Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00952276
Other study ID # FUF16
Secondary ID UTN: U1111-1111-
Status Completed
Phase Phase 2
First received August 3, 2009
Last updated August 26, 2011
Start date October 2009
Est. completion date March 2011

Study information

Verified date August 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.

Primary Objectives:

- To describe the immunogenicity of the candidate vaccines after a single injection.

- To describe the safety of the candidate vaccines after a single injection.


Description:

Participants will receive a single injection of their randomized vaccine on Day 0.


Recruitment information / eligibility

Status Completed
Enrollment 548
Est. completion date March 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria :

- Healthy adults aged 18 years or older on the day of inclusion

- Informed consent has been signed and dated

- Able to attend all scheduled visits and comply with all trial procedures

- For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Exclusion Criteria :

- Known pregnancy or positive urine pregnancy test

- Currently breastfeeding a child

- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination

- Planned participation in another clinical trial during the present trial period

- Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for the inactivated seasonal influenza vaccine, within two weeks preceding trial vaccination

- Planned receipt of any vaccine prior to the Day 42 blood sample

- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response

- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C

- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances

- Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination

- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination

- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures

- Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion

- Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator

- Previous participation in a swine-origin A/H1N1 pandemic flu trial except if performed in 1976

- Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009

- Febrile illness (temperature = 100.4°F [= 38.0°C ]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination

- Personal or family history of Guillain-Barré syndrome

- Active neoplastic disease or a history of any hematologic malignancy

- Known seizure/epilepsy history and/or taking anti-seizure medication

- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study

- Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening

- Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening

- Receipt of any monovalent 2009 pandemic H1N1 vaccine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Normal saline solution
0.5 mL, Intramuscular on Day 0

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers = 10 (1/dilution) on Day 0 and Day 21 post-vaccination. Day 0 and Day 21 post-vaccination No
Primary Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer = 40 (1/dil). Day 0 and Day 21 post-vaccination No
Primary Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Day 0 and Day 21 post-vaccination No
Primary Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age = 65 Years Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers = 10 (1/dil). Day 0 and Day 21 post-vaccination No
Primary Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age = 65 Years Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer = 40 (1/dil). Day 0 and Day 21 post-vaccination No
Primary Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age = 65 Years Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Day 0 and Day 21 post-vaccination No
Primary Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering Day 0 up to Day 7 post-vaccination No
Primary Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age = 65 Years Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Day 0 up to Day 7 post-vaccination No
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A

External Links