Flublok or Fluzone With Advax-CpG55.2 or AF03
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03945825 |
Recruitment Status :
Completed
First Posted : May 10, 2019
Last Update Posted : October 5, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza Influenza Immunisation | Drug: AF03 Biological: Delta Inulin-CpG55.2 Biological: Influenza Virus Quadrivalent Inactivated Vaccine Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 241 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Phase I Study to Assess the Safety, Reactogenicity and Immunogenicity of Two Quadrivalent Seasonal Influenza Vaccines (Fluzone(R) or Flublok(R)) With or Without One of Two Adjuvants (AF03 or Advax-CpG55.2) in Healthy Adults 18-45 Years of Age |
Actual Study Start Date : | June 10, 2019 |
Actual Primary Completion Date : | September 18, 2020 |
Actual Study Completion Date : | September 18, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90, n=40
|
Biological: Influenza Virus Quadrivalent Inactivated Vaccine
2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval |
Experimental: Group 2
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90, n=40
|
Drug: AF03
A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether Biological: Influenza Virus Quadrivalent Inactivated Vaccine 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval |
Experimental: Group 3
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90, n=40
|
Biological: Delta Inulin-CpG55.2
A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd) Biological: Influenza Virus Quadrivalent Inactivated Vaccine 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval |
Experimental: Group 4
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40
|
Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine
2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval |
Experimental: Group 5
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40
|
Drug: AF03
A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval |
Experimental: Group 6
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40
|
Biological: Delta Inulin-CpG55.2
A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd) Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval |
- Geometric mean fold rise (GMFR) in hemagglutination inhibition (HAI) titers against the 2018/2019 QIV strains [ Time Frame: Day 29 ]
- Geometric mean fold rise (GMFR) in neuraminidase inhibition (NAI) titers against neuraminidase (NA) antigens in the 2018/2019 QIV strains [ Time Frame: Day 29 ]
- Geometric mean fold rise (GMFR) in neutralizing (Neut) titers against the 2018/2019 QIV strains [ Time Frame: Day 1 through Day 29 ]
- Geometric mean titers (GMTs) of serum hemagglutination inhibition (HAI) against the 2018/2019 QIV strain [ Time Frame: Day 1 through Day 29 ]
- Occurrence of abnormal clinical safety laboratory adverse events (AEs) [ Time Frame: Day 1 through Day 8 ]
- Occurrence of all serious adverse events (SAEs) [ Time Frame: Day 1 through Day 365 ]
- Occurrence of solicited injection site and systemic reactogenicity events [ Time Frame: Day 1 through Day 8 ]
- Occurrence of unsolicited adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]
- Percentage of subjects achieving hemagglutination inhibition (HAI) titer seroconversion against 2018/2019 QIV strains [ Time Frame: Day 29 ]HAI seroconversion defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >/= 1:40 or a pre-vaccination titer >/= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
- Percentage of subjects achieving neuraminidase inhibition (NAI) seroconversion [ Time Frame: Day 29 ]NAI seroconversion defined as >/= 4-fold rise in post vaccination antibody titers against the NA antigens in the 2018/2019 QIV.
