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

Pneumococcal Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531322
• Other study ID #: B1851046
• Secondary ID: 6096A1-1000
• Status: Completed
• Phase: Phase 1
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 55 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
• 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
• 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Huaian	Jiangsu
China	Pfizer Investigational Site	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting Adverse Events		Baseline to Month 1

External Links

•   To obtain contact information for a study center near you, click here.