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PCV13 in Non-pregnant Papua New Guinean Women

Completed
Conditions
Pneumococcal Infections
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
Primary Outcome Measures
NameTimeMethod
Immunogenicity28 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
NameTimeMethod
Reactogenicity24-48 hours after vaccination

Proportion (% \& 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination

Adverse events28 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

Papua New Guinea Institute of Medical Research
🇵🇬Goroka, Eastern Hghlands Province, Papua New Guinea

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