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Phase 2 N=366 Randomized Quadruple-blind Prevention

Panblok H7 Vaccine Adjuvanted With AS03 or MF59

Influenza, Human

Enrolled (actual)
366
Serious AEs
2.7%
Results posted
Sep 2019
Primary outcome: Primary: Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03 — 42; 44; 36 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
3.75 ug Panblok H7 (Biological); 7.5 ug Panblok H7 (Biological); 15 ug Panblok H7 (Biological); MF59 (Biological); AS03 (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Biomedical Advanced Research and Development Authority
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03
42; 44; 36
PRIMARY
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03
25; 28; 27
PRIMARY
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
37; 30; 29
PRIMARY
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59
27; 24; 28
PRIMARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
0; 0; 0; 7; 10; 13
PRIMARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
0; 0; 0; 1; 3; 0
PRIMARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
50; 54; 57
PRIMARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
38; 36; 47
SECONDARY
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03
3; 1; 3
SECONDARY
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59
1; 2; 0
SECONDARY
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03
11; 8; 13
SECONDARY
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59
9; 16; 10
SECONDARY
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03
0; 0; 0
SECONDARY
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59
0; 0; 0
SECONDARY
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03
24; 25; 22
SECONDARY
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59
24; 24; 21
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
0; 0; 0; 7; 10; 13
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
38; 36; 47
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
50; 54; 57
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
276.3; 400.7; 489.1
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
0; 0; 0; 1; 3; 0
SECONDARY
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
0; 0; 1; 51; 50; 54
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
75.4; 103; 124.3
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
75.4; 103; 124.3
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
163.8; 274.9; 313.1
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
163.8; 274.9; 313.1
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
47.4; 58.6; 71.1
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
47.4; 58.6; 71.1
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
0; 0; 0; 7; 10; 13
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
0; 0; 0; 1; 3; 0
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
0; 0; 0; 2; 5; 4
SECONDARY
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
0; 0; 1; 1; 0; 0
SECONDARY
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
7; 10; 12; 53; 53; 56
SECONDARY
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
1; 2; 0; 47; 47; 48
SECONDARY
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
2; 5; 4; 48; 52; 55
SECONDARY
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
1; 0; 0; 37; 35; 47
SECONDARY
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
0; 0; 0; 40; 39; 44
SECONDARY
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
0; 2; 7; 53; 53; 56
SECONDARY
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
1; 1; 0; 46; 44; 47
SECONDARY
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
276.3; 400.7; 489.1
SECONDARY
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
5.0; 5; 5; 5.3; 6.2; 6.3
SECONDARY
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
5.1; 5; 5; 5.2; 5; 5.2
SECONDARY
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
5; 5; 5.2; 6.4; 7.8; 8.9
SECONDARY
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
5.1; 5.3; 5.1; 5.8; 6; 5.9

Summary

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Eligibility Criteria

Inclusion Criteria

  • Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
  • Provide written informed consent prior to the initiation of any study-related procedures.
  • Are able to understand and comply with planned study procedures.
  • Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
  • Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  • Agree to stay in contact with the study site for the duration of the study, have no current plans to move from the study area, and agree to provide updated contact information as necessary.

Exclusion Criteria

  • Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.
  • Women who are pregnant or breast feeding. Women of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours prior to each vaccination.

Women of childbearing potential are defined as postmenarcheal and premenopausal females capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >12 months, tubal ligation >12 months, bilateral salpingo-oophorectomy, or hysterectomy.

  • Women of childbearing potential who refuse to use an acceptable method of birth control from screening to Day 50 (Visit 7) or, if sexually active with a male partner, who have not used a reliable birth control method during the 2 months prior to screening.

Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female participant's Screening Visit, and this male is the sole partner for that participant (the information on the male partner's sterility can come from the site personnel's review of the participant medical records or interview with the participant on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).

  • Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months, or plans to receive immunosuppressive therapy/cytotoxic treatment during study participation.
  • Have an active neoplastic disease or a history of any hematologic malignancy. However, participants with superficial skin cancer who do not require intervention other than local excision are not excluded.
  • Have long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or prednisone equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening in this study. However, participants on low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical steroids are not excluded.
  • History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.
  • History of hospitalization for psychiatric illness, attempted suicide, or having been deemed a danger to self or others within the past 10 years.
  • Have received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to screening
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03283319). 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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