Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

NCT ID: NCT00907777

Last Updated: 2020-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-23
• Study Completion Date: 2009-10-05

Brief Summary

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Conditions

Infections, Streptococcal; Streptococcus Pneumoniae

Keywords

Haemophilus influenzae; Streptococcus pneumoniae; safety; Pneumococcal conjugate vaccine; immunogenicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pn Group

Subjects receiving GSK 1024850A vaccine.

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK 1024850A

Intervention Type: BIOLOGICAL

One dose of vaccine will be injected intramuscularly into the deltoid.

Prev Group

Subjects receiving Prevenar™ vaccine.

Group Type: ACTIVE_COMPARATOR

Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

Intervention Type: BIOLOGICAL

One dose of vaccine will be injected intramuscularly into the deltoid.

Interventions

Pneumococcal conjugate vaccine GSK 1024850A

One dose of vaccine will be injected intramuscularly into the deltoid.

Intervention Type: BIOLOGICAL

Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

One dose of vaccine will be injected intramuscularly into the deltoid.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female between, and including, 46-50 months of age at the time of vaccination.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
• Written informed consent obtained from both parents/guardians of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
• Administration of any pneumococcal vaccine since the end of study NCT00333450.
• Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
• History of any neurologic disorders or seizures
• Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
• History of hypotonic-hyporesponsive episode after any previous vaccination.
• Major congenital defects or serious chronic illness.
• History of invasive pneumococcal diseases.
• Acute disease at the time of vaccination
• Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

• Minimum Eligible Age: 46 Months
• Maximum Eligible Age: 50 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Bad Lobenstein, Thuringia, Germany

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, Germany

GSK Investigational Site

Weimar, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

Countries

Germany

References

Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.

Reference Type: BACKGROUND

PMID: 21909049 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2008-007605-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

112807

Identifier Type: -

Identifier Source: org_study_id