Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study

Dose Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Randomized, Controlled, Observer Blind Phase II Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02316470

Enrollment

500

Registered

2014-12-15

Start date

2014-12-31

Completion date

2015-10-31

Last updated

2017-06-08

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

Conditions

Clostridium Difficile

Keywords

Clostridium difficile, Valneva, Phase 2, Healthy adults

Brief summary

Phase 2, randomized, observer-blind, placebo-controlled, multi-centric study including 4 parallel study groups. 500 Subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be randomized in a (3:3:3:1) ratio to receive either VLA84 75 µg w/o (without) Alum, VLA84 200 µg w/o Alum, VLA84 200 µg w/ (with) Alum (150 subjects each), or placebo (50 subjects), as i.m. (intramuscular) vaccinations into alternating arms, on Days 0, 7 and 28

Detailed description

This is a randomized, controlled, observer-blind Phase 2 study which aims to confirm the optimal dose and formulation of VLA84 in healthy adults aged ≥ 50 years of age. The study will be enrolled in two age strata, subjects aged 50 - 64 years and subjects aged 65 years and older, in a 1:1 ratio. 500 subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be randomized in a 3:3:3:1 ratio to receive either VLA84 75 µg w/o Alum, VLA84 200 µg w/o Alum, VLA84 200 µg w/ Alum (150 subjects each), or placebo (50 subjects). Vaccinations consist of two i.m. injections administered in close proximity to each other in the deltoid region at Day 0, 7 and 28, starting with the non-dominant arm and alternating arms between the vaccination days. The study will investigate the immunogenicity and safety of VLA84 up to six months after the last vaccination, i.e. 210 days per subject. The study includes eight outpatient visits on days 0, 7, 14, 28, 35, 56, 120 and 210. Serum will be collected to assess humoral immunity at days 0, 7, 14, 28, 35, 56, 120 and 210. The study is OBSERVER blind. This means only pre-defined study staff will be unblinded, e.g., staff responsible for IMP accountability, preparation and administration, monitor responsible IMP accountability, or safety staff in case of safety reasons. All other persons involved in study conduct will remain blinded.

Interventions

BIOLOGICALVLA84

a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B

BIOLOGICALPlacebo

phosphate buffered saline (PBS) solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects aged ≥50 years of good general health, including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, or type 2 diabetes mellitus. * Informed consent form has been signed and dated

Exclusion criteria

* Subjects with any confirmed or suspected prior Clostridium difficile infection episode * Previous vaccination against Clostridium difficile with any (investigational) vaccine or receipt of (investigational) monoclonal antibodies against Clostridium difficile toxins * Use of any other investigational or non-registered medicinal product within 30 days prior to VLA84 vaccination at Visit 1 (Day 0) and throughout the entire study period. * Active or passive vaccination four weeks before first vaccination at Visit 1 and during the entire study period, except for influenza (seasonal or pandemic) and pneumococcal vaccines which may be administered outside a 7-days interval before and after any trial vaccination * Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile) * Known thrombocytopenia, bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion or until Visit 4 (Day28), contraindicating i.m. vaccination as judged by the investigator * Clinically relevant renal, hepatic, cardiac, pulmonary or central nervous disorders, as judged by the investigator. Subjects with hypercholesterolemia, hypertension, or type 2 diabetes mellitus requiring medication are allowed if disease is adequately controlled * Receipt of blood or blood-derived products in the past 3 months or anticipation of such products during the study period * Known congenital, hereditary or acquired immunodeficiency, including known infection with human immunodeficiency virus (HIV), administration of chronic (defined as longer than 14 days) immunosuppressants or other immune-modifying drugs within 30 days prior to VLA84 vaccination at Visit 1 (Day 0) and during the study until Visit 5 (Day 35). For corticosteroids this means prednisone or equivalent ≥ 0.05 mg/kg/day; topical and inhaled steroids are allowed. Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to first VLA84 vaccination at Visit 1 (Day 0) and until Visit 5 (Day 35) * History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded * Any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled * Known hypersensitivity or allergic reactions to one of the components of the vaccine * Inability or unwillingness to provide informed consent * Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities) * Persons who are in a dependent relationship with the sponsor, an investigator or other study team members, or the study center. Dependent relationships include close relatives and household members (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel

Design outcomes

Primary

Measure	Time frame	Description
Seroconversion Rate (SCR) on Day 56	Day 56	Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;

Secondary

Measure	Time frame	Description
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	Days 14, 28, 35, 120 and 210	Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210;
Seroconversion Rate (SCR) for IgG Against Toxin A	14, 28, 35, 56, 120 and 210	Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A;
Seroconversion Rate (SCR) for IgG Against Toxin B	Days 14, 28, 35, 56, 120 and 210	Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B;
Geometric Mean Titer (GMT) for IgG Against Toxin A	Days 0, 14, 28, 35, 56, 120 and 210	Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;
Geometric Mean Titer (GMT) for IgG Against Toxin B	Days 0, 14, 28, 35, 56, 120 and 210	Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;
GMT for Toxin A Neutralizing Antibodies	Days 0, 35, 56, 120 and 210	GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
GMT for Toxin B Neutralizing Antibodies	Days 0, 35, 56, 120 and 210	GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	Days 14, 28, 35, 56, 120 and 210	Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older)
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	Day 56 and Day 210	percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older (65+))
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Days 0, 14, 28, 35, 56, 120, 210	GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older)
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Days 0, 35, 56, 120 and 210	GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older) \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	Days 35, 56, 120, 210	Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Responder Rate (RR) for Toxin A Neutralizing Antibodies	Days 35, 56, 120 and 210	Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Responder Rate (RR) for Toxin B Neutralizing Antibodies	Days 35, 56, 120 and 210	Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	Days 35, 56, 120 and 210	Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120\* and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older) \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Rate of Study Participants With at Least One SAE (Serious Adverse Event)	Day 56 and Day 210	percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210
Rate of Study Participants With at Least One Related SAE	Day 56 and Day 210	percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210
Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	Day 56 and Day 210	percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)
Rate of Study Participants With at Least One Related Unsolicited AE	Day 56 and Day 210	percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)
Rates of Study Participants With at Least One Solicited Local and Systemic AE	within 7 Days after each vaccination	percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	within 7 Days after each vaccination	percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - \< 65 years and 65 years and older)

Countries

Germany, United States

Participant flow

Participants by arm

Arm	Count
VLA84 75 mcg (Microgram) w/o Alum VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B Placebo: phosphate buffered saline (PBS) solution	148
VLA84 200 mcg w/o Alum VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B	152
VLA84 200 mcg With Alum VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B	152
Placebo Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections Placebo: phosphate buffered saline (PBS) solution	48
Total	500

Baseline characteristics

Characteristic	VLA84 75 mcg (Microgram) w/o Alum	VLA84 200 mcg w/o Alum	VLA84 200 mcg With Alum	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	76 Participants	75 Participants	75 Participants	24 Participants	250 Participants
Age, Categorical Between 18 and 65 years	72 Participants	77 Participants	77 Participants	24 Participants	250 Participants
Age, Continuous	64.3 years STANDARD_DEVIATION 8.86	64.1 years STANDARD_DEVIATION 9.34	63.9 years STANDARD_DEVIATION 9.15	63.7 years STANDARD_DEVIATION 9.49	64.0 years STANDARD_DEVIATION 9.13
Region of Enrollment Germany	30 Participants	33 Participants	34 Participants	9 Participants	106 Participants
Region of Enrollment United States	118 Participants	119 Participants	118 Participants	39 Participants	394 Participants
Sex: Female, Male Female	75 Participants	82 Participants	87 Participants	24 Participants	268 Participants
Sex: Female, Male Male	73 Participants	70 Participants	65 Participants	24 Participants	232 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	75 / 148	94 / 152	89 / 152	23 / 48
serious Total, serious adverse events	4 / 148	5 / 152	3 / 152	2 / 48

Outcome results

Primary

Seroconversion Rate (SCR) on Day 56

Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;

Time frame: Day 56

Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210

Arm	Measure	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) on Day 56	71.5 percentage of study participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) on Day 56	83.0 percentage of study participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) on Day 56	59.6 percentage of study participants
Placebo	Seroconversion Rate (SCR) on Day 56	0.0 percentage of study participants

p-value: <0.0001Cochran-Mantel-Haenszel

p-value: 0.0261Cochran-Mantel-Haenszel

p-value: 0.0364Cochran-Mantel-Haenszel

p-value: <0.0001Cochran-Mantel-Haenszel

Secondary

Geometric Mean Titer (GMT) for IgG Against Toxin A

Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;

Time frame: Days 0, 14, 28, 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 120	1563.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 210	866.0 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 28	412.3 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 14	227.2 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 0	40.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 56	2868.9 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 35	1056.6 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 0	37.4 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 210	1395.3 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 56	4328.5 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 14	350.9 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 35	2083.7 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 28	623.2 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 120	2533.8 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 56	4687.6 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 0	44.9 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 14	226.1 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 28	717.7 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 35	3545.6 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 120	2416.7 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 210	1288.8 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 28	36.3 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 210	34.3 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 120	31.4 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 14	38.1 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 0	37.6 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 56	33.9 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin A	GMT at Day 35	34.9 EU/ml

Secondary

Geometric Mean Titer (GMT) for IgG Against Toxin B

Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;

Time frame: Days 0, 14, 28, 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 0	150.1 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 120	1304.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 56	2370.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 14	778.4 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 210	863.3 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 28	949.2 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 35	1651.4 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 120	1699.9 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 35	2377.1 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 28	1026.5 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 56	3336.5 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 210	1023.0 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 14	951.8 EU/ml
VLA84 200 mcg w/o Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 0	107.4 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 35	1165.9 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 0	131.9 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 14	585.0 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 28	754.5 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 56	1449.4 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 120	881.3 EU/ml
VLA84 200 mcg With Alum	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 210	595.4 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 28	107.6 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 210	96.1 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 120	92.1 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 14	98.8 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 0	104.3 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 56	107.8 EU/ml
Placebo	Geometric Mean Titer (GMT) for IgG Against Toxin B	GMT at Day 35	107.0 EU/ml

Secondary

GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group

GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older)

Time frame: Days 0, 14, 28, 35, 56, 120, 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	157.6 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 50 - < 65	630.3 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	714.1 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 50 - < 65	729.3 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	1392.2 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	42.6 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 50 - < 65	1034.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	1832.7 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	1053.1 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	3032.4 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	2581.7 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	1032.3 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 50 - < 65	1391.8 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 65 and older	209.0 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	1944.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	792.9 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	38.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 65 and older	424.4 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 65 and older	1221.5 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	1060.0 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	3173.6 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 50 - < 65	248.0 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 65 and older	952.7 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 65 and older	1747.7 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 65 and older	1628.7 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	941.1 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 50 - < 65	400.1 EU/ml
VLA84 75 mcg (Microgram) w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	142.6 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	1677.7 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	114.6 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 50 - < 65	851.8 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	1317.8 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 65 and older	1348.5 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 50 - < 65	1101.1 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 50 - < 65	531.3 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 65 and older	819.1 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	1510.9 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 50 - < 65	1292.3 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	2803.8 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 50 - < 65	2135.4 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 65 and older	228.8 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	2962.2 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 65 and older	812.5 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	100.6 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	37.0 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	3960.3 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	4099.8 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	2579.7 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	37.7 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 65 and older	453.8 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	794.1 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	4566.4 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 65 and older	2478.7 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	1901.3 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	1288.6 EU/ml
VLA84 200 mcg w/o Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 50 - < 65	2589.3 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	1039.7 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	41.2 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	48.8 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 65 and older	236.0 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 50 - < 65	216.4 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 50 - < 65	704.2 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	3502.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	4344.8 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 50 - < 65	2221.4 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	1269.8 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 65 and older	731.4 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	3589.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	5052.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 65 and older	2629.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	1307.8 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	131.7 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 50 - < 65	476.7 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 50 - < 65	569.8 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	1316.9 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 50 - < 65	745.6 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	501.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	132.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 65 and older	715.9 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 65 and older	995.1 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	1305.4 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	1593.2 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 65 and older	1041.9 EU/ml
VLA84 200 mcg With Alum	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	705.6 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	35.6 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 65 and older	32.9 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 65 and older	38.5 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	122.1 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	37.3 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	32.1 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	115.5 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 65 and older	114.8 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 65 and older	35.6 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	33.0 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 65 and older	105.7 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 65 and older	120.7 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 120, 50 - < 65	29.9 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	30.5 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	44.3 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	110.4 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	38.1 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 28, 50 - < 65	37.1 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	31.4 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	83.7 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	103.3 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 28, 50 - < 65	94.8 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	136.0 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 120, 50 - < 65	79.7 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 14, 50 - < 65	83.9 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	87.8 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin A: GMT at Day 14, 50 - < 65	37.7 EU/ml
Placebo	GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	79.2 EU/ml

