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Study of Two Investigational Pneumococcal Vaccines 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
Pneumococcal Vaccine Formulation 4
Pneumococcal Vaccine Formulation 5
Placebo
Sponsored by
Sanofi
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 Vaccine

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:

  • Known 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, or 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(s) 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
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
  • Laboratory confirmed / self-reported thrombocytopenia contraindicating intramuscular 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 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Pneumococcal Vaccine Formulation 1

Pneumococcal Vaccine Formulation 2

Pneumococcal Vaccine Formulation 3

Pneumococcal Vaccine Formulation 4

Pneumococcal Vaccine Formulation 5

Pooled placebo Group

Arm Description

Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively.

Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively.

Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively.

Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively.

Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively.

Participants will receive an injection of a placebo on Day 0 and Day 30, respectively.

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 Investigational Pneumococcal vaccines after 2 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
September 29, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01444339
Brief Title
Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. Primary Objective: - To evaluate the safety and tolerability of two investigational pneumococcal vaccines. Observational Objective: - To evaluate the immunogenicity of the investigational pneumococcal vaccines.
Detailed Description
An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased 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 Vaccine

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pneumococcal Vaccine Formulation 1
Arm Type
Experimental
Arm Description
Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively.
Arm Title
Pneumococcal Vaccine Formulation 2
Arm Type
Experimental
Arm Description
Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively.
Arm Title
Pneumococcal Vaccine Formulation 3
Arm Type
Experimental
Arm Description
Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively.
Arm Title
Pneumococcal Vaccine Formulation 4
Arm Type
Experimental
Arm Description
Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively.
Arm Title
Pneumococcal Vaccine Formulation 5
Arm Type
Experimental
Arm Description
Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively.
Arm Title
Pooled placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants will receive an injection of a placebo on Day 0 and Day 30, respectively.
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Formulation 1
Intervention Description
0.5 mL, intramuscular (1 middle dose)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Formulation 2
Intervention Description
0.5 mL, intramuscular (2 low doses)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Formulation 3
Intervention Description
0.5 mL, intramuscular (2 middle doses)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Formulation 4
Intervention Description
0.5 mL, intramuscular (2 middle doses)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine Formulation 5
Intervention Description
0.5 mL, intramuscular (2 high doses)
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
30 days post-vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity of Investigational Pneumococcal vaccines after 2 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 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: Known 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, or 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(s) 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 Planned receipt of any vaccine in the 4 weeks following the trial vaccination Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C Laboratory confirmed / self-reported thrombocytopenia contraindicating intramuscular 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
23123106
Citation
Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
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Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

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