Meningococcal ImmunizationPhase 1NCT06165276
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
A Phase 1 study testing Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). and Meningococcal Group C-CRM197 Conjugate Vaccine in people with Meningococcal Immunization, run by Sanofi Pasteur, a Sanofi Company.
Trial summary
The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The primary objectives and their endpoints will be assessed in infants who receive TetraMen-T. Read more about this study
- Who is it for?
- Ages 60 days to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Immunization
- What is being tested?
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). and Meningococcal Group C-CRM197 Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2006to 27 Aug 2008
- Phase
- Phase 1
- 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 60 days to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: -Subject is healthy, as determined by medical history and physical assessment.
-At the time of vaccination on Day 0, subject was the following age: Adults: aged ≥18 to < 40 years Toddlers: aged ≥12 to < 19 months Infants: aged 2 months + 28 days (60 to 88 days)
- Institutional Review Board (IRB)-approved informed consent form signed by the subject or the subject's parent/legal guardian. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: Phase I Study of the Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine in Adults, Toddlers, and Infants
The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The primary objectives and their endpoints will be assessed in infants who receive TetraMen-T. The secondary objectives and their endpoints will be assessed only in the subset of infants who receive a booster dose of TetraMen-T.
Primary objectives:
Read more
- To describe the safety profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg olysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with djuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered concomitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®).
- To describe the immunogenicity profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered on comitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®).
Secondary objectives:
- To describe the safety profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per erogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
- To describe the immunogenicity profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
Read the detailed description
Up to 24 months
- Conditions
- Meningococcal Immunization
- Being tested
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T)., Meningococcal Group C-CRM197 Conjugate Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Biological
Also called 395
Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)
Meningococcal Group C-CRM197 Conjugate VaccineBiological
Also called Menjugate®
Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Adults receiving Low Dose TetraMen-T with adjuvant Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 2 | Experimental | Adults receiving High Dose TetraMen-T without adjuvant Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 3 | Experimental | Toddlers receiving Low Dose TetraMen-T with adjuvant Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 4 | Experimental | Toddlers receiving High Dose TetraMen-T without adjuvant Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 5 | Experimental | Infants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 6 | Experimental | Infants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 7 | Experimental | Infants receiving High Dose TetraMen-T without adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months Receives: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). |
| Group 8 | Active comparator | Infants receiving Menjugate ®. Subjects were to receive a booster dose of low-dose adjuvanted TetraMen-T at age 13 months. Routine vaccines were deferred. Receives: Biological: Meningococcal Group C-CRM197 Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Measured: Up to 7 days after injection
Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
Measured: Up to 28 days after injection
Presence of serious adverse events (SAEs) throughout the trial.
Measured: From baseline up to 24 months
Incidence of treatment-emergent antibodies responses
Measured: From baseline up to 24 months
Secondary outcomes (4)
After booster dose of TetraMen-T: Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Measured: Up to 7 days after injection
After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
Measured: Up to 28 days after injection
After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.
Measured: From baseline up to 24 months
After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start25 Jul 2006
- Primary completion27 Aug 2008
- Study completion27 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal ImmunizationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165276
- Sponsor's protocol ID
- MET28
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine in Adults, Toddlers, and Infants
- ClinicalTrials.gov ID
- NCT06165276
- Acronym / sponsor ID
- MET28
- Conditions
- Meningococcal Immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2006 (actual)
- Primary completion
- 27 Aug 2008 (actual)
- Study completion
- 27 Aug 2008 (actual)
- First posted
- 11 Dec 2023 (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 study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The primary objectives and their endpoints will be assessed in infants who receive TetraMen-T. The secondary objectives and their endpoints will be assessed only in the subset of infants who receive a booster dose of TetraMen-T.
Primary objectives:
- To describe the safety profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg olysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with djuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered concomitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®).
- To describe the immunogenicity profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered on comitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®).
Secondary objectives:
- To describe the safety profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per erogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
- To describe the immunogenicity profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
Detailed description
Up to 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Adults receiving Low Dose TetraMen-T with adjuvant |
| Group 2 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Adults receiving High Dose TetraMen-T without adjuvant |
| Group 3 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Toddlers receiving Low Dose TetraMen-T with adjuvant |
| Group 4 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Toddlers receiving High Dose TetraMen-T without adjuvant |
| Group 5 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Infants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months |
| Group 6 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Infants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months |
| Group 7 | Experimental | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Infants receiving High Dose TetraMen-T without adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months |
| Group 8 | Active comparator | Biological: Meningococcal Group C-CRM197 Conjugate VaccineInfants receiving Menjugate ®. Subjects were to receive a booster dose of low-dose adjuvanted TetraMen-T at age 13 months. Routine vaccines were deferred. |
Who may qualify
- Ages
- 60 days to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).Also: 395Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM) | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
| Meningococcal Group C-CRM197 Conjugate VaccineAlso: Menjugate®Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM) | Biological | Group 8 |
Primary outcome
Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Time frame: Up to 7 days after injection
Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
Time frame: Up to 28 days after injection
Presence of serious adverse events (SAEs) throughout the trial.
Time frame: From baseline up to 24 months
Incidence of treatment-emergent antibodies responses
Time frame: From baseline up to 24 months
4 secondary outcomes
After booster dose of TetraMen-T: Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Time frame: Up to 7 days after injection
After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
Time frame: Up to 28 days after injection
After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.
Time frame: From baseline up to 24 months
After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses
Time frame: From baseline up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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 1 study testing Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T). and Meningococcal Group C-CRM197 Conjugate Vaccine in people with Meningococcal Immunization, run by Sanofi Pasteur, a Sanofi Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 11 Dec 2023. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection (time frame: Up to 7 days after injection). The study lists 4 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 11 Dec 2023.