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PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae

NCT02133469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3281

Last updated 2016-05-20

No results posted yet for this study

Summary

A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F combined) in 2 to 5 years old healthy Chinese children.

Conditions

  • Streptococcal Pneumonia
  • Nasopharyngeal Diseases
  • Vaccination Adverse Event

Interventions

BIOLOGICAL

PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)

injection 0.5 mL, single dose

BIOLOGICAL

Hib Vaccine

Single Dose

Sponsors & Collaborators

  • Beijing Municipal Health Bureau

    collaborator OTHER

  • Beijing Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Centers for Disease Control and Prevention, China

    lead OTHER_GOV

Principal Investigators

  • Wu Jiang, Bachelor · Beijing Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02133469 on ClinicalTrials.gov