PCV13 in Non-pregnant Papua New Guinean Women

Telethon Kids Institute50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Papua New Guinea Institute of Medical Research

Goroka, Eastern Hghlands Province, Papua New Guinea

Outcomes

Primary Outcomes

Immunogenicity

Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)

Time frame: 28 days

Secondary Outcomes

Reactogenicity

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

Time frame: 24-48 hours after vaccination

Adverse events

Proportion (% \& 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination

Time frame: 28 days

Data from ClinicalTrials.gov

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