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

Completed · Phase 2 · Has a placebo group

Conditions studied: Infections, Streptococcal

In brief

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.

Key facts

Study ID

NCT01545375

Run by

GlaxoSmithKline

People needed

1806

Starts

2012-05-21

Expected to finish

2016-07-26

Last updated by the study team

2019-12-27

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Chinle, Arizona, United States
• GSK Investigational Site — Fort Defiance, Arizona, United States
• GSK Investigational Site — Whiteriver, Arizona, United States
• GSK Investigational Site — Gallup, New Mexico, United States
• GSK Investigational Site — Shiprock, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.