Pneumococcal ImmunizationPhase 1NCT06698198
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
A Phase 1 study testing Pneumococcal Conjugate Vaccine and Prevnar 13® in people with Pneumococcal Immunization, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
Trial summary
This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Immunization
- What is being tested?
- Pneumococcal Conjugate Vaccine and Prevnar 13®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Dec 2018to 30 Sep 2019
- 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday)
- Informed Consent Form (ICF) has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- Body mass index within the range of 18.5 and 29.9 kg/m2
Who cannot join
- Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccine injection until at least 4 weeks after injection. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial injection, except for influenza vaccination, which may be received at least 2 weeks before SP0202 or Prevnar 13 injection.
- Previous vaccination against S. pneumoniae with either a pneumococcal conjugate vaccine (PCV) or a Pneumococcal polysaccharide vaccines (PPSV).
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Investigational Site Number: 0002
Metairie, Louisiana, 70427
Investigational Site Number: 0001
Newark, New Jersey, 07103
About this study
This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.
- Conditions
- Pneumococcal Immunization
- Being tested
- Pneumococcal Conjugate Vaccine, Prevnar 13®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Conjugate VaccineBiological
Suspension for Intramuscular injection
Prevnar 13®Biological
Suspension for Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I | Experimental | Participants will receive 1 intramuscular injection of PCV formulation SP0202-I Receives: Biological: Pneumococcal Conjugate Vaccine |
| Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II | Experimental | Participants will receive 1 intramuscular injection of PCV formulation SP0202-II Receives: Biological: Pneumococcal Conjugate Vaccine |
| Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III | Experimental | Participants will receive 1 intramuscular injection of PCV formulation SP0202-III Receives: Biological: Pneumococcal Conjugate Vaccine |
| Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV | Experimental | Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV Receives: Biological: Pneumococcal Conjugate Vaccine |
| Group 5: Prevnar 13® | Active comparator | Not described Receives: Biological: Prevnar 13® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection
Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Measured: Up to 30 minutes post-vaccination
Occurrence of solicited injection site and systemic reactions
Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)
Measured: Up to 7 days post-vaccination
Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection
Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.
Measured: Up to 30 days after vaccination
Serotype-specific immunoglobulin type G (IgG) concentrations
Geometric Mean (GM) of serotype-specific IgG concentrations for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by electro-chemiluminescence (ECL) assay
Measured: Up to 30 days after vaccination
Serotype-specific opsonophagocytic activity (OPA) titers
GM of serotype-specific OPA titers for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by multiplex opsonophagocytic assay (MOPA)
Measured: Up to 30 days after vaccination
Secondary outcomes (4)
Serotype-specific IgG concentrations ratio (post/pre-vaccination)
GM of serotype-specific IgG concentrations ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL assay
Measured: Up to 30 days after vaccination
≥ 4-fold serotype-specific IgG concentrations increase
Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to 1 month post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL
Measured: Up to 30 days after vaccination
Serotype-specific OPA titers ratio (post/pre-vaccination)
GM of serotype-specific OPA titers ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA
Measured: Up to 30 days after vaccination
≥ 4-fold serotype-specific OPA titers increase
Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA
Measured: Up to 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start3 Dec 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698198
- Sponsor's protocol ID
- PSK00007
- Other IDs
- PSK00007, U1111-1210-0812
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)
- ClinicalTrials.gov ID
- NCT06698198
- Acronym / sponsor ID
- PSK00007
- Conditions
- Pneumococcal Immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Nov 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.
This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I | Experimental | Biological: Pneumococcal Conjugate VaccineParticipants will receive 1 intramuscular injection of PCV formulation SP0202-I |
| Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II | Experimental | Biological: Pneumococcal Conjugate VaccineParticipants will receive 1 intramuscular injection of PCV formulation SP0202-II |
| Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III | Experimental | Biological: Pneumococcal Conjugate VaccineParticipants will receive 1 intramuscular injection of PCV formulation SP0202-III |
| Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV | Experimental | Biological: Pneumococcal Conjugate VaccineParticipants will receive 1 intramuscular injection of PCV formulation SP0202-IV |
| Group 5: Prevnar 13® | Active comparator | Biological: Prevnar 13® |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday)
- Informed Consent Form (ICF) has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- Body mass index within the range of 18.5 and 29.9 kg/m2
Key exclusion criteria (6 listed)
- Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccine injection until at least 4 weeks after injection. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial injection, except for influenza vaccination, which may be received at least 2 weeks before SP0202 or Prevnar 13 injection.
- Previous vaccination against S. pneumoniae with either a pneumococcal conjugate vaccine (PCV) or a Pneumococcal polysaccharide vaccines (PPSV).
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
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 |
|---|---|---|
| Pneumococcal Conjugate VaccineSuspension for Intramuscular injection | Biological | Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I, Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II, Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III, Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV |
| Prevnar 13®Suspension for Intramuscular injection | Biological | Group 5: Prevnar 13® |
Primary outcome
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection
Time frame: Up to 30 minutes post-vaccination
Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Occurrence of solicited injection site and systemic reactions
Time frame: Up to 7 days post-vaccination
Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)
Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection
Time frame: Up to 30 days after vaccination
Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.
Serotype-specific immunoglobulin type G (IgG) concentrations
Time frame: Up to 30 days after vaccination
Geometric Mean (GM) of serotype-specific IgG concentrations for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by electro-chemiluminescence (ECL) assay
Serotype-specific opsonophagocytic activity (OPA) titers
Time frame: Up to 30 days after vaccination
GM of serotype-specific OPA titers for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by multiplex opsonophagocytic assay (MOPA)
4 secondary outcomes
Serotype-specific IgG concentrations ratio (post/pre-vaccination)
Time frame: Up to 30 days after vaccination
≥ 4-fold serotype-specific IgG concentrations increase
Time frame: Up to 30 days after vaccination
Serotype-specific OPA titers ratio (post/pre-vaccination)
Time frame: Up to 30 days after vaccination
≥ 4-fold serotype-specific OPA titers increase
Time frame: Up to 30 days after vaccination
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 20 Nov 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pneumococcal Conjugate Vaccine and Prevnar 13® in people with Pneumococcal Immunization, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection (time frame: Up to 30 minutes post-vaccination). The study lists 5 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 20 Nov 2024.