NCT07406334 A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose
| NCT ID | NCT07406334 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | GlaxoSmithKline |
| Condition | Pneumonia, Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2027-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2026-05-15 with a primary completion date of 2027-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.
Eligibility Criteria
Inclusion Criteria: 1. Participants' parent(s)/Legally acceptable representative \[LAR(s)\] who, in the opinion of the investigator, can and will comply with all protocol requirements. 2. Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior any study-specific procedure is performed. 3. A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration. 4. Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study. 5. To the best knowledge of the participant's parent(s)/LAR(s), the child has been eligible for pneumococcal vaccination and has completed a 2-dose primary series with PCV10. Exclusion Criteria: 1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 2. Hypersensitivity to latex. 3. History of microbiologically proven Invasive pneumococcal Disease (IPD). 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 5. Major congenital defects, as assessed by the investigator. 6. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures. 7. Condition that in the judgment of the investigator would make intramuscular injection unsafe. 8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. 9. Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period. 10. Previous vaccination with any pneumococcal vaccine other than PCV10. 11. Previous receipt of more than 2 pneumococcal vaccine doses (primary series or booster). 12. Planned administration/administration of any inactivated or otherwise non-live vaccine in the period starting 14 days before and ending 14 days after the dose of study intervention administration or planned administration/administration of any live vaccine in the period starting 28 days before and ending 28 days after the dose of study intervention administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention. 13. Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt up to 30 days of study intervention administration. 14. Chronic administration of immune-modifying drugs and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * For corticosteroids: prednisone equivalent ≥0.5 mg/kg/day (maximum 20 mg/day) within 90 days prior for pediatric participants. * Inhaled and topical steroids are allowed. 15. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention. 16. Any child of trial personnel or their immediate dependents, family, or household members. 17. Child in care.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07406334 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 15 Months, studying Pneumonia, Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07406334 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07406334 currently recruiting?
Yes, NCT07406334 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07406334 trial being conducted?
This trial is being conducted at Soweto, South Africa, Pretoria, South Africa.
Who is sponsoring the NCT07406334 clinical trial?
NCT07406334 is sponsored by GlaxoSmithKline. The trial plans to enroll 45 participants.