Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children

Pneumococcal Infectious Diseases Clinical Trial

Official title:

A Phase III Clinical Trial for a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285036
• Other study ID #: Walvax-01
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2014
• Last updated: November 5, 2014
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: November 2014
• Source: Walvax Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck & Co., Inc.) controlled phase 3 clinical trial was conducted.

Description:

The World Health Organization (WHO) estimated that more than 800 000 children younger than 5 years died from pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death. Pneumococcal polysaccharide vaccines have progressed from 2-valent vaccines to the current 23-valent vaccine, which has been available since the early 1980s. The 23-valent vaccine includes serotypes accounting for 72% to 95% of invasive pneumococcal disease, depending on the geographic area. Many countries have added pneumococcal polysaccharide vaccine to their existing national immunization programs or recommended it for people aged 65 years and older and for individuals aged 2-64 who are at increased risk of pneumococcal disease.

A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck & Co., Inc.) controlled phase 3 clinical trial was conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1660
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Healthy participants older than 2 years were recruited and enrolled in September or October 2012.

• Participants with axillary temperature less than Celsius 37 degrees

• Not yet having received pneumococcal vaccine and other prevention products within 7 days.

Exclusion Criteria:

• Exclusion criteria were any known primary or secondary immunodeficiency

• Allergy

• Severe cardiovascular disease bleeding disorders

• Receipt of immunoglobulin or blood products within one month and so on.-

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pneumococcal Infections
• Pneumococcal Infectious Diseases

Intervention

Biological:
• vaccination PPV23
All eligible participants were stratified into four age strata namely, 2 to 6 years, 7 to 17 years, 18 to 59 years and more than 60 years. Stratified, block randomization with a size of eight was applied. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Blood samples were obtained from each subject at baseline, day 30-35 after injection, to evaluate immunogenicity.
• vaccination PNEUMOVAX 23
Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.

Locations

Country	Name	City	State
China	Guangxi Provincial Center for Diseases Control and Prevention	Nanning	Guangxi

Sponsors (3)

Lead Sponsor	Collaborator
Walvax Biotechnology Co., Ltd.	Fourth Military Medical University, Guangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of 2-fold increase of anti-pneumococcal antibody		30 days after the injection of vaccination	No
Secondary	geometric mean concentration (GMC)		30 days after the injection of vaccination	No
Secondary	geometric mean fold increase (GMFI)		30 days after the injection of vaccination	No