PCV13 in Non-pregnant Papua New Guinean Women

NCT ID: NCT04183322

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-10

Study Completion Date

2018-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumococcal Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pneumococcal conjugate vaccine PCV Reactogenicity Immunogenicity Women childbearing age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PCV13 13-valent PCV Prevnar13 Prevenar13

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Papua New Guinea Institute of Medical Research

OTHER_GOV

Sponsor Role collaborator

Telethon Kids Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Papua New Guinea Institute of Medical Research

Goroka, Eastern Hghlands Province, Papua New Guinea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Papua New Guinea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33292822 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB 1515

Identifier Type: -

Identifier Source: org_study_id