NCT02955160

A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years

A Phase 1, Randomized, Controlled, Observer-blinded Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults Aged 18 To 49 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Multivalent	Pneumococcal conjugate vaccine
BIOLOGICAL	Tdap	Tetanus, diphtheria, and pertussis vaccine

Timeline

• Start date: 2016-11-03
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-11-04
• Last updated: 2018-09-11

Locations

1 site across 1 country: United States