Clinical Trials Register

Summary
EudraCT Number:	2014-001117-41
Sponsor's Protocol Code Number:	201330
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:	2018-02-22
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

2014-001117-41

A.3

Full title of the trial

A phase IV, open‐label, non‐randomised, multi‐centre study to assess the immunogenicity and safety of Infanrix hexa™ administered as primary
vaccination in healthy infants born to mothers given Boostrix™ during pregnancy or post‐delivery in 116945 [DTPA (BOOSTRIX)‐047].

Studio multicentrico di fase IV in aperto non randomizzato atto a valutare l’immunogenicità e la sicurezza di Infanrix hexa® quando è somministrato come vaccinazione primaria in lattanti nati sani da madri vaccinate con Boostrix® durante la gravidanza oppure in post‐partum nello studio 116945 [DTPA (BOOSTRIX)‐047]. Studio multicentrico di fase IV in aperto non randomizzato atto a valutare l’immunogenicità e la sicurezza di Infanrix hexa® quando è somministrato come vaccinazione primaria in lattanti nati sani da madri
vaccinate con Boostrix® durante la gravidanza oppure in post‐partum nello studio 116945 [DTPA (BOOSTRIX)‐047].

A.3.1

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

Immunogenicity and safety study of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery.

Studio atto a valutare l’immunogenicità e la sicurezza di Infanrix hexa® in lattanti nati sani da madri vaccinate con Boostrix® durante la gravidanza oppure in post‐partum.

A.3.2

Name or abbreviated title of the trial where available

DTPA (BOOSTRIX)-048 PRI

A.4.1

Sponsor's protocol code number

201330

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	GLAXOSMITHKLINE BIOLOGICALS
B.1.3.4	Country	Belgium
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	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Biologicals
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de I'Institut, 89
B.5.3.2	Town/ city	Rixensart
B.5.3.3	Post code	1330
B.5.3.4	Country	Belgium
B.5.4	Telephone number	00442089904466
B.5.5	Fax number	0
B.5.6	E-mail	GSKClinicalSupportHD@gsk.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	Yes
D.2.1.1.1	Trade name	INFANRIX HEXA - POLVERE E SOSPENSIONE PER SOSPENSIONE INIETTABILE 1 FLACONCINO + 1 SIRINGA PRERIEMPITA 0.5 ML USO INTRAMUSCOLARE
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE BIOLOGICALS S.A.
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	Powder for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	DIPHTHERIA TOXOID
D.3.9.4	EV Substance Code	SUB12489MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB12608MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	PERTUSSIS TOXOID
D.3.9.4	EV Substance Code	SUB14817MIG
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	FILAMENTOUS HAEMAGGLUTININ
D.3.9.4	EV Substance Code	SUB38509
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	PRN
D.3.9.3	Other descriptive name	PERTUSSIS PERTACTIN
D.3.9.4	EV Substance Code	SUB20527
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	8
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
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
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30925
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30926
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25336
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30927
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30928
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	2.2
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Healthy volunteers [Primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)].

Volontari sani [Immunizzazione primaria del lattante contro difterite, tetano, pertosse, epatite B, poliomielite e malattia da Haemophilus influenzae di tipo b (Hib)]

E.1.1.1

Medical condition in easily understood language

Diphtheria, Lock jaw, Whopping cough, Hepatitis B
Polio, Influenza

Difterite, tetano, pertosse, pertosse, epatite B, poliomielite, influenza

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10006025
E.1.2	Term	Bordetella pertussis laryngotracheobronchitis
E.1.2	System Organ Class	100000004862

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 assess the immunological response to DTPa-HBV-IPV/Hib in terms of seroprotection status for diphtheria, tetanus, hepatitis B, poliovirus and
Hib antigens, and in terms of vaccine response to the pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.

Valutare la risposta immunologica a Infanrix hexa in termini di stato di sieroprotezione per gli
antigeni di difterite, tetano, epatite B, poliovirus e Hib e in termini di risposta vaccinale agli
antigeni della pertosse un mese dopo la somministrazione dell’ultima dose di vaccinazione
primaria nei lattanti nati da madri vaccinate con Boostrix durante la gravidanza o
nell’immediato post‐partum.

