PCV13 in Non-pregnant Papua New Guinean Women

Pneumococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183322
• Other study ID #: IRB 1515
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Pneumococcal Infections

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