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NCT02736240
Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in 2-71 Months Old Healthy Infants and Toddlers (the Youngest Could be 6 Weeks Old)
Phase 3 trial testing 7-valent pneumococcal conjugate vaccine in Diseases Caused by Streptococcus Pneumoniae Serotypes in 2,760 participants. Completed in 3 December 2017.
3 December 2017
Quick facts
| Lead sponsor | Walvax Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 2,760 |
| Start date | 8 April 2016 |
| Primary completion | 3 December 2017 |
| Estimated completion | 3 December 2017 |
Drugs / interventions tested
- 7-valent pneumococcal conjugate vaccine — full drug profile →
- 13-valent pneumococcal polysaccharide conjugate vaccine — full drug profile →
Conditions studied
- Diseases Caused by Streptococcus Pneumoniae Serotypes — all drugs for Diseases Caused by Streptococcus Pneumoniae Serotypes →
Sponsor
Walvax Biotechnology Co., Ltd. — full company profile →
Who can join
Adults 2 Months to 71 Months, any sex, with Diseases Caused by Streptococcus Pneumoniae Serotypes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China.
Chen JJ, Yuan L, Huang Z, Shi NM, et al · · 2016 · cited 8× · PMID 27798013 · DOI 10.1136/bmjopen-2016-012488 -
Immunogenicity and Safety of a Novel 13-Valent Pneumococcal Vaccine in Healthy Chinese Infants and Toddlers.
Zhao Y, Li G, Xia S, Ye Q, et al · · 2022 · cited 5× · PMID 35615504 · DOI 10.3389/fmicb.2022.870973
Verify or expand the search:
- PubMed search for NCT02736240
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Walvax Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT04847102 — A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Popul · Phase 3 · unknown
- NCT04450498 — A Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine in Healthy Subjects Aged 2-10 Years · Phase 4 · completed
- NCT04236960 — Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population. · Phase 1 · 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 NCT02736240 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Walvax Biotechnology Co., Ltd.
- Last refreshed: 14 October 2020
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/NCT02736240.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing