CClinicalTrials.gg
CompletedNCT01531322Updated Sep 7, 2018

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

A Phase 1 interventional study of 13-valent Pneumococcal Conjugate Vaccine and 13-valent Pneumococcal Conjugate Vaccine in Pneumococcal Infection, sponsored by Pfizer. Completed at 2 sites in China. Open to participants aged 42 Days to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
42 Days to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumococcal Infection

Keywords

  • 13vPnC
  • Healthy subjects
  • China
03

In context

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 72 is below the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Days to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Group 1

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

    Biological: 13-valent Pneumococcal Conjugate Vaccine

  • Experimental
    Group 2

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

    Biological: 13-valent Pneumococcal Conjugate Vaccine

  • Experimental
    Group 3

    Infants aged approximately 2 months (42 to 98 days)

    Biological: 13-valent Pneumococcal Conjugate Vaccine

Interventions

  • Biological13-valent Pneumococcal Conjugate Vaccine

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

  • Biological13-valent Pneumococcal Conjugate Vaccine

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

  • Biological13-valent Pneumococcal Conjugate Vaccine

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

06

What researchers measure

Primary outcomes

  1. Number of participants reporting Adverse Events

    Time frame: Baseline to Month 1

07

Study locations

2 sites
  • Pfizer Investigational Site
    Huaian, Jiangsu 223300, China
  • Pfizer Investigational Site
    Nanjing, Jiangsu 210009, China
08

References and documents

Publications

  • Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985. PubMed 26668712 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01531322
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 10, 2012
Start date
Oct 2011
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Sep 7, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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