Clinical Trials Register

Summary
EudraCT Number:	2010-020840-36
Sponsor's Protocol Code Number:	V98_04
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:	2011-04-20
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

2010-020840-36

A.3

Full title of the trial

A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent group B Streptococcus Vaccine in Healthy Pregnant Women

A.3.1

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

Testing a vaccine in pregnant woman to protect their newborn babies from blood poisoning caused by a bacterium

A.4.1

Sponsor's protocol code number

V98_04

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	Novartis Vaccines and Diagnostics GmbH
B.1.3.4	Country	Germany
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	Novartis Vaccines and Diagnostics GmbH
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	Novartis Vaccines & Diagnostics
B.5.2	Functional name of contact point	Suzanne Jonkheer
B.5.3	Address:
B.5.3.1	Street Address	Hullenbergweg 83-85
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1101 CL
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31205640589
B.5.6	E-mail	suzanne.jonkheer@novartis.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	Group B Streptococcus (Group B strep.) Trivalent Vaccine
D.3.2	Product code	Group B strep. vaccine
D.3.4	Pharmaceutical form	Powder for solution 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.3.9.3	Other descriptive name	Group B strep. CPSla-CRM Conjugated
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Group B strep. CPSlb-CRM Conjugated
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Group B strep. CPSIII-CRM Conjugated
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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
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 infusion
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

Invasive group B streptococcus disease

E.1.1.1

Medical condition in easily understood language

Invasive Group B strep. disease in new borns

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	13.1
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

To compare placental transfer of anti-group B Streptococcus CPS antibodies among infants born to vaccinated and to control mothers.

E.2.2

Secondary objectives of the trial

Pregnant women
▫ To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects 30 days post injection.
▫ To evaluate the kinetics of anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects at baseline, 30 days post vaccination, delivery and 3 months after delivery.

Infant
▫ To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in infants born to vaccinated subjects at birth and 3 months of age.
▫ To evaluate the response to routine anti-diphtheria vaccination among infants born to vaccine and placebo vaccinated subjects at 1 month after the third routine vaccination.

Safety Objectives:
▫ Pregnant Women: To evaluate safety and tolerability of a trivalent Group B strep. vaccine (5/5/5 µg of each glycoconjugate).
▫ Infants: To evaluate outcome of infants born to vaccine and placebo recipients, at birth, 3 and 6 months of age.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Healthy pregnant women 18-40 years of age inclusive

E.4

Principal exclusion criteria

Women at risk for poor obstetrical outcome at screening such as gestational diabetes, pre-eclampsia / eclampsia, women at risk of pre-term labor, and history of previous obstetrical complications including delivery of pre-term infant

E.5 End points

E.5.1

Primary end point(s)

Proportion (%) of maternal anti-Group B strep. CPS antibody that is transferred to the newborn, calculated as the ratio between cord blood antibody level (µg/ml) and maternal antibody level (µg/ml) at time of delivery, per each serotype.

E.5.1.1

Timepoint(s) of evaluation of this end point

At delivery

E.5.2

Secondary end point(s)

Pregnant women:
- GMC and GMR (i.e. GMC at different time points over baseline) of anti- Group B strep. CPS antibody (at study day 1 (GMC only), study day 31, at delivery, and at 3 months post delivery).
- Proportion (%) showing a serotype specific serum IgG level over 1mg/mL, 3mg/mL, and 5 mg/mL) (at study day 31, at delivery, and at 3 months post delivery).
- Proportion (%) showing a 2/3/4 fold rises of GMC between study day 1 and study day 31 and between study day 1 and delivery.

Infants:
-GMC of anti- Group B strep. CPS antibody in infants at birth (cord blood) and 3 months of age.
- Proportion (%) of newborns, with anti-CPS antibodies above different thresholds (i.e. 1mg/mL, 3mg/mL, 5mg/mL) as measured at birth and 3 months of age.
- GMC of anti-diphtheria antibodies in sera of infants collected at 1 month after the last routine infant immunization

Safety Endpoints
- Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events, and serious adverse events. Systemic and local reactogenicity will be evaluated for 7 days after vaccination. For women, all AEs will be recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study will be recorded. SAEs will be collected for the duration of the trial. Obstetrical outcomes will be included in this analysis.
- Infant outcome will be monitored by physical exam at birth (including Apgar), 3 months of age and 1 month after the last routine infant immunization. The infant’s development status will be evaluated at 1 month after the last routine infant immunization by performing the Denver Developmental Screening Test II. For infants SAEs will be recorded from birth until study conclusion for the infant.

E.5.2.1

Timepoint(s) of evaluation of this end point

- Day 1
- Day 31
- at delivery
- 5 vs 7 months post delivery

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

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

Yes

E.8.1.2

Open

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

Observer blind

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

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

Canada

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 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:

100

F.1.3

Elderly (>=65 years)

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

F.3.3.3

Pregnant women

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

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)

The standard of care for pregnant women and their children will not be affected by this trial. Women and infants will continue in the care of their respecting physicians after the trial has ended.

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

2011-05-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-08-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-10-17

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