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

Purpose

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.

Condition	Intervention	Phase
Prophylaxis Pneumococcal Vaccine	Biological: Pneumococcal (vaccine)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Post at least 1 dose: rectal fever >39°C [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post each dose: solicited/unsolicited AEs (4/31 days), SAEs (whole study); post dose 2 & 3: Ab conc to vaccine antigens [ Designated as safety issue: No ]

Enrollment:	1572
Study Start Date:	June 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334334

Show 64 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

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.

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.

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.

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.

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.

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. Epub 2009 Aug 8. Review.

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. Epub 2009 Oct 13. Review.

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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00334334 History of Changes
Other Study ID Numbers:	107005
Study First Received:	June 6, 2006
Last Updated:	November 1, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Streptococcus pneumonia, vaccine

ClinicalTrials.gov processed this record on May 16, 2013