Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

To Assess Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With DTPa-combined Vaccines and MenC or Hib-MenC Vaccines During the First 6 Months of Age.

Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1572
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10315
    • GSK Investigational Site
  • Berlin, Germany, 10967
    • GSK Investigational Site
  • Berlin, Germany, 12627
    • GSK Investigational Site
  • Berlin, Germany, 12679
    • GSK Investigational Site
  • Berlin, Germany, 14197
    • GSK Investigational Site
  • Berlin, Germany, 13355
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
      • GSK Investigational Site
    • Boennigheim, Baden-Wuerttemberg, Germany, 74357
      • GSK Investigational Site
    • Bretten, Baden-Wuerttemberg, Germany, 75015
      • GSK Investigational Site
    • Ettenheim, Baden-Wuerttemberg, Germany, 77955
      • GSK Investigational Site
    • Karlsruhe, Baden-Wuerttemberg, Germany, 76189
      • GSK Investigational Site
    • Kehl, Baden-Wuerttemberg, Germany, 77694
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68309
      • GSK Investigational Site
    • Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
      • GSK Investigational Site
    • Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70469
      • GSK Investigational Site
    • Tettnang, Baden-Wuerttemberg, Germany, 88069
      • GSK Investigational Site
  • Bayern
    • Cham, Bayern, Germany, 93413
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81735
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81675
      • GSK Investigational Site
    • Noerdlingen, Bayern, Germany, 86720
      • GSK Investigational Site
    • Olching, Bayern, Germany, 82140
      • GSK Investigational Site
    • Roding, Bayern, Germany, 93426
      • GSK Investigational Site
  • Hessen
    • Eschwege, Hessen, Germany, 37269
      • GSK Investigational Site
    • Frankfurt, Hessen, Germany, 60389
      • GSK Investigational Site
    • Niedernhausen, Hessen, Germany, 65527
      • GSK Investigational Site
  • Niedersachsen
    • Wolfenbuettel, Niedersachsen, Germany, 38302
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Herford, Nordrhein-Westfalen, Germany, 32049
      • GSK Investigational Site
    • Hille, Nordrhein-Westfalen, Germany, 32479
      • GSK Investigational Site
    • Loehne, Nordrhein-Westfalen, Germany, 32584
      • GSK Investigational Site
    • Muenster, Nordrhein-Westfalen, Germany, 48163
      • GSK Investigational Site
    • Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
      • GSK Investigational Site
    • Bodenheim, Rheinland-Pfalz, Germany, 55294
      • GSK Investigational Site
    • Frankenthal, Rheinland-Pfalz, Germany, 67227
      • GSK Investigational Site
    • Gerolstein, Rheinland-Pfalz, Germany, 54568
      • GSK Investigational Site
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
    • Trier, Rheinland-Pfalz, Germany, 54290
      • GSK Investigational Site
    • Trier, Rheinland-Pfalz, Germany, 54294
      • GSK Investigational Site
    • Worms, Rheinland-Pfalz, Germany, 67547
      • GSK Investigational Site
  • Sachsen
    • Doebeln, Sachsen, Germany, 04720
      • GSK Investigational Site
    • Singwitz, Sachsen, Germany, 02692
      • GSK Investigational Site
  • Thueringen
    • Lobenstein, Thueringen, Germany, 07356
      • GSK Investigational Site
    • Weimar, Thueringen, Germany, 99425
      • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-021
    • GSK Investigational Site
  • Debica, Poland, 39-200
    • GSK Investigational Site
  • Krakow, Poland
    • GSK Investigational Site
  • Poznan, Poland, 61-709
    • GSK Investigational Site
  • Siemianowice Slaskie, Poland, 41-103
    • GSK Investigational Site
  • Tarnow, Poland, 33-100
    • GSK Investigational Site
  • Wola, Poland, 43-225
    • GSK Investigational Site
• Spain
  • Bilbao, Spain, 48013
    • GSK Investigational Site
  • Blanes (Girona), Spain, 17300
    • GSK Investigational Site
  • Burgos, Spain, 09005
    • GSK Investigational Site
  • Madrid, Spain, 28047
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28035
    • GSK Investigational Site
  • Marid, Spain, 28040
    • GSK Investigational Site
  • Montgat/Barcelona, Spain, 08390
    • GSK Investigational Site
  • Málaga, Spain, 29011
    • GSK Investigational Site
  • Móstoles/Madrid, Spain, 28935
    • GSK Investigational Site
  • San t Vicenç del Horts ( Barcelona), Spain, 08620
    • GSK Investigational Site
  • Tona/Barcelona, Spain, 08551
    • GSK Investigational Site
  • Valladolid, Spain, 47010
    • GSK Investigational Site
  • Vélez-Málaga / Málaga, Spain, 29700
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female between, and including, 6-16 weeks (42 to 118 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 preceding the first dose of study vaccine, or planned use during the entire study period.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
• Previous vaccinations against diseases which are targeted by the vaccines used in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Post at least 1 dose: rectal fever >39°C

