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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,281
injection 0.5 mL, single dose
Single Dose
Huairou District Center for Disease Prevention and Control
Beijing, Beijing Municipality, China
Daxing District Center for Disease Prevention and Control
Beijing, Beijing Municipality, China
Chongwen District Center for Disease Control and Prevention
Beijing, Beijing Municipality, China
Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination
Time frame: 6 months
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
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Shijingshan District Center for Disease Control and Prevention
Beijing, Beijing Municipality, China
Xuanwu District Center for Disease Control and Prevention
Beijing, Beijing Municipality, China
Chaoyang District Center for Disease Control and Prevention
Chaoyang District, Beijing Municipality, China
Dongcheng District Center for Disease Control and Prevention
Dongcheng District, Beijing Municipality, China
Fengtai District Center for Disease Control and Prevention
Fengtai District, Beijing Municipality, China
Xicheng District Center for Disease Prevention and Control
Xicheng District, Beijing Municipality, China
Category of adverse event related to vaccination in PVC7 group and Hib group.
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.
Time frame: 6 months after vaccination