Active — Not RecruitingPhase 2

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

Philippines421 participantsStarted 2025-01-27

Plain-language summary

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

Who can participate

Age range

42 Days – 56 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
. Any condition that may increase risk of study participation or interfere with interpretation of study results
. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 7 days after Doses 1,2,3

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

Timeframe: From Dose 1 to 28 days after Dose 3

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

Timeframe: From Dose 1 to 6 months after Dose 3

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

Timeframe: From Dose 1 to 6 months after Dose 3

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

Timeframe: from Dose 1 to 6 months after Dose 3

Trial details

NCT IDNCT06790290

SponsorInventprise Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-03

View on ClinicalTrials.gov More Pneumococcal Disease, Invasive trials

Who can participate

Age range

42 Days – 56 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
. Any condition that may increase risk of study participation or interfere with interpretation of study results
. 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)

What they're measuring

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

Timeframe: 7 days after Doses 1,2,3

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

Timeframe: From Dose 1 to 28 days after Dose 3

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

Timeframe: From Dose 1 to 6 months after Dose 3

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

Timeframe: From Dose 1 to 6 months after Dose 3

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

Timeframe: from Dose 1 to 6 months after Dose 3