Secondary Outcome Measures

Outcome Measure
Post each dose: solicited/unsolicited AEs (4/31 days), SAEs (whole study); post dose 2 & 3: Ab conc to vaccine antigens

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.
• Wysocki J, Tejedor JC, Grunert D, Konior R, Garcia-Sicilia J, Knuf M, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S77-88. doi: 10.1097/INF.0b013e318199f609.
• 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.
• Tejedor JC, Brzostek J, Konior R, Grunert D, Kolhe D, Baine Y, Van Der Wielen M. Antibody Persistence in Young Children 5 Years after Vaccination with a Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C Conjugate Vaccine Coadministered with Diphtheria-Tetanus-Acellular Pertussis-Based and Pneumococcal Conjugate Vaccines. Clin Vaccine Immunol. 2016 Jul 5;23(7):555-63. doi: 10.1128/CVI.00057-16. Print 2016 Jul.
• 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.
• Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• 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.
• Hausdorff WP et al. Estimation of the direct impact of a 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV) candidate against invasive pneumococcal disease (IPD). Abstract presented at the 6th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Reykjavik, Iceland, 8-12 June 2008.
• Knuf M et al. Safety and reactogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV). Abstract presented at the 6th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Reykjavik, Iceland, 8-12 June 2008.
• Poolman J et al. Anti-pneumococcal serotype 19F/A antibody functionality is influenced by the vaccine conjugation method. Abstract presented at the PHAA, 12th National Immunisation Conference. Adelaide, Australia, 17-19 August 2010.
• Poolman J et al. Functionality of conjugate vaccine-induced antibodies against pneumococcal serotype 19F is influenced by the conjugation method. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• 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.
• Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• Schuerman L et al. Immune responses to the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) appear not influenced by co-administration with DTPw-combination vaccine. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• Schuerman L et al. OPA assay is more reliable predictor of vaccine effectiveness against invasive pneumococcal disease (IPD) than ELISA antibody measurements. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
• Schuerman L et al. Prevention of invasive pneumococcal disease and meningitis with PHiD-CV when used according to a 2+1 schedule. Abstract presented at the Meningitis Research Foundation Conference (MRFC). London, UK, 11-12 November 2009.
• Tejedor JC et al. Co-administration of the new 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHIDCV) with other routine paediatric vaccines. Abstract presented at the 6th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Reykjavik, Iceland, 8-12 June 2008.
• Wysocki J et al. Immunogenicity of the new 10-valent pneumoccocal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiDCV) in infants after 3-dose priming before 6 months of age. Abstract presented at the 6th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Reykjavik, Iceland, 8-12 June 2008.

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: June 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: June 6, 2006
• First Submitted That Met QC Criteria: June 6, 2006
• First Posted (Estimate): June 7, 2006

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Streptococcus pneumonia, vaccine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: 107005

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. Dataset Specification
   Information identifier: 107005
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 107005
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 107005
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 107005
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 107005
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 107005
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register