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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pneumococcal Infection

Treatments: Biological: 13-valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01531322

6096A1-1000

B1851046

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 42 days to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Group 1

Experimental group

Description:

Adults aged 18 through 55 years (before the fifty sixth birthday)

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Group 2

Experimental group

Description:

Children aged 3 through 5 years (before the sixth birthday)

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Group 3

Experimental group

Description:

Infants aged approximately 2 months (42 to 98 days)

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine