Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorMAXVAX Biotechnology Limited Liability Company

About this trial

A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age

Eligibility criteria

Qualifiers

Adult females 18-49 years old on the day of vaccination.

Generally healthy, as established by medical history and clinical examination before vaccination and absence of unresolved acute disease or acute exacerbation of chronic disease.

Intent to reside in the area of the study site for the throughout the study visits and also available for phone follow ups after vaccination.

Signing an Informed Consent Form indicating that the purpose, procedures and potential risks and benefits of the study have been explained including an opportunity to ask questions.

Disqualifiers

Recent RSV exposure/vaccination: History of RSV infection within 6 months or prior RSV vaccination.

Pregnancy/lactation: Pregnant, breastfeeding, or planning pregnancy within 90 days post-vaccination.

Recent investigational products: Received any investigational product within 30 days or plans study participation during this trial.

Recent vaccines: Live vaccine within 30 days or any other vaccine within 14 days before study vaccination, or planned vaccination within 3 months after.

Trial design

Treatments tested in this trial

  • MKK900 60 µg
  • MKK900 120 µg
  • ABRYSVO®

Treatment groups

120 Participants
are divided into 3 treatment groups