Clinical Trials Register

Summary
EudraCT Number:	2014-004013-85
Sponsor's Protocol Code Number:	ZKSJ0073
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-11-19
Trial 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

Germany - PEI

A.2

EudraCT number

2014-004013-85

A.3

Full title of the trial

Sequential versus simultaneous vaccination with pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPV23) in unvaccinated older adults: Immunological memory and antibody levels

Sequentielle versus simultane Impfung mit Pneumokokkenkonjugatvakzine (PCV13) und Pneumokokkenpolysaccharidvakzine (PPV23) bei impfnaiven älteren Erwachsenen: Immunologisches Gedächtnis und Antikörperspiegel

A.3.1

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

Staggered vaccination compared to simultaneous vaccination with pneumococcal conjugate vaccine (PCV13) and Pneumokokkenpolysaccharidvakzine (PPV23) in unvaccinated older adults: Immunological memory and antibody levels

Versetzte Impfung im Vergleich zu gleichzeitigen Impfung mit Pneumokokkenkonjugatvakzine (PCV13) und Pneumokokkenpolysaccharidvakzine (PPV23) bei impfnaiven älteren Erwachsenen: Immunologisches Gedächtnis und Antikörperspiegel

A.3.2

Name or abbreviated title of the trial where available

SimVac

A.4.1

Sponsor's protocol code number

ZKSJ0073

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	Friedrich Schiller University Jena
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	BMBF
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Jena University Hospital, Center for Clinical Studies
B.5.2	Functional name of contact point	Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Salvador-Allende-Platz 27
B.5.3.2	Town/ city	Jena
B.5.3.3	Post code	07747
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4936419396652
B.5.5	Fax number	+4936419399969
B.5.6	E-mail	ZKS-Projektmanagement@med.uni-jena.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Prevenar 13®
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.1	Product name	Prevenar 13®
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Pneumovax ®23 Fertigspritze PNEUMOVAX® 23, Durchstechflasche
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD Sharp & Dohme GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.1	Product name	Pneumovax 23
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

previously unvaccinated older healthy adults

bislang nicht geimpfte ältere gesunde Erwachsene

E.1.1.1

Medical condition in easily understood language

previously unvaccinated older healthy adults

bislang nicht geimpfte ältere gesunde Erwachsene

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10069578
E.1.2	Term	Pneumococcal immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Immune response of the B-memory cells in each vaccine Group to the four pneumococcal serotypes with the highest clinical relevance serotyp 3, 14, 19A and 23F after 27-28 weeks after the first vaccination (visit 5) compared to the time prior to the first vaccination (visit 1).

Immunantwort der B-Gedächtniszellen gegenüber den vier Pneumokokken-Serotypen mit der höchsten klinischen Relevanz Serotyp 3, 14, 19A und 23F nach 27 bis 28 Wochen nach der 1. Impfung (Visite 5) im Vergleich zum Zeitpunkt vor der 1. Impfung (Visite 1) in jeder Impfgruppe.

E.2.2

Secondary objectives of the trial

•Determination of the serotype-specific memory B cells to serotype 3, 14, 19A and 23F to visit 2, 4, 7 and 8 for each vaccine group compared to visit 1
•Measurement of serotype-specific immunoglobulin G against the 12 serotypes which included in both PCV13 and PPV23 serotyp 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F to visit 3, 4, 6, 7 and 8 for each vaccine group compared to visit 1
•Detection of adverse events (AE) and serious adverse events (SAE) for 28 days after each vaccination

•Bestimmung der Serotyp-spezifischen B-Gedächtniszellen gegenüber Serotyp 3, 14, 19A und 23F zur Visite 2, 4, 7 und 8 für jede Impfgruppe im Vergleich zur Visite 1
•Messung von Serotyp-spezifischen Immunglobulin G gegenüber den 12 Serotypen, die sowohl in PCV13 und PPV23 enthalten sind Serotyp 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F und 23F zur Visite 3, 4, 6, 7 und 8 für jede Impfgruppe im Vergleich zur Visite 1.
•Erfassung der unerwünschten Ereignisse (AE) und der schwerwiegenden unerwünschten Ereignisse (SAE) für 28 Tage nach jeder Impfung.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• male and female adults aged 60 years
• written informed consent

• Männliche und weibliche Erwachsene im Alter ab 60 Jahren
• schriftliche Einwilligung

E.4

Principal exclusion criteria

•Hypersensitivity to any component of the vaccine
•prior pneumococcal vaccination
•Pneumonia in the last 2 months
•active infection
•autoimmune disorder (e.g. lupus erythematodes,Wegener's granulomatosis)
•ongoing or planned immunosuppressive therapy (with corticosteroid therapy from a prednisolone equivalent dose ≥ 5 mg /d)
•active tumor disease
•drug or alcohol abuse, or estimate other diseases that do not allow the person concerned, the nature and scope and possible consequences of the trial, incl. non-cooperation
•expectancy of life < 2 years
•receive blood products in the last six month
•all states which represent a contraindication to intramuscular administration of vaccines
•blood coagulation disorders (e.g. haemophilia, use of oral anticoagulation ,current thrombolytic therapy )
•incineration, injury or infection at the planned injection position
•Plegie or paresis of the extremities at the planned injection position
•states of shock
•parallel participation in another clinical trial with intervention

