PCV13 in Non-pregnant Papua New Guinean Women

Telethon Kids Institute

Status: Completed

Conditions: Pneumococcal Infections

Treatments: Biological: 13-valent pneumococcal conjugate vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04183322

IRB 1515

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Women of childbearing age

Description:

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).

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine