NCT01451086

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 capsular polysaccharides induce antibody production and such antibody is effective in preventing pneumococcal disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old and older and in adults of all ages have showed immunogenic response. In order to provide more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical trial is planed to conduct.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3 healthy

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

October 11, 2011

Last Update Submit

March 14, 2013

Conditions

Healthy

Keywords

SafetyImmunogenicityPneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

  • To evaluate the immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine after vaccination

    To evaluate the percentage of subjects exhibiting a ≥ 2 fold increase in IGG antibody level after vaccination

    28 days after vaccination

Secondary Outcomes (1)

  • To evaluate the safety of 23-valent Pneumococcal Polysaccharide Vaccine after vaccination

    28 days after vaccination

Study Arms (2)

vaccine made by Beijing Minhai Biotechnology Co., Ltd

EXPERIMENTAL

Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.

Biological: vaccine made by Beijing Minhai Biotechnology Co., Ltd

vaccine made by Chengdu Institute of Biological Products

ACTIVE COMPARATOR

Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.

Biological: vaccine made by Chengdu Institute of Biological Products

Interventions

vaccine made by Beijing Minhai Biotechnology Co., LtdBIOLOGICAL

Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.

vaccine made by Beijing Minhai Biotechnology Co., Ltd
vaccine made by Chengdu Institute of Biological ProductsBIOLOGICAL

Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.

vaccine made by Chengdu Institute of Biological Products

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

Long-Term Synaptic Depression

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 13, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

CN(1)