•Überempfindlichkeit gegenüber einem der Bestandteile der beiden Vakzine
•vorherige Pneumokokken-Impfung erhalten
•Pneumonie in den letzten 2 Monaten
•aktive Infektion
•Autoimmunerkrankung (z.B. Lupus erythematodes, Morbus Wegener)
•laufende oder geplante immunsuppressive Therapie (bei Kortiko-steroidtherapie ab einer Prednisolonäquivalenzdosis ≥ 5 mg/d)
•aktive Tumorerkrankung
•Drogen- oder Alkoholabusus oder sonstige Erkrankungen, die es dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen, inkl. mangelnde Kooperationsbereitschaft
•Lebenserwartung < 2 Jahre
•Blutprodukte im letzten halben Jahr erhalten
•alle Zustände, die eine Kontraindikation gegen eine intramus-kuläre Verabreichung der Impfstoffe darstellen
•Blutgerinnungsstörungen (wie Hämophilie, Einnahme oraler Anti¬koagulantien, aktuelle Lysetherapie)
•Verbrennung, Verletzungen oder Hautinfektionen an der geplan¬ten Injektionsstelle
•Plegie oder Parese der Extremität, wo geimpft werden soll
•Schockzustände
•parallele Teilnahme des Probanden an einer anderen klinischen Prüfung mit Intervention

E.5 End points

E.5.1

Primary end point(s)

Change of immune response of pneumococcal specific memory B cells to the four pneumococcal serotypes 3, 14, 19A and 23F after 27-28 weeks (visit 5) after 1st vaccination compared to the time prior to vaccination (Visit 1) for each vaccine group.

Veränderung der Immunantwort der Pneumokokken-spezifischen B-Gedächtniszellen gegenüber den vier Pneumokokken-Serotypen 3, 14, 19A und 23F nach 27 bis 28 Wochen (Visite 5) nach 1. Impfung im Vergleich zum Zeitpunkt vor der Impfung (Visite 1) für jede Impfgruppe.

E.5.1.1

Timepoint(s) of evaluation of this end point

after 27-28 weeks (visit 5) after 1st vaccination compared to the time prior to vaccination (visit 1)

nach 27 bis 28 Wochen (Visite 5) nach 1. Impfung im Vergleich zum Zeitpunkt vor der Impfung (Visite 1)

E.5.2

Secondary end point(s)

(1) endpoints related to safety during the treatment period: occurence of AEs and SAEs
(2) endpoints related to efficacy:
•Change of immune response of pneumococcal specific memory B cells to the four pneumococcal serotypes 3, 14, 19A and 23F at visit 2,4, 7 and 8 for each vaccine group compared to visit 1
•Increase in pneumococcal specific immunoglobulin G antibody concentrations obverse the 12 serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F at visit 3, 4, 6, 7 and 8 for each vaccine group compared to visit 1

(1)Endpunkte bezogen auf Sicherheit (Safety) während der Behandlungsperiode: Auftreten von AEs und SAEs
(2)Endpunkte bezogen auf die Wirksamkeit (Efficacy):
•Veränderung der Immunantwort der Pneumokokken-spezi-fischen B-Gedächtniszellen gegenüber den Serotyp 3, 14, 19A und 23F zur Visite 2, 4, 7 und 8 für jede Impfgruppe im Vergleich zur Visite 1
•Anstieg der Pneumokokken-spezifischen Immunglobulin G Antikörperkonzentrationen gegenüber den 12 Serotypen 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F und 23F zur Visite 3, 4, 6, 7 und 8 für jede Impfgruppe im Vergleich zur Visite 1

E.5.2.1

Timepoint(s) of evaluation of this end point

endpoints related to safety : during Treatment period
endpoints related to efficacy: at visit 2,3,4, 6, 7 and 8 for each vaccine group compared to visit 1

(1)Endpunkte bezogen auf Sicherheit: im Verlauf der Behandlungsperiode
(2)Endpunkte bezogen auf die Wirksamkeit: zur Visite 2, 3, 4, 6, 7 und 8 für jede Impfgruppe im Vergleich zur Visite 1

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

simultane und sequentielle Impfung mit Prevenar und Pneumovax sowie Einfachimpfung mit Pneumovax.

simultaneous/sequential vaccination with Prevenar and Pneumovax,single vaccination with Pneumovax.

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

Last Visit Last Subject (LVLS)

Letzter Besuch des letzten Probanden

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

132

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

132

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

Keine

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

2016-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-11-06

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