PCV13 in Non-pregnant Papua New Guinean Women
Completed
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: 13-valent pneumococcal conjugate vaccine
- Registration Number
- NCT04183322
- Lead Sponsor
- Telethon Kids Institute
- Brief Summary
This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- Healthy
- Non-pregnant
- 18-45 years old
Exclusion Criteria
- Known hypersensitivity to any vaccine component
- Known/suspected to be immunocompromised
- Receipt of corticosteroids ≤30 days before
- Pregnant (pregnancy tests will be performed)
- Not being well at the time of vaccination
- Plan to travel out of the area in the month post-vaccination
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women of childbearing age 13-valent pneumococcal conjugate vaccine Healthy non-pregnant women between 18 and 45 years old living in Goroka, Papua New Guinea, will receive one dose of 13-valent pneumococcal conjugate vaccine (PCV).
- Primary Outcome Measures
Name Time Method Immunogenicity 28 days Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)
- Secondary Outcome Measures
Name Time Method Reactogenicity 24-48 hours after vaccination Proportion (% \& 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination
Adverse events 28 days Proportion (% \& 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination
Trial Locations
- Locations (1)
Papua New Guinea Institute of Medical Research
🇵🇬Goroka, Eastern Hghlands Province, Papua New Guinea