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

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).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: Multivalent; Biological: Tdap

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female adults 18 to 49 years of age.
2. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study.
3. Negative serum pregnancy test for all female subjects who are of childbearing potential.

Exclusion Criteria:

1. Baseline laboratory test results outside of the normal reference range considered clinically significant.
2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine.
3. History of culture-proven invasive disease caused by S pneumoniae.
4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation.
6. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study participation and for at least 6 months after the last dose of investigational product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multivalent; Pneumococcal conjugate vaccine	Biological: Multivalent; Pneumococcal conjugate vaccine
Active Comparator: Tdap; Tetanus, diphtheria, and pertussis vaccine	Biological: Tdap; Tetanus, diphtheria, and pertussis vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site).	Day 15
Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, chills, rash, decreased appetite, nausea/vomiting, new muscle pain, aggravated muscle pain, new joint pain, and aggravated joint pain).	Day 15
Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.	1 month after vaccination
Percentage of subjects with clinical laboratory abnormalities after vaccination.	Day 6
Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.	6 months after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination.	1 month after vaccination
Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination.	1 month after vaccination

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections
• Other Study ID Numbers: B7471001