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Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults

NCT02062281 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2225

Last updated 2014-02-13

No results posted yet for this study

Summary

The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.

Conditions

Interventions

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)

BIOLOGICAL

trivalent influenza vaccine

Single 0.5ml trivalent influenza vaccine was administered IM

BIOLOGICAL

23vPPV+TIV

Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.

Sponsors & Collaborators

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Shanghai Institute Of Biological Products

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • ma fubao, doctor · Jiangsu CDC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062281 on ClinicalTrials.gov