Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly
|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|
|Primary Completion Date :||June 2015|
|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.
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|