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Phase 2 N=149 Randomized Prevention

Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4

Avian Influenza · Influenza · Influenza Immunisation

Enrolled (actual)
149
Serious AEs
0.7%
Results posted
Aug 2020
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination — 36.8; 22.7 titer

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
AS03 (Drug); Inactivated influenza H7N9 vaccine (Biological); Influenza Virus Quadrivalent Inactivated Vaccine (Biological); Phosphate Buffered Saline (PBS) diluent (Other)
Age
Adult · 19+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination
36.8; 22.7
PRIMARY
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
547.7; 503.6; 480.4; 284.0; 289.8; 462.6
PRIMARY
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
230.4; 186.0; 227.6; 481.3; 518.4; 788.9
PRIMARY
GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination
88.4; 50.5
PRIMARY
Number of Participants Reporting Serious Adverse Events (SAEs)
0; 1; 0
PRIMARY
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
3; 1; 0; 1; 0; 0
PRIMARY
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
5; 0; 1; 1; 1; 0
PRIMARY
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
0; 0; 1; 4; 1; 5
PRIMARY
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
44; 18; 14; 44; 30; 17
PRIMARY
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
24; 24; 32; 32; 4; 3
PRIMARY
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
17; 30; 2; 2; 2; 4
PRIMARY
Occurrence of Study Vaccine-related SAEs
0; 0; 0
PRIMARY
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
1; 0; 2; 13; 0; 3
PRIMARY
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
0; 1; 8; 7; 17; 14
PRIMARY
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
0; 2; 10; 5; 11; 4
PRIMARY
Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
51; 38
PRIMARY
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
82; 74
PRIMARY
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
53; 58; 55; 49; 55; 72
PRIMARY
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
100; 96; 93; 93; 94; 100
PRIMARY
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
51; 38
PRIMARY
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
98; 85; 93; 93; 94; 100
PRIMARY
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
84; 74
SECONDARY
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
5.7; 5.7
SECONDARY
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
9.9; 6.6
SECONDARY
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
5.9; 5.4
SECONDARY
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
22.3; 18.4
SECONDARY
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
18; 11; 4; 0; 1; 0
SECONDARY
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
12; 6; 2; 1; 1; 1
SECONDARY
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
4; 1; 1; 1; 1
SECONDARY
Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
6; 6; 2; 1; 2; 0
SECONDARY
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
7; 2; 0; 1; 1; 0
SECONDARY
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
3; 3; 1; 1; 1; 0
SECONDARY
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination
2; 1; 1
SECONDARY
Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
14; 2
SECONDARY
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
34; 28
SECONDARY
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
0; 0
SECONDARY
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
14; 2
SECONDARY
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
2; 0
SECONDARY
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
34; 28

Summary

This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This study is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4.

Eligibility Criteria

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.
  • Are males or non-pregnant females, 19 -64 years of age, inclusive.
  • 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, Emergency Room (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.
  • Oral temperature is less than 100.0°F.
  • Pulse is 47 to 100 beats per minute (bpm), inclusive.
  • Systolic blood pressure is 85 to 150 mmHg, inclusive (subjects 65 years of age).
  • Diastolic blood pressure is 55 to 95 mmHg, inclusive.
  • ESR is less than 30 mm per hour.
  • 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.

-- Includes 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").

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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03318315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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