Clinical Trials Register

Summary
EudraCT Number:	2011-004518-40
Sponsor's Protocol Code Number:	PCV13-HIV2011
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-08
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004518-40

A.3

Full title of the trial

Serological response to antipneumococcal vaccination and consequent impact on Streptococcus pneumoniae nasal carriage in HIV positive adults: a prospective study using 13-valent conjugate vaccine

Risposta sierologica alla vaccinazione antipneumococcica e relativo effetto sulla colonizzazione nasale da Streptococcus pneumoniae in adulti HIV positivi: studio prospettico sull'efficacia del vaccino coniugato 13-valente

A.3.1

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

Serological response to antipneumococcal vaccination and consequent impact on Streptococcus pneumoniae nasal carriage in HIV positive adults

Risposta sierologica alla vaccinazione antipneumococcica e relativo effetto sulla colonizzazione nasale da Streptococcus pneumoniae in adulti HIV positivi

A.3.2

Name or abbreviated title of the trial where available

PCV13-HIV2011

A.4.1

Sponsor's protocol code number

PCV13-HIV2011

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	AZIENDA OSPEDALIERA SENESE
B.1.3.4	Country	Italy
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	M.I.U.R. (Ministero dell'Istruzione Universita' e Ricerca)
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliera Senese - Universita' degli Studi di Siena
B.5.2	Functional name of contact point	UOC Malattie Infettive Univ.
B.5.3	Address:
B.5.3.1	Street Address	Viale Bracci 14
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0577-586533
B.5.5	Fax number	0577-233462
B.5.6	E-mail	montagnani2@unisi.it

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	Yes
D.2.1.1.1	Trade name	PREVENAR 13*IM 10SIR 0,5ML
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
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	Vaccino pneumococcico coniugato 13 valente
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.5
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

HIV positive adults with out previous PPV23 or PCV7 vaccination

adulti HIV positivi senza pregressa vaccinazione con PPV23 o con PCV7

E.1.1.1

Medical condition in easily understood language

HIV positive adults with out previous pneumococcal vaccination

adulti HIV positivi non precedentemente vaccinati per pneumococco

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10035652
E.1.2	Term	Pneumococcus infection in conditions classified elsewhere and of unspecified site
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

To determine the rate of nasal colonization by different pneumococcal serotypes in HIV-positive adults, in relation to baseline antibody titers at T0; to define serological response after 2 doses of PCV13 vaccine (booster dose after 8 weeks) in HIV+ adults; to evaluate the effect of 2 doses PCV13 vaccine in terms of nasal pneumococcal carriage and occurrence of invasive pneumococcal diseases.

Il progetto si propone di valutare, in modo prospettico, la risposta anticorpale a 2 dosi di PCV-13 e la prevalenza della colonizzazione nasofaringea da S. pneumoniae in una popolazione HIV+ non ospedalizzata, correlando i dati anamnestici, clinici, sierologici e microbiologici; valutare l'effetto di due dosi di PCV13 in termini di colonizzazione nasofaringea e sviluppo di patologia pneumococcica invasiva.

E.2.2

Secondary objectives of the trial

To determine pneumococcal serotypes and chemosusceptibility to different antibiotic and to evaluate the prevalence of multiresistant strains; to evaluate molecular epidemiology of pneumococcal isolates.

La ricerca permettera' di valutare la percentuale di PNSSP, PRSP e/o multiresistenti, ed i sierotipi di pneumococco circolanti in questo tipo di popolazione, in relazione al titolo anticorpale al T0. Con l`analisi dei dati clinici anamnestici ed i successivi follow up, sara` possibile distinguere i soggetti portatori a breve e a lungo termine, stabilirne i fattori di rischio e la frequenza di infezione. Le analisi molecolari permetteranno di definire l`epidemiologia dell`acquisizione, valutando l`eventuale diffusione clonale di alcuni sierotipi di S. pneumoniae e la correlazione genetica fra isolati da portatore e da malattia.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

OTHER SUBSTUDIES:
Microbiological and serogical study regarding pneumococcal infections in HIV positive and HIV negative adults regardeles polysaccaride pneumococcal vaccine, v. 2 14.11.11

ALTRI SOTTOSTUDI:
Studio microbiologico e sierologico in soggetti HIV positivi ed HIV negativi indipendentemente da pregresso vaccino polisaccaridico 23-valente per valutare le infezioni pneumococciche, v. 2 14.11.11

E.3

Principal inclusion criteria

age > 18 years availability from the part of the patient or the legal guardian to furnish his/her own consent free and informed access to the structures in out-patient regime or of Day Hospital CD4. 200 cells / µl in two determinations consecutive precedents to the T0

eta' > 18 anni disponibilita' dal parte del paziente o del tutore legale a fornire il proprio consenso libero ed informato accesso alle strutture in regime ambulatoriale o di Day Hospital CD4 ≥ 200 cell/µl in due determinazioni consecutive precedenti al T0

E.4

Principal exclusion criteria

age > 65 years acute infectious pathology in fit antibiosi in action or pregressa < = 7 days previous vaccination with PPV23 or with PCV7 pregnancy therapy immunomodulant in fit immunodepression not HIV related

eta' >65 anni patologia infettiva acuta in atto antibiosi in atto o pregressa <= 7 giorni pregressa vaccinazione con PPV23 o con PCV7 gravidanza terapia immunomodulante in atto immunodepressione non HIV relata

E.5 End points

E.5.1

Primary end point(s)

to define serological response after 2 doses of PCV13 vaccine (booster dose after 8 weeks) in HIV+ adults

determinare la risposta anticorpale indotta da vaccinazione primaria con vaccino coniugato 13-valente e successiva dose booster ad 8 settimane in adulti HIV+

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year

1 anno

E.5.2

Secondary end point(s)

To determine the rate of nasal colonization by different pneumococcal serotypes in HIV-positive adults, in relation to baseline antibody titers at T0; to evaluate the effect of 2 doses PCV13 vaccine in terms of nasal pneumococcal carriage and occurrence of invasive pneumococcal diseases; to determine chemosusceptibility to different antibiotic and to evaluate the prevalence of multiresistant strains to evaluate molecular epidemiology of pneumococcal isolates.

Valutare l`entita' della colonizzazione da differenti sierotipi di S. pneumoniae in soggetti HIV positivi, in relazione al livello anticorpale al T0; definire l`effetto delle due dosi di PCV13 sulla colonizzazione nasale e sull`insorgenza di infezioni pneumococciche invasive in adulti HIV+; valutare la chemiosensibilita' degli isolati ai differenti antibiotici e stabilire la percentuale di isolati multiresistenti; valutare l`epidemiologia molecolare degli pneumococchi isolati.

E.5.2.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

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

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

Yes

E.6.13.1

Other scope of the trial description

immunogenicity in immunocompromised adults

immunogenicita' in adulti immunodepressi

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

LVLS

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

Number of subjects for this age range:

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:

F.1.3

Elderly (>=65 years)

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

F.U. 12 months

F.U. per 12 mesi

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

2011-10-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-20

P. End of Trial
P.	End of Trial Status	Completed

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