Clinical Trials Register

Summary
EudraCT Number:	2015-003094-15
Sponsor's Protocol Code Number:	V98_06E1
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-02-11
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2015-003094-15

A.3

Full title of the trial

A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects

A.3.1

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

Revaccination of healthy non-pregnantwomen with a second dose of a vaccine to asess its safety and the protection it gives from blood poisoning caused by a bacterium

A.4.1

Sponsor's protocol code number

V98_06E1

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 S.A.
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 S.A.
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 S.A.
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de l'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	4420 899 4466
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	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.3.1	Product name	Lyophilized GBS Trivalent Vaccine
D.3.4	Pharmaceutical form	Powder 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	Not Applicable
D.3.9.3	Other descriptive name	GBS CPSIa-CRM
D.3.9.4	EV Substance Code	SUB130505
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not Applicable
D.3.9.3	Other descriptive name	GBS CPSIb-CRM
D.3.9.4	EV Substance Code	SUB130506
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not Applicable
D.3.9.3	Other descriptive name	GBS CPSIII-CRM
D.3.9.4	EV Substance Code	SUB130507
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	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

Healthy person immune response to a second dose of Group B Streptococcus
polysaccharide capsule antigens

E.1.1.1

Medical condition in easily understood language

Healthy person immune response to a second dose of GBS Trivalent Vaccine.

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	18.1
E.1.2	Level	PT
E.1.2	Classification code	10053588
E.1.2	Term	Group B streptococcus neonatal sepsis
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

Immunogenicity Objective
To evaluate the immunogenicity of a second dose of GBS Trivalent Vaccine (5 μg without adjuvant) administered approximately 4-6 years after the initial GBS vaccination, measured by ELISA.

Safety Objective
To assess the safety and tolerability of a second dose of GBS Trivalent Vaccine (5 μg without adjuvant) administered approximately 4-6 years after the initial dose.

E.2.2

Secondary objectives of the trial

To further characterize the immune response following a dose of GBS Trivalent Vaccine (5 μg without adjuvant) in study subjects and in subgroups of subjects defined by prevaccination serotype-specific GBS antibody LLQ status in the V98_06 study or V98_06E1 for the naïve subjects.
To assess the impact of a dose of the GBS Trivalent Vaccine (5 μg without adjuvant) on the serum level of anti diphtheria antibodies in subjects who received study vaccination (active or placebo) as part of the V98_06 and naïve subjects from V98_06E1

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria
described.
1. Healthy, non-pregnant subjects who have received a single 5 μg dose of GBS Trivalent Vaccine or placebo in the V98_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past.
2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
4. Individuals who can comply with study procedures including follow-up.
5. Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of nonchildbearing potential

E.4

Principal exclusion criteria

1. Progressive, unstable or uncontrolled clinical conditions.
2. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
3. Abnormal function of the immune system resulting from:
a. Clinical conditions, including but not limited to known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder (as per the judgment of the Investigator)
b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
d. Receipt of immunosuppressive therapy within 90 days prior to informed consent
4. Received immunoglobulins or any blood products within 180 days prior to informed consent.
5. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
6. Study personnel as an immediate family or household member.
7. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
8. Individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination.
9. Individuals who anticipate becoming pregnant prior to the end of the study, Day 181 Visit.10. Individuals who are nursing (breastfeeding).
11. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study.
12. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1.
13. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1.
14. Individuals with a history of severe allergic reactions after previous vaccinations or medications, such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component or medical equipment including latex used in this study.
15. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
16. Individuals with history of substance or alcohol abuse within the past 2 years.

E.5 End points

E.5.1

Primary end point(s)

Primary Safety Endpoint(s)
The frequency and percentage of subjects with solicited local and systemic AEs from vaccination to day 7 in study V98_06E1. Time intervals after vaccination that will be summarized are: the first 30 minutes after vaccination, days 1-3 (excluding the first 30 min), days 4-7 and days 1-7 (excluding the first 30 min).
The frequency and percentage of subjects with any unsolicited AEs from the day of vaccination (day 1 in study V98_06E1) to day 31.
The frequency and percentage of subjects with SAEs, medically attended AEs, and AEs leading to study withdrawal from vaccination in study V98_06E1 to day 181.

Primary Immunogenicity Endpoint(s)
The primary immunogenicity endpoints are the percentages of subjects who reach predefined sequential serotype-specific (Ia, Ib and III) serum antibody levels at day 61 post vaccination, as measured by ELISA.

E.5.1.1

Timepoint(s) of evaluation of this end point

See E.5.1

E.5.2

Secondary end point(s)

The secondary immunogenicity endpoints are:
The percentage of subjects reaching pre-defined sequential serotype-specific (Ia, Ib and III) serum antibody levels as measured by ELISA at other time points and in subgroups of subjects defined by their pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study (or the V98_06E1 study for the naive group).
The serotype-specific (Ia, Ib, and III) geometric mean concentrations (GMCs) as measured by ELISA at days 31 and 61 post-vaccination in study V98_06E1 and in the subgroups of subjects defined according to their pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study (or V98_06E1 study for the naive group).
The within subject geometric mean ratio (GMR) of serotype-specific (Ia, Ib & III) serum antibody levels as measured by ELISA at day 31 and 61. The GMRs will be determined relative to pre-vaccination in V98_06E1 and separately relative to pre-vaccination in V98_06 for all groups except the naive group. The GMRs will also be determined for
subgroups of subjects defined according to their pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study or V98_06E1 study for the naive group.
Reverse cumulative distribution function (RCDF) curves of serotype-specific (Ia, Ib and III) serum antibody levels, as measured by ELISA, at pre-vaccination in V98_06 study or V98_06E1 study for the naive group, vaccination, day 31 and day 61 post-vaccination in all subjects and by pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study or V98_06E1 study for the naive group.
The anti-diphtheria geometric mean antibody concentrations measured by ELISA for samples collected before the first vaccination with GBS Trivalent Vaccine in the V98_06 study or V98_06E1 study for the naive group and on day 61 post-vaccination in V98_06E1.

E.5.2.1

Timepoint(s) of evaluation of this end point

See E.5.2

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

Yes

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Extension study

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

Single dose of GBS antigens given to Naive subjects or placebo controlled subjects from parent study

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

Completion of Last Subject Last Visit

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

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:

220

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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

220

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)

standard of care

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

2016-02-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-08

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

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