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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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 |
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 May 03, 2016
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections