Pneumococcal Infections
Conditions
Keywords
Pneumococcal conjugate vaccine, PCV, Reactogenicity, Immunogenicity, Women childbearing age
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.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
Sponsors
Papua New Guinea Institute of Medical Research
Telethon Kids Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 28 days | Proportion (% & 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination |
| Reactogenicity | 24-48 hours after vaccination | Proportion (% & 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination |
Countries
Papua New Guinea
Outcome results
None listed