Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

An Open, Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00327522

Enrollment

Registered

2006-05-18

Start date

2006-06-30

Completion date

Unknown

Last updated

2008-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylactic Pneumococcal Diseases

Brief summary

The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Detailed description

The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Interventions

BIOLOGICALpneumococcal vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy male or female between 18 and 40 years of age * 23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion criteria

* Previous vaccination against Streptococcus pneumoniae. * History of pneumonia within 3 years prior to the first vaccination * Any confirmed or suspected immunosuppressive or immunodeficient condition * All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. * Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal) * History of administration of an experimental/licensed vaccine containing similar adjuvants. * History of chronic alcohol consumption and/or drug abuse. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.

Design outcomes

Primary

Measure	Time frame
Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;	—
Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026