Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults

March 17, 2015 updated by: Sanofi Pasteur, a Sanofi Company

This study is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers.

Primary Objective:

  • To evaluate the safety and tolerability of an investigational pneumococcal vaccine.

Observational Objective:

  • To evaluate the immunogenicity of an investigational Pneumococcal vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each vaccination.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 50 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and comply with all trial procedures
  • Subject is healthy, as determined by medical history and physical examination
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to first vaccination until 4 weeks after the last vaccination.

Exclusion Criteria:

  • History of anaphylactic reaction or asthma
  • Unknown pregnancy or positive serum/urine pregnancy test
  • Currently breastfeeding a child
  • Chronic illness, that in the opinion of the investigator, is at a stage that could interfere with trial conduct or completion
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination which may be received at least two weeks before the study vaccines
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for pandemic influenza vaccination in the event of a local or national immunization program
  • Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • Laboratory confirmed/self-reported thrombocytopenia contraindicating intramuscular (IM) vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
  • Previous vaccination against pneumococcal disease (in the previous 5 years)
  • History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
  • At high risk for pneumococcal infection during the trial
  • Living in a household with children <5 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine Formulation 1 (Low dose)
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).
Biological: Pneumococcal vaccine Formulation 1
0.5 mL, Intramuscular (Low dose)
Experimental: Vaccine Formulation 2 (Middle dose)
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).
Biological: Pneumococcal vaccine Formulation 2
0.5 mL, Intramuscular (Middle dose)
Experimental: Vaccine Formulation 3 (High dose)
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).
Biological: Pneumococcal vaccine Formulation 3
0.5 mL, Intramuscular (High dose)
Placebo Comparator: Placebo Pooled
Participants who receive 2 injections of tris buffered saline
Biological: Placebo
0.5 mL, Intramuscular
Other Names:
  • Tris Buffered Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Time Frame: Days 0 through 30 post-vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Days 0 through 30 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Time Frame: Days 0 and 30 days post-vaccination
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Days 0 and 30 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Director: Medical Director, Sanofi Pasteur Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPR06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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