Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

NCT01444339 | Completed Phase 1

• 1 other identifier: PPR05
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Pneumonia

Keywords

Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  30 days post-vaccination

Secondary Outcomes (1)

• Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations

  Days 0 and 30 post-vaccination

Study Arms (6)

Pneumococcal Vaccine Formulation 1

EXPERIMENTAL

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

Biological: Pneumococcal Vaccine Formulation 1

Pneumococcal Vaccine Formulation 2

EXPERIMENTAL

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

Biological: Pneumococcal Vaccine Formulation 2

Pneumococcal Vaccine Formulation 3

EXPERIMENTAL

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

Biological: Pneumococcal Vaccine Formulation 3

Pneumococcal Vaccine Formulation 4

EXPERIMENTAL

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

Biological: Pneumococcal Vaccine Formulation 4

Pneumococcal Vaccine Formulation 5

EXPERIMENTAL

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

Biological: Pneumococcal Vaccine Formulation 5

Pooled placebo Group

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Pneumococcal Vaccine Formulation 1 BIOLOGICAL

0.5 mL, intramuscular (1 middle dose)

Pneumococcal Vaccine Formulation 1

Pneumococcal Vaccine Formulation 2 BIOLOGICAL

0.5 mL, intramuscular (2 low doses)

Pneumococcal Vaccine Formulation 2

Pneumococcal Vaccine Formulation 3 BIOLOGICAL

0.5 mL, intramuscular (2 middle doses)

Pneumococcal Vaccine Formulation 3

Pneumococcal Vaccine Formulation 4 BIOLOGICAL

0.5 mL, intramuscular (2 middle doses)

Pneumococcal Vaccine Formulation 4

Pneumococcal Vaccine Formulation 5 BIOLOGICAL

0.5 mL, intramuscular (2 high doses)

Pneumococcal Vaccine Formulation 5

Placebo BIOLOGICAL

0.5 mL, intramuscular

Also known as: Tris buffered saline

Pooled placebo Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Allschwil, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23123106 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pneumococcal Infections; Pneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Sanofi Pasteur Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 30, 2011

Record last verified: 2011-09

Locations

CH (1)