NCT02062281

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

A Phase 4, Randomized, Single-blind Trial to Evaluate Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine When Administered Simultaneously With Trivalent Inactivated Influenza Vaccine in Healthy Children Aged 3-7years and Healthy Adults 65 Aged 50-65years.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,225 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 3 Years – 65 Years
• Healthy volunteers: Accepted

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

• Pneumococcal Infection
• Influenza

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2014-02-13
• Last updated: 2014-02-13

Locations

1 site across 1 country: China