E.2.2

Secondary objectives of the trial

•To assess persistence of antibodies against diphtheria, tetanus and pertussis antigens, before the first dose of DTPa-HBV-IPV/Hib in infants
born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery. •To assess the immunological response to DTPa-HBV-IPV/Hib and 13Pn
in terms of antibody concentrations or titres against all antigens, one month* after the last dose of the primary vaccination in infants born to mothers vaccinated with Boostrix during pregnancy or immediately postdelivery. •To assess the immunological response to DTPa-HBV-IPV/Hib in terms of seropositivity rates against pertussis antigens, one month after the last dose of the primary vaccination in infants born to mothers
vaccinated with Boostrix during pregnancy or immediately post-delivery. •To assess the safety and reactogenicity of DTPa-HBV-IPV/Hib and 13Pn
in terms of solicited and unsolicited symptoms and serious adverse events (SAEs).

Valutare la persistenza degli anticorpi per gli antigeni di difterite,tetano e pertosse prima della somm della 1°dose di Infanrix hexa nei lattanti nati da madri vaccinate con Boostrix durante la gravidanza o nell’immediato post‐partum;Valutare la risposta immunologica a Infanrix hexa e a Prevenar13 in termini di concentrazioni o titoli anticorpali contro tutti gli antigeni un mese* dopo la somm dell’ultima dose di vaccinazione primaria nei lattanti nati da madri vaccinate con Boostrix durante la gravidanza o nell’immediato post‐partum.*In alcuni paesi/regioni in cui è previsto uno schema vaccinale a 3dosi per Infanrix hexa,Prevenar13 potrebbe essere somm con uno schema di vaccinazione primaria a 2 o 3 dosi. In tal caso, la valutazione sarà eseguita un mese dopo la somm dell’ultima dose di Infanrix hexa indipendentemente dalla vaccinazione con Prevenar13.Nei paesi/regioni in cui è previsto uno schema a 2 dosi per Infanrix hexa, Prevenar13 sarà co‐somm contestualmente a Infanrix hexa.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
•A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the
first vaccinationat the time of the first vaccination.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
•Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of
the investigator. *Medically stable refers to the condition of premature infants who do not
require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.

- Avere un genitore o un rappresentante legalmente riconosciuto [LAR] che, a giudizio dello sperimentatore, abbia la capacità e l’intenzione di soddisfare i requisiti fissati dal protocollo (ad
es. compilazione delle schede diario, disponibilità a effettuare visite di follow‐up).
- Consenso informato scritto da parte del genitore/LAR, rilasciato prima della conduzione di una qualsiasi procedura specifica per lo studio.
- Soggetti di sesso femminile o maschile di età compresa tra le 6 e le 14 settimane d’età (inclusa
l’età di 6 settimane e fino a 14 settimane e 6 giorni compiuti) al momento della prima vaccinazione.
- Soggetti sani sulla base dell’anamnesi medica e dell’esame clinico prima dell’accesso allo studio.
- Bambini nati da madri arruolate nello studio 116945 [DTPA (BOOSTRIX)‐047].
- I prematuri con un quadro medico stabile* nati dopo una gestazione di 27‐36 settimane possono
essere arruolati nello studio a discrezione del giudizio del medico sperimentatore.
*Per “quadro medico stabile” si intende che il prematuro non necessita di un supporto medico
significativo o di un trattamento attuale per malattia debilitante e ha dimostrato un decorso
clinico di recupero continuo al momento in cui riceverà la prima dose del vaccino in studio.

E.4

Principal exclusion criteria

•Child in care
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean predni-sone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
•Administration of any chronic drug therapy to be continued during the study period.
•A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30
days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation
schedule, that are allowed at any time during the study period. *In case an emergency mass vaccination for an unforeseen public health
threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or package insert (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
•Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
•History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID),
based on medical history and physical examination (no laboratory testing required).
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Major congenital defects
•Serious chronic illness.
•History of any neurological disorders or seizures.
•Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of
the investigator.
•Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or
planned administration during the study period.
•Hypersensitivity to latex.

