vaccination, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luan-Yin Chang, MD (886-23123456 ext. 75128, ly7077@tpts6.seed.net.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2010.