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

Study Timeline

• Study Start: 2016-05-10
• Primary Completion: 2016-09-14
• Study Completion: 2018-04-10
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Status Verified: 2019-12
• Study First Posted: 2019-12-03
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-17

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

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