Secondary

GMT for Toxin A Neutralizing Antibodies

GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 0, 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 0	11.0 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 35	93.5 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 56	143.1 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 210	95.1 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 35	155.2 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 0	10.3 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 56	200.9 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 210	168.7 Titer
VLA84 200 mcg With Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 210	189.4 Titer
VLA84 200 mcg With Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 56	153.3 Titer
VLA84 200 mcg With Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 0	10.8 Titer
VLA84 200 mcg With Alum	GMT for Toxin A Neutralizing Antibodies	GMT at Day 35	148.7 Titer
Placebo	GMT for Toxin A Neutralizing Antibodies	GMT at Day 35	10.3 Titer
Placebo	GMT for Toxin A Neutralizing Antibodies	GMT at Day 56	10.3 Titer
Placebo	GMT for Toxin A Neutralizing Antibodies	GMT at Day 210	10.2 Titer
Placebo	GMT for Toxin A Neutralizing Antibodies	GMT at Day 0	10.0 Titer

Secondary

GMT for Toxin B Neutralizing Antibodies

GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 0, 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 56	69.8 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 210	51.0 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 35	72.9 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 0	17.4 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 35	99.6 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 56	74.3 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 0	15.9 Titer
VLA84 200 mcg w/o Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 210	61.0 Titer
VLA84 200 mcg With Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 35	61.6 Titer
VLA84 200 mcg With Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 0	19.1 Titer
VLA84 200 mcg With Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 210	43.0 Titer
VLA84 200 mcg With Alum	GMT for Toxin B Neutralizing Antibodies	GMT at Day 56	52.3 Titer
Placebo	GMT for Toxin B Neutralizing Antibodies	GMT at Day 210	17.2 Titer
Placebo	GMT for Toxin B Neutralizing Antibodies	GMT at Day 56	19.1 Titer
Placebo	GMT for Toxin B Neutralizing Antibodies	GMT at Day 0	18.3 Titer
Placebo	GMT for Toxin B Neutralizing Antibodies	GMT at Day 35	18.6 Titer

Secondary

GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group

GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older) \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 0, 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	11.2 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	101.7 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	138.2 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	81.3 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	10.8 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	86.2 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	148.0 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	110.3 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	15.4 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	59.4 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	56.9 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	44.1 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	19.5 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	88.7 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	84.8 Titer
VLA84 75 mcg (Microgram) w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	58.6 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	120.4 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	16.7 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	53.3 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	69.9 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	57.9 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	114.2 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	215.3 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	95.0 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	10.0 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	187.3 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	187.5 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	199.4 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	15.2 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	151.9 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	86.7 Titer
VLA84 200 mcg w/o Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	10.6 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	169.3 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	10.6 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	61.6 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	188.5 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	190.5 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	45.9 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	19.3 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	61.7 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	50.7 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	53.9 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	40.3 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	10.9 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	130.3 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	18.9 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	124.3 Titer
VLA84 200 mcg With Alum	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	188.4 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 65 and older	20.9 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 65 and older	10.4 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 50 - < 65	10.0 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 50 - < 65	10.0 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 65 and older	23.8 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 56, 65 and older	10.7 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 65 and older	24.1 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 50 - < 65	10.6 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 0, 65 and older	10.0 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 35, 50 - < 65	14.2 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 35, 65 and older	10.0 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 50 - < 65	14.9 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 56, 65 and older	23.8 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 0, 50 - < 65	13.6 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin A: GMT at Day 210, 50 - < 65	10.0 Titer
Placebo	GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group	Toxin B: GMT at Day 210, 50 - < 65	14.1 Titer

Secondary

Rate of Study Participants With at Least One Related SAE

percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210

Time frame: Day 56 and Day 210

Population: Safety Population = study participants with at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One Related SAE	up to Day 56	0.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One Related SAE	up to Day 210	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One Related SAE	up to Day 210	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One Related SAE	up to Day 56	0.0 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One Related SAE	up to Day 210	0.0 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One Related SAE	up to Day 56	0.0 percentage of participants
Placebo	Rate of Study Participants With at Least One Related SAE	up to Day 56	0.0 percentage of participants
Placebo	Rate of Study Participants With at Least One Related SAE	up to Day 210	0.0 percentage of participants

Secondary

Rate of Study Participants With at Least One Related Unsolicited AE

percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)

Time frame: Day 56 and Day 210

Population: Safety Population = study participants with at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 56	11.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 210	11.5 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 210	13.2 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 56	12.5 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 56	7.9 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 210	7.9 percentage of participants
Placebo	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 56	4.2 percentage of participants
Placebo	Rate of Study Participants With at Least One Related Unsolicited AE	up to Day 210	4.2 percentage of participants

