Influenza Clinical Trial
Official title:
Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Infants Aged Between 6-12months Old
NCT number | NCT01355172 |
Other study ID # | FLU10T11C |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | May 15, 2011 |
Last updated | July 12, 2012 |
Start date | November 2010 |
Verified date | July 2012 |
Source | Adimmune Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan : Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 1 Year |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medicine University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Adimmune Corporation |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HA antibody titers will be determined using the WHO HAI reference technique. | Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination. | No | |
Secondary | 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. | 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. |
(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. | Yes |
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