Clinical Trials Register

Summary
EudraCT Number:	2016-003866-14
Sponsor's Protocol Code Number:	B5091007
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-03-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2016-003866-14

A.3

Full title of the trial

A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study To Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile Vaccine In Adults 50 Years Of Age And Older

Placebom kontrolované, randomizované klinické skúšanie fázy 3 so zaslepeným pozorovateľom hodnotiace účinnosť, bezpečnosť a znášanlivosť vakcíny Clostridium Difficile u dospelých vo veku najmenej 50 rokov

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to assess whether a vaccine against Clostridium difficile prevents the disease, and whether it is safe and well tolerated when given to adults 50 years of age and older

A.4.1

Sponsor's protocol code number

B5091007

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer Inc, 235 East 42nd Street, New York, NY 10017
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	001 800718 1021
B.5.5	Fax number	001 303 739 1119
B.5.6	E-mail	clinicaltrials.gov_inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	PF-06425090
D.3.4	Pharmaceutical form	Powder and suspension for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	CLOSTRIDIUM DIFFICILE TOXOID (A AND B)
D.3.9.3	Other descriptive name	PF-06425090
D.3.9.4	EV Substance Code	SUB88747
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary C difficile infection (CDI)

E.1.1.1

Medical condition in easily understood language

Clostridium difficile is a bacterium that can infect the bowel and cause severe diarrhoea

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10054236
E.1.2	Term	Clostridium difficile infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10012748
E.1.2	Term	Diarrhoea, Clostridium difficile
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary Efficacy Objective:
To demonstrate that Pfizer’s C difficile vaccine is effective in reducing the incidence of a first primary episode of CDI

Primary Safety Objective:
To evaluate the safety profile of Pfizer’s C difficile vaccine as measured by the percentage of subjects reporting local reactions and systemic events, AEs, and SAEs.

E.2.2

Secondary objectives of the trial

3-Dose Family
To evaluate the efficacy of Pfizer’s C difficile vaccine in reducing:
-incidence of all CDI cases
To evaluate the efficacy of Pfizer’s C difficile vaccine in reducing the severity of CDI, defined by:
-The duration of CDI episodes
-The requirement to seek medical attention.
To evaluate the efficacy of Pfizer’s C difficile vaccine in reducing the incidence of recurrent CDI.

At-Least-2-Dose/Only-2-Dose Family
To evaluate the efficacy of Pfizer’s C difficile vaccine in reducing:
- incidence of all CDI cases
-incidence of recurrent CDI
In subjects who receive only 2 doses of vaccine, to evaluate the efficacy of Pfizer’s C difficile vaccine in reducing:
-The incidence of a first primary episode of CDI.
-The incidence of recurrent CDI.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1.Evidence of a personally signed and dated ICD indicating that the subject has been informed of all pertinent aspects of the study.
2.Willing and able to comply with scheduled visits, vaccination plan, and other study procedures.
3.50 Years or older at enrollment.
4.Subjects with an increased risk of future contact with healthcare systems by virtue of:
•At least 1 inpatient hospitalization ≥2 nights’ duration in the previous 12 months; or
•At least 2 emergency room visits in the previous 12 months; or
•At least 10 outpatient visits (primary and/or secondary care visits; defined as an in-person visit to the office/clinic of a prescribing healthcare provider for the purposes of the diagnosis, treatment, or ongoing management of a medical condition, excluding pharmacy and mental health visits) in the previous 12 months; or
•Residence in a skilled nursing facility (a residential institution that provides professional nursing care and rehabilitation services, usually following discharge from the hospital); or
•Residence in a nursing home (a residential institution that provides assistance with activities of daily living); or
•Inpatient hospitalization ≥2 nights’ duration scheduled ≥37 days after randomization.
Or subjects who have received systemic (ie, oral or injected) antibiotics for a minimum of 48 hours at any time in the previous 12 weeks.
5.Ability to be contacted by telephone during study participation.
6.Negative urine pregnancy test for female subjects of childbearing potential.
Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
a.Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
b.Have undergone a documented hysterectomy and/or bilateral oophorectomy;
c.Have medically confirmed ovarian failure.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

E.4

Principal exclusion criteria

Subjects with any of the following characteristics/conditions will not be included in the study:
1.Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
2.Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until Visit 5 (1 month after the third vaccination).
3.Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
4.Prior episode of CDI, confirmed by either laboratory test or diagnosis of pseudomembranous colitis at colonoscopy, at surgery, or histopathologically.
5.Receipt of blood products or immunoglobulins within 6 months before enrollment.
6.Subjects who may be unable to respond to vaccination because of:
•Metastatic malignancy; or
•End-stage renal disease (glomerular filtration rate <15 mL/min/1.73 m2 or on dialysis); or
•Any serious medical disorder that in the investigator’s opinion is likely to be fatal within the next 12 months; or
•Congenital or acquired immunodeficiency; or
•Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days of enrollment; or
•Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
7.Known infection with human immunodeficiency virus (HIV).
8.Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
9.Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
10.Prior small- or large-bowel resection (does not include appendectomy).
11.Any condition or treatment resulting in frequent diarrhea (≥3 loose stools per day more than once per month), as reported by the subject.
12.Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavioral or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
13.Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) and are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 28 days after the last dose of investigational product.

E.5 End points

E.5.1

Primary end point(s)

Primary Efficacy Endpoint:
CDI incidence per 1000 person-years of follow-up

Primary Safety Endpoints:
•Local reactions (pain, erythema, and induration)
•Systemic events (fever, vomiting, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) as self-reported on electronic diaries (e-diaries)
•Nonserious AEs
•SAEs

E.5.1.1

Timepoint(s) of evaluation of this end point

• CDI incidence per 1000 person-years of follow-up is assessed during up to 2 time periods :
- After receipt of the third dose of investigational product onwards.
- After receipt of the second dose of investigational product onwards.

• Local reactions: for up to 7 days following each dose of investigational product.
•Systemic events: for up to 7 days following each dose of investigational product.
•Nonserious AEs: from the signing of the informed consent document (ICD) to 1 month after receipt of the third dose of investigational product.
•SAEs: from the signing of the ICD to 6 months after receipt of third dose of investigational product.

E.5.2

Secondary end point(s)

3-Dose Family
•CDI incidence per 1000 person-years of follow-up
•Mean time to resolution of diarrhea in first primary episodes of CDI
•Proportion of subjects experiencing a first primary episode of CDI who have a non–protocol-related medically attended visit during the CDI episode.
•CDI incidence per 1000 person-years of follow-up, assessed after the third dose of investigational product onwards.

At Least-2-Dose/Only-2-Dose Family
•CDI incidence per 1000 person-years of follow-up

E.5.2.1

Timepoint(s) of evaluation of this end point

CDI incidence per 1000 person-years of follow-up is assessed during 2 time periods:
- After receipt of the third dose of investigational product onwards. (3-Dose Family)
- After receipt of the second dose of investigational product onwards. (At Least-2-Dose/Only-2-Dose Family).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

observer blinded

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

128

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Belgium

Bulgaria

Canada

Chile

Colombia

Czechia

Finland

France

Germany

Hungary

Japan

Korea, Republic of

Peru

Poland

Portugal

Slovakia

Spain

Sweden

Taiwan

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of trial in a Member State of the European Union is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

4000

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

12000

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

persons in nursing home, skilled nursing facility

F.4 Planned number of subjects to be included

F.4.1

In the member state

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

3860

F.4.2.2

In the whole clinical trial

17476

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-06-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-02-11

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