Secondary

Rate of Study Participants With at Least One SAE (Serious Adverse Event)

percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210

Time frame: Day 56 and Day 210

Population: Safety Population = study participants who received at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 56	0.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 210	2.7 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 210	3.3 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 56	0.7 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 56	0.0 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 210	2.0 percentage of participants
Placebo	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 56	4.2 percentage of participants
Placebo	Rate of Study Participants With at Least One SAE (Serious Adverse Event)	up to Day 210	4.2 percentage of participants

Secondary

Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)

percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)

Time frame: Day 56 and Day 210

Population: Safety Population = study participants with at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 56	33.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 210	43.9 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 210	39.5 percentage of participants
VLA84 200 mcg w/o Alum	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 56	32.2 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 56	30.9 percentage of participants
VLA84 200 mcg With Alum	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 210	40.1 percentage of participants
Placebo	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 56	29.2 percentage of participants
Placebo	Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)	up to Day 210	37.5 percentage of participants

Secondary

Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group

percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older (65+))

Time frame: Day 56 and Day 210

Population: Safety Population = study participants with at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 50 - < 60	37.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 50 - < 60	2.8 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 50 - < 60	0.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 50 - < 60	0.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 50 - < 60	0.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 50 - < 60	50.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 56, 50 - < 60	12.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 210, 50 -< 60	12.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 65 and older	1.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 65 and older	2.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 65 and older	0.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 65 and older	0.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 60 and older	28.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 60 and older	38.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 56, 60 and older	10.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 210, 60 and older	10.5 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 50 - < 60	41.6 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 65 and older	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 210, 60 and older	13.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 65 and older	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 56, 60 and older	13.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 65 and older	2.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 50 - < 60	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 65 and older	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 50 - < 60	33.8 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 56, 50 - < 60	11.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 50 - < 60	0.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 50 - < 60	3.9 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 60 and older	30.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 210, 50 -< 60	13.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 60 and older	37.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 50 - < 60	1.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 50 - < 60	39.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 50 - < 60	28.6 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 60 and older	41.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 56, 50 - < 60	9.1 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 210, 50 -< 60	9.1 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 210, 60 and older	6.7 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 65 and older	0.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 65 and older	4.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 56, 60 and older	6.7 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 65 and older	0.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 65 and older	0.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 50 - < 60	0.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 50 - < 60	0.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 60 and older	33.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 50 - < 60	0.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 50 - < 60	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 210, 60 and older	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 210, 50 -< 60	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 50 - < 60	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 50 - < 60	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 60 and older	41.7 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsolicited AE up to Day 56, 50 - < 60	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 60 and older	33.3 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 50 - < 60	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 56, 50 - < 60	25.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 210, 65 and older	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any unsolicited AE up to Day 210, 50 - < 60	33.3 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 56, 65 and older	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	any related unsol. AE up to Day 56, 60 and older	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	SAEs up to Day 56, 65 and older	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 50 - < 60	0.0 percentage of participants
Placebo	Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group	related SAEs up to Day 210, 65 and older	0.0 percentage of participants

Secondary

Rates of Study Participants With at Least One Solicited Local and Systemic AE

percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms

Time frame: within 7 Days after each vaccination

Population: Safety Population = study participants with at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 1st vaccination	17.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 2nd vaccination	17.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 3rd vaccination	15.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, overall	28.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 1st vaccination	23.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 2nd vaccination	17.8 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 3rd vaccination	13.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, overall	35.4 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 2nd vaccination	27.6 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 1st vaccination	23.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 2nd vaccination	29.6 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, overall	42.1 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 3rd vaccination	16.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, overall	48.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 3rd vaccination	29.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 1st vaccination	19.1 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 3rd vaccination	16.9 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 3rd vaccination	25.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, overall	46.7 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 1st vaccination	21.1 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 2nd vaccination	17.8 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, overall	37.5 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 1st vaccination	19.7 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 2nd vaccination	30.9 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 3rd vaccination	10.6 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, overall	21.3 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 2nd vaccination	12.8 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any local solicited AE, after 1st vaccination	14.9 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 1st vaccination	21.3 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, overall	38.3 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 3rd vaccination	12.8 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE	any systemic solicited AE, after 2nd vaccination	14.9 percentage of participants

