PCV13 in Non-pregnant Papua New Guinean Women
Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedFirst Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedDecember 17, 2019
December 1, 2019
4 months
November 27, 2019
December 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity
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 Outcomes (2)
Reactogenicity
24-48 hours after vaccination
Adverse events
28 days
Study Arms (1)
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).
Interventions
Eligibility Criteria
50 healthy non-pregnant women aged between 18-45 years old living in Goroka, Papua New Guinea.
You may qualify if:
- Healthy
- Non-pregnant
- years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Papua New Guinea Institute of Medical Research
Goroka, Eastern Hghlands Province, 441, Papua New Guinea
Related Publications (1)
Javati S, Masiria G, Elizah A, Matlam JP, Ford R, Richmond PC, Lehmann D, Pomat WS, van den Biggelaar AHJ. An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea. Pneumonia (Nathan). 2020 Nov 25;12(1):13. doi: 10.1186/s41479-020-00076-1.
PMID: 33292822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2019
First Posted
December 3, 2019
Study Start
May 10, 2016
Primary Completion
September 14, 2016
Study Completion
April 10, 2018
Last Updated
December 17, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share