- Bambino/a sottoposto/a a custodia;- Somministrazione cronica (intesa come somministrazione di durata >14 giorni in totale) di immunosoppressori o altri farmaci immuno‐modulanti durante il periodo che va dalla nascita al momento antecedente la somministrazione della prima dose di vaccino. Per quanto riguarda i corticosteroidi, ciò corrisponde a una dose di prednisone ≥0,5 mg/kg/die o equivalente. È consentito l’uso di steroidi per via topica e inalatoria;- Somministrazione di farmaci immuno‐modulanti a lunga durata d’azione in qualsiasi momento durante lo svolgimento dello studio (ad es. infliximab);- Somministrazione di terapie farmacologiche croniche da proseguirsi durante lo svolgimento dello studio;- Somministrazione di un vaccino non previsto dal protocollo sperimentale durante il periodo compreso tra i 30 giorni precedenti la somministrazione di ciascuna dose di vaccino e i 30 giorni successivi*, fatta eccezione per il vaccino antinfluenzale inattivato e altri vaccini somministrati nel contesto del piano nazionale/regionale di prevenzione vaccinale, la cui somministrazione è ammessa in qualsiasi momento dello studio.*Qualora le autorità sanitarie pubbliche prevedano un programma di vaccinazione di massa di emergenza giustificata da un problema di sanità pubblica imprevisto (ad es. una pandemia) al di fuori del programma di prevenzione vaccinale di routine, il periodo sopraindicato potrà essere ridotto laddove necessario per il vaccino in questione, a condizione che si tratti di un prodotto autorizzato e usato conformemente al relativo RCP o foglio illustrativo e nel rispetto delle raccomandazioni governative locali ed a condizione che lo sponsor abbia rilasciato un’approvazione scritta;- Contemporanea partecipazione ad un altro studio clinico – in qualsiasi momento durante lo svolgimento dello studio – in cui il soggetto sia stato o sarà esposto a un vaccino/prodotto sperimentale o non sperimentale (dispositivo o prodotto farmaceutico);- Vaccinazione pregressa contro Hib, difterite, tetano, pertosse, malattia pneumococcica e/o poliomielite dopo la nascita;- Anamnesi positiva per malattia da Hib, difterite, tetano, pertosse, malattia pneumococcica, infezione da poliovirus ed epatite B;- Qualsiasi condizione di immunosoppressione o immunodeficienza confermata o sospetta, inclusa immunodeficienza combinata grave (SCID), sulla base dell’anamnesi medica e dell’esame obiettivo (test di laboratorio non necessari);- Anamnesi familiare positiva per immunodeficienza congenita o ereditaria;- Anamnesi positiva per una qualunque reazione o ipersensibilità che potrebbe essere esacerbata da un qualsiasi componente del vaccino;- Difetti congeniti maggiori;- Malattia cronica grave;- Anamnesi positiva per disturbi neurologici o crisi convulsive;- Malattia acuta e/o febbre al momento dell’arruolamento;- La febbre è intesa come una temperatura corporea ≥ 37,5 °C misurata per via orale,
ascellare o timpanica, oppure ≥ 38,0 °C per via rettale; - I soggetti apiretici con una malattia minore (ad es. diarrea lieve, lieve infezione delle alte vie aeree) possono essere arruolati a discrezione del giudizio del medico sperimentatore;- Somministrazione di immunoglobuline e/o qualunque prodotto ematico nel periodo compreso tra la nascita e il momento antecedente alla somministrazione della prima dose dei vaccini sperimentali, o somministrazione programmata durante lo svolgimento dello studio;- Ipersensibilità al lattice.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity with respect to components of DTPa-HBV-IPV/Hib.
- Anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, antipoliovirus type 2, anti-poliovirus type 3 and anti-polyribosyl-ribitol
phosphate (anti-PRP) seroprotection status.
- Vaccine response to PT, FHA and PRN antigens.

Immunogenicità relativamente ai componenti di Infanrix hexa.
- Stato di sieroprotezione antidifterica, antitetanica, anti‐HB, anti‐poliovirus di tipo 1, anti‐poliovirus di tipo 2, anti‐poliovirus di tipo 3 e anti‐poliribosilribitolfosfato (anti‐
PRP), un mese dopo la somministrazione dell’ultima dose di vaccinazione primaria.
- Risposta vaccinale agli antigeni PT, FHA e PRN un mese dopo la somministrazione
dell’ultima dose di vaccinazione primaria.

E.5.1.1

Timepoint(s) of evaluation of this end point

Month 3 or Month 5 (depending on vaccination schedule of the country).

Mese 3 o mese 5 (in base allo schema vaccinale previsto dal paese/regione)

E.5.2

Secondary end point(s)

Occurrence of serious adverse events.

Eventi avversi seri
- Insorgenza di SAE nel periodo compreso tra la somministrazione della prima dose di
vaccino e il termine dello studio.

E.5.2.1

Timepoint(s) of evaluation of this end point

From Month 0 up to Month 3 or Month 5 (depending on vaccination schedule of the country).

Durante il periodo compreso tra la somministrazione della prima dose di vaccino e il termine dello studio.

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

Immunogenicità

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

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

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

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

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

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

Information not present in EudraCT

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

Australia

Canada

Czech Republic

Finland

Italy

Spain

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

Last testing results released of samples collected at Visit 4.

Ultimi risultati dei test relativi ai campioni raccolti in occasione della visita 4.

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

680

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)

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

Information not present in EudraCT

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

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

520

F.4.2.2

In the whole clinical trial

680

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

Nessuno

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

2017-01-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-08

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

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Select Rare Disease:
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Orphan Designation Number:
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