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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)

Completed Phase 3 Last updated 14 October 2020
What this trial tests

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.

Timeline
8 April 2016
Primary endpoint
3 December 2017
3 December 2017

Quick facts

Lead sponsorWalvax Biotechnology Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment2,760
Start date8 April 2016
Primary completion3 December 2017
Estimated completion3 December 2017

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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

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Trials by the same sponsor.

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