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Trial record 2 of 147 for:    sanofi adjuvant

Sanofi 2017 H7N9 With/Without AS03 in Adults/Elderly

This study is not yet open for participant recruitment.
Verified October 4, 2017 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
ClinicalTrials.gov Identifier:
NCT03312231
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females 19 years and older that is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) administered at different dosages given with or without AS03 adjuvant. Eligible subjects will be randomized into 5 study groups, stratified by age. The study will enroll up to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older. Study duration is approximately 16 months with subject participation duration approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient.

Condition Intervention Phase
Avian Influenza Influenza Immunisation Drug: AS03 Biological: Inactivated influenza H7N9 vaccine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Study in Healthy Adults 19 Years and Older to Assess the Safety, Reactogenicity and Immunogenicity of a Sanofi Pasteur A/H7N9 Inactivated Influenza Vaccine Administered Intramuscularly With or Without AS03 Adjuvant

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) of serum HAI antibodies [ Time Frame: Day 43 ]
  • Geometric Mean Titers (GMTs) of serum Neut antibodies [ Time Frame: Day 43 ]
  • Occurrence of clinical safety laboratory adverse events [ Time Frame: Day 1 to day 8 ]
  • Occurrence of clinical safety laboratory adverse events [ Time Frame: Day 22 to day 29 ]
  • Occurrence of solicited injection site events [ Time Frame: Day 1 to day 8 ]
  • Occurrence of solicited injection site events [ Time Frame: Day 22 to day 29 ]
  • Occurrence of study vaccine-related serious adverse events (SAEs) [ Time Frame: Day 1 to day 387 ]
  • Occurrence of systemic reactogenicity events [ Time Frame: Day 1 to day 8 ]
  • Occurrence of systemic reactogenicity events [ Time Frame: Day 22 to day 29 ]
  • Percentage of subjects achieving HAI antibodies titer = / > 1:40 [ Time Frame: Day 43 ]
  • Percentage of subjects achieving Neut antibodies titer = / > 1:40 [ Time Frame: Day 43 ]
  • Percentage of subjects achieving seroconversion (defined as either HAI antibodies pre-vaccination titer <1:10 and a post-vaccination titer = / > 1:40 or a pre-vaccination titer = / > 1:10 and min. 4-fold rise in post-vaccination titer) [ Time Frame: Day 43 ]
  • Percentage of subjects achieving seroconversion (defined as either Neut antibodies pre-vaccination titer <1:10 and a post-vaccination titer = / > 1:40 or a pre-vaccination titer = / > 1:10 and min. 4-fold rise in post-vaccination titer) [ Time Frame: Day 43 ]

Secondary Outcome Measures:
  • GMTs of serum HAI antibodies [ Time Frame: Day 1 ]
  • GMTs of serum HAI antibodies [ Time Frame: Day 22 ]
  • GMTs of serum HAI antibodies [ Time Frame: Day 29 ]
  • GMTs of serum HAI antibodies [ Time Frame: Day 8 ]
  • GMTs of serum Neut antibodies [ Time Frame: Day 1 ]
  • GMTs of serum Neut antibodies [ Time Frame: Day 22 ]
  • GMTs of serum Neut antibodies [ Time Frame: Day 29 ]
  • GMTs of serum Neut antibodies [ Time Frame: Day 8 ]
  • Occurrence of all serious adverse events (SAEs), regardless of the assessment of relatedness [ Time Frame: Day 1 to day 387 ]
  • Occurrence of all unsolicited adverse events, regardless of the assessment of seriousness or relatedness [ Time Frame: Day 1 to day 43 ]
  • Occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs), and potentially immune-mediated medical conditions (PIMMCs ) [ Time Frame: Day 1 to day 387 ]
  • Occurrence of study vaccine-related unsolicited non-serious AEs [ Time Frame: Day 1 to day 43 ]
  • Percentage of subjects achieving HAI antibodies titers of 1:40 or greater [ Time Frame: Day 1 ]
  • Percentage of subjects achieving HAI antibodies titers of 1:40 or greater [ Time Frame: Day 22 ]
  • Percentage of subjects achieving HAI antibodies titers of 1:40 or greater [ Time Frame: Day 29 ]
  • Percentage of subjects achieving HAI antibodies titers of 1:40 or greater [ Time Frame: Day 8 ]
  • Percentage of subjects achieving Neut antibodies titers of 1:40 or greater [ Time Frame: Day 1 ]
  • Percentage of subjects achieving Neut antibodies titers of 1:40 or greater [ Time Frame: Day 22 ]
  • Percentage of subjects achieving Neut antibodies titers of 1:40 or greater [ Time Frame: Day 29 ]
  • Percentage of subjects achieving Neut antibodies titers of 1:40 or greater [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion against the influenza 2017 H7N9 vaccine strain [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion against the influenza 2017 H7N9 vaccine strain [ Time Frame: Day 29 ]
  • Percentage of subjects achieving seroconversion against the influenza 2017 H7N9 vaccine strain [ Time Frame: Day 8 ]

Estimated Enrollment: 640
Anticipated Study Start Date: November 6, 2017
Estimated Study Completion Date: August 1, 2019
Estimated Primary Completion Date: May 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22, n=100 (19-64 years old) and n=60 (65 and older)
Drug: AS03
Oil-in-water emulsion based adjuvant system
Biological: Inactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine
Experimental: Group 2
7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22, n=100 (19-64 years old) and n=60 (65 and older)
Drug: AS03
Oil-in-water emulsion based adjuvant system
Biological: Inactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine
Experimental: Group 3
15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22, n=100 (19-64 years old) and n=60 (65 and older)
Drug: AS03
Oil-in-water emulsion based adjuvant system
Biological: Inactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine
Experimental: Group 4
15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22, n=50 (19-64 years old) and n=30 (65 and older)
Biological: Inactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine
Experimental: Group 5
45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22, n=50 (19-64 years old) and n=30 (65 and older)
Biological: Inactivated influenza H7N9 vaccine
Monovalent 2017 H7N9 inactivated influenza vaccine

Detailed Description:
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females 19 years and older. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) administered at different dosages given with AS03 adjuvant (3.75 mcg, 7.5 mcg and 15 mcg of HA per dose) or without adjuvant (15 mcg and 45 mcg of HA per dose). Eligible subjects will be randomized into one of 5 study groups, stratified by age. The study will enroll up to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older. The study duration is approximately 16 months with subject participation duration approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient. The secondary objectives are: 1) to assess unsolicited non-serious adverse events (AEs) following receipt of two doses of a 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without AS03 adjuvant; 2) to assess medically-attended adverse events (MAAEs) including new-onset chronic medical conditions (NOCMCs), potentially immune-mediated medical conditions (PIMMCs), and all serious adverse events (SAEs) following receipt of two doses of a 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without AS03 adjuvant; 3) to assess the serum HAI and Neut antibody responses approximately 7 and 21 days following receipt of a single dose, and approximately 7 days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of recipient.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provide written informed consent prior to initiation of any study procedures.
  2. Are able to understand and comply with planned study procedures and be available for all study visits.
  3. Are males or non-pregnant females, 19 years of age and older, inclusive.
  4. Are in good health. - As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER, or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.
  5. Oral temperature is less than 100.0°F.
  6. Pulse is 47 to 100 bpm, inclusive.
  7. Systolic blood pressure is 85 to 150 mmHg, inclusive (subjects <65 years of age), 85 to 160 mmHg, inclusive (subjects = / > 65 years of age).
  8. Diastolic blood pressure is 55 to 95 mmHg, inclusive.
  9. Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour.
  10. Women of childbearing potential must use an acceptable contraception method from 30 days before first study vaccination until 60 days after last study vaccination.

    - Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.

    -- Acceptable contraception includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill").

  11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Exclusion Criteria:

  1. Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.

    - An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.

  2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation.

    - Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.

  3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
  4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  5. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
  6. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
  7. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
  8. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
  9. Have a personal or family history of narcolepsy.
  10. Have a history of Guillain-Barré syndrome.
  11. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
  12. Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
  13. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
  14. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
  15. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
  16. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
  17. Have taken high-dose inhaled corticosteroids within 30 days prior to each study vaccination.

    - High-dose defined as per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-reference-html#estimated-comparative-daily-doses

  18. Received a licensed live vaccine within 30 days prior to the first study vaccination, or plan to receive a licensed live vaccine within 30 days before or after each study vaccination.
  19. Received or plan to receive a licensed, inactivated, vaccine (excluding all flu vaccines) within 14 days before or after each study vaccination.
  20. Received or plan to receive an inactivated seasonal flu vaccine within 21 days before or after each study vaccination.
  21. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to each study vaccination.
  22. Received an experimental agent within 30 days prior to the first study vaccination, or expect to receive an experimental agent during the 13-month trial-reporting period.

    - Including vaccine, drug, biologic, device, blood product, or medication.

    -- Other than from participation in this trial.

  23. Are participating or plan to participate in another clinical trial with an interventional agent that will be received during the 13-month trial-reporting period.

    - Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.

  24. Received or plan to receive an influenza A/H7 vaccine or have a history of influenza A/H7 subtype infection.

    - And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients.

  25. Have traveled to mainland China and had substantial direct contact with live or freshly slaughtered poultry or pigeons within the past five years.

    - Substantial contact is defined as visited a poultry farm and/or a live poultry market.

  26. Occupational exposure to or substantial direct physical contact with birds in the past year and through the 21 days after the second study vaccination.

    - Exposure to free range chickens in the yard is exclusionary. Casual contact with birds at petting zoos or county or state fairs or having pet birds does not exclude subjects from study participation.

  27. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination.
  28. Plan to travel outside the US (continental US, Hawaii, and Alaska) from enrollment through 21 days after the second study vaccination.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312231


Contacts
Contact: Lisa A Jackson 12064425216 jackson.l@ghc.org

Locations
United States, Georgia
Emory Vaccine Center - The Hope Clinic Not yet recruiting
Decatur, Georgia, United States, 30030-1705
United States, Iowa
University of Iowa - Vaccine Research and Education Unit Not yet recruiting
Iowa City, Iowa, United States, 52242-2600
United States, Maryland
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore Not yet recruiting
Baltimore, Maryland, United States, 21201-1509
United States, North Carolina
Duke Human Vaccine Institute - Duke Clinical Vaccine Unit Not yet recruiting
Durham, North Carolina, United States, 27704
United States, Washington
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases Not yet recruiting
Seattle, Washington, United States, 98101-1466
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03312231     History of Changes
Other Study ID Numbers: 17-0075
HHSN272201400004I
First Submitted: October 12, 2017
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: October 4, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
A/H7N9
Immunogenicity
Influenza
Safety
Sanofi Pasteur
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs