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OpenTrials
Completed

NCT Number: 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

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).

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multivalent

Biological

Pneumococcal conjugate vaccine

TDAP

Biological

Tetanus, diphtheria, and pertussis vaccine

Primary outcomes

  1. 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

  2. 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).

    Time frame: Day 15

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

    Time frame: 1 month after vaccination

  4. Percentage of subjects with clinical laboratory abnormalities after vaccination.

    Time frame: Day 6

  5. 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 outcomes

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

    Time frame: 1 month after vaccination

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

    Time frame: 1 month after vaccination

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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