Last reviewed · How we verify
NCT06608199
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
Phase 3 trial testing pneumococcal disease prevention in Pneumococcal Vaccines in 500 participants. Currently enrolling.
1 June 2025
Quick facts
| Lead sponsor | Beijing Minhai Biotechnology Co., Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 500 |
| Start date | 1 November 2024 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 October 2026 |
| Sites | 3 locations across Indonesia |
Drugs / interventions tested
- pneumococcal disease prevention — full drug profile →
Conditions studied
- Pneumococcal Vaccines — all drugs for Pneumococcal Vaccines →
- Pneumococcal Infections — all drugs for Pneumococcal Infections →
Sponsor
Beijing Minhai Biotechnology Co., Ltd — full company profile →
Who can join
Adults 6 Weeks to 8 Weeks, any sex, with Pneumococcal Vaccines or Pneumococcal Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent Vaccines at 2,4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06608199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Beijing Minhai Biotechnology Co., Ltd trials
Trials by the same sponsor.
- NCT06752174 — A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero · Phase 3 · completed
- NCT04756323 — A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged · Phase 2 · unknown
- NCT04758273 — A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and · Phase 1 · unknown
- NCT06210737 — A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years · Phase 4 · completed
- NCT07297186 — Phase III Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell) · Phase 3 · completed
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 NCT06608199 (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 Beijing Minhai Biotechnology Co., Ltd
- Last refreshed: 24 March 2025
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/NCT06608199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing