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    Summary
    EudraCT Number:2021-003214-40
    Sponsor's Protocol Code Number:MVX0004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-16
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2021-003214-40
    A.3Full title of the trial
    A multicentre, multinational, parallel group, observer-blind, randomised, placebo-controlled study on the Group B Streptococcus vaccine (GBS-NN/NN2), investigating the immunogenicity and safety of four vaccination regimens in pregnant woman, assessing IgG specific to AlpN proteins in cord blood and maternal blood, and the safety profile in mother and infant up to 6 months post-delivery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of 4 regimens of Group B Streptococcus vaccine (GBS-NN/NN2) in pregnant women.
    A.4.1Sponsor's protocol code numberMVX0004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMinervaX Aps
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinervaX Aps
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMinervaX Aps
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOle Maaløvs Vej 3
    B.5.3.2Town/ cityCopenhagen N
    B.5.3.3Post code2200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4526838437
    B.5.6E-mailbtc@Minervax.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGBS NN/NN2 vaccine
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGBS-NN
    D.3.9.2Current sponsor codeGBS-NN
    D.3.9.3Other descriptive nameGBS-NN
    D.3.9.4EV Substance CodeSUB176639
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.35
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGBS-NN2
    D.3.9.2Current sponsor codeGBS-NN2
    D.3.9.3Other descriptive nameGBS-NN2
    D.3.9.4EV Substance CodeSUB196931
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.35
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in vial
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Group B Streptococcus infection in neonates.
    E.1.1.1Medical condition in easily understood language
    Prevention of Group B Streptococcus infection in newborns.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10053588
    E.1.2Term Group B streptococcus neonatal sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the concentrations of IgG specific to the AlpN proteins (RibN, Alp1N, Alp2N and AlpCN) in cord blood from babies, born to women who received the GBS-NN/NN2 vaccine or placebo, according to four vaccination regimens during pregnancy, between the GBS-NN/NN2 and placebo groups:
    • Group 1: 2 doses GBS-NN/NN2 at 26 & 30 weeks GA
    • Group 2: 2 doses GBS-NN/NN2 at 22 & 26 weeks GA
    • Group 3: 2 doses GBS-NN/NN2 at 22 & 30 weeks GA
    • Group 4: 1 dose GBS-NN/NN2 at 26 weeks GA
    • Group 5: Placebo at 22, 26, and 30 weeks GA
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in pregnant women from 22 (±1) weeks GA and to evaluate developmental milestones in the baby up to 6 months post-delivery.
    To compare the concentrations of IgG, specific to the AlpN proteins (RibN, Alp1N, Alp2N and AlpCN) in maternal blood at delivery, from women who received the GBS-NN/NN2 vaccine or placebo, according to four vaccination regimens during pregnancy, between the GBS-NN/NN2 and placebo groups .
    Secondary immunogenicity objectives:
    • To compare the concentrations of IgG specific to the AlpN proteins, in maternal blood at 4 weeks after each dose of vaccine/placebo for the different vaccination regimens
    • To evaluate the ratios of antibody concentrations between maternal and cord blood at delivery
    • To evaluate the concentrations of IgG specific to the AlpN proteins, up to 3 months post-delivery, in infant blood
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy pregnant woman above the legally defined age of consent at the time of screening
    2. Carrying a normal singleton pregnancy and is at 21+0 to 23+6 weeks GA at the planned time of the 1st vaccination, as established by first/second trimester ultrasound examination
    3. Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with ICH GCP and local legislation prior to the first study intervention
    4. Grants access to her own and her baby’s study related medical records
    E.4Principal exclusion criteria
    1. Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine
    2. BMI of <17 or >40 at the time of screening
    3. HIV, HBV and/or HCV positive or positive for syphilis
    4. Knowingly carrying, at screening, a malformed or genetically abnormal foetus, incl. renal pelvis dilation, single umbilical artery (screening will be undertaken after the ultrasound conducted for the detection of anomalies)
    5. Chronic or pregnancy induced hypertension at screening, >1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension
    6. Experienced a previous stillbirth prior to going into labour
    7. Gestational, type 1 or type 2 diabetes
    8. Potential placenta previa as per malformation ultrasound scan
    9. Rhesus negative and has anti-D antibodies or other potential harmful antibodies
    10. Known or suspected allergies to any components of the vaccine including to aluminium or aminoglycoside antibiotics, or an allergic reaction related to a previous vaccination
    11. Fever (temperature >37.9°C) on the day of receiving the first dose or an acute infection in the 7 days before the first dose (the first dose can be delayed if gestational age permits)