- Percentage of subjects achieving neutralizing (Neut) titer seroconversion against the 2018/2019 QIV strains [ Time Frame: Day 29 ]Neut titer seroconversion defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer >/= 1:40 or a pre-vaccination titer >/= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
- Percentage of subjects with a neutralizing (Neut) titer >/= 1:40 against the 2018/2019 QIV strains [ Time Frame: Day 1 through Day 29 ]
- Percentage of subjects with hemagglutination inhibition (HAI) titer >/= 1:40 against the 2018/2019 QIV strains [ Time Frame: Day 1 through Day 29 ]
- Ratio of geometric mean titers (GMTs) of serum hemagglutination inhibition (HAI) against the 2018/2019 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 1 through Day 29 ]
- Ratio of serum neuraminidase inhibition (NAI) geometric mean titer (GMT) between adjuvanted and unadjuvanted study groups [ Time Frame: Day 1 through Day 29 ]
- Ratio of serum neutralizing (Neut) geometric mean titer (GMT) between adjuvanted and unadjuvanted study groups [ Time Frame: Day 1 through Day 29 ]
- Serum neuraminidase inhibition (NAI) geometric mean titer (GMT) [ Time Frame: Day 1 through Day 29 ]
- Serum neutralizing (Neut) geometric mean titer (GMT) [ Time Frame: Day 1 through Day 29 ]
- Geometric mean fold rise (GMFR) in hemagglutination inhibition (HAI) against heterologous H1 and H3 influenza strains [ Time Frame: Day 1 through Day 365 ]
- Geometric mean fold rise (GMFR) in hemagglutination inhibition (HAI) titers against the 2018/2019 QIV strains [ Time Frame: Day 1 through Day 365 ]
- Geometric mean fold rise (GMFR) in neuraminidase inhibition (NAI) titers against the 2018/2019 QIV strains [ Time Frame: Day 1 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Geometric mean fold rise (GMFR) in neutralizing (Neut) titers against the 2018/2019 QIV strains [ Time Frame: Day 1 through Day 365 ]
- Geometric mean fold rise (GMFR) in serum neuraminidase inhibition (NAI) against heterologous N1 and N2 neuraminidase (NA) antigens [ Time Frame: Day 1 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Geometric mean fold rise (GMFR) of neutralizing (Neut) antibody titers against heterologous H1 and H3 influenza strains [ Time Frame: Day 1 through Day 365 ]
- Occurrence of protocol specified adverse events of special interests (AESIs), medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) [ Time Frame: Day 1 through Day 365 ]
- Percentage of subjects achieving a hemagglutination inhibition (HAI) titer >/= 1:40 against 2018/2019 QIV strains [ Time Frame: Day 8 through Day 365 ]
- Percentage of subjects achieving a hemagglutination inhibition (HAI) titer >/= 1:40 against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]
- Percentage of subjects achieving a hemagglutination inhibition (HAI) titer >/= 1:40 against heterologous H1 and H3 influenza strains [ Time Frame: Day 1 through Day 365 ]
- Percentage of subjects achieving hemagglutination inhibition (HAI) titer seroconversion against 2018/2019 QIV antigens and strains [ Time Frame: Day 8 through Day 365 ]
- Percentage of subjects achieving hemagglutination inhibition (HAI) titer seroconversion against 2019/2020 QIV strains [ Time Frame: Day 118 ]
- Percentage of subjects achieving hemagglutination inhibition (HAI) titer seroconversion against heterologous H1 and H3 influenza strains [ Time Frame: Day 8 through Day 365 ]
- Percentage of subjects achieving neuraminidase inhibition (NAI) titer seroconversion against 2018/2019 QIV antigens and strains [ Time Frame: Day 8 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Percentage of subjects achieving neuraminidase inhibition (NAI) titer seroconversion against 2019/2020 QIV strains [ Time Frame: Day 118 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Percentage of subjects achieving neutralizing (Neut) titer >/= 1:40 against 2018/2019 QIV strains [ Time Frame: Day 8 through Day 365 ]
- Percentage of subjects achieving neutralizing (Neut) titer seroconversion against 2018/2019 QIV antigens and strains [ Time Frame: Day 8 through Day 365 ]
- Percentage of subjects achieving neutralizing (Neut) titer seroconversion against 2019/2020 QIV strains [ Time Frame: Day 118 ]
- Percentage of subjects achieving neutralizing (Neut) titer seroconversion against heterologous H1 and H3 influenza strains [ Time Frame: Day 8 through Day 365 ]
- Percentage of subjects achieving seroconversion against heterologous N1 and N2 neuraminidase (NA) antigens [ Time Frame: Day 8 through Day 365 ]NA antigens will only be assessed on study groups 1, 2, and 3.
