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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 16, 2006
Last updated: November 21, 2012
Last verified: November 2012

Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.

Condition Intervention Phase
Prophylaxis Pneumococcal Vaccine
Biological: Pneumococcal (vaccine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: To Assess Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix™ Hexa) at 2, 4 and 6 Months of Age.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • After each dose: Grade 3 AEs

Secondary Outcome Measures:
  • After each dose: solicited/unsolicited AEs (4/31 days),SAEs (whole study); 1 month post 3: antibody concns to vaccine antigens

Estimated Enrollment: 240
Study Start Date: April 2006
Intervention Details:
    Biological: Pneumococcal (vaccine)
    Other Name: Pneumococcal (vaccine)
Detailed Description:

Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK Biologicals' Havrix + DTPa combined vaccine


Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 preceding the first dose of study vaccine, or planned use during the study period.
  • Planned administration/ administration of a 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00338351

GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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 Identifier: NCT00338351     History of Changes
Other Study ID Numbers: 106208
Study First Received: June 16, 2006
Last Updated: November 21, 2012
Health Authority: Chile:Ministerio de Salud de Chile processed this record on October 23, 2014