Secondary

Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group

percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - \< 65 years and 65 years and older)

Time frame: within 7 Days after each vaccination

Population: Safety Population = study participants with at least one study vaccination

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 65 and older	16.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 50 -< 65	14.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 50 -< 65	17.4 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 50 -< 65	29.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 50 -< 65	18.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 65 and older	20.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 65 and older	13.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 65 and older	28.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc., 50 - < 65	29.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc., 50 - < 65	16.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc., 50 - < 65	18.8 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall, 50 - < 65	40.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc.,65 and older	17.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc.,65 and older	18.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc.,65 and older	8.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall ,65 and older	30.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 65 and older	28.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc., 50 - < 65	26.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall ,65 and older	37.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall, 50 - < 65	46.8 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc.,65 and older	17.8 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc., 50 - < 65	28.6 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 50 -< 65	32.4 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc., 50 - < 65	14.9 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 65 and older	10.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 65 and older	26.0 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 50 -< 65	53.2 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 50 -< 65	31.2 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc.,65 and older	21.3 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 65 and older	42.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc.,65 and older	26.7 percentage of participants
VLA84 200 mcg w/o Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 50 -< 65	27.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 65 and older	28.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 65 and older	21.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc.,65 and older	17.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 65 and older	27.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 65 and older	41.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall ,65 and older	30.7 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc., 50 - < 65	24.7 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc., 50 - < 65	18.2 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc.,65 and older	12.2 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc., 50 - < 65	21.6 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall, 50 - < 65	44.2 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 50 -< 65	18.2 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 50 -< 65	33.8 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc.,65 and older	17.3 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 50 -< 65	23.0 percentage of participants
VLA84 200 mcg With Alum	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 50 -< 65	51.9 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall ,65 and older	37.5 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 65 and older	20.8 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 50 -< 65	13.0 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 50 -< 65	17.4 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc.,65 and older	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 3rd vacc., 65 and older	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc.,65 and older	20.8 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 50 -< 65	17.4 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 1st vacc., 65 and older	12.5 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 2nd vacc., 50 - < 65	21.7 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, after 2nd vacc., 65 and older	8.3 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc., 50 - < 65	8.7 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 3rd vacc.,65 and older	16.7 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, after 1st vacc., 50 - < 65	21.7 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any local sol. AE, overall, 50 -< 65	21.7 percentage of participants
Placebo	Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group	any systemic sol. AE, overall, 50 - < 65	39.1 percentage of participants

Secondary

Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B

Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 35, 56, 120, 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 35	42.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 210	38.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 56	46.0 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 35	54.1 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 210	46.2 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 56	51.9 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 56	36.9 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 35	40.4 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 210	27.7 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 35	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 210	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B	RR Day 56	0.0 percentage of participants

Secondary

Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group

Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120\* and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older) \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 60 and older	39.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 50 - < 60	52.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 50 - < 60	40.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 50 - < 60	36.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 60 and older	52.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 60 and older	52.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 60 and older	39.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 50 - < 60	67.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 50 - < 60	56.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 60 and older	42.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 60 and older	57.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 50 - < 60	53.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 60 and older	70.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 50 - < 60	49.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 60 and older	45.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 60 and older	68.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 50 - < 60	43.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 50 - < 60	38.8 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 50 - < 60	77.3 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 50 - < 60	70.6 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 50 - < 60	61.8 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 60 and older	42.4 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 60 and older	50.7 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 50 - < 60	57.4 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 50 - < 60	50.0 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 60 and older	43.9 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 60 and older	65.7 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 50 - < 60	61.8 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 60 and older	53.7 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 50 - < 60	50.0 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 60 and older	52.2 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 60 and older	72.7 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 50 - < 60	77.9 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 50 - < 60	55.9 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 60 and older	46.3 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 60 and older	79.1 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 60 and older	80.3 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 50 - < 60	42.9 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 50 - < 60	35.7 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 50 - < 60	72.9 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 50 - < 60	83.8 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 60 and older	67.6 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 60 and older	38.0 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 60 and older	85.5 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 50 - < 60	42.9 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 50 - < 60	37.1 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 50 - < 60	25.0 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 60 and older	42.3 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 60 and older	39.4 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 60 and older	30.4 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 50 - < 60	25.0 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 60 and older	38.0 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 60 and older	30.4 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 50 - < 60	67.1 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 210, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 210, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 56, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 35, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A Day 35, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 210, 50 - < 60	4.5 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox A and B Day 56, 50 - < 60	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 56, 60 and older	0.0 percentage of participants
Placebo	Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	RR Tox B Day 35, 50 - < 60	0.0 percentage of participants

