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

Primary Purpose

Pneumococcal Infections, Streptococcus Pneumoniae Infections, Pneumococcal Pneumonia

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Pneumococcal vaccine Formulation 1
Pneumococcal vaccine Formulation 2
Pneumococcal vaccine Formulation 3
Placebo
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Pneumococcal infections, Streptococcus pneumoniae Infections, Pneumococcal Vaccines

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Vaccine Formulation 1 (Low dose)

Vaccine Formulation 2 (Middle dose)

Vaccine Formulation 3 (High dose)

Placebo Pooled

Arm Description

Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).

Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).

Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).

Participants who receive 2 injections of tris buffered saline

Outcomes

Primary Outcome Measures

Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Secondary Outcome Measures

Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).

Full Information

First Posted
September 28, 2011
Last Updated
March 17, 2015
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01444352
Brief Title
Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections, Streptococcus Pneumoniae Infections, Pneumococcal Pneumonia
Keywords
Pneumococcal infections, Streptococcus pneumoniae Infections, Pneumococcal Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine Formulation 1 (Low dose)
Arm Type
Experimental
Arm Description
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).
Arm Title
Vaccine Formulation 2 (Middle dose)
Arm Type
Experimental
Arm Description
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).
Arm Title
Vaccine Formulation 3 (High dose)
Arm Type
Experimental
Arm Description
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).
Arm Title
Placebo Pooled
Arm Type
Placebo Comparator
Arm Description
Participants who receive 2 injections of tris buffered saline
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine Formulation 1
Intervention Description
0.5 mL, Intramuscular (Low dose)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine Formulation 2
Intervention Description
0.5 mL, Intramuscular (Middle dose)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine Formulation 3
Intervention Description
0.5 mL, Intramuscular (High dose)
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tris Buffered Saline
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Description
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame
Days 0 through 30 post-vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Description
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Days 0 and 30 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Ltd.
Official's Role
Study Director
Facility Information:
City
Allschwil
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23153437
Citation
Kamtchoua T, Bologa M, Hopfer R, Neveu D, Hu B, Sheng X, Corde N, Pouzet C, Zimmermann G, Gurunathan S. Safety and immunogenicity of the pneumococcal pneumolysin derivative PlyD1 in a single-antigen protein vaccine candidate in adults. Vaccine. 2013 Jan 2;31(2):327-33. doi: 10.1016/j.vaccine.2012.11.005. Epub 2012 Nov 12.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
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Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults

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