Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
This study has been completed.
Information provided by (Responsible Party):
First received: May 15, 2011
Last updated: July 12, 2012
Last verified: July 2012
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
||Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old
Primary Outcome Measures:
- HA antibody titers will be determined using the WHO HAI reference technique. [ Time Frame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation. [ Time Frame: (4 weeks after two doses of study vaccine, 4 weeks apart), Physical examination will be performed at each visit. Reactogenicity will be recorded for 7 days after each vaccination. ] [ Designated as safety issue: Yes ]
Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.
The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
| Study Start Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||6 Months to 1 Year
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination;
- Subject's parent(s) or legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
- Subject must be in good physical health on the basis of medical history, physical examination;
- Subject's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
- Subjects had received influenza vaccine;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- Personal or family history of Guillain- Barre' Syndrome;
- An acute febrile illness within 1 week prior to vaccination;
- Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
- Subjects with influenza-like illness as defined by the presence of fever (temperature >= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;
- History of wheezing or bronchodilator use within 3 months prior to study vaccine;
- Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- Receipt of any blood products, including immunoglobulin in the prior 3 months;
- Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
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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: NCT01355172
|China Medicine University Hospital
|Taichung, Taiwan, 404 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 15, 2011
||July 12, 2012
||Taiwan : Food and Drug Administration
Keywords provided by Adimmune Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 11, 2016
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections