A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study

Assess Lot-to-lot Consistency of 3 Lots (Double Blind Design) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Vaccine and Evaluate Non-inferiority to Prevenar™ (Single Blind Design) When Administered as 3-dose Primary Immunization Course Before 6 Months of Age

Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Biological: Pneumococcal (vaccine)

Detailed Description

Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined vaccine; Control group receiving Prevenar + DTPa combined vaccine

• Study Type: Interventional
• Enrollment: 1600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Jyvaskyla, Finland, 40100
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Kotka, Finland, 48100
    • GSK Investigational Site
  • Kuopio, Finland, 70100
    • GSK Investigational Site
  • Lahti, Finland, 15140
    • GSK Investigational Site
  • Oulu, Finland, 90100
    • GSK Investigational Site
  • Pori, Finland, 28120
    • GSK Investigational Site
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33200
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
  • Vantaa, Finland, 01300
    • GSK Investigational Site
  • Vantaa, Finland, 01600
    • GSK Investigational Site
• France
  • Bernay, France, 27300
    • GSK Investigational Site
  • Colombes, France, 92701
    • GSK Investigational Site
  • Courbevoie, France, 92400
    • GSK Investigational Site
  • Créteil, France, 94000
    • GSK Investigational Site
  • Dax, France, 40100
    • GSK Investigational Site
  • Draguignan, France, 83300
    • GSK Investigational Site
  • Essey les Nancy, France, 54270
    • GSK Investigational Site
  • Le Havre, France, 76600
    • GSK Investigational Site
  • Maromme, France, 76150
    • GSK Investigational Site
  • Nice, France, 06300
    • GSK Investigational Site
  • Nogent-sur-Marne, France, 94130
    • GSK Investigational Site
  • Paris, France, 75019
    • GSK Investigational Site
  • Rouen, France, 76000
    • GSK Investigational Site
  • Saint Quentin, France, 02100
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-021
    • GSK Investigational Site
  • Debica, Poland, 39-200
    • GSK Investigational Site
  • Krakow, Poland, 31-202
    • GSK Investigational Site
  • Poznan, Poland, 61-709
    • GSK Investigational Site
  • Siemianowice Slaskie, Poland, 41-103
    • GSK Investigational Site
  • Trzebnica, Poland, 55-100
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
• Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lot-to-lot consistency: antibody (Ab) concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD
Non-inferiority of 10-valent pneumococcal conjugate vaccine (pooled data of 3 10-Pn-PD-DiT vaccine groups) w.r.t. Prevenar: all anti-pneumococcal serotypes Ab concentrations>=0.20 µg/mL

Secondary Outcome Measures

Outcome Measure	Time Frame
Unsolicited adverse events within 31 days, SAEs (whole study period)
After each vaccination, occurrence of: solicited local, general symptoms within 4 days;	After each vaccination
1m post dose3: For all vaccine pneumococcal serotypes: Opsono titres
Antibody (Ab) concentrations >= 0.20 µg/mL
Ab concentrations to protein D and seropositivity (S+) status
S+/seroprotection status to antigens in DTPa combo vaccine

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.
• Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.
• Poolman J, Frasch C, Nurkka A, Kayhty H, Biemans R, Schuerman L. Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 2011 Feb;18(2):327-36. doi: 10.1128/CVI.00402-10. Epub 2010 Dec 1.
• Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.
• Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsene JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef.
• Hausdorff WP, Dagan R, Beckers F, Schuerman L. Estimating the direct impact of new conjugate vaccines against invasive pneumococcal disease. Vaccine. 2009 Dec 9;27(52):7257-69. doi: 10.1016/j.vaccine.2009.09.111. Epub 2009 Oct 13.
• Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: March 8, 2006
• First Submitted That Met QC Criteria: March 23, 2006
• First Posted (Estimate): March 28, 2006

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: 105553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 105553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 105553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 105553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 105553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 105553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 105553
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register