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

NCT00907777 | Completed Phase 3 Results

• 2 other identifiers: 1128072008-007605-37
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• Vaccine Pneumococcal Serotype Antibody Concentrations

  The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

  Before (PRE) and one month after (POST) the additional dose

Secondary Outcomes (8)

• Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

  Before (PRE) and one month after (POST) the additional dose

• Cross-reactive Pneumococcal Serotype Antibody Concentrations

  Before (PRE) and one month after (POST) the additional dose

• Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes

  Before (PRE) and one month after (POST) the additional dose

• Anti-protein D Antibody Concentrations

  Before (PRE) and one month after (POST) the additional dose

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

  During the 8-day (Days 0-7) post-additional dose

Study Arms (2)

Pn Group

EXPERIMENTAL

Subjects receiving GSK 1024850A vaccine.

Biological: Pneumococcal conjugate vaccine GSK 1024850A

Prev Group

ACTIVE COMPARATOR

Subjects receiving Prevenar™ vaccine.

Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

Interventions

Pneumococcal conjugate vaccine GSK 1024850A BIOLOGICAL

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

Pn Group

Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's) BIOLOGICAL

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

Prev Group

Eligibility Criteria

• Age: 46 Months - 50 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68163, Germany

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, 32549, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

Location

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, 41236, Germany

Location

GSK Investigational Site

Willich, North Rhine-Westphalia, 47877, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04178, Germany

Location

GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

Location

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, 98724, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

GSK Investigational Site

Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Berlin, 14197, Germany

Location

Related Publications (1)

• 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.

  PMID: 21909049 BACKGROUND

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.

MeSH Terms

Conditions

Streptococcal Infections; Haemophilus Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: June 23, 2009
• Primary Completion: October 5, 2009
• Study Completion: October 5, 2009
• Last Updated: November 23, 2020
• Results First Posted: January 6, 2017

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (17)