Streptococcus Agalactiae InfectionPhase 2/3NCT06494475
GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age
A Phase 2/3 study testing GBS-NN/NN2 vaccine and Tdap vaccine in people with Streptococcus Agalactiae Infection, run by Minervax ApS.
Trial summary
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Agalactiae Infection
- What is being tested?
- GBS-NN/NN2 vaccine and Tdap vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2024to 21 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ≥18 to ≤49 years of age with a body mass index (BMI) of >17.5 to <40 kg/m2.
- Able to read, understand and capable of giving personal signed informed consent.
- Participants who are willing and able to comply with all trial procedures including completion of the electronic diary (eDiary) using their own personal mobile phone for 28 days after each dose.
- Healthy females at enrolment, as determined by medical history, physical examination, and clinical judgement of the investigator or participants with well controlled, well treated underlying conditions which will not impact the trial assessments.
- Women of childbearing potential must be:
- Documented to be surgically sterile or post-menopausal, or
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- Willing to practice true abstinence throughout the trial and have a negative pregnancy test on Day 1, or
- Having same sex partners only, or
- Using at least one highly effective contraceptive measure, such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) or non-hormonal methods (eg, intrauterine device, intrauterine hormone releasing system) throughout the trial and have a negative pregnancy test on Day 1.
- Expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.
Who cannot join
- Pregnant women (positive urine pregnancy test on Day 1), women planning to become pregnant during the trial, and breastfeeding women.
- Women of childbearing potential not planning or willing to take adequate contraception (defined in inclusion criteria) from enrolment until 28 days after the last vaccination.
- Current or history of drug or alcohol abuse, as judged by the investigator.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of GBS-NN/NN2 or any diphtheria toxoid-containing or CRM197-containing vaccine.
- History of microbiologically proven invasive disease caused by GBS, such as primary or secondary bacteriaemia, septic arthritis, endocarditis, prosthetic joint infection, necrotising myositis and fasciitis or pyelonephritis.
- Acute febrile illness, fever (temperature ≥38 degrees Celsius) before randomisation or an acute infection in the 7 days before screening and before the first dose.
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- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Any acute or chronic medical condition that, in the investigator's judgement, would make the participant unsuitable for participation in the trial.
- Any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator's judgement, make the participant unsuitable for participation in the trial.
- Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during participation in the trial (from the first to the last visit).
- Vaccination within the previous 5 years with the Tdap vaccine or a vaccine containing any individual component thereof.
- Participants who have received any vaccine within 30 days of the first dose, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each dose and/or 7 days prior to the third dose.
- Participants who have received antipyretics/analgesics treatment within 72 hours prior to administration.
- Participants receiving immunosuppressive or immunomodulatory therapy, including steroids at immunosuppressive doses (10 mg or more prednisolone equivalent daily for 2 weeks or more during the past) or immunoglobulins in the 6 months prior to screening.
- Receipt or planned receipt of blood/plasma products, from 60 days before the first dose until the end of the trial.
- Participation in other trials involving investigational drug/vaccine(s) within 28 days prior to trial entry and/or planned during the trial.
- Participants with a deltoid muscle not being sufficiently large to permit the administration of 2 separate vaccinations at the same time visit, as determined by the investigator.
- Any personnel involved in the conduct of the trial (and their family members), including but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees.
About this study
Official title: A Randomised, Observer-Blind Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of a Group B Streptococcus Vaccine (GBS-NN/NN2) When 1 Dose is Administered Concomitantly With the Tdap Vaccine in Healthy-non Pregnant Women 18 to 49 Years of Age Compared to When Each Vaccine is Administered Alone
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered alone or in combination with Tdap, and to evaluate the safety of GBS-NN/NN2 when administered alone or in combination with Tdap in terms of serious adverse events (SAEs) and unsolicited adverse events (AEs).
- Conditions
- Streptococcus Agalactiae Infection
- Being tested
- GBS-NN/NN2 vaccine, Tdap vaccine, Placebo
- Keywords
- Immunology, Group B Streptococcus Vaccine, Streptococcus Agalactiae, Tdap
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN/NN2 vaccineDrug
Intramuscular injection.
Tdap vaccineDrug
Also called Boostrix®
Intramuscular injection.
