Assess the Safety & Immunogenicity of Prime-Boost Vaccina... | NCT03497845

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
a VN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant	Experimental	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).	Biological: VN Biological: gf/WA Biological: AS03 adjuvant
b IN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant	Experimental	Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).	Biological: IN Biological: gf/WA Biological: AS03 adjuvant
c dk/BANG with AS03 Adjuvant, then gf/WA with AS03 Adjuvant	Experimental	Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).	Biological: dk/BANG Biological: gf/WA Biological: AS03 adjuvant
d gf/WA with AS03 Adjuvant, then IN with AS03 Adjuvant	Experimental	Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).	Biological: IN Biological: gf/WA Biological: AS03 adjuvant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VN	Biological	0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	a VN with AS03 Adjuvant, then gf/WA with AS03 Adjuvant g VN with MF59 Adjuvant, then gf/WA with MF59 Adjuvant

Measure	Description	Time Frame
Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series	Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses	8 days post-vaccination
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series	Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses	8 days post-vaccination
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series	Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)	Day 43
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series	Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)	Day 163

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is a male or nonpregnant female 18 to 49 years of age, inclusive, on Day 1 (first vaccination).
Will avoid nonstudy vaccinations until 21 days after the last vaccination.
Provides written informed consent prior to the initiation of any study-related procedures.
Has a stable health status, as established by physical examination, vital sign measurements, and medical history.
Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
Is able to understand and comply with planned study procedures.
Lives a reasonable distance from the site to be able to travel to and from the site for follow-up visits and agrees to go to the site for evaluation in the case of an adverse event.
Agrees to stay in contact with the site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.

Exclusion Criteria:

Has a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal, or chicken protein), or allergy to squalene-based adjuvants or has had severe reactions following previous immunizations with contemporary influenza virus vaccines.
A woman who has a positive urine pregnancy test prior to vaccination in this study or a woman who is breastfeeding.
A female of childbearing potential (a) who refuses to use an acceptable method of birth control (b) from Day 1 (first vaccination) to end-of-study visit and, if sexually active, who has not used a reliable birth control method for at least 2 months prior to Day 1 (first vaccination).
1. Female of childbearing potential is defined as post-onset menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >1 year, tubal ligation >1 year, bilateral salpingo-oophorectomy, or hysterectomy.
2. Adequate contraception is defined as a contraceptive method with 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 Day 1 (first vaccination), and this male is the sole partner for that subject (The information on the male sterility can come from the site personnel's review of the subject's medical records or interview with the subject 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).
Is immunosuppressed as a result of an underlying illness or treatment, or anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months prior to Day 1 (first vaccination).
Has an active neoplastic disease or a history of any hematologic malignancy. A subject with superficial skin cancer who does not require intervention other than local excision is not excluded.
Has long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening. (Low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
Has a neurological or psychiatric diagnosis, which, although stable, is judged by the investigator to render the potential subject unable or unlikely to comply with the protocol or to provide accurate safety reports.
Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 3 months prior to Day 1 (first vaccination).
Has received any live vaccine within 4 weeks or inactivated vaccines within 2 weeks prior to Day 1 (first vaccination). This includes seasonal influenza vaccines.
Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes potentially immune-mediated medical conditions such as Guillain-Barré syndrome, narcolepsy, current or history of autoimmune or chronic inflammatory disease.
Has a first-degree relative with narcolepsy.
Has an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per subject report, within 3 days prior to each vaccination. Subjects with an acute illness can be rescheduled for a vaccination as long as the vaccination visit is within the visit window. Note that subjects may return for randomization following resolution of the acute illness as long as recruitment remains open and subjects are within 14 days of signing consent.
Has a Grade 2 or greater (by US Food and Drug Administration toxicity grade) safety laboratory value at screening.
Has received an experimental agent (vaccine, biologic, device, blood product, or medication) within 1 month prior to Day 1 (first vaccination) in this study or plans receipt of an experimental agent during the study period.
Is participating or plans to participate in another interventional clinical study (either active or follow-up phase) during the study period.
Has received an influenza H5 vaccine in the past or has a history of H5 influenza infection prior to enrollment.
Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
Has a history of alcohol or drug abuse within 5 years prior to Day 1 (first vaccination).
Has a body mass index >35 kg/m2.
Has any condition that would, in the opinion of the investigator, place him or her at an unacceptable risk of injury or render him or her unable to meet the requirements of the protocol (including site of injection reactogenicity assessments).
Is a first-degree relative of any person working on this study: site or sponsor.

Facility	Status	City	State	ZIP	Country	Contacts
Optimal Research		San Diego	California	92108	United States
Optimal Research

ID	Title	Description
FG000	a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 26, 2018	Apr 9, 2020

Arm/Group Information

ID	Title	Description
BG000	a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG001	b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG002	c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG003	d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant	Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG004	e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG005	f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142) gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG006	g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG007	h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG008	i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG009	j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant	Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG010	k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG011	l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant	Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142). gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
BG012	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms.

Subjects in A-D and G-J did not receive 3 doses

If a subject experienced multiple occurrences of the same solicited local AE, only the most severe solicited local AE was counted. If a subject had multiple AEs the number of events analyzed may be greater than the overall number of participants analyzed.

Subjects in A-D and G-J did not receive 3 doses

Posted

Number

Events

8 days post-vaccination

ID	Title	Description
OG000	a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG001	b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG002	c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG003	d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant	Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG004	e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG005	f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142) gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG006	g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG007	h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG008	i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG009	j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant	Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG010	k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG011	l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant	Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142). gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Units	Counts
Participants	OG00060 OG00158 OG00261 OG003

Title	Denominators	Categories
AEs in subjects who received Dose 1 : Mild	ParticipantsOG00060 ParticipantsOG00158 ParticipantsOG00261 ParticipantsOG003

Primary

Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series

Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses

If a subject experienced multiple occurrences of the same solicited local AE, only the most severe solicited local AE was counted.

Number Analyzed per Row = Participants with available data Subjects in A-D and G-J did not receive 3 doses

Posted

Number

Events

8 days post-vaccination

ID	Title	Description
OG000	a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG001	b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Primary

Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series

Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

Seroprotection Rate by Strain (with 95% confidence interval) of HAI antibodies at Day 43 (21 days after Dose 2)

Posted

Number

95% Confidence Interval

percentage of participants

Day 43

ID	Title	Description
OG000	a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG001	b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG002

Primary

Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series

Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)

Seroprotection Rate by Strain (with 95% confidence interval) of HAI antibodies at Day 163 (21 days after Dose 3). Measurement of participants remaining rather than enrolled.

Posted

Number

95% Confidence Interval

percentage of participants

Day 163

ID	Title	Description
OG000	e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
OG001	f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142) gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	a VN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	60	1	60	46	60
EG001	b IN With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	58	2	58	45	58
EG002	c dk/BANG With AS03 Adjuvant, Then gf/WA With AS03 Adjuvant	Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	61	1	61	44	61
EG003	d gf/WA With AS03 Adjuvant, Then IN With AS03 Adjuvant	Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	60	0	60	43	60
EG004	e dk/BANG With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	1	59	2	59	47	59
EG005	f gf/WA With AS03 Adjuvant, Then Bhg/QL With AS03 Adjuvant	Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142) gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose AS03 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	62	0	62	47	62
EG006	g VN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). VN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	59	2	59	40	59
EG007	h IN With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	60	1	60	36	60
EG008	i dk/BANG With MF59 Adjuvant, Then gf/WA With MF59 Adjuvant	Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	61	0	61	40	61
EG009	j gf/WA With MF59 Adjuvant, Then IN With MF59 Adjuvant	Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22). IN: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	59	0	59	41	59
EG010	k dk/BANG With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant	Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142). dk/BANG: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	61	4	61	45	61
EG011	l gf/WA With MF59 Adjuvant, Then Bhg/QL With MF59 Adjuvant	Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142). gf/WA: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose bhg/QL: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose MF59 adjuvant: 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose	0	60	1	60	42	60

