Evaluation of Pneumococcal Vaccine Formulations in Young Adults

NCT00707798 | Completed Phase 1

• 1 other identifier: 111651
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infections, Streptococcal

Keywords

Young adults; Pneumococcal vaccine,; Streptococcus pneumoniae,

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 Visit 1 to study conclusion

• Occurrence of any grade 3 laboratory abnormalities

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

Secondary Outcomes (4)

• 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 haematological, biochemical, or urinary abnormalities

  At 1 and 7 days after each vaccine dose

• Anti-pneumococcal and anti-NTHi candidate vaccine antigens

  At Days 0, 30 and 90

Study Arms (7)

Formulation 1

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A

Formulation 2

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A

Formulation 3

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A

Formulation 4

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A

Formulation 5

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A

Formulation 6

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A

23 valent pneumococcal vaccine

ACTIVE COMPARATOR

Biological: Pneumo 23™

Interventions

Pneumococcal vaccine GSK2189242A BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested

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: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• A male or female between, and including, 18 and 40 years old at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
• If the subject is female, and of child-bearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.

You may not qualify if:

• Previous vaccination against Streptococcus pneumoniae.
• 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 \> 7 days preceding or \> 7 days following each vaccine dose (after collection of 7-day safety data).
• Bacterial pneumonia within 3 years prior to 1st vaccination.
• Invasive pneumococcal disease (IPD) within 3 years prior to 1st vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of thrombocytopenia or bleeding disorder.
• History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
• 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.
• Acute disease at the time of enrolment/vaccination.
• Physical examination positive for acrocyanosis, jaundice, splenomegaly.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Publications (1)

• Leroux-Roels G, Maes C, De Boever F, Traskine M, Ruggeberg JU, Borys D. Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine. 2014 Nov 28;32(50):6838-46. doi: 10.1016/j.vaccine.2014.02.052. Epub 2014 Mar 6.

  PMID: 24607003 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 111651 can be found on the GSK Clinical Study Register

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: June 30, 2008
• First Posted: July 1, 2008
• Study Start: June 30, 2008
• Primary Completion: January 15, 2009
• Study Completion: January 15, 2009
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)