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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531322

Enrollment

Registered

2012-02-10

Start date

2011-10-31

Completion date

2012-01-31

Last updated

2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infection

Keywords

13vPnC, Healthy subjects, China

Brief 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.

Interventions

BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

42 Days to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of participants reporting Adverse Events	Baseline to Month 1

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026