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Completed

NCT Number: NCT01531322

A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.

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Key information

Conditions

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

Age range

42 day–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Huaian, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age at the time of enrollment is:
  • 18 through 55 years (before the fifty sixth birthday) for Group 1.
  • 3 through 5 years (before the sixth birthday) for Group 2.
  • 42 to 98 days for Group 3.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion criteria

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal vaccine.

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Primary outcomes

  1. Number of participants reporting Adverse Events

    Time frame: Baseline to Month 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2012
Registry last updated
Sep 7, 2018

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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