PlaceboDrug
Intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (coadministration [CA] Group/1 upper limb) | Experimental | Participants will receive a single placebo dose on Day 1. They will then receive two doses of the GBS-NN/NN2 vaccine on Days 29 and 57, respectively. The second dose on Day 57 will be administered in combination with the Tdap vaccine, with both injections given in the same upper limb. Receives: Drug: GBS-NN/NN2 vaccine; Drug: Tdap vaccine; Drug: Placebo |
| Group 2 (CA Group/2 upper limbs) | Experimental | Participants will receive a single placebo dose on Day 1 and two doses of the GBS NN/NN2 vaccine on Days 29 and 57, respectively. The second dose on Day 57 will be administered in combination with the Tdap vaccine, with the GBS-NN/NN2 injection in one upper limb and the Tdap injection in the other upper limb. Receives: Drug: GBS-NN/NN2 vaccine; Drug: Tdap vaccine |
| Group 3 (non-coadministration [NCA] Group/1 upper limb) | Experimental | Participants will receive two doses of the GBS NN/NN2 vaccine on Days 1 and 29, respectively. On Day 57, they will receive a single dose of the Tdap vaccine administered in combination with a placebo, with both injections (Tdap and placebo) given in the same upper limb. Receives: Drug: GBS-NN/NN2 vaccine; Drug: Tdap vaccine; Drug: Placebo |
| Group 4 (NCA Group/2 upper limbs) | Experimental | Participants will receive two doses of the GBS-NN/NN2 vaccine on Days 1 and 29, respectively. On Day 57, they will receive a single dose of the Tdap vaccine, administered in combination with a placebo. The Tdap vaccine will be injected in one upper limb and the placebo in the other upper limb. Receives: Drug: GBS-NN/NN2 vaccine; Drug: Tdap vaccine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Expressing Anti-tetanus Toxoid Antibody Concentration ≥0.1 IU/mL
Measured: Day 85
Number of Participants Expressing Anti-diphtheria Toxoid Antibody Concentrations ≥0.1 IU/mL
Measured: Day 85
Number of Participants Expressing Anti-pertussis Toxin Antibodies
Measured: Day 85
Number of Participants Expressing Anti-filamentous Hemagglutinin (FHA) Antibodies
Measured: Day 85
Number of Participants Expressing Anti-pertactin (PRN) Antibodies
Measured: Day 85
Number of Participants Expressing RibN Antibody
Measured: Day 85
Number of Participants Expressing Alp1N Antibody
Measured: Day 85
Number of Participants Expressing Alp2N Antibody
Measured: Day 85
Number of Participants Expressing AlpCN Antibody
Measured: Day 85
Number of Participants Experiencing Solicited Local Adverse Events (AEs)
Measured: Day 63
Number of Participants Experiencing Solicited Systemic AEs
Measured: Day 63
Number of Participants Experiencing Unsolicited AEs
Measured: Day 85
Number of Participants Experiencing SAEs
An SAE is any occurrence that results in death, poses a life-threatening situation, necessitates inpatient hospitalization or the extension of an existing hospital stay, leads to persistent or significant disability or incapacity, involves a congenital anomaly or birth defect, or is considered an important medical event that, while not resulting in death, being life-threatening, or requiring hospitalization, still warrants serious concern.
Measured: Day 85
Secondary outcomes (1)
Number of Participants Experiencing Medically-attended Adverse Events (MAAEs)
A MAAE is defined as an AE that leads to an unscheduled visit to a health care professional.
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start17 Dec 2024 (estimated)
- Primary completion21 Jun 2025 (estimated)
- Study completion21 Jun 2025 (estimated)
Why it stopped: The trial has been postponed for later in the development program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Agalactiae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494475
- Sponsor's protocol ID
- MVX009
- Other IDs
- 2023-508563-73-00, U1111-1300-2150, 2023
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Observer-Blind Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of a Group B Streptococcus Vaccine (GBS-NN/NN2) When 1 Dose is Administered Concomitantly With the Tdap Vaccine in Healthy-non Pregnant Women 18 to 49 Years of Age Compared to When Each Vaccine is Administered Alone
- ClinicalTrials.gov ID
- NCT06494475
- Acronym / sponsor ID
- MVX009
- Conditions
- Streptococcus Agalactiae Infection
- Keywords
- Immunology, Group B Streptococcus Vaccine, Streptococcus Agalactiae, Tdap
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial has been postponed for later in the development program
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Study start
- 17 Dec 2024 (estimated)
- Primary completion
- 21 Jun 2025 (estimated)
- Study completion
- 21 Jun 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered alone or in combination with Tdap, and to evaluate the safety of GBS-NN/NN2 when administered alone or in combination with Tdap in terms of serious adverse events (SAEs) and unsolicited adverse events (AEs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (coadministration [CA] Group/1 upper limb) | Experimental | Drug: GBS-NN/NN2 vaccine, Drug: Tdap vaccine, Drug: PlaceboParticipants will receive a single placebo dose on Day 1. They will then receive two doses of the GBS-NN/NN2 vaccine on Days 29 and 57, respectively. The second dose on Day 57 will be administered in combination with the Tdap vaccine, with both injections given in the same upper limb. |
| Group 2 (CA Group/2 upper limbs) | Experimental | Drug: GBS-NN/NN2 vaccine, Drug: Tdap vaccineParticipants will receive a single placebo dose on Day 1 and two doses of the GBS NN/NN2 vaccine on Days 29 and 57, respectively. The second dose on Day 57 will be administered in combination with the Tdap vaccine, with the GBS-NN/NN2 injection in one upper limb and the Tdap injection in the other upper limb. |
| Group 3 (non-coadministration [NCA] Group/1 upper limb) | Experimental | Drug: GBS-NN/NN2 vaccine, Drug: Tdap vaccine, Drug: PlaceboParticipants will receive two doses of the GBS NN/NN2 vaccine on Days 1 and 29, respectively. On Day 57, they will receive a single dose of the Tdap vaccine administered in combination with a placebo, with both injections (Tdap and placebo) given in the same upper limb. |
| Group 4 (NCA Group/2 upper limbs) | Experimental | Drug: GBS-NN/NN2 vaccine, Drug: Tdap vaccine, Drug: PlaceboParticipants will receive two doses of the GBS-NN/NN2 vaccine on Days 1 and 29, respectively. On Day 57, they will receive a single dose of the Tdap vaccine, administered in combination with a placebo. The Tdap vaccine will be injected in one upper limb and the placebo in the other upper limb. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women ≥18 to ≤49 years of age with a body mass index (BMI) of >17.5 to <40 kg/m2.
