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Clinical Trial Summary

The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.


Clinical Trial Description

Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts. Participants will be involved in the study for approximately one year including screening and safety follow-up. Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05782179
Study type Interventional
Source Minervax ApS
Contact
Status Completed
Phase Phase 1
Start date March 1, 2023
Completion date May 23, 2024

See also
  Status Clinical Trial Phase
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Completed NCT04258995 - A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS Phase 2
Recruiting NCT05726006 - Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.