Phase I Clinical Trial of a Candidate PCV13 in Healthy People
- Summary
- Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world. This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
- Short title
- Phase I Clinical Trial of a Candidate PCV13 in Healthy People
- Official title
- Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-12-01
- First posted
- 2022-11-02
- Registry last updated
- 2022-11-17
- Primary completion date
- 2024-06-01
- Start date
- 2022-11-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Wuhan BravoVax Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05602480
- ClinicalTrials.gov ID
- NCT05602480
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masking description
- One arm, open label in subjects aged 3 months and above; Randomized, blinded and active comparator in subjects aged 2 months.
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Safety in terms of adverse reactions
Timeframe: within 30 minutes post each vaccination
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
Safety in terms of adverse events
Timeframe: within 7 days post each vaccination
Occurrence of solicited AEs of each subject
Safety in terms of adverse events
Timeframe: within 30 days post each vaccination
Occurrence of non-solicited AEs of each subject
Safety in terms of SAEs
Timeframe: within 6 months post last vaccination
Occurrence of SAEs of each subject
Safety in terms of laboratory-based AEs
Timeframe: within 4 days post each vaccination
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
Immunogencity in terms of seropositivity rates by ELISA
Timeframe: 30 days post basic vaccination
Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group
Immunogencity in terms of GMC by ELISA
Timeframe: 30 days post basic vaccination
GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group
Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL
Timeframe: 30 days post basic vaccination
Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL
Immunogencity Comparison with control vaccine group
Timeframe: 30 days post basic vaccination
Comparison of the seropositivity rates, GMC of serotype-specific pneumococcal IgG antibody and the Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL in subjects aged 2 months of Experimental group and Control group
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 6 Weeks
- Healthy volunteers
- Yes
- Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
- Subjects or guardians must provide informed consent forms with personal signature and date;
- Male and female of childbearing age should agree to take effective contraception measures;
- Subjects or guardians can obey the requirements of the clinical study;
- Axillary temperature below 37.3 °C.
- Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
- Received any pneumococcal vaccine;
- Allergic history to any drugs, vaccine or vaccine-related component;
- Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly;
- Breast-feeding or pregnant women, or positive U-HCG;
- High blood pressure uncontrolled by medication;
- Known or suspected immune deficiency or immune suppression;
- Serious congenital malformation, history of organ resection or serious chronic illness;
- Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);
- History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;
- History of convulsions, epilepsy or encephalopathy or a family history of mental illness;
- A vaccination-related contraindications that other investigator believes;
- Plans to participate in or is participating in any other clinical study;
- Any other factors judged by investigator that may interfere subject's compliance with the protocol.
- Xiangtan Maternal and Child Health HospitalXiangtan, ChinaRecruiting
Related records
Drugs (1)
Collaborators (2)
- Hunan Provincial Center for Disease Control and Prevention
- Liaoning Chengda Biotechnology CO., LTD
Lead sponsors (1)
Conditions (2)
- Pneumococcal infection Primary condition
- Streptococcal pneumonia