Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01355172
First received: May 15, 2011
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: AdimFlu-S
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Infants Aged Between 6-12months Old

Resource links provided by NLM:


Further study details as provided by Adimmune Corporation:

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.



Enrollment: 59
Study Start Date: November 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: AdimFlu-S
    0.25mL per injection 2 injections at 4 weeks apart
  Eligibility

Ages Eligible for Study:   6 Months to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355172

Locations
Taiwan
China Medicine University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
Adimmune Corporation
  More Information

No publications provided

Responsible Party: Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01355172     History of Changes
Other Study ID Numbers: FLU10T11C
Study First Received: May 15, 2011
Last Updated: July 12, 2012
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Adimmune Corporation:
Influenza
Vaccine
Immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014