- Ratio of serum hemagglutination inhibition (HAI) geometric mean titer (GMT) against 2018/2019 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 8 through Day 365 ]
- Ratio of serum hemagglutination inhibition (HAI) geometric mean titer (GMT) against heterologous H1 and H3 influenza strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 1 through Day 365 ]
- Ratio of serum hemagglutination inhibition (HAI) geometric mean titers (GMTs) against 2019/2020 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 90 through Day 118 ]
- Ratio of serum neuraminidase inhibition (NAI) geometric mean titer (GMT) against 2018/2019 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 8 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Ratio of serum neuraminidase inhibition (NAI) geometric mean titers (GMTs) against 2019/2020 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 90 through Day 118 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Ratio of serum neuraminidase inhibition (NAI) geometric mean titers (GMTs) against heterologous N1 and N2 neuraminidase (NA) antigens between adjuvanted and unadjuvanted study groups [ Time Frame: Day 1 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Ratio of serum neutralizing (Neut) geometric mean titer (GMT) against 2018/2019 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 8 through Day 365 ]
- Ratio of serum neutralizing (Neut) geometric mean titers (GMTs) against 2019/2020 QIV strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 90 through Day 118 ]
- Ratio of serum neutralizing (Neut) geometric mean titers (GMTs) against heterologous H1 and H3 influenza strains between adjuvanted and unadjuvanted study groups [ Time Frame: Day 1 through Day 365 ]
- Serum hemagglutination inhibition (HAI) geometric mean fold rise (GMFR) against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]
- Serum hemagglutination inhibition (HAI) geometric mean titer (GMT) against 2018/2019 QIV strains [ Time Frame: Day 8 through Day 365 ]
- Serum hemagglutination inhibition (HAI) geometric mean titer (GMT) against heterologous H1 and H3 influenza strains [ Time Frame: Day 1 through Day 365 ]
- Serum hemagglutination inhibition (HAI) geometric mean titers (GMTs) against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]
- Serum neuraminidase inhibition (NAI) geometric mean fold rise (GMFR) against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Serum neuraminidase inhibition (NAI) geometric mean titer (GMT) against 2018/2019 QIV strains [ Time Frame: Day 8 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Serum neuraminidase inhibition (NAI) geometric mean titers (GMTs) against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Serum neuraminidase inhibition (NAI) geometric mean titers (GMTs) against heterologous N1 and N2 neuraminidase (NA) antigens [ Time Frame: Day 1 through Day 365 ]NAI titers will only be assessed on study groups 1, 2, and 3.
- Serum neutralizing (Neut) geometric mean fold rise (GMFR) against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]
- Serum neutralizing (Neut) geometric mean titer (GMT) against 2018/2019 QIV strains [ Time Frame: Day 8 through Day 365 ]
- Serum neutralizing (Neut) geometric mean titer (GMT) against heterologous H1 and H3 influenza strains [ Time Frame: Day 1 through 365 ]
- Serum neutralizing (Neut) geometric mean titers (GMTs) against 2019/2020 QIV strains [ Time Frame: Day 90 through Day 118 ]

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: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Provide written informed consent prior to initiation of any study procedures.
- Are able to understand and comply with planned study procedures and be available for all study visits.
- Must agree to the collection of venous blood per protocol.
- Are males or non-pregnant females, 18 to 45 years of age, inclusive at time of enrollment.
- Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric 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, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or 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. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted.
- Oral temperature is less than 100.0 degrees Fahrenheit.
- Pulse is 47 to 100 beats per minute, inclusive.
- Systolic blood pressure is 85 to 140 mmHg, inclusive.
- Diastolic blood pressure is 55 to 90 mmHg, inclusive.
-
Screening laboratories (Erythrocyte Sedimentation Rate (ESR), White Blood Cells (WBC), Hemoglobin (Hgb), Platelets (PLTs), Alanine Aminotransferase (ALT), Total Bilirubin (T. Bili), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Alkaline Phosphatase (ALP) serum lipase, serum amylase and Creatinine (Cr)) are within acceptable parameters*.
*ESR must be below 30 mm/hr; WBC >3.90 K/MM3 and <10.60 K/MM3; Hgb >/= 11.5 g/dl (women) or >/= 12.5 g/dl (men); PLTs (EDTA) 140-415 K/MM3; PLTs (Citrate) 125-325 K/MM3 ALT </= 43 U/L (women) or </= 60 U/L (men); T Bili </=1.20 mg/dl; Cr < 1.1 mg/dl (women) or < 1.4 mg/dl (men); AST 10-36 U/L (women) or 10-43 U/L (men); GGT 5--32 U/L (women) or 10-49 U/L (men); ALP 30-115 U/L (women) or 43-115 U/L (men); lipase 13-60 U/L; amylase (Total) 35-121 U/L, for subjects to qualify for randomization and vaccination.
