Which vaccine schedule works best? new study aims to protect babies from pneumococcal disease
NCT ID NCT07591181
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two schedules (2+1 vs 3+1 doses) of a 13-valent pneumococcal vaccine in 210 healthy infants starting at 2 months old. Researchers will measure antibody levels and track side effects to find the best way to prevent pneumococcal infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13)
- What this could lead to
- If successful, this could help determine the most effective and safe vaccination schedule to protect infants from pneumococcal disease.
- What could go wrong
- This is an early-stage study with only 210 participants, so results may not apply broadly. The vaccine may not show clear differences between schedules.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 89 days
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1: Age at enrollment: 2 months (60-89 days) 2: A healthy male or female infant, born at term (≥37 weeks' gestation), with a birth weight of ≥2500 g 3: Parents/guardians must provide written informed consent, and participants must be capable of using a thermometer and a ruler and of completing the daily log card as instructed 4: Able to adhere to study protocols, including completing all visits and blood collections Exclusion Criteria: 1. received any pneumococcal vaccine before enrollment or schedule to receive a non-study pneumococcal vaccine during the study 2. A history of culture-confirmed invasive disease caused by Streptococcus pneumoniae 3. Known allergy to vaccine components, including excipients, diphtheria toxoid, tetanus toxoid, etc. 4. Acute illness at enrollment or axillary temperature \>37°C 5. Immune deficiency, chronic illness, or use of immunosuppressive therapy 6. Patients with thrombocytopenia, any coagulation disorder, or those receiving anticoagulant therapy 7. Participation in another clinical trial within the past 30 days or during this study 8. Has received another live attenuated vaccine within the past 14 days, or another inactivated vaccine within the past 7 days 9. Has received immunoglobulin within the past month 10. Any circumstances that researchers believe may affect the evaluation of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.