Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults
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|ClinicalTrials.gov Identifier: NCT02062281|
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Infection Influenza||Biological: 23-valent pneumococcal polysaccharide vaccine Biological: trivalent influenza vaccine Biological: 23vPPV+TIV||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2225 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 4, Randomized, Single-blind Trial to Evaluate Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine When Administered Simultaneously With Trivalent Inactivated Influenza Vaccine in Healthy Children Aged 3-7years and Healthy Adults 65 Aged 50-65years.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Active Comparator: 23-valent Pneumococcal Polysaccharide vaccine
0.5ml 23-valent pneumococcal Polysaccharide vaccine made by Chengdu Institute of Biological Products Co.,Ltd.
lot number: 20130106-1, duration:JAN,17,2015.
Biological: 23-valent pneumococcal polysaccharide vaccine
Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)
Active Comparator: Trivalent Influenza Vaccine
0.5ml trivalent influenza vaccine made by Shanghai Institute of Biological Products Co.,Ltd.
lot number:20130713, duration:Jul,1,2014.
Biological: trivalent influenza vaccine
Single 0.5ml trivalent influenza vaccine was administered IM
Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.
- Immunogenicity of 23vPPV [ Time Frame: 1 month after 23vPPV vaccination ]IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese.
- Immunogenicity of TIV [ Time Frame: 1 month after TIV vaccination ]Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
- adverse events following the immunization (AEFI) [ Time Frame: 28 days after 23vPPV and TIV vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062281
|Yangzhong Center for Disease Control and Prevention|
|Zhenjiang, Jiangsu, China, 212200|
|Principal Investigator:||ma fubao, doctor||Jiangsu CDC|