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Non-systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG0030 events0 affected60 at risk EG0040 events0 affected59 at risk EG0050 events0 affected62 at risk EG0060 events0 affected59 at risk EG0070 events0 affected60 at risk EG0080 events0 affected61 at risk EG0090 events0 affected59 at risk EG0100 events0 affected61 at risk EG0110 events0 affected60 at risk
Gun Shot Wound	Injury, poisoning and procedural complications	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Acute Appendicitis	Infections and infestations	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Major Depressive Episode with Suicidal Intent	Psychiatric disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Pregnancy with Spontaneous Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Extrasystoles/Ventricluar Premature Contractions	Cardiac disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected58 at risk EG0020 events0 affected61 at risk EG003
Ankyloglossia, congenital	Congenital, familial and genetic disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0011 events1 affected58 at risk EG0020 events0 affected61 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0021 events1 affected61 at risk EG003
Major depression	Psychiatric disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Bartholin's Abscess	Infections and infestations	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA (20.0)	Non-systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA (20.0)	Systematic Assessment	EG00042 events42 affected60 at risk EG00135 events35 affected58 at risk EG00236 events36 affected61 at risk EG00335 events35 affected60 at risk EG00435 events35 affected59 at risk EG00536 events36 affected62 at risk EG00622 events22 affected59 at risk EG00726 events26 affected60 at risk EG00825 events25 affected61 at risk EG00928 events28 affected59 at risk EG01033 events33 affected61 at risk EG01125 events25 affected60 at risk
Fatigue	General disorders	MedDRA (20.0)	Systematic Assessment	EG00015 events15 affected60 at risk EG00114 events14 affected58 at risk EG00212 events12 affected61 at risk EG003
Chills	General disorders	MedDRA (20.0)	Systematic Assessment	EG00010 events10 affected60 at risk EG0017 events7 affected58 at risk EG0026 events6 affected61 at risk EG003
Injection site swelling	General disorders	MedDRA (20.0)	Systematic Assessment	EG0005 events5 affected60 at risk EG0012 events2 affected58 at risk EG0026 events6 affected61 at risk EG003
Injection site erythema	General disorders	MedDRA (20.0)	Systematic Assessment	EG0005 events5 affected60 at risk EG0014 events4 affected58 at risk EG0025 events5 affected61 at risk EG003
Pyrexia	General disorders	MedDRA (20.0)	Systematic Assessment	EG0003 events3 affected60 at risk EG0011 events1 affected58 at risk EG0021 events1 affected61 at risk EG003
Injection site bruising	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 events0 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003
Headache	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG00021 events21 affected60 at risk EG00116 events16 affected58 at risk EG0028 events8 affected61 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0003 events3 affected60 at risk EG0012 events2 affected58 at risk EG0022 events2 affected61 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG00017 events17 affected60 at risk EG00113 events13 affected58 at risk EG00214 events14 affected61 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0004 events4 affected60 at risk EG0014 events4 affected58 at risk EG0024 events4 affected61 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0009 events9 affected60 at risk EG0016 events6 affected58 at risk EG0027 events7 affected61 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0004 events4 affected60 at risk EG0015 events5 affected58 at risk EG0025 events5 affected61 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 events1 affected60 at risk EG0013 events3 affected58 at risk EG0023 events3 affected61 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 events3 affected60 at risk EG0012 events2 affected58 at risk EG0020 events0 affected61 at risk EG003
Iron Deficiency Anemia	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 events1 affected60 at risk EG0010 events0 affected58 at risk EG0020 events0 affected61 at risk EG003

ID	Term
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D001715	Bird Diseases
D000820	Animal Diseases