Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children

GlaxoSmithKline1 site in 1 country466 target enrollmentAugust 10, 2009

ConditionsInfections, Streptococcal

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Streptococcal
Sponsor: GlaxoSmithKline
Enrollment: 466
Locations: 1
Primary Endpoint: Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Detailed Description

This protocol posting has been updated according to Protocol Amendment 1, July 2009

Registry

clinicaltrials.gov

Start Date

August 10, 2009

End Date

October 27, 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
•Subjects who previously participated in study NCT00496015
•For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment
•For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•History of seizures or progressive neurological disease.
•Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
•Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
•A family history of congenital or hereditary immunodeficiency.

Outcomes

Primary Outcomes

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Time Frame: At 7-10 days after the first vaccine dose

Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

Secondary Outcomes

Memory B-cell Detection for Vaccine Polysaccharides (PS)(Prior to (Day 0) and 7-10 days after the first vaccine dose)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes(At Month 12, one month after the second vaccine dose)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period following each dose and across doses)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period following each dose and across doses)
Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 31 days (Days 0-30) after each vaccination)
Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Month 10 or Month 12))
Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A(At Month 12, one month after the second vaccine dose)
Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Number of Nasopharyngeal Swabs With Haemophilus Influenzae(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Antibody Concentrations Against Protein D (Anti-PD)(At Month 12, one month after the second vaccine dose)
Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)(At 25-36 months post-vaccination in previous 107137 (NCT00496015) study)
Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Antibody Concentrations Against Vaccine Pneumococcal Serotypes(At Month 12, one month after the second vaccine dose)
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A(At Month 12, one month after the second vaccine dose)
Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)
Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs(At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age)