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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00334334
First received: June 6, 2006
Last updated: November 1, 2012
Last verified: October 2012
  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:


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:
Schuerman L et al. (2011) 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. 18(12):2161-2167.
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.
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.

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 April 15, 2014