New 24-Strain pneumonia vaccine trial launches for kids
NCT ID NCT07333352
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study tests a new vaccine (RZ700) designed to protect infants and young children against 24 types of pneumococcal bacteria, which can cause pneumonia, meningitis, and ear infections. About 480 healthy children aged 6 weeks to 71 months will receive the vaccine to see if it triggers a strong immune response and is safe. The goal is to find a vaccine that covers more strains than current options.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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480 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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6 weeks to 71 months
- 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: * Healthy subjects aged 2 months (minimum 6 weeks) and 7-71 months, whose guardians can provide valid identification documents for both the subjects and themselves, as well as proof of their guardianship relationship. * The guardians of the subjects voluntarily agree to their participation in this trial, sign the Informed Consent Form (ICF), and are willing to comply with all requirements of this clinical trial protocol. * The guardians of the subjects have the ability to understand the trial procedures (non-illiterate). Exclusion Criteria: * Subjects who have received any type of pneumococcal vaccine prior to enrollment, plan to receive a pneumococcal vaccine during the trial, or have a history of invasive diseases caused by Streptococcus pneumoniae (confirmed by any clinical, serological, or microbiological method). * Subjects with abnormal physical examination results that are deemed clinically significant by a clinician. * Subjects with suspected or confirmed fever (axillary temperature ≥ 37.5℃) within 3 days prior to enrollment; or those with an axillary temperature ≥ 37.5℃ on the day before the first dose of vaccination. * Subjects with a history of acute illness, acute exacerbation of chronic illness, systemic use of antibiotics or antiviral drugs within 3 days prior to the first dose of vaccination; or those who have taken antipyretic, analgesic, or antiallergic drugs (e.g., acetaminophen, ibuprofen, loratadine, cetirizine, etc.) within 3 days prior to the first dose of vaccination. * Subjects with a history of allergy to any component of the study vaccine, any vaccine containing tetanus toxoid, or a previous history of severe allergy to any vaccine or drug (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, immune thrombocytopenic purpura, local allergic necrotizing reaction, dyspnea, angioedema, etc.); or a previous history of the aforementioned severe adverse reactions following the use of any vaccine or drug. * Subjects who have received inactivated vaccines, subunit vaccines, or recombinant vaccines within 7 days prior to enrollment; or live attenuated vaccines, adenovirus vector vaccines, etc., within 14 days prior to enrollment. * Subjects who have received any other investigational drugs within 3 months prior to enrollment or plan to use them during the trial; those who have received whole blood, plasma, or blood products (e.g., immunoglobulin therapy) within 3 months prior to enrollment or plan to receive such treatments during the trial. * Subjects with a history of thrombocytopenia, idiopathic thrombocytopenic purpura, or other coagulation disorders diagnosed by a hospital; or a history of receiving anticoagulant therapy. * Subjects with a known current or past history of infectious diseases diagnosed by a hospital, such as active tuberculosis, hepatitis B, hepatitis C, HIV infection, etc. * Subjects with known or suspected severe chronic diseases (e.g., liver and kidney diseases, malignant tumors, infectious or allergic skin diseases, hemolytic uremic syndrome); or those whose condition is in the progressive stage and cannot be stably controlled. * Infants aged 2 months (minimum 6 weeks) and 7-11 months with abnormal birth weight (\<2500g), abnormal gestational age (\<37 weeks or \>42 weeks), abnormal delivery (dystocia, instrumental delivery), or a history of asphyxia or neuroorganic damage. * Infants aged 2 months (minimum 6 weeks) and 7-11 months with severe eczema or severe jaundice (grade 3 or above). * Subjects with severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or severe chronic diseases (e.g., tetralogy of Fallot, tricuspid atresia, Down syndrome, sickle cell anemia, etc.). * Subjects with neurological diseases or neurodevelopmental disorders (e.g., febrile convulsions, epilepsy, encephalopathy, focal neurological deficits, encephalomyelitis or transverse myelitis, Guillain-Barré syndrome); or a history of mental illness in the subjects themselves or their biological parents. * Subjects with a history of congenital or acquired immunodeficiency, immunosuppression, or autoimmune diseases; or those who have received immunomodulatory therapy within 6 months (e.g., immunosuppressive doses of glucocorticoids \[dosage reference: equivalent to prednisone ≥0.5mg/kg/day for more than 2 weeks\], monoclonal antibodies, thymopeptides, interferons, etc.); or plan to receive such treatments from enrollment to 30 days after the last dose of vaccination. Topical medications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted. * Subjects with asplenia, functional asplenia, or asplenia/resplenectomy caused by any condition. * Subjects whose guardians may be unable to comply with trial procedures, adhere to agreements, plan to permanently relocate from the region before the trial is completed, or be away from the local area for a long time during scheduled visits. * Researchers believe that the subject has any other factors that make them unsuitable for participating in the clinical trial, such that continued participation cannot ensure the subject's maximum benefit.
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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.
Contacts and locations
Locations
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Jishan County Center for Disease Control and Prevention
Yuncheng, Shanxi, 043200, China
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Kuangqu District Center for Disease Control and Prevention of Yangquan City
Yangquan, Shanxi, 045000, China
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Luzhou District Center for Disease Control and Prevention
Changzhi, Shanxi, 046011, China
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Qinxian County Center for Disease Control and Prevention
Changzhi, Shanxi, 046400, China
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Shangdang District Center for Disease Control and Prevention of Changzhi City
Yuncheng, Shanxi, 047100, China
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Xinjiang County Center for Disease Control and Prevention
Yuncheng, Shanxi, 043100, China
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Yongji City Center for Disease Control and Prevention
Yuncheng, Shanxi, 044500, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New vaccine aims to shield against 24 pneumonia strains
- New pneumonia vaccine trial aims to shield 3,000 kids from deadly infection
- New pneumonia vaccine shows promise in early trial for kids
- New vaccine aims to shield toddlers from 24 pneumonia strains
- New 24-Valent pneumonia vaccine shows promise in kids trial
- New vaccine targets 24 pneumococcal strains in major trial