-
Women of childbearing potential* must use an acceptable contraception method** from at least 30 days before the first study vaccination until 60 days after the second study vaccination.
*Not sterilized via bilateral oophorectomy, tubal ligation/ salpingectomy, hysterectomy, or successful Essure(R) 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 has passed since the last menses if menopausal.
- Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, barrier methods such as condoms or diaphragms/cervical cap with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination.
- For a woman with potential to become pregnant, she understands that in the event of pregnancy during the study she will be approached to enroll in the Sanofi Pregnancy Registry.
- Must agree to have residual specimens (i.e. residual/excess of per protocol specifications).
Exclusion Criteria:
-
Have an acute illness*, as determined by the site Principal Investigator (PI) 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 PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
-
Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.
*Including acute, subacute, intermittent or chronic medical disease or condition 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.
- Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
- Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
- Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
- Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
- Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
- Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
- Have a history of Guillain-Barré Syndrome (GBS).
- Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
- Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
- Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
-
Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere* with subject compliance or safety evaluations.
*As determined by the site PI or appropriate sub-investigator.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
- Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
-
Have taken high-dose inhaled corticosteroids* within 30 days prior to study vaccination.
*High-dose defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.
- Received or plan to receive a licensed, live vaccine (excluding all licensed, seasonal LAIVs) within 30 days before or after the study vaccination.
- Received or plan to receive a licensed, inactivated vaccine (excluding all licensed, seasonal IIVs) within 14 days before or after each study vaccination.
- Have received any 2018/2019 seasonal influenza vaccine within the 6 months prior to enrollment.
- Plans to receive any 2019/2020 seasonal influenza vaccine within approximately 90 days of receipt of the first study vaccination.
- Have a known history of documented influenza infection within the past 6 months.
- Received immunoglobulin or other blood products (except Rho D immunoglobulin) within 90 days prior to study vaccination.
-
Received an experimental agent* within 30 days prior to the study vaccination or expect to receive another experimental agent* during the trial-reporting period*.
*Including vaccine, drug, biologic, device, blood product, or medication.
**Other than from participation in this trial.
***Approximately 12 months after the first study vaccination.
-
Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the trial-reporting period**.
*Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
**Approximately 12 months after the first study vaccination.
- Female subjects who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
- Plan to travel outside the US (continental US, Hawaii and Alaska) from the time of study vaccination through approximately 90 days after the first study vaccination.
- Planning to donate blood within 4 months following first vaccination.
Exclusion Criteria for Second Study Vaccination:
All study participants will be expected to receive the second study vaccination except under the circumstances listed below. The second study vaccination will not be administered to a subject if any of the following criteria are met:
- Meets the contraindication on the package insert to receipt of licensed influenza vaccine.
- As deemed necessary by the site principal investigator or appropriate sub-investigator for noncompliance or other reasons.
- Subject refusal of further study vaccination.
- Withdrawal of consent.
- Subject is lost to follow-up.
- Termination of this trial.
- New information becomes available that makes further participation unsafe.

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): NCT03945825
United States, Georgia | |
Emory Children's Center - Pediatric Infectious Diseases | |
Atlanta, Georgia, United States, 30322-1014 | |
United States, Iowa | |
University of Iowa - Vaccine Research and Education Unit | |
Iowa City, Iowa, United States, 52242-2600 | |
United States, Maryland | |
University of Maryland Baltimore - School of Medicine - Medicine | |
Baltimore, Maryland, United States, 21201-1509 | |
United States, Missouri | |
Saint Louis University - Center for Vaccine Development | |
Saint Louis, Missouri, United States, 63104-1015 | |
United States, North Carolina | |
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit | |
Durham, North Carolina, United States, 27704 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center - Infectious Diseases | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Tennessee | |
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | |
Nashville, Tennessee, United States, 37232-2573 | |
United States, Texas | |
Baylor College of Medicine - Molecular Virology and Microbiology | |
Houston, Texas, United States, 77030-3411 |
Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT03945825 |
Other Study ID Numbers: |
18-0011 HHSN272201300015I |
First Posted: | May 10, 2019 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | September 11, 2020 |
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 |
Immunogenicity Influenza Influenza Vaccine |
Phase 1 Quadrivalent Safety |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |