Reverse Genetic H9N2 Influenza Vaccine Study in Adults

A Randomized, Double Blind, Multi-center, Phase 1/2 Study to Assess Safety and Immunogenicity of Five Dose Levels of a Reverse Genetic (RG) Reassortant H9N2 Pandemic Influenza Vaccine in Healthy Subjects Aged 18 to 49 Years

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320696

Enrollment

353

Registered

2011-03-22

Start date

2011-03-31

Completion date

2012-05-31

Last updated

2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Brief summary

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.

Interventions

BIOLOGICALReverse Genetic (RG) reassortant A/H9N2 influenza vaccine

Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is 18 to 49 years of age, inclusive, on the day of screening * Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to study entry * Subject is generally healthy, as determined by the investigator's clinical judgement through collection of medical history and performance of a physical examination * Subject is physically and mentally capable of participating in the study as determined by the investigator * Subject agrees to keep a daily record of symptoms for the duration of the study * If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to first vaccination and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study at least one of the following types of US Food and Drug Administration (FDA) approved birth control measures shall be applied through completion of the Day 181 study visit: * Hormonal types of birth control (such as implants or birth control pills) or an intrauterine device * A barrier type of birth control measure (i.e. condoms, diaphragms, cervical caps, etc.)

Exclusion criteria

* Subject has a history of exposure to H9N2 influenza virus or a history of vaccination with an H9N2 influenza vaccine * Subject is at potential occupational risk of contracting H9N2 influenza infection (e.g. poultry workers) * Subject currently suffers from or has a history of a significant (requiring hospitalization or change in intervention in past 6 months)neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome as determined by the investigator * Subject has a body temperature of \>= 100.4 degrees Fahrenheit (\>= 38.0 degrees Celsius) on the day of vaccination, by oral measurement. \[NOTE: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided: 1) body temperature measured orally has decreased to \< 100.4 degrees Fahrenheit (\< 38.0 degrees Celsius); 2) all other inclusion/

Design outcomes

Primary

Measure	Time frame
Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination	21 days after 2nd vaccination
Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination	21 days after 2nd vaccination
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	7 days after 1st and 2nd vaccination

Secondary

Measure	Time frame
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	21 days after 1st and 2nd vaccination
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	21 days after 1st and 2nd vaccination
Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline	21 days after 1st vaccination
Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	21 days after 1st and 2nd vaccination
Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	21 days after 1st and 2nd vaccination
Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination	21 days after 1st vaccination
Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	180 days after 1st vaccination
Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	180 days after 1st vaccination
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	7 days after 1st and 2nd vaccination
Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Through study completion by all subjects, an average of 181 days (+/- 14 days)
Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	180 days after 1st vaccination
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 1st and 2nd vaccination
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 1st and 2nd vaccination

Countries

United States

Participant flow

Pre-assignment details

Of the 353 enrolled participants, 275 met inclusion criteria and were randomized to treatment.

Participants by arm

Arm	Count
3.75 µg Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22	56
7.5 µg Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22	55
15 µg Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22	54
30 µg Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22	55
45 µg Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22	55
Total	275

Baseline characteristics

Characteristic	3.75 µg	7.5 µg	15 µg	30 µg	45 µg	Total
Age, Continuous	32.5 years STANDARD_DEVIATION 8.6	32.6 years STANDARD_DEVIATION 8.7	33.8 years STANDARD_DEVIATION 8.1	35.8 years STANDARD_DEVIATION 9.3	34.1 years STANDARD_DEVIATION 9	33.8 years STANDARD_DEVIATION 8.8
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	5 Participants	2 Participants	4 Participants	4 Participants	19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants	50 Participants	52 Participants	51 Participants	51 Participants	256 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants	8 Participants
Race (NIH/OMB) Black or African American	9 Participants	7 Participants	11 Participants	9 Participants	11 Participants	47 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	45 Participants	45 Participants	41 Participants	44 Participants	42 Participants	217 Participants
Sex: Female, Male Female	33 Participants	27 Participants	31 Participants	31 Participants	29 Participants	151 Participants
Sex: Female, Male Male	23 Participants	28 Participants	23 Participants	24 Participants	26 Participants	124 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 56	0 / 55	0 / 54	0 / 55	0 / 55
other Total, other adverse events	15 / 56	23 / 55	27 / 54	27 / 55	28 / 55
serious Total, serious adverse events	0 / 56	0 / 55	0 / 54	0 / 55	0 / 55

Outcome results

Primary

Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination

Time frame: 21 days after 2nd vaccination

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination	28 Participants
7.5 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination	28 Participants
15 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination	39 Participants
30 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination	42 Participants
45 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination	48 Participants

Primary

Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination

Time frame: 21 days after 2nd vaccination

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination	27 Participants
7.5 µg	Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination	27 Participants
15 µg	Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination	38 Participants
30 µg	Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination	41 Participants
45 µg	Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination	48 Participants

Primary

Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity

Time frame: 7 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (NUMBER)
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Severe	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Severe	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Severe	1 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Mild	9 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Severe	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Unknown	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Unknown	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Moderate	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Mild	6 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Unknown	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination: Moderate	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Mild	6 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Unknown	0 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination: Moderate	1 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Mild	3 participants
3.75 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Moderate	1 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Severe	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Moderate	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Severe	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Moderate	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Unknown	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Mild	10 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination: Moderate	2 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Mild	13 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Unknown	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Severe	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Severe	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Unknown	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination: Moderate	1 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Unknown	0 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Mild	8 participants
7.5 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Mild	3 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Mild	16 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination: Moderate	2 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Severe	1 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Mild	7 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Severe	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Unknown	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Moderate	3 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Severe	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Unknown	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Severe	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Mild	14 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Unknown	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Moderate	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination: Moderate	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Unknown	0 participants
15 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Mild	12 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Severe	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Unknown	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Mild	17 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Moderate	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Unknown	1 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Mild	10 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Moderate	2 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Severe	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Unknown	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Mild	10 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination: Moderate	1 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Severe	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Mild	4 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination: Moderate	1 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Severe	0 participants
30 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Unknown	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Mild	3 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Mild	11 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Unknown	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Severe	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Mild	20 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination: Moderate	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Moderate	2 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 2nd vaccination : Mild	18 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Unknown	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Unknown	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 2nd vaccination : Severe	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Severe	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Unknown	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination : Severe	0 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with systemic reactions within 7 days after 1st vaccination: Moderate	2 participants
45 µg	Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity	Number of subjects with injection site reactions within 7 days after 1st vaccination : Moderate	3 participants

Secondary

Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays

Time frame: 180 days after 1st vaccination

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
3.75 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by SRH Assay	3.4 Fold change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by MN Assay	5.4 Fold change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by HI Assay	2.7 Fold change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by MN Assay	9.1 Fold change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by HI Assay	3.9 Fold change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by SRH Assay	4.5 Fold change in Antibody Response
15 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by SRH Assay	3.7 Fold change in Antibody Response
15 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by HI Assay	4.3 Fold change in Antibody Response
15 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by MN Assay	10.3 Fold change in Antibody Response
30 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by SRH Assay	4.5 Fold change in Antibody Response
30 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by HI Assay	6.1 Fold change in Antibody Response
30 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by MN Assay	13.3 Fold change in Antibody Response
45 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by HI Assay	8.1 Fold change in Antibody Response
45 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by MN Assay	19.9 Fold change in Antibody Response
45 µg	Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured by SRH Assay	5.1 Fold change in Antibody Response

Secondary

Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays

Time frame: 21 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
3.75 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by HI assay	3.2 Fold Change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by HI assay	5.7 Fold Change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by MN assay	8 Fold Change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by MN assay	22.2 Fold Change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by SRH assay	2.7 Fold Change in Antibody Response
3.75 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by SRH assay	3.7 Fold Change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by SRH assay	3.9 Fold Change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by SRH assay	4.5 Fold Change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by HI assay	4.5 Fold Change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by MN assay	14.4 Fold Change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by MN assay	25.5 Fold Change in Antibody Response
7.5 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by HI assay	6.6 Fold Change in Antibody Response
15 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by MN assay	34.0 Fold Change in Antibody Response
15 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by SRH assay	3.2 Fold Change in Antibody Response
15 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by HI assay	7.8 Fold Change in Antibody Response
15 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by MN assay	18.9 Fold Change in Antibody Response
15 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by HI assay	10.7 Fold Change in Antibody Response
15 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by SRH assay	3.7 Fold Change in Antibody Response
30 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by MN assay	38.9 Fold Change in Antibody Response
30 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by HI assay	12.7 Fold Change in Antibody Response
30 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by MN assay	26.7 Fold Change in Antibody Response
30 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by SRH assay	4.4 Fold Change in Antibody Response
30 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by SRH assay	4.0 Fold Change in Antibody Response
30 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by HI assay	10.4 Fold Change in Antibody Response
45 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by SRH assay	5.1 Fold Change in Antibody Response
45 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by MN assay	44.1 Fold Change in Antibody Response
45 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by HI assay	19.8 Fold Change in Antibody Response
45 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by SRH assay	5.5 Fold Change in Antibody Response
45 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 2nd vaccination by MN assay	67.4 Fold Change in Antibody Response
45 µg	Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays	Fold increase of antibody response measured after 1st vaccination by HI assay	15.5 Fold Change in Antibody Response

Secondary

Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period

Time frame: Through study completion by all subjects, an average of 181 days (+/- 14 days)

Arm	Measure	Group	Value (NUMBER)
3.75 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Mild	25 Events
3.75 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Moderate	2 Events
3.75 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Severe	2 Events
3.75 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Unknown	0 Events
7.5 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Mild	54 Events
7.5 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Unknown	0 Events
7.5 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Moderate	5 Events
7.5 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Severe	0 Events
15 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Unknown	0 Events
15 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Moderate	7 Events
15 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Severe	1 Events
15 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Mild	67 Events
30 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Mild	46 Events
30 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Moderate	4 Events
30 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Unknown	1 Events
30 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Severe	0 Events
45 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Unknown	0 Events
45 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Severe	0 Events
45 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Moderate	10 Events
45 µg	Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period	Mild	64 Events

Secondary

Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays

Time frame: 21 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by MN assay	49 Participants
3.75 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by SRH area	30 Participants
3.75 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by MN assay	40 Participants
3.75 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by HI assay	27 Participants
3.75 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by HI assay	16 Participants
3.75 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by SRH area	35 Participants
7.5 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by SRH area	39 Participants
7.5 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by MN assay	49 Participants
7.5 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by HI assay	21 Participants
7.5 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by MN assay	44 Participants
7.5 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by HI assay	27 Participants
7.5 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by SRH area	42 Participants
15 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by MN assay	47 Participants
15 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by HI assay	32 Participants
15 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by SRH area	35 Participants
15 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by HI assay	38 Participants
15 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by MN assay	49 Participants
15 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by SRH area	38 Participants
30 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by MN assay	51 Participants
30 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by HI assay	41 Participants
30 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by HI assay	35 Participants
30 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by MN assay	52 Participants
30 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by SRH area	43 Participants
30 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by SRH area	42 Participants
45 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by MN assay	53 Participants
45 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by HI assay	40 Participants
45 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by HI assay	48 Participants
45 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by SRH area	42 Participants
45 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 1st vaccination : Measured by MN assay	53 Participants
45 µg	Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays	Antibody response 21 days after the 2nd vaccination : Measured by SRH area	44 Participants

Secondary

Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination

Time frame: 21 days after 1st vaccination

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination	17 Participants
7.5 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination	22 Participants
15 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination	33 Participants
30 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination	35 Participants
45 µg	Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination	40 Participants

Secondary

Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays

Time frame: 180 days after 1st vaccination

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	9 Participants
3.75 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	30 Participants
3.75 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	34 Participants
7.5 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	41 Participants
7.5 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	17 Participants
7.5 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	43 Participants
15 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	44 Participants
15 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	21 Participants
15 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	36 Participants
30 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	28 Participants
30 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	43 Participants
30 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	47 Participants
45 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	52 Participants
45 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	31 Participants
45 µg	Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	40 Participants

