CClinicalTrials.gg
CompletedNCT01444352Updated Mar 18, 2015

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

A Phase 1 interventional study of Pneumococcal vaccine Formulation 1 and Pneumococcal vaccine Formulation 2 in Pneumococcal Infections, Streptococcus Pneumoniae Infections and Pneumococcal Pneumonia, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Pneumococcal Infections
  • Streptococcus Pneumoniae Infections
  • Pneumococcal Pneumonia

Keywords

  • Pneumococcal infections
  • Streptococcus pneumoniae Infections
  • Pneumococcal Vaccines
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Vaccine Formulation 1 (Low dose)

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

    Biological: Pneumococcal vaccine Formulation 1

  • Experimental
    Vaccine Formulation 2 (Middle dose)

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

    Biological: Pneumococcal vaccine Formulation 2

  • Experimental
    Vaccine Formulation 3 (High dose)

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

    Biological: Pneumococcal vaccine Formulation 3

  • Placebo comparator
    Placebo Pooled

    Participants who receive 2 injections of tris buffered saline

    Biological: Placebo

Interventions

  • BiologicalPneumococcal vaccine Formulation 1

    0.5 mL, Intramuscular (Low dose)

  • BiologicalPneumococcal vaccine Formulation 2

    0.5 mL, Intramuscular (Middle dose)

  • BiologicalPneumococcal vaccine Formulation 3

    0.5 mL, Intramuscular (High dose)

  • BiologicalPlacebo

    0.5 mL, Intramuscular

    Also known as: Tris Buffered Saline

06

What researchers measure

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.

    Time frame: Days 0 through 30 post-vaccination

Secondary outcomes

  1. Immunogenicity of Pneumococcal Vaccine After two Vaccinations

    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

07

Study locations

1 site
  • Allschwil, Switzerland
08

References and documents

Publications

  • 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. PubMed 23153437 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01444352
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Sep 30, 2011
Start date
Jun 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Mar 18, 2015

Study contacts

Medical Director
study director · Sanofi Pasteur Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion