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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04183322
Other study ID # IRB 1515
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2016
Est. completion date April 10, 2018

Study information

Verified date December 2019
Source Telethon Kids Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 10, 2018
Est. primary completion date September 14, 2016
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
13-valent pneumococcal conjugate vaccine


Locations

Country Name City State
Papua New Guinea Papua New Guinea Institute of Medical Research Goroka Eastern Hghlands Province

Sponsors (2)

Lead Sponsor Collaborator
Telethon Kids Institute Papua New Guinea Institute of Medical Research

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

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