- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02133469
PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae
Effectiveness of PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae in 2 to 5 Years Old Healthy Chinese Children.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 101400
- Huairou District Center for Disease Prevention and Control
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Beijing, Beijing, China, 102600
- Daxing District Center for Disease Prevention and Control
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Beijing, Beijing, China
- Chongwen District Center for Disease Control and Prevention
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Beijing, Beijing, China
- Shijingshan District Center for Disease Control and Prevention
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Beijing, Beijing, China
- Xuanwu District Center for Disease Control and Prevention
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Chaoyang District, Beijing, China
- Chaoyang District Center for Disease Control and Prevention
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Dongcheng District, Beijing, China
- Dongcheng District Center for Disease Control and Prevention
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Fengtai District, Beijing, China
- Fengtai District Center for Disease Control and Prevention
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Xicheng District, Beijing, China, 100120
- Xicheng District Center for Disease Prevention and Control
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy children aged 2 to 5 years.
- Evidence of a personally signed and dated informed consent document indicating that the parent(s) (or legal guardian) has been informed of all pertinent aspects of the study.
- Subjects and parents / legal guardian/ adult caregiver who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Available for entire study period and whose parent/legal guardian/adult caregiver can be reached by telephone.
- Healthy child as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Receipt of a full series or catch-up dose of licensed or investigational Hib vaccinations.
- Contraindication to vaccination with a pneumococcal conjugate vaccine or Hib.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti-metabolites, chemotherapy and immunomodulatory agents.
- Major known congenital malformation or serious chronic disorder.
- Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible.
- Significant neurologic disorder including congenital neurological disease in sibling of the subject or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb's palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies) within 12 weeks prior to enrollment.
- Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in purely observational studies is acceptable.
- Subjects whose parents or legal representative are investigational site staff members or subjects whose parents or legal representative are Pfizer employees directly involved in the conduct of the trial.
Temporary Exclusion Criteria(The following conditions are temporary or self-limiting and a subject may be included in the study once the condition(s) has/have resolved and no other exclusion criteria are met):
- Subjects with current febrile illness (axillary temperature of ≥ 38.0ºC).
- Subjects who used antibiotics within the previous 15 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PCV7 (Vaccine)
Randomized group of 1634 subjects to be administered a single dose of PCV7 (Hib vaccine offered at end of study).
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injection 0.5 mL, single dose
Other Names:
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Active Comparator: Hib vaccine
Randomized group of 1634 subjects to be administered a single dose of Hib Vaccine(PCV7 vaccine offered at end of study).
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Single Dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carriage Rate of vaccine-serotype S. pneumoniae in PCV7 group versus Hib group.
Time Frame: 60 days
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60 days
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Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Time Frame: Baseline before vaccination
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Baseline before vaccination
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Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Time Frame: 60 days after vaccination
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60 days after vaccination
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Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Time Frame: 6 months after vaccination
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6 months after vaccination
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Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.
Time Frame: Baseline before vaccination
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Baseline before vaccination
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Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.
Time Frame: 60 days after vaccination
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60 days after vaccination
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Carriage rates of individual serotype S. pneumoniae in PCV7 group and Hib group.
Time Frame: 6 months after vaccination
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6 months after vaccination
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Carriage rate of antibiotic resistant S. pneumoniae as a group in PCV7 group and Hib group.
Time Frame: 6 months after vaccination
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6 months after vaccination
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Percentage of adverse event related to vaccination in PVC7 group and Hib group.
Time Frame: 6 months after vaccination
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6 months after vaccination
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Category of adverse event related to vaccination in PVC7 group and Hib group.
Time Frame: 6 months after vaccination
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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.
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6 months after vaccination
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Collaborators and Investigators
Investigators
- Principal Investigator: Wu Jiang, Bachelor, Beijing Centers for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Pneumonia, Bacterial
- Pneumococcal Infections
- Pneumonia
- Pneumonia, Pneumococcal
- Nasopharyngeal Diseases
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- BJCDCWJ201201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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