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

Primary Purpose

Infections, Streptococcal

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pneumococcal (vaccine)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Streptococcal

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

After each vaccination, occurrence of: solicited local, general symptoms within 4 days;
Unsolicited adverse events within 31 days, SAEs (whole study period)
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

Full Information

First Posted
March 8, 2006
Last Updated
September 23, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00307554
Brief Title
A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1600 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Jyvaskyla
ZIP/Postal Code
40100
Country
Finland
Facility Name
GSK Investigational Site
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
GSK Investigational Site
City
Kotka
ZIP/Postal Code
48100
Country
Finland
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
GSK Investigational Site
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28120
Country
Finland
Facility Name
GSK Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
Facility Name
GSK Investigational Site
City
Bernay
ZIP/Postal Code
27300
Country
France
Facility Name
GSK Investigational Site
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
GSK Investigational Site
City
Courbevoie
ZIP/Postal Code
92400
Country
France
Facility Name
GSK Investigational Site
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
GSK Investigational Site
City
Dax
ZIP/Postal Code
40100
Country
France
Facility Name
GSK Investigational Site
City
Draguignan
ZIP/Postal Code
83300
Country
France
Facility Name
GSK Investigational Site
City
Essey les Nancy
ZIP/Postal Code
54270
Country
France
Facility Name
GSK Investigational Site
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
GSK Investigational Site
City
Maromme
ZIP/Postal Code
76150
Country
France
Facility Name
GSK Investigational Site
City
Nice
ZIP/Postal Code
06300
Country
France
Facility Name
GSK Investigational Site
City
Nogent-sur-Marne
ZIP/Postal Code
94130
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
GSK Investigational Site
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
GSK Investigational Site
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-021
Country
Poland
Facility Name
GSK Investigational Site
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-709
Country
Poland
Facility Name
GSK Investigational Site
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
GSK Investigational Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
19325447
Citation
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.
Results Reference
background
PubMed Identifier
19833248
Citation
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.
Results Reference
background
PubMed Identifier
19325452
Citation
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.
Results Reference
background
PubMed Identifier
21123523
Citation
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.
Results Reference
background
PubMed Identifier
19666154
Citation
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.
Results Reference
background
PubMed Identifier
21994351
Citation
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.
Results Reference
background
PubMed Identifier
19325449
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105553
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105553
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105553
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105553
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105553
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105553
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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