Secondary

Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays

Time frame: 180 days after 1st vaccination

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	10 Participants
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	46 Participants
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	38 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	43 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	17 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	49 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	45 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	22 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	50 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	28 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	51 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	49 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay	52 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay	31 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays	Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay	51 Participants

Secondary

Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20

Time frame: 21 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 1st vaccination	45 Participants
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 2nd vaccination	51 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 1st vaccination	48 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 2nd vaccination	51 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 1st vaccination	49 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 2nd vaccination	50 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 2nd vaccination	53 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 1st vaccination	55 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 1st vaccination	54 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20	21 days after 2nd vaccination	54 Participants

Secondary

Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2

Time frame: 21 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 1st vaccination	45 Participants
3.75 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 2nd vaccination	49 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 1st vaccination	48 Participants
7.5 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 2nd vaccination	52 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 1st vaccination	49 Participants
15 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 2nd vaccination	51 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 2nd vaccination	52 Participants
30 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 1st vaccination	53 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 1st vaccination	53 Participants
45 µg	Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2	21 days after 2nd vaccination	54 Participants

Secondary

Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination

Time frame: 7 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Fever	0 Participants
3.75 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Malasie	1 Participants
3.75 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Shivering	0 Participants
3.75 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Fever	0 Participants
3.75 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Malasie	0 Participants
3.75 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Shivering	1 Participants
7.5 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Malasie	2 Participants
7.5 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Shivering	0 Participants
7.5 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Fever	0 Participants
7.5 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Shivering	3 Participants
7.5 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Fever	0 Participants
7.5 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Malasie	2 Participants
15 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Fever	0 Participants
15 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Malasie	3 Participants
15 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Fever	0 Participants
15 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Shivering	0 Participants
15 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Malasie	2 Participants
15 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Shivering	0 Participants
30 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Fever	0 Participants
30 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Malasie	1 Participants
30 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Shivering	0 Participants
30 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Shivering	0 Participants
30 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Malasie	0 Participants
30 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Fever	0 Participants
45 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Malasie	0 Participants
45 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Shivering	2 Participants
45 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Malasie	2 Participants
45 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Shivering	0 Participants
45 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 2nd vaccination : Fever	1 Participants
45 µg	Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination	After 1st vaccination : Fever	0 Participants

Secondary

Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline

Time frame: 21 days after 1st vaccination

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline	16 Participants
7.5 µg	Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline	21 Participants
15 µg	Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline	32 Participants
30 µg	Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline	35 Participants
45 µg	Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline	40 Participants

Secondary

Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination

Time frame: 21 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 1st vaccination	30 Participants
3.75 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 2nd vaccination	35 Participants
7.5 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 1st vaccination	39 Participants
7.5 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 2nd vaccination	42 Participants
15 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 1st vaccination	35 Participants
15 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 2nd vaccination	38 Participants
30 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 2nd vaccination	43 Participants
30 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 1st vaccination	42 Participants
45 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 1st vaccination	42 Participants
45 µg	Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination	Number of subjects with seroconversion 21 days after the 2nd vaccination	44 Participants

Secondary

Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline

Time frame: 21 days after 1st and 2nd vaccination

Population: Participant number differs from 1st to 2nd vaccination due to dropouts

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
3.75 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 1st vaccination	40 Participants
3.75 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 2nd vaccination	49 Participants
7.5 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 1st vaccination	44 Participants
7.5 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 2nd vaccination	49 Participants
15 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 1st vaccination	47 Participants
15 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 2nd vaccination	49 Participants
30 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 2nd vaccination	51 Participants
30 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 1st vaccination	52 Participants
45 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 1st vaccination	53 Participants
45 µg	Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline	Number of subjects with seroconversion 21 days after 2nd vaccination	53 Participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026

Reverse Genetic H9N2 Influenza Vaccine Study in Adults

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination

Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination

Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity

Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays

Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays

Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period

Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays

Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination

Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays

Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays

Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20

Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2

Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination

Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline

Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination

Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline