Status:
COMPLETED
Safety and Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in 2 to 70 Years Old Healthy People in China
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Beijing Minhai Biotechnology Co., Ltd
Conditions:
Healthy
Eligibility:
All Genders
2-70 years
Phase:
PHASE3
Brief Summary
Pneumococcal infection is a leading cause of death throughout the world and a major cause of pneumonia, bacteremia, meningitis, and otitis media. It has been established that purified pneumococcal ca...
Detailed Description
Pneumonia is a major cause of morbidity and mortality in developing countries. Pneumonia is predominantly bacterial in origin: isolation rates of Streptococcus pneumoniae and Haemophilus influenzae we...
Eligibility Criteria
Inclusion
- Aged 2 to 70 years on the day of inclusion
- Informed consent form signed by subjects and parent/guardian
- Subjects and parents/guardians able to attend all scheduled visits and comply with all study procedures
Exclusion
- Subjects with any pneumococcal vaccine before vaccination
- History of pneumococcal infection
- Women in pregnancy or lactation period in trial period
- Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia
- Known or suspected immune dysfunction, including persons with congenital immunodeficiency or persons with HIV positive.
- Functional or anatomic asplenia
- Patients treated with chemotherapy in past 5 years or administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial
- Receipt of blood or blood-derived products in the 3 months preceding vaccination
- Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination
- Receipt of any live virus vaccine in the 30 days preceding vaccination
- Receipt of any subunit vaccine and inactivated vaccine in the 14 days before vaccination
- Thrombocytopenia, bleeding disorder
- History of asthma，angioneurotic edema，diabetes mellitus or malignancy tumor
- History of thyroid gland excision or treatment for thyroid gland disease in last 12 months
- Hypertension, blood pressure still above 145/95mmHg even with drug treatment
- History of eclampsia, epilepsia, psychosis
- Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination
- In progress of anti-tuberculosis prophylaxis or therapy
- Those can not fulfill the protocol or can not sign the informed consent form for any medical, psychological, social, occupational and other reasons, according to investigator judgment
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01451086
Start Date
October 1 2011
End Date
August 1 2012
Last Update
March 15 2013
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China