Secondary

Responder Rate (RR) for Toxin A Neutralizing Antibodies

Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 35	55.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 210	62.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 56	68.6 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 35	68.1 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 210	75.0 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 56	78.5 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 56	76.6 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 35	67.4 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 210	84.7 percentage of participants
Placebo	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 35	0.0 percentage of participants
Placebo	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 210	0.0 percentage of participants
Placebo	Responder Rate (RR) for Toxin A Neutralizing Antibodies	RR Day 56	0.0 percentage of participants

Secondary

Responder Rate (RR) for Toxin B Neutralizing Antibodies

Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.

Time frame: Days 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 35	48.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 210	39.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 56	52.6 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 35	57.8 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 210	47.0 percentage of participants
VLA84 200 mcg w/o Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 56	56.3 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 56	38.3 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 35	42.6 percentage of participants
VLA84 200 mcg With Alum	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 210	27.7 percentage of participants
Placebo	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 35	0.0 percentage of participants
Placebo	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 210	2.2 percentage of participants
Placebo	Responder Rate (RR) for Toxin B Neutralizing Antibodies	RR Day 56	0.0 percentage of participants

Secondary

SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group

Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older)

Time frame: Days 14, 28, 35, 56, 120 and 210

Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 65 and older	90.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 65 and older	42.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 65 and older	38.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 65 and older	45.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 65 and older	58.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 65 and older	31.4 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 50 to < 65	32.8 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 65 and older	88.4 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 65 and older	72.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 50 to < 65	70.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 65 and older	37.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 65 and older	70.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 50 to < 65	32.8 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 65 and older	60.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 65 and older	65.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 65 and older	60.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 65 and older	70.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 65 and older	94.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 50 to < 65	49.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 50 to < 65	34.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 50 to < 65	58.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 50 to < 65	55.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 65 and older	72.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 50 to < 65	49.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 65 and older	58.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 50 to < 65	31.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 50 to < 65	58.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 50 to < 65	74.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 50 to < 65	47.7 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 65 and older	54.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 50 to < 65	37.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 50 to < 65	89.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 50 to < 65	81.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 50 to < 65	55.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 50 to < 65	70.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 50 to < 65	86.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 65 and older	50.7 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 50 to < 65	72.1 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 65 and older	39.4 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 50 to < 65	54.4 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 65 and older	58.2 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 50 to < 65	55.9 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 65 and older	74.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 65 and older	91.0 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 65 and older	80.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 65 and older	89.4 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 65 and older	34.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 50 to < 65	45.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 50 to < 65	86.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 50 to < 65	72.1 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 65 and older	68.7 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 50 to < 65	80.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 50 to < 65	72.7 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 65 and older	66.7 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 50 to < 65	94.0 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 65 and older	44.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 65 and older	65.7 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 50 to < 65	92.4 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 65 and older	42.4 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 65 and older	79.1 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 65 and older	74.2 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 50 to < 65	74.2 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 65 and older	65.2 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 65 and older	81.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 50 to < 65	52.9 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 65 and older	75.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 50 to < 65	80.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 50 to < 65	67.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 50 to < 65	85.3 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 50 to < 65	42.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 50 to < 65	86.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 50 to < 65	97.1 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 65 and older	49.3 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 65 and older	40.8 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 65 and older	87.3 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 50 to < 65	27.1 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 50 to < 65	34.3 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 50 to < 65	50.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 50 to < 65	60.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 50 to < 65	50.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 50 to < 65	41.2 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 65 and older	28.2 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 65 and older	50.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 65 and older	59.2 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 65 and older	57.1 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 65 and older	47.8 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 50 to < 65	38.6 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 50 to < 65	74.3 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 50 to < 65	94.3 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 50 to < 65	95.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 50 to < 65	95.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 50 to < 65	95.6 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 65 and older	33.8 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 65 and older	64.8 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 65 and older	97.2 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 65 and older	95.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 65 and older	91.3 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 50 to < 65	30.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 50 to < 65	35.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 50 to < 65	50.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 50 to < 65	60.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 50 to < 65	50.0 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 50 to < 65	41.2 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 65 and older	40.8 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 65 and older	46.5 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 65 and older	50.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 65 and older	59.2 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 65 and older	58.6 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 50 to < 65	9.1 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 50 to < 65	9.1 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 65 and older	4.2 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 56; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 50 to < 65	9.1 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 50 to < 65	9.1 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 50 to < 65	4.5 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 210; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 210; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 14; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 120; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 120; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 56; 50 to < 65	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 35; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 35; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 35; 50 to < 65	4.5 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 14; 50 to < 65	4.5 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 56; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 28; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A and B at Day 28; 50 to < 65	4.5 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin B at Day 28; 50 to < 65	4.5 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 14; 65 and older	0.0 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 210; 50 to < 65	4.5 percentage of participants
Placebo	SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group	SCR against Toxin A at Day 120; 50 to < 65	0.0 percentage of participants

