PCV13 in Non-pregnant Papua New Guinean Women

December 13, 2019 updated by: Telethon Kids Institute

Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Papua New Guinea
    • Eastern Hghlands Province
      • Goroka, Eastern Hghlands Province, Papua New Guinea, 441
        • Papua New Guinea Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

50 healthy non-pregnant women aged between 18-45 years old living in Goroka, Papua New Guinea.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women of childbearing age
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).
Biological: 13-valent pneumococcal conjugate vaccine
Other Names:
  • PCV13
  • Prevenar13
  • Prevnar13
  • 13-valent PCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 28 days
Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactogenicity
Time Frame: 24-48 hours after vaccination
Proportion (% & 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination
24-48 hours after vaccination
Adverse events
Time Frame: 28 days
Proportion (% & 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telethon Kids Institute

Collaborators

Papua New Guinea Institute of Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Actual)

September 14, 2016

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 1515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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