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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

Primary Purpose

Pneumococcal Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Multivalent

Tdap

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Baseline laboratory test results outside of the normal reference range considered clinically significant.
History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine.
History of culture-proven invasive disease caused by S pneumoniae.
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation.
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.

Sites / Locations

New Haven Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multivalent

Tdap

Arm Description

Pneumococcal conjugate vaccine

Tetanus, diphtheria, and pertussis vaccine

Outcomes

Primary Outcome Measures

Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site).

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).

Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.

Percentage of subjects with clinical laboratory abnormalities after vaccination.

Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.

Secondary Outcome Measures

Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination.

Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination.

Full Information

NCT ID

NCT02955160

First Posted

November 2, 2016

Last Updated

September 7, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02955160

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

November 3, 2016 (Actual)

Primary Completion Date

August 1, 2017 (Actual)

Study Completion Date

August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumococcal Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multivalent

Arm Type

Experimental

Arm Description

Pneumococcal conjugate vaccine

Arm Title

Tdap

Arm Type

Active Comparator

Arm Description

Tetanus, diphtheria, and pertussis vaccine

Intervention Type

Biological

Intervention Name(s)

Multivalent

Intervention Description

Pneumococcal conjugate vaccine

Intervention Type

Biological

Intervention Name(s)

Tdap

Intervention Description

Tetanus, diphtheria, and pertussis vaccine

Primary Outcome Measure Information:

Title

Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site).

Time Frame

Day 15

Title

Time Frame

Day 15

Title

Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.

Time Frame

1 month after vaccination

Title

Percentage of subjects with clinical laboratory abnormalities after vaccination.

Time Frame

Day 6

Title

Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.

Time Frame

6 months after vaccination

Secondary Outcome Measure Information:

Title

Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination.

Time Frame

1 month after vaccination

Title

Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination.

Time Frame

1 month after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adults 18 to 49 years of age. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study. Negative serum pregnancy test for all female subjects who are of childbearing potential. Exclusion Criteria: Baseline laboratory test results outside of the normal reference range considered clinically significant. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine. History of culture-proven invasive disease caused by S pneumoniae. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

New Haven Clinical Research Unit

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7471001&StudyName=A%20Phase%201%2C%20Randomized%2C%20Controlled%2C%20Observer-blinded%20Trial%20to%20Evaluate%20the%20Safety%20and%20Immunogenicity%20of%20a%20Multivalent%20Pneumococcal%20Conjugate%20Vaccine%20in%20Healthy%20Adults%20Aged%2018%20to%2049%20Years

Description

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

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7471001&StudyName=A+Phase+1%2C+Randomized%2C+Controlled%2C+Observer-blinded+Trial+To+Evaluate+The+Safety+And+Immunogenicity+Of+A+Multivalent+Pneumococcal+Conjugate+Vaccine+In+Healthy+Adults+Aged+18+To+49+Years

Description

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

Learn more about this trial

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

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