Evaluation of Pneumococcal Vaccine Formulations in Elderly

NCT00756067 | Completed Phase 1

• 1 other identifier: 111652
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.

Conditions

Infections, Streptococcal

Keywords

Streptococcus pneumoniae; pneumococcal vaccine

Outcome Measures

Primary Outcomes (4)

• Occurrence of any vaccine related and grade 3 solicited local and general adverse events

  During a 7-day follow up period after each vaccine dose

• Occurrence of any vaccine related and grade 3 unsolicited adverse events

  During a 31-day follow up period after each vaccine dose

• Occurrence of any vaccine related serious adverse events (SAE)

  From dose 1 to study conclusion

• Occurrence of any grade 3 laboratory abnormalities

  At 1 and 7 days after each vaccine dose

Secondary Outcomes (5)

• Occurrence of any solicited local and general adverse events

  During a 7-day follow up period after each vaccine dose

• Occurrence of any unsolicited adverse events

  During a 31-day follow up period after each vaccine dose

• Occurrence of any laboratory abnormalities

  At 1 and 7 days after each vaccine dose

• Occurrence of any medically significant conditions prompting emergency room visits or physician visits regardless of casual relationship to vaccination or intensity

  From dose 1 to study conclusion

• Anti-pneumococcal and anti-NTHi candidate vaccine antigens

  At Days 0, 30 and 90

Study Arms (7)

Formulation 1

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189241A

Formulation 2

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189241A

Formulation 3

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189241A

Formulation 4

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189241A

Formulation 5

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189241A

Formulation 6

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189241A

23 valent pneumococcal vaccine

ACTIVE COMPARATOR

Biological: Pneumo 23™

Interventions

Pneumococcal vaccine GSK2189241A BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Formulation 1; Formulation 2; Formulation 3; Formulation 4; Formulation 5; Formulation 6

Pneumo 23™ BIOLOGICAL

One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.

23 valent pneumococcal vaccine

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
• Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health.
• Written informed consent obtained from the subject.

You may not qualify if:

• Previous vaccination against Streptococcus pneumoniae (with a licensed vaccine or with an investigational candidate vaccine).
• Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7 days preceding or at least 7 days following any vaccine dose.
• Administration of immunoglobulins and/or any blood products within the last 3 months.
• Bacterial pneumonia within 3 years prior to 1st vaccination.
• Invasive pneumococcal disease (I.P.D) within 3 years prior to 1st vaccination.
• History of thrombocytopenia or bleeding disorder.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
• History of administration of an experimental/licensed vaccine containing MPL or QS21.
• Current serious neurologic or mental disorders.
• Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
• All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Malmo, SE-205 02, Sweden

Location

GSK Investigational Site

Örebro, SE-701 85, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

Related Publications (1)

• Pauksens K, Nilsson AC, Caubet M, Pascal TG, Van Belle P, Poolman JT, Vandepapeliere PG, Verlant V, Vink PE. Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults. Clin Vaccine Immunol. 2014 May;21(5):651-60. doi: 10.1128/CVI.00807-13. Epub 2014 Mar 5.

  PMID: 24599529 DERIVED

Related Links

• Results for study 111652 can be found on the GSK Clinical Study Register
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: September 19, 2008
• Primary Completion: May 28, 2009
• Study Completion: May 28, 2009
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (3)