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

Infections, Streptococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307554
• Other study ID #: 105553
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2006
• Last updated: September 23, 2016
• Start date: November 2005
• Est. completion date: June 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Streptococcal
• Streptococcal Infections

Intervention

Biological:
• Pneumococcal (vaccine)

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Jyvaskyla
Finland	GSK Investigational Site	Kokkola
Finland	GSK Investigational Site	Kotka
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Vantaa
Finland	GSK Investigational Site	Vantaa
France	GSK Investigational Site	Bernay
France	GSK Investigational Site	Colombes
France	GSK Investigational Site	Courbevoie
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Dax
France	GSK Investigational Site	Draguignan
France	GSK Investigational Site	Essey les Nancy
France	GSK Investigational Site	Le Havre
France	GSK Investigational Site	Maromme
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Nogent-sur-Marne
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Rouen
France	GSK Investigational Site	Saint Quentin
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Siemianowice Slaskie
Poland	GSK Investigational Site	Trzebnica

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Finland,  France,  Poland, 

References & Publications (7)

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. Review. — View 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. Review. — View 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. Review. — View Citation

Poolman J, Frasch C, Nurkka A, Käyhty 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. — View 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. Review. — View 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. — View Citation

Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsène 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. — View Citation

Outcome

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

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