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NCT05831124
A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults
Phase 1 trial testing Low dose multivalent pneumococcal conjugate vaccine formulation A in Pneumococcal Disease in 90 participants. Completed in 26 June 2024.
26 June 2024
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 90 |
| Start date | 19 April 2023 |
| Primary completion | 26 June 2024 |
| Estimated completion | 26 June 2024 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- Low dose multivalent pneumococcal conjugate vaccine formulation A
- Low dose multivalent pneumococcal conjugate vaccine formulation B
- Low dose of multivalent pneumococcal conjugate vaccine control — full drug profile →
- Standard dose multivalent pneumococcal conjugate vaccine control — full drug profile →
Conditions studied
- Pneumococcal Disease — all drugs for Pneumococcal Disease →
Sponsor
Pfizer — full company profile →
Who can join
Adults 50 to 64, any sex, with Pneumococcal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis. Meningitis is an infection in which the tissue around the brain and spine is swollen. Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected. This study is seeking for healthy participants who: * are above 50 years of age and less than 64 years of age. * have not taken any vaccine for pneumococcal diseases before. * have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine. All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective. Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these visits. Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05831124
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT06524414 — A Study to Learn About How a New Pneumococcal Vaccine Works in Infants · Phase 2 · active not recruiting
- NCT06182124 — A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults · Phase 1, PHASE2 · active not recruiting
- NCT06044077 — A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healt · Phase 3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05831124 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 29 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05831124.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing