Safety and Efficacy of wSp Vaccine in Young Children
ConditionAcute Otitis Media (AOM)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-7
SponsorSerum Life Science Europe GmbH
About this trial
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.
The main questions it aims to answer are:
Does wSp vaccine reduce pneumococcal colonization in the nose? Does wSp vaccine safely stimulate the immune system to produce antibodies and protective immune responses?
Researchers will compare children receiving two injections of wSp vaccine to those receiving saline placebo to see if wSp vaccine reduces colonization and boosts immunity.
Participants will:
Receive two injections of either wSp or saline at approximately 7 and 9 months of age.
Have blood samples taken at 6 and/or 12 months to measure immune responses. Have nasal swabs collected at several time points and during infections from 6-24 months.
Be monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections.
Eligibility criteria
Qualifiers
Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment
Healthy subject as established by medical history and clinical examination before entering into the study.
Received 3 doses of PCV15 or PCV20.
Written informed consent obtained from the subject's parent/legal guardian.
Disqualifiers
Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
Known or suspected impairment of immunological function, based on medical history and physical examination.
Has a history of congenital or acquired immunodeficiency.
Chronic administration (defined > 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
Trial design
Treatments tested in this trial
- wSp vaccine
- Saline (0.9% NaCl)
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
Serum Life Science Europe GmbH
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Rochester General Hospital
Collaborator
Serum Institute of India Pvt. Ltd.
Collaborator
Alira Health
Collaborator
Source ClinicalTrials.gov