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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02955160•Pfizer

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 49 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Key Dates

Start Date

November 3, 2016

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

September 11, 2018

Enrollment

ACTUAL participants

Conditions

Pneumococcal Infections

Interventions

Multivalent

BIOLOGICAL

Tdap

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

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