Clostridium DifficilePhase 2NCT02316470
Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study
A Phase 2 study testing VLA84 in people with Clostridium Difficile, run by Valneva Austria GmbH at 10 sites in 2 countries.
Trial 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/… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- VLA84
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2014to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
eStudy Site, Chula Vista
Chula Vista, California, 91911
Optimal Research LLC
Huntsville, Alabama, 35802
eStudy Site, La Mesa
La Mesa, California, 91942
Optimal Research LLC
Melbourne, Florida, 32934
Optimal Research LLC
Mishawaka, Indiana, 46545
eStudy Site, Oceanside
Oceanside, California, 92056
Optimal Research LLC
Peoria, Illinois, 61614
Germany3 sites
Berliner Zentrum für Reise- und Tropenmedizin
Berlin, 10117
KFGN Klinische Forschung Hannover- Mitte GmbH
Hanover, 30159
Klinik und Poliklinik für Innere Medizin der Universität Rostock
Rostock, 18057
About this study
Official title: 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
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
Read the 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.
- Conditions
- Clostridium Difficile
- Being tested
- VLA84, Placebo
- Keywords
- Clostridium difficile, Valneva, Phase 2, Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLA84Biological
a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
PlaceboBiological
phosphate buffered saline (PBS) solution
| Study group | Role | What they receive |
|---|---|---|
| VLA84 75 mcg (microgram) w/o Alum | Active comparator | 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 Receives: Biological: VLA84; Biological: Placebo |
| VLA84 200 mcg w/o Alum | Active comparator | 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 Receives: Biological: VLA84 |
| VLA84 200 mcg with Alum | Active comparator | 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 Receives: Biological: VLA84 |
| Placebo | Placebo comparator | Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Day 56
Secondary outcomes (21)
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;
Measured: Days 14, 28, 35, 120 and 210
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;
Measured: 14, 28, 35, 56, 120 and 210
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;
Measured: Days 14, 28, 35, 56, 120 and 210
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;
Measured: Days 0, 14, 28, 35, 56, 120 and 210
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;
Measured: Days 0, 14, 28, 35, 56, 120 and 210
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.
Measured: Days 0, 35, 56, 120 and 210
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.
Measured: Days 0, 35, 56, 120 and 210
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)
Measured: Days 14, 28, 35, 56, 120 and 210
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)
Measured: Days 0, 14, 28, 35, 56, 120, 210
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.
Measured: Days 0, 35, 56, 120 and 210
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.
Measured: Days 35, 56, 120, 210
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.
Measured: Days 35, 56, 120 and 210
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.
Measured: Days 35, 56, 120 and 210
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.
Measured: Days 35, 56, 120 and 210
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
Measured: Day 56 and Day 210
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
Measured: Day 56 and Day 210
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)
Measured: Day 56 and Day 210
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)
Measured: Day 56 and Day 210
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
Measured: within 7 Days after each vaccination
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+))
Measured: Day 56 and Day 210
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)
Measured: within 7 Days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katrin Dubischar, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316470
- Sponsor's protocol ID
- VLA84-201
- Status last verified
- Apr 2017
- First submitted
- 9 Dec 2014
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02316470
- Acronym / sponsor ID
- VLA84-201
- Conditions
- Clostridium Difficile
- Keywords
- Clostridium difficile, Valneva, Phase 2, Healthy adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Posted 8 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VLA84 75 mcg (microgram) w/o Alum | Active comparator | Biological: VLA84, Biological: PlaceboVLA84 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 200 mcg w/o Alum | Active comparator | Biological: VLA84VLA84 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 200 mcg with Alum | Active comparator | Biological: VLA84VLA84 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 |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLA84a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B | Biological | VLA84 200 mcg w/o Alum, VLA84 200 mcg with Alum, VLA84 75 mcg (microgram) w/o Alum |
| Placebophosphate buffered saline (PBS) solution | Biological | Placebo, VLA84 75 mcg (microgram) w/o Alum |
Primary outcome
Seroconversion Rate (SCR) on Day 56
Time frame: 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;
21 secondary outcomes
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B
Time frame: Days 14, 28, 35, 120 and 210
Seroconversion Rate (SCR) for IgG Against Toxin A
Time frame: 14, 28, 35, 56, 120 and 210
Seroconversion Rate (SCR) for IgG Against Toxin B
Time frame: Days 14, 28, 35, 56, 120 and 210
Geometric Mean Titer (GMT) for IgG Against Toxin A
Time frame: Days 0, 14, 28, 35, 56, 120 and 210
Geometric Mean Titer (GMT) for IgG Against Toxin B
Time frame: Days 0, 14, 28, 35, 56, 120 and 210
GMT for Toxin A Neutralizing Antibodies
Time frame: Days 0, 35, 56, 120 and 210
GMT for Toxin B Neutralizing Antibodies
Time frame: Days 0, 35, 56, 120 and 210
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
Time frame: Days 14, 28, 35, 56, 120 and 210
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Time frame: Days 0, 14, 28, 35, 56, 120, 210
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Time frame: Days 0, 35, 56, 120 and 210
Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B
Time frame: Days 35, 56, 120, 210
Responder Rate (RR) for Toxin A Neutralizing Antibodies
Time frame: Days 35, 56, 120 and 210
Responder Rate (RR) for Toxin B Neutralizing Antibodies
Time frame: Days 35, 56, 120 and 210
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
Time frame: Days 35, 56, 120 and 210
Rate of Study Participants With at Least One SAE (Serious Adverse Event)
Time frame: Day 56 and Day 210
Rate of Study Participants With at Least One Related SAE
Time frame: Day 56 and Day 210
Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)
Time frame: Day 56 and Day 210
Rate of Study Participants With at Least One Related Unsolicited AE
Time frame: Day 56 and Day 210
Rates of Study Participants With at Least One Solicited Local and Systemic AE
Time frame: within 7 Days after each vaccination
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
Time frame: Day 56 and Day 210
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
Time frame: within 7 Days after each vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin Dubischar study director
Valneva Austria GmbH
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VLA84 in people with Clostridium Difficile, run by Valneva Austria GmbH at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion Rate (SCR) on Day 56 (time frame: Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.