Secondary

SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B

Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210;

Time frame: Days 14, 28, 35, 120 and 210

Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 28	38.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 210	54.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 14	31.4 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 120	64.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 35	56.9 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 14	38.8 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 28	49.6 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 35	68.9 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 120	77.4 percentage of participants
VLA84 200 mcg w/o Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 210	68.9 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 120	53.6 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 35	50.4 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 28	37.6 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 14	27.7 percentage of participants
VLA84 200 mcg With Alum	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 210	44.5 percentage of participants
Placebo	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 14	2.2 percentage of participants
Placebo	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 35	2.2 percentage of participants
Placebo	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 120	0.0 percentage of participants
Placebo	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 28	2.2 percentage of participants
Placebo	SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B	SCR at Day 210	0.0 percentage of participants

Comparison: statistical test was applied across all treatment groups at each of the listed time points.p-value: <0.0001Fisher-Freeman-Halton Test

Secondary

Seroconversion Rate (SCR) for IgG Against Toxin A

Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A;

Time frame: 14, 28, 35, 56, 120 and 210

Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 28	51.8 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 120	88.3 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 14	36.5 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 56	92.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 35	70.1 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 210	85.1 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 35	80.0 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 56	94.1 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 210	87.1 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 28	63.0 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 120	91.7 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 14	46.3 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 35	90.8 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 14	36.2 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 28	69.5 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 210	93.4 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 56	96.5 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 120	95.7 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 35	4.3 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 28	4.3 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 210	2.2 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 120	0.0 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 14	4.3 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin A	SCR at Day 56	0.0 percentage of participants

Comparison: statistical test was applied across all treatment groups at each of the listed time points.p-value: <0.0001Fisher-Freeman-Halton Test

Secondary

Seroconversion Rate (SCR) for IgG Against Toxin B

Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B;

Time frame: Days 14, 28, 35, 56, 120 and 210

Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210

Arm	Measure	Group	Value (NUMBER)
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 120	64.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 14	35.0 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 210	55.2 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 35	56.9 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 28	41.6 percentage of participants
VLA84 75 mcg (Microgram) w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 56	71.5 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 120	78.2 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 56	83.7 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 210	70.5 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 28	53.3 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 14	44.0 percentage of participants
VLA84 200 mcg w/o Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 35	70.4 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 35	50.4 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 14	35.5 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 28	41.1 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 56	59.6 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 120	54.3 percentage of participants
VLA84 200 mcg With Alum	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 210	45.3 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 210	0.0 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 120	0.0 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 28	2.2 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 14	2.2 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 56	2.2 percentage of participants
Placebo	Seroconversion Rate (SCR) for IgG Against Toxin B	SCR at Day 35	4.3 percentage of participants

Comparison: statistical test was applied across all treatment groups at each of the listed time points.p-value: <0.0001Fisher-Freeman-Halton Test

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026

Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Seroconversion Rate (SCR) on Day 56

Geometric Mean Titer (GMT) for IgG Against Toxin A

Geometric Mean Titer (GMT) for IgG Against Toxin B

GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group

GMT for Toxin A Neutralizing Antibodies

GMT for Toxin B Neutralizing Antibodies

GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group

Rate of Study Participants With at Least One Related SAE

Rate of Study Participants With at Least One Related Unsolicited AE

Rate of Study Participants With at Least One SAE (Serious Adverse Event)

Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)

Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group

Rates of Study Participants With at Least One Solicited Local and Systemic AE

Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group

Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B

Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group

Responder Rate (RR) for Toxin A Neutralizing Antibodies

Responder Rate (RR) for Toxin B Neutralizing Antibodies

SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group

SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B

Seroconversion Rate (SCR) for IgG Against Toxin A

Seroconversion Rate (SCR) for IgG Against Toxin B