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

NCT02285036 | Completed Phase 3 DMC

• 1 other identifier: Walvax-01
• Study Type: interventional
• Target: 1,660
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumococcal Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• the rate of 2-fold increase of anti-pneumococcal antibody

  30 days after the injection of vaccination

Secondary Outcomes (2)

• geometric mean concentration (GMC)

  30 days after the injection of vaccination

• geometric mean fold increase (GMFI)

  30 days after the injection of vaccination

Study Arms (2)

A newly PPV23

EXPERIMENTAL

The treatment pneumococcal vaccine was developed by Yunnan Walvax Biotech Co., Ltd (Walvax) China, is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in China. The dose of vaccine is an individual with a 0.5ml dose contains 23 kinds of pneumococcal polysaccharide serotypes each 25μg, and does not contain any preservatives. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.

Biological: vaccination PPV23

PNEUMOVAX 23

ACTIVE COMPARATOR

PNEUMOVAX 23 is an established US-licensed vaccine and manufactured by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.

Biological: vaccination PNEUMOVAX 23

Interventions

vaccination PPV23 BIOLOGICAL

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.

A newly PPV23

vaccination PNEUMOVAX 23 BIOLOGICAL

Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.

PNEUMOVAX 23

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Allergy
• Severe cardiovascular disease bleeding disorders
• Receipt of immunoglobulin or blood products within one month and so on.-

Sponsors & Collaborators

• Walvax Biotechnology Co., Ltd.: lead
• Guangxi Center for Disease Control and Prevention: collaborator
• Air Force Military Medical University, China: collaborator

Study Sites (1)

Guangxi Provincial Center for Diseases Control and Prevention

Nanning, Guangxi, China

Location

Study Officials

• Yanping Li

  Guangxi Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 6, 2014
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

CN (1)