Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly
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|ClinicalTrials.gov Identifier: NCT02451969|
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Infections||Biological: investigational 23-valent PPV Biological: control 23-valent PPV||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1760 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||February 2017|
Experimental: Experimental Group
Biological: investigational 23-valent PPV
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
Active Comparator: Control Group
Biological: control 23-valent PPV
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.
- The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes [ Time Frame: 28 days ]For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).
- The incidences of adverse events (AEs) [ Time Frame: 28 days ]After each injection, a 30-minute safety observation was conducted immediately. The body temperature, occurrence of solicited local and general AEs on day 0 - 7 were reported. Unsolicited AEs occurred during day 0 - 28 were also reported. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).
- The increases of relative antibody concentration against each of the 23 pneumococcal serotypes [ Time Frame: 28 days ]The relative antibody concentrations in the pre- and post-immunization serum samples were measured using ELISA.
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): NCT02451969
|Kaifeng County Center for Disease Control and Prevention|
|Kaifeng, Henan, China, 475100|
|Principal Investigator:||Weiping Ru, BS||Henan Provincial Center for Disease Control and Prevention|