Text Size

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01641133
First received: July 12, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The primary aim of this study is to assess the reactogenicity of Synflorix™ vaccine and Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with either Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix™ vaccine and Prevenar 13™ vaccine after primary vaccination at 2 and 4 months of age with either Synflorix™ or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix™ vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix™ vaccine or Prevenar 13™ vaccine or Prevenar 13™ and Synflorix™, respectively.


Condition Intervention Phase
Pneumococcal Diseases
 Biological: Synflorix™
Biological: Prevenar 13 ™
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of grade 3 solicited adverse events (AE) [ Time Frame: Within 4 days (Day 0- Day 3) after any dose of primary vaccination ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 unsolicited AE [ Time Frame: Within 31 days (Day 0- Day 30) after any dose of primary vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0-Day 3) after each vaccine dose and within 31 days (Day 0 - Day 30) after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0-Day 30) after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of Serious adverse events [ Time Frame: From first vaccination (Month 0) up to study end (11-14 months). ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the pneumococcal vaccine(s) [ Time Frame: One month after primary vaccination, prior to and one month after booster vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Subjects will receive Synflorix™ at Month 0, Month 2 and Month 10.
 Biological: Synflorix™
3 doses administered intramuscularly for Group A, 2 doses administered intramuscularly for Group B, 1 dose administered intramuscularly for Group C.
Experimental: Group B
Subjects will receive Prevenar 13™ at Month 0 and Synflorix™ at Month 2 and Month 10.
 Biological: Synflorix™
3 doses administered intramuscularly for Group A, 2 doses administered intramuscularly for Group B, 1 dose administered intramuscularly for Group C.
Biological: Prevenar 13 ™
1 dose administered intramuscularly for Group B, 2 doses administered intramuscularly for Group C.
Experimental: Group C
Subjects will receive Prevenar 13 ™ at Month 0 and Month 2 and Synflorix™ at Month10.
 Biological: Synflorix™
3 doses administered intramuscularly for Group A, 2 doses administered intramuscularly for Group B, 1 dose administered intramuscularly for Group C.
Biological: Prevenar 13 ™
1 dose administered intramuscularly for Group B, 2 doses administered intramuscularly for Group C.

Detailed Description:

This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

  Eligibility

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

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any seizures or progressive neurological disease.
  • Administration of immunoglobulins and/or blood products since birth or planned use during the study.
  • Acute disease and/or fever at the time of enrolment.
  • Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641133

Locations
Mexico
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62210
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
GSK Investigational Site
Mexico, Mexico, 04530
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01641133     History of Changes
Other Study ID Numbers: 115992
Study First Received: July 12, 2012
Last Updated: April 25, 2013
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Keywords provided by GlaxoSmithKline:
pneumococcal conjugate vaccine
Synflorix™
Prevenar 13™
Pneumococcal diseases

ClinicalTrials.gov processed this record on May 22, 2013