Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Adults and Elders

NCT ID: NCT01003145

Last Updated: 2012-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-04-30

Brief Summary

This was a randomized, laboratory-blinded study in healthy male and non-pregnant female designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). In the adult cohort, all volunteers were randomized in a 1:1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart, 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart or 1 injection of AdimFlu-S (A/H1N1) 15 mcg HA. In the elders cohort, all volunteers were randomized in a 1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart or 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart.

Following immunization, safety was measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination; and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing included hemagglutinin inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

H1N1 vaccine of 15 μg HA on Day 0

15 μg HA (0.5 mL) per injection, 1 injection

50 adults (aged 18~60 years) were assigned to receive one injection of H1N1 vaccine

Group Type: EXPERIMENTAL

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Intervention Type: BIOLOGICAL

H1N1 vaccine of 15 μg HA on Day 0 and 21

15 μg HA (0.5 mL) per injection, 2 injections

50 adults (aged 18~60 years) and 50 elders (aged over 60 years) were assigned to receive two injections of H1N1 vaccine 3 weeks apart

Group Type: EXPERIMENTAL

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Intervention Type: BIOLOGICAL

H1N1 vaccine of 30 μg HA on Day 0 and 21

30 μg HA (1 mL) per injection, 2 injections

50 adults (aged 18~60 years) and 50 elders (aged over 60 years) were assigned to receive two injections of H1N1 vaccine 3 weeks apart

Group Type: EXPERIMENTAL

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Intervention Type: BIOLOGICAL

Interventions

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Intervention Type: BIOLOGICAL

Other Intervention Names

AdimFlu-S (A/H1N1)

Eligibility Criteria

Inclusion Criteria

• Males or non-pregnant females and age ≧ 18 years;
• Willing and able to adhere to visiting schedules and all study requirements;
• In good physical health on the basis of medical history, physical examination;
• Subject should read and sign the study-specific informed consent.

Exclusion Criteria

• Subject ever received influenza vaccine within the previous 6 months;
• 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;
• Subjects, with bleeding or any coagulation disorder, who receive anticoagulants in the preceding 3 weeks, thus posing a contraindication for 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 who disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
• Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
• Immunodeficiency, immunosuppressive or household contact with immunosuppression;
• History of wheezing or have been using bronchodilator within 3 months prior to study vaccination;
• Receipt of live virus vaccine within 1 month prior to study vaccination or expected receipt within 2 months after first study vaccination;
• Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt of vaccination within 3 weeks after the immunogenicity evaluation period;
• Receipt of any blood products, including immunoglobulin in the prior 3 months;
• Underlying condition, in the investigator's opinion, that may be inappropriate for vaccination;
• Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adimmune Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Adimmune Corporation

Principal Investigators

Szu Min Hsieh

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Feng Yee Chang

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Yung Ching Liu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Wang Fang Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University Wang Fang Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Kung HC, Huang KC, Kao TM, Lee YC, Chang FY, Wang NC, Liu YC, Lee WS, Liu HJ, Chen CI, Chen CH, Huang LM, Hsieh SM. A clinical study to assess the immunogenicity and safety of a monovalent 2009 influenza A (H1N1) vaccine in an area with low-level epidemics of pandemic influenza. Vaccine. 2010 Oct 21;28(45):7337-43. doi: 10.1016/j.vaccine.2010.08.073. Epub 2010 Sep 17.

Reference Type: DERIVED

PMID: 20817013 (View on PubMed)

Kao TM, Hsieh SM, Kung HC, Lee YC, Huang KC, Huang LM, Chang FY, Wang NC, Liu YC, Lee WS, Liu HE, Chen CI, Chen CH. Immune response of single dose vaccination against 2009 pandemic influenza A (H1N1) in the Taiwanese elderly. Vaccine. 2010 Aug 31;28(38):6159-63. doi: 10.1016/j.vaccine.2010.07.026. Epub 2010 Jul 24.

Reference Type: DERIVED

PMID: 20659517 (View on PubMed)

Other Identifiers

FLU09001

Identifier Type: -

Identifier Source: org_study_id