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

Pneumococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955160
• Other study ID #: B7471001
• Status: Completed
• Phase: Phase 1
• Start date: November 3, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• Multivalent
Pneumococcal conjugate vaccine
• Tdap
Tetanus, diphtheria, and pertussis vaccine

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.		1 month after vaccination
Primary	Percentage of subjects with clinical laboratory abnormalities after vaccination.		Day 6
Primary	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	Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination.		1 month after vaccination
Secondary	Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination.		1 month after vaccination

External Links

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