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

Pneumococcal Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444352
• Other study ID #: PPR06
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2011
• Last updated: March 17, 2015
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pneumococcal Infections
• Pneumococcal Pneumonia
• Pneumonia
• Pneumonia, Pneumococcal
• Streptococcus Pneumoniae Infections

Intervention

Biological:
• Pneumococcal vaccine Formulation 1
0.5 mL, Intramuscular (Low dose)
• Pneumococcal vaccine Formulation 2
0.5 mL, Intramuscular (Middle dose)
• Pneumococcal vaccine Formulation 3
0.5 mL, Intramuscular (High dose)
• Placebo
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 0 through 30 post-vaccination	No
Secondary	Immunogenicity of Pneumococcal Vaccine After two Vaccinations	Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).	Days 0 and 30 days post-vaccination	No

External Links

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