A Phase 3 interventional study of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) in Streptococcus Pneumoniae Infections, sponsored by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 3 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 3, Interventional, and Prevention
This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population
298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.
This study's enrollment of 1,110 is above the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
370 infants aged 3 months were enrolled in this group.
Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
370 infants aged 3 months were enrolled in this group.
Biological: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
370 infants aged 3 months were enrolled in this group.
Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Antibody positive conversion rate
The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups，respectively.
Time frame: 30 days after full vaccination
AEs within 0-30 minutes after vaccination
The occurrence of all adverse events within 0-30 minutes after each dose of vaccination
Time frame: 0-30 minutes after vaccination
Solicited AEs within 0-7 days after vaccination
The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination
Time frame: 0-7 days after vaccination
Unsolicited AEs within 0-30 days after vaccination
The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination.
Time frame: 0-30 days after vaccination
SAE within 0-6 months after primary immunization
The occurrence of all serious adverse events within 0-6 months after primary immunization.
Time frame: 0-6 months after primary immunization
Positive rate of IgG antibodies
Positive rate of susceptible individuals with 15 serotype specific pneumococcal IgG antibodies (percentage of subjects with antibody concentration ≥ 0.35 μ g/ml)
Time frame: 30 days after full vaccination
GMC of IgG antibody
GMC of IgG antibody against 15 serotype specific pneumococcal.
Time frame: 30 days after full vaccination
Ran from Sep 2021 to primary completion in Mar 2024, 29 months.
Of 81 industry-sponsored phase 3 interventional studies under Pneumococcal Infections, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 29 months is above that.
Counting every sponsor, half of 82 studies reached it within 13 months; a quarter within 9 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd →