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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae in 2 to 5 Years Old Healthy Chinese Children.

Brief 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.

Detailed Summary:

In 2005, clinical trials with PCV7 (Prevenar) were first conducted in China. In the phase 3 study involving Chinese infants, Prevenar was shown to be immunogenic, well tolerated, and safe when given either separately or concomitantly with a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine at 3, 4, and 5 months of age. Controlled clinical trials elsewhere in the world showed the correlation between immunogenicity and disease prevention. In addition to the direct effect of Prevenar, immunization of children has also reduced the incidence of disease in adults. The changes are presumed to be due to reductions in nasopharyngeal carriage of vaccine serotype S. pneumoniae in children who have been vaccinated.

The purpose of this study will be to assess the effectiveness of Prevenar vaccination to reduce vaccine serotype (VT) NPC rates in Chinese children aged 2 to 5 years old.


Sponsor: Centers for Disease Control and Prevention, China

Current Primary Outcome: Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Carriage Rate of vaccine-serotype S. pneumoniae in PCV7 group versus Hib group. [ Time Frame: 60 days ]
  • Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group. [ Time Frame: Baseline before vaccination ]
  • Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group. [ Time Frame: 60 days after vaccination ]
  • Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group. [ Time Frame: 6 months after vaccination ]
  • Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group. [ Time Frame: Baseline before vaccination ]
  • Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group. [ Time Frame: 60 days after vaccination ]
  • Carriage rates of individual serotype S. pneumoniae in PCV7 group and Hib group. [ Time Frame: 6 months after vaccination ]
  • Carriage rate of antibiotic resistant S. pneumoniae as a group in PCV7 group and Hib group. [ Time Frame: 6 months after vaccination ]
  • Percentage of adverse event related to vaccination in PVC7 group and Hib group. [ Time Frame: 6 months after vaccination ]
  • Category of adverse event related to vaccination in PVC7 group and Hib group. [ Time Frame: 6 months after vaccination ]
    Adverse effects are classified as referenced from the China Food and Drug Administration's "Preventive Vaccines Clinical Study Adverse Effects Assessment Standards". This evaluation of systemic reactions is partially based on standards for classification set by the United States National Institutes of Health and the National Institute of Allergy and Infectious Diseases.


Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention, China

Dates:
Date Received: May 7, 2014
Date Started: June 2012
Date Completion:
Last Updated: May 19, 2016
Last Verified: May 2014