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Pneumococcal Disease, InvasivePhase 2NCT06790290

Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

A Phase 2 study testing Formulation B, Formulation C and Formulation D in people with Pneumococcal Disease, Invasive, run by Inventprise Inc. at 3 sites in Philippines.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase 2 trial to evaluate safety and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in Healthy Infants Read more about this study

Who is it for?
Ages 42 to 56 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease, Invasive
What is being tested?
Formulation B, Formulation C and Formulation D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
3 sitesPhilippines
Study dates
27 Jan 2025to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 42 to 56 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Inclusion Criteria: Participants who meet all the following criteria may be included in the study:

  1. Age 42 to 56 days, inclusive, at the time of Dose 1
  2. Good general health status, as determined by medical history, physical examination, vital signs, and clinical judgment
  3. Product of normal full-term pregnancy (37 to 42 weeks' gestation)
  4. Birth weight ≥ 2000 g
  5. Length and weight ≥ -2 standard deviations (SD) for age and sex, according to the Philippine national child growth standards (see Appendix 1)
  6. Willingness of parent/guardian for the child to attend all protocol visits and to have all protocol-required procedures
  7. Provision of written informed consent by legally acceptable representative

Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study:

  1. Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
  2. Any condition that may increase risk of study participation or interfere with interpretation of study results
  3. Immunodeficiency or chronic administration (> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra- articular, or inhaled glucocorticoids permitted)
  4. History of sepsis or pneumonia
  5. History of anaphylaxis or angioedema
  6. History of severe reaction to immunization
  7. Known hypersensitivity to any of the ingredients in either IVT PCV-25 or Prevnar 20
  8. Contraindication to any concomitant vaccine or to Prevnar 20, according to each vaccine's product information
  9. Prior receipt of a licensed or investigational pneumococcal vaccine
  10. Prior receipt of any diphtheria, tetanus, pertussis, Hib, or polio vaccine
  11. Prior receipt of > 1 dose of HepB vaccine
  12. Receipt of HepB vaccine at age ≥ 30 days
  13. Receipt of an inactivated vaccine within 14 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
  14. Receipt of a live vaccine within 28 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
  15. Receipt of blood transfusion or blood products before Day 1 or planned receipt through Day 85
  16. Receipt of any other IP before Day 1
  17. Planned elective hospitalization or surgical procedure through the end of the study
  18. Family member of employee of Inventprise, vendors, or research sites associated with the study
  19. Any medical, psychiatric, or social condition, or occupational or other responsibility of the parent/guardian that, in the judgment of the Investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or an ability to provide informed consent

Temporary Delay Criteria: administration of IVT PCV-25 / Prevnar20 will be delayed for any participant who meets any of the following criteria:

  1. Receipt of any inactivated vaccine within 14 days or any live vaccine within 28 days
  2. Febrile illness (eg, temperature ≥ 38.0°C) or other acute illness within 48 hours
  3. Any other signs or symptoms or medication use that could inhibit the proper vaccine administration of the IP or interpretation of diary data

Trial locations and contacts

3 sites in 1 country.

Philippines3 sites

  • Health Index Multispecialty Clinic

    Bacoor, Cavite

  • Grand Centennial Homes Clinic

    Kawit, Cavite

  • University of the Philippines-National Health Institute_Doña Nena Health Center

    Pasay, National Capital Region

Other trials in Philippines

About this study

Official title: Phase 2, Randomized, Double-blind, Active-controlled Study Evaluating the Safety and Immunogenicity of IVT PCV-25 in Healthy Infants Administered With the WHO Expanded Programme on Immunization 3+0 Vaccine Schedule

Phase 2 trial to evaluate safety and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in Healthy Infants

Read the detailed description

A Phase 2 multicenter, randomized, active-controlled, double-blind study to evaluate safety and immunogenicity of a 3-dose intramuscular (IM) regimen of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Infant participants will be randomized in a 1:1:1:1 ratio to receive 3 IM injections of one IVT PCV-25 formulation or the active comparator (Prevnar 20) at 4-week intervals (at approximately 6, 10 and 14 weeks of age) with routine infant vaccines administered on the same day as IVT PCV-25/Prevnar 20.

Being tested
Formulation B, Formulation C, Formulation D, Prevnar20
Keywords
Vaccine, Healthy Volunteer
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formulation BBiological

    IVT PCV-25

  • Formulation CBiological

    IVT PCV-25

  • Formulation DBiological

    IVT PCV-25

  • Prevnar20Biological

    20 valent pneumococcal conjugate vaccine

Study groups in NCT06790290
Study groupRoleWhat they receive
Group A (Low dose)ExperimentalInfant participants will receive three 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1, 29 and 57
Receives: Biological: Formulation B
Group B (High dose)ExperimentalInfant participants will receive three 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1, 29 and 57
Receives: Biological: Formulation C
Group C (Hybrid dose)ExperimentalInfant participants will receive three 0.5mL dose of IVT PCV-25 Formulation D administered by intramuscular injection on Day 1, 29 and 57
Receives: Biological: Formulation D
Group D (Comparator)Active comparatorInfant participants will receive three 0.5mL dose of Prevnar20 administered by intramuscular injection on Day 1, 29 and 57
Receives: Biological: Prevnar20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3

    To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, Percentage of Participants with Reactogenicity Events 7 days after Doses 1,2,3

    Measured: 7 days after Doses 1,2,3

  2. Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 3

    To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age

    Measured: From Dose 1 to 28 days after Dose 3

  3. Percentage of participants with medically attended AEs (MAAEs) from Dose 1 to 6 months after Dose 3

    To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10,and 14 weeks of age

    Measured: From Dose 1 to 6 months after Dose 3

  4. Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 3

    To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age

    Measured: From Dose 1 to 6 months after Dose 3

  5. Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose

    To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age

    Measured: from Dose 1 to 6 months after Dose 3

Secondary outcomes (3)

  1. Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose

    To assess the humoral immunogenicity of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age

    Measured: 28 days after each dose

  2. Ratio of geometric mean concentrations (GMCs) of serotype-specific IgG, comparing each IVT PCV-25 formulation to Prevnar 20 at 28 days after each dose

    To assess the humoral immunogenicity of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age

    Measured: 28 days after each dose

  3. Ratio of geometric mean titers (GMTs) of serotype-specific functional antibody measured by opsonophagocytic assay (OPA), comparing each IVT PCV-25 formulation to Prevnar 20 at 28 days after Dose 3

    To assess the humoral immunogenicity of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age

    Measured: 28 days after each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start27 Jan 2025
  3. Primary completion3 Apr 2025
  4. Study completionDec 2026 (estimated)

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects are randomized in four groups, 1:1:1:1, each receiving 3 doses of one of three vaccine formulations or comparator.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790290
Sponsor's protocol ID
IVT 121
Status last verified
Apr 2025
First submitted
16 Jan 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Formulation B, Formulation C and Formulation D in people with Pneumococcal Disease, Invasive, run by Inventprise Inc. at 3 sites in Philippines.

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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Philippines. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3 (time frame: 7 days after Doses 1,2,3). 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?

On the ClinicalTrials.gov record for NCT06790290.

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 2 Sep 2025.

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