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Antibody Titer Analysis After H1N1 Vaccination in Pediatric Haemato-oncology Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01046227
First received: January 8, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Serology Analysis
Novel H1N1 Influenza Vaccination
Pediatric Haemato-oncology Patients
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antibody Titer Analysis Afer Monovalent Vaccination in Pediatric Haemato-oncology Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum for serology of H1N1 antibody Nasopharyngeal or oropharyngeal swab for Novel H1N1 PCR


Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Serology study before and after Influenza A (2009) monovalent vaccine, inactivated
Other Name: Influenza Virus Vaccine, AdimFlu-S (A/H1N1)

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046227

Contacts
Contact: Luan-Yin Chang, MD 886-23123456 ext 75128 ly7077@tpts6.seed.net.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Luan-Yin Chang, MD    886-2-23123456 ext 71528    ly7077@tpts6.seed.net.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Luan-Yin Chang, MD National Taiwan University Hospital, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01046227     History of Changes
Other Study ID Numbers: 200912031R
Study First Received: January 8, 2010
Last Updated: January 8, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Serology
Monovalent inactivated H1N1 vaccine
Pediatric haemato-oncology patients

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014