NCT02955160

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

November 2, 2016

Last Update Submit

September 7, 2018

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Multivalent

EXPERIMENTAL

Pneumococcal conjugate vaccine

Biological: Multivalent

Tdap

ACTIVE COMPARATOR

Tetanus, diphtheria, and pertussis vaccine

Biological: Tdap

Interventions

MultivalentBIOLOGICAL

Pneumococcal conjugate vaccine

Multivalent
TdapBIOLOGICAL

Tetanus, diphtheria, and pertussis vaccine

Tdap

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Vaccines, Combined

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

VaccinesBiological ProductsComplex Mixtures

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

November 3, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

US(1)