    12. Received systemic steroids in the 6 weeks before the first dose (inhaled and topical steroids are acceptable)
    13. Any lesion (including tattoos) at the planned injection site that will impair the assessment of the injection site.
    14. Received immunosuppressive medication, chemotherapy or radiotherapy in the 24 weeks before the first dose
    15. Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before the first dose
    16. Anaemia, haemoglobin (<10 g/dL, 100 g/L, 6.2 mmol/L)
    17. Currently breast feeding
    18. Received any investigational medicinal product or vaccine in the 12 weeks or 5 half-lives before the first dose
    19. Received an approved vaccine within the 4 weeks before the first dose or expects to receive an approved vaccine during the study. (Routine vaccinations recommended during pregnancy (e.g., pertussis and influenza) are permitted but every effort should be made to separate routine vaccinations from the trial vaccinations by at least 7 days.)
    20. Known or suspected immunodeficiency or cancer (leukaemia, lymphoma), or a family history of congenital or hereditary immunodeficiency
    21. History or presence of uncontrolled cardiovascular disease, pulmonary, hepatic, gall bladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, or autoimmune disease
    22. History of, or current drug or alcohol abuse
    23. In the opinion of the investigator not suitable for inclusion in the study
    24. The pregnancy is considered high risk by treating physicians
    E.5 End points
    E.5.1Primary end point(s)
    The following primary endpoints will be evaluated, by group:, to support the primary objectives:
    • Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby:
    o The geometric mean antibody concentrations at birth will be calculated
    o The proportions of babies who achieve a concentration of IgG specific to the AlpN proteins above 0.1, 0.2, 0.5, 1, 2, 4 and 8 µg/mL at birth will be calculated
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time of the primary immunological analysis will be at the time of delivery, anticipated to be approximately 18
    weeks (4 ½ months) from administration of the first dose at 22 weeks gestational age (GA) or 14 weeks (3½ months)
    from administration of the first dose at 26 weeks GA.
    Implementation of an early analysis of study data for the primary and key secondary endpoints available up to 72 hours after delivery (Visit 8).
    E.5.2Secondary end point(s)
    The following key safety secondary endpoint(s) will be evaluated in the mother:
    Local and systemic reactogenicity and adverse events:
    • Solicited injection site reactions following the vaccinations
    • Solicited systemic adverse events following the vaccinations
    • All other adverse events following the vaccinations
    • Laboratory tests; urinalysis; vital signs (heart rate, blood pressure, oral body temperature); physical examinations
    The following key safety secondary endpoints will be evaluated in the baby:
    • Gestational age; weight; length; head circumference; Apgar score at 1, 5 and 10 minutes
    • Developmental milestones at 6 months of age
    The following secondary immunogenicity endpoints will be evaluated, by group and time-point:
    • Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood:
    o The geometric mean antibody concentrations at delivery, and geometric mean concentration ratios relative to baseline will be calculated
    o The proportions of mothers who achieve a concentration of IgG specific to the AlpN proteins above 0.1, 0.2, 0.5, 1, 2, 4 and 8 µg/mL at delivery will be calculated
    o The geometric mean antibody concentrations at 4 weeks after each dose of vaccine/placebo and geometric mean concentration ratios relative to baseline will be calculated
    • The ratios of antibody concentrations between maternal and cord blood at delivery will be calculated
    The following immunogenicity endpoints will be evaluated in the baby:
    • Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby at 1 month and 3 months of age:
    o The geometric mean antibody concentrations at 1 month and 3 months after birth will be calculated
    o The proportions of babies who achieve a concentration of IgG specific to the AlpN proteins above 0.1, 0.2, 0.5, 1, 2, 4 and 8 µg/mL at 1 month and 3 months after birth will be calculated.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary safety endpoints will be evaluated in the mother and up to 6 months of age in the baby. Secondary immunological endpoints in the mother will be evaluated until delivery and in the baby will be evaluated at birth, 1 and 3 months of age.
    Implementation of an early analysis of study data for the primary and key secondary endpoints available up to 72 hours after delivery (Visit 8).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Saline
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    South Africa
    United Kingdom
    E.8.7Trial 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
    The end of the study is the completion of results for the primary and secondary immunogenicity analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 270
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 270
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 270
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    270 pregnant woman will be included in the study and their babies will be followed from birth until 6 months post-delivery. Parents must consent before birth to allow follow up on their babies.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 270
    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.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-18
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