CompletedNot Applicable

Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China

China10 participantsStarted 2013-09

Plain-language summary

Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution

Who can participate

Age range90 Days

SexALL

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Inclusion criteria

✓. Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain).
✓. ≤90 days old at the time of GBS confirmation.
✓. Voluntary written informed consent provided.

What they're measuring

Incidence of group B streptococcal (GBS) disease

Timeframe: From birth to 90 days of age

Case Fatality Rate of GBS disease

Timeframe: From birth to 90 days of age

GBS serotype distribution

Timeframe: From birth to 90 days of age

Trial details

NCT IDNCT01933646

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Invasive Group B Streptococcal Disease trials