Clinical trial • Phase I • Infectious Disease
Pneumococcal conjugate vaccine for Pneumococcal infection
Phase I trial of Pneumococcal conjugate vaccine for Pneumococcal infection. Randomised, active-controlled; comparator not specified. 80 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Pneumococcal infection
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 19-11-2024
Trial design
Randomised, active-controlled; comparator not specified Phase I trial across 1 site in Belgium.
- Randomised
- Yes
- Comparator
- Active-controlled; comparator not specified
- Target Sample Size
- 80
Eligibility
Recruits 80 No vulnerable population selected; participants are healthy adult volunteers aged 18-50 years..
- Vulnerable Population
- No vulnerable population selected; participants are healthy adult volunteers aged 18-50 years.
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 80
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 19-11-2024
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 80
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Center for Vaccinology (CEVAC)
- Principal Investigator Name
- Isabel Leroux-Roels
- Principal Investigator Email
- isabel.lerouxroels@uzgent.be
- Contact Person Name
- Isabel Leroux-Roels
- Contact Person Email
- isabel.lerouxroels@uzgent.be
- Number Of Participants
- 80
Sponsor
Primary sponsor
- Full Name
- LiteVax B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- PCV-LITE
- Active Substance
- Pneumococcal conjugate vaccine
- Modality
- Vaccine
Related trials
Other published trials that may interest you.
- PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE for Pneumococcal infection
- Conditioned medium from a co-culture of M2-macrophages and fat-derived mesenchymal cells for Acute respiratory distress syndrome (ARDS) | SARS-CoV-2 infection | Influenza A infection | Influenza B infection | Respiratory syncytial virus (RSV) infection
- ACICLOVIR for Recurrent herpes labialis | Herpes simplex labialis
- AMIKACIN SULFATE for Sepsis | Neutropenia
- LENACAPAVIR, ISLATRAVIR for HIV-1 infection