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

NCT00334334 | Completed Phase 3

• 1 other identifier: 107005
• Study Type: interventional
• Target: 1,572
• Locations: 3 countries
• Sites: 66

Brief Summary

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.

Conditions

Infections, Streptococcal

Keywords

Streptococcus pneumonia, vaccine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Pneumococcal (vaccine) BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (66)

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, 88348, Germany

Location

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, 74357, Germany

Location

GSK Investigational Site

Bretten, Baden-Wurttemberg, 75015, Germany

Location

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, 77955, Germany

Location

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, 76189, Germany

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68309, Germany

Location

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, 71720, Germany

Location

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

GSK Investigational Site

Tettnang, Baden-Wurttemberg, 88069, Germany

Location

GSK Investigational Site

Cham, Bavaria, 93413, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81675, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81735, Germany

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Olching, Bavaria, 82140, Germany

Location

GSK Investigational Site

Roding, Bavaria, 93426, Germany

Location

GSK Investigational Site

Eschwege, Hesse, 37269, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60389, Germany

Location

GSK Investigational Site

Niedernhausen, Hesse, 65527, Germany

Location

GSK Investigational Site

Wolfenbüttel, Lower Saxony, 38302, Germany

Location

GSK Investigational Site

Herford, North Rhine-Westphalia, 32049, Germany

Location

GSK Investigational Site

Hille, North Rhine-Westphalia, 32479, Germany

Location

GSK Investigational Site

Löhne, North Rhine-Westphalia, 32584, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48163, Germany

Location

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, 32457, Germany

Location

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, 55543, Germany

Location

GSK Investigational Site

Bodenheim, Rhineland-Palatinate, 55294, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Gerolstein, Rhineland-Palatinate, 54568, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54294, Germany

Location

GSK Investigational Site

Worms, Rhineland-Palatinate, 67547, Germany

Location

GSK Investigational Site

Döbeln, Saxony, 04720, Germany

Location

GSK Investigational Site

Singwitz, Saxony, 02692, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10967, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12627, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12679, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13355, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14197, Germany

Location

GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

GSK Investigational Site

Bydgoszcz, 85-021, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, Poland

Location

GSK Investigational Site

Poznan, 61-709, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Wola, 43-225, Poland

Location

GSK Investigational Site

Bilbao, 48013, Spain

Location

GSK Investigational Site

Blanes (Girona), 17300, Spain

Location

GSK Investigational Site

Burgos, 09005, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28035, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Marid, 28040, Spain

Location

GSK Investigational Site

Málaga, 29011, Spain

Location

GSK Investigational Site

Montgat/Barcelona, 08390, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

GSK Investigational Site

San T Vicenç Del Horts ( Barcelona), 08620, Spain

Location

GSK Investigational Site

Tona/Barcelona, 08551, Spain

Location

GSK Investigational Site

Valladolid, 47010, Spain

Location

GSK Investigational Site

Vélez-Málaga / Málaga, 29700, Spain

Location

Related Publications (21)

• 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.

  PMID: 19325447 BACKGROUND

• 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.

  PMID: 19833248 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19325452 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21123523 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19666154 BACKGROUND

• 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.

  PMID: 21994351 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19325449 BACKGROUND

• 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.

  PMID: 19325450 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27145999 DERIVED

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; Pneumonia

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

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: June 6, 2006
• First Posted: June 7, 2006
• Study Start: June 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (45); PL (7); ES (14)