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OpenTrials
Completed

NCT Number: NCT04183322

PCV13 in Non-pregnant Papua New Guinean Women

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Papua New Guinea Institute of Medical Research

Goroka, Eastern Hghlands Province, 441, Papua New Guinea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

Other names: PCV13, 13-valent PCV, Prevnar13, Prevenar13

Primary outcomes

  1. Immunogenicity

    Time frame: 28 days

    Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)

Secondary outcomes

  1. Reactogenicity

    Time frame: 24-48 hours after vaccination

    Proportion (% & 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination

  2. Adverse events

    Time frame: 28 days

    Proportion (% & 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination

Sponsors and collaborators

Lead sponsor

Telethon Kids Institute

Other

Collaborators

  • Papua New Guinea Institute of Medical Research

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Dec 3, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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