Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01545375
First received: March 1, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.


Condition Intervention Phase
Infections, Streptococcal
Biological: Pneumococcal vaccine GSK2189242A
Biological: Placebo
Biological: Prevnar 13®
Biological: PedvaxHIB®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of any clinical AOM episodes diagnosed and verified against American Academy of Pediatrics (AAP) criteria. [ Time Frame: From two weeks after the administration of the third primary dose of the study vaccine up to study end (Month 22) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of any healthcare-provider-diagnosed clinical AOM. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of any clinical AOM episodes diagnosed and verified against modified AAP criteria. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of any recurrent AOM (at least 3 episodes in 6 months or at least 4 episodes in 12 months). [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of any draining AOM. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of any draining pneumococcal AOM. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of any medically attended ALRI. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of medically attended ALRI with fever documented at the visit or history of fever within 3 days preceding a given episode. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of any medically attended healthcare-provider-diagnosed ALRI with fever documented at the visit or history of fever within 3 days preceding a given episode. [ Time Frame: From the administration of the first vaccine dose (Day 0) up to study end (Month 22) ] [ Designated as safety issue: No ]
  • Occurrence of S. pneumoniae (any and serotype specific) in the nasopharynx (in the Carriage subgroup). [ Time Frame: One month post-dose 3 (Month 5), prior to booster vaccination (Month 10) and six (Month 16) and twelve (Month 22) months post-booster vaccination ] [ Designated as safety issue: No ]
  • Immune responses to components of the investigational vaccine in terms of antibody concentrations and activity (in the Immuno/reacto subgroup). [ Time Frame: One month post-dose 3 (Month 5), prior to booster vaccination (Month 10), one (Month 11) and twelve (Month 22) months post-booster vaccination ] [ Designated as safety issue: No ]
  • Immune responses to components of the co-administered Prevnar 13® vaccine in terms of antibody concentrations (in the Immuno/reacto subgroup) [ Time Frame: One month post-dose 3 (Month 5), prior to booster vaccination (Month 10) and one month post-booster vaccination (Month 11) ] [ Designated as safety issue: No ]
  • Immune responses to components of the co-administered PedvaxHIB® vaccine in terms of antibody concentration (in the Immuno/reacto subgroup). [ Time Frame: One month post-dose 3 (Month 5), prior to booster vaccination (Month 10) and one month post-booster vaccination (Month 11) ] [ Designated as safety issue: No ]
  • Immune responses to components of the co-administered Prevnar 13® vaccine for additional parameters (in a subset of children among children in the Immuno/reacto subgroup). [ Time Frame: One month post-dose 3 (Month 5) and one month post-booster vaccination (Month 11) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general adverse events (AEs) (in the Immuno/reacto subgroup) [ Time Frame: Within 4 days (Day 0 - Day 3) after each pneumococcal vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited AEs (in the Immuno/reacto subgroup) [ Time Frame: Within 31 days (Day 0 - Day 30) after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of SAEs (in all children) [ Time Frame: During the entire study period (from Day 0 to Month 22) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: May 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Infants receiving GSK2189242A vaccine co-administered with Prevnar 13® and PedvaxHIB®. PedvaxHIB® will be given as study vaccine for infants of the Immuno/reacto subgroup; for the other infants, this vaccine will be given as part of the routine vaccination schedule
Biological: Pneumococcal vaccine GSK2189242A
4 doses administered intramuscularly
Biological: Prevnar 13®
4 doses administered intramuscularly
Biological: PedvaxHIB®
4 doses administered intramuscularly
Placebo Comparator: Group B
Infants receiving placebo vaccine co-administered with Prevnar 13® and PedvaxHIB® . PedvaxHIB® will be given as study vaccine for infants of the Immuno/reacto subgroup; for the other infants, this vaccine will be given as part of the routine vaccination schedule
Biological: Placebo
4 doses administered intramuscularly
Biological: Prevnar 13®
4 doses administered intramuscularly
Biological: PedvaxHIB®
4 doses administered intramuscularly

Detailed Description:

The study will also evaluate the impact of the pneumococcal vaccine GSK2189242A on nasopharyngeal carriage in a subgroup of children called Carriage subgroup. Immunogenicity and reactogenicity of the pneumococcal vaccine GSK2189242A will be evaluated in another subgroup of children called Immuno/reacto subgroup.

  Eligibility

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

Inclusion Criteria:

  • Subject who the investigator believes that their parent(s)/Legally Authorized Representative(s) (LARs) can and will comply with the requirements of the protocol.
  • A male or female American Indian infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Voluntary, written informed consent obtained from the parents/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
  • Healthy subject as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of more than 35 6/7 weeks.

Exclusion Criteria:

For all infants:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol starting from 30 days before each dose and ending 30 days after each dose of study vaccines, with the exception of licensed inactivated influenza vaccines and recommended pediatric vaccines.
  • 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.
  • Previous vaccination against S. pneumoniae.
  • Obstruction or anomalies of the nasopharyngeal space.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including latex.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Any medical or social condition which might interfere with the assessment of the study objectives in the opinion of the investigator.

For infants in the Immuno/reacto subgroup only:

• Previous vaccination against H. influenzae type b.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545375

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, Arizona
GSK Investigational Site Recruiting
Chinle, Arizona, United States, 86505
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Fort Defiance, Arizona, United States, 86504
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Whiteriver, Arizona, United States, 85941
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, New Mexico
GSK Investigational Site Recruiting
Gallup, New Mexico, United States, 87301
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Shiprock, New Mexico, United States, 87420
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01545375     History of Changes
Other Study ID Numbers: 115597, 2011-003956-38
Study First Received: March 1, 2012
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
nasopharyngeal carriage
safety
immunogenicity
US
Pneumococcal vaccine
efficacy
Streptococcus pneumoniae
infants

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014