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Clinical Trials/NCT00463437
NCT00463437CompletedPhase 3

Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

GlaxoSmithKline64 sites in 3 countries1,437 target enrollmentStarted: April 25, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,437
Locations
64
Primary Endpoint
Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
11 Months to 18 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • •A male or female between, and including, 11-18 months of age at the time of the booster vaccination.
  • •A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine.
  • •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

  • •Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
  • •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
  • •Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines).
  • •Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study
  • •History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease.
  • •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • •History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • •Acute disease at the time of enrolment.
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • •A family history of congenital or hereditary immunodeficiency.
  • •Major congenital defects or serious chronic illness.
  • •Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).

Outcomes

Primary Outcomes

Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)

Time Frame: During the 4-day (Day 0-3) period after the booster vaccination

Fever was measured as rectal temperature.

Secondary Outcomes

  • Number of Subjects Reporting Solicited Local Symptoms(During the 4-day (Day 0-3) period after the booster vaccination)
  • Number of Subjects Reporting Solicited General Symptoms(During the 4-day (Day 0-3) period after the booster vaccination)
  • Number of Subjects Reporting Serious Adverse Events (SAE)(From the beginning of the study up to the end of the extended 6-month safety follow-up period)
  • Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 31-day (Day 0-30) period after the booster vaccination)
  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
  • Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (64)

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