- Able to read, understand and capable of giving personal signed informed consent.
- Participants who are willing and able to comply with all trial procedures including completion of the electronic diary (eDiary) using their own personal mobile phone for 28 days after each dose.
- Healthy females at enrolment, as determined by medical history, physical examination, and clinical judgement of the investigator or participants with well controlled, well treated underlying conditions which will not impact the trial assessments.
- Women of childbearing potential must be:
Key exclusion criteria (18 listed)
- Pregnant women (positive urine pregnancy test on Day 1), women planning to become pregnant during the trial, and breastfeeding women.
- Women of childbearing potential not planning or willing to take adequate contraception (defined in inclusion criteria) from enrolment until 28 days after the last vaccination.
- Current or history of drug or alcohol abuse, as judged by the investigator.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of GBS-NN/NN2 or any diphtheria toxoid-containing or CRM197-containing vaccine.
- History of microbiologically proven invasive disease caused by GBS, such as primary or secondary bacteriaemia, septic arthritis, endocarditis, prosthetic joint infection, necrotising myositis and fasciitis or pyelonephritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBS-NN/NN2 vaccineIntramuscular injection. | Drug | Group 1 (coadministration [CA] Group/1 upper limb), Group 2 (CA Group/2 upper limbs), Group 3 (non-coadministration [NCA] Group/1 upper limb), Group 4 (NCA Group/2 upper limbs) |
| Tdap vaccineAlso: Boostrix®Intramuscular injection. | Drug | Group 1 (coadministration [CA] Group/1 upper limb), Group 2 (CA Group/2 upper limbs), Group 3 (non-coadministration [NCA] Group/1 upper limb), Group 4 (NCA Group/2 upper limbs) |
| PlaceboIntramuscular injection. | Drug | Group 1 (coadministration [CA] Group/1 upper limb), Group 3 (non-coadministration [NCA] Group/1 upper limb), Group 4 (NCA Group/2 upper limbs) |
Primary outcome
Number of Participants Expressing Anti-tetanus Toxoid Antibody Concentration ≥0.1 IU/mL
Time frame: Day 85
Number of Participants Expressing Anti-diphtheria Toxoid Antibody Concentrations ≥0.1 IU/mL
Time frame: Day 85
Number of Participants Expressing Anti-pertussis Toxin Antibodies
Time frame: Day 85
Number of Participants Expressing Anti-filamentous Hemagglutinin (FHA) Antibodies
Time frame: Day 85
Number of Participants Expressing Anti-pertactin (PRN) Antibodies
Time frame: Day 85
Number of Participants Expressing RibN Antibody
Time frame: Day 85
Number of Participants Expressing Alp1N Antibody
Time frame: Day 85
Number of Participants Expressing Alp2N Antibody
Time frame: Day 85
Number of Participants Expressing AlpCN Antibody
Time frame: Day 85
Number of Participants Experiencing Solicited Local Adverse Events (AEs)
Time frame: Day 63
Number of Participants Experiencing Solicited Systemic AEs
Time frame: Day 63
Number of Participants Experiencing Unsolicited AEs
Time frame: Day 85
Number of Participants Experiencing SAEs
Time frame: Day 85
An SAE is any occurrence that results in death, poses a life-threatening situation, necessitates inpatient hospitalization or the extension of an existing hospital stay, leads to persistent or significant disability or incapacity, involves a congenital anomaly or birth defect, or is considered an important medical event that, while not resulting in death, being life-threatening, or requiring hospitalization, still warrants serious concern.
1 secondary outcome
Number of Participants Experiencing Medically-attended Adverse Events (MAAEs)
Time frame: Day 85
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GBS-NN/NN2 vaccine and Tdap vaccine in people with Streptococcus Agalactiae Infection, run by Minervax ApS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Expressing Anti-tetanus Toxoid Antibody Concentration ≥0.1 IU/mL (time frame: Day 85). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.