A Phase 3 interventional study of ACYW135 Meningococcal Polysaccharide Vaccine and A+C Meningococcal Polysaccharide Vaccine in Meningitis, sponsored by Hualan Biological Engineering, Inc.. Completed. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-09.
Sponsored by Hualan Biological Engineering, Inc. · Phase 3, Interventional, and Prevention
The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase III clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine.
The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.
380 studies on the registry are indexed under Meningitis; 32 are open to participants now.
This study's enrollment of 900 is above the median of 215 across 262 interventional studies indexed under Meningitis.
Browse Meningitis studies →Hualan Biological Engineering, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
0.5 ml/ dose, containing 50 μg of each antigen; lot No.: 20040601, manufacturing date: June 9, 2004 and the expiration date: till June 2006
Biological: ACYW135 Meningococcal Polysaccharide Vaccine
0.5 ml/ dose; each ampoule or dose contains 100 μg (one single human dose) and 50 μg of each antigen; lot No.: 20050805 and the expiration date: Aug. 24, 2007
Biological: A+C Meningococcal Polysaccharide Vaccine
600 subjects were divided into three groups (200 subjects in each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
Also known as: Hualan Bio
300 subjects were divided into three groups (100 subjects in each group), adult (16\~30 years of age), early youth (7\~15 years of age) and children (2\~6 years of age) to receive Group AC Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
Also known as: Lanzhou Institute
Safety
Systemic and local adverse reactions after the vaccination; adverse events
Time frame: Dat 28 after vaccination
Immunogenicity
4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization
Time frame: The 4th week after immunization
No study locations are listed for this record.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hualan Biological Engineering, Inc.