Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age

Completed · Phase 3

Conditions studied: Neisseria Meningitidis, Haemophilus Influenzae Type b

In brief

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.

Key facts

Study ID

NCT01978093

Run by

GlaxoSmithKline

People needed

600

Starts

2014-02-01

Expected to finish

2016-03-18

Last updated by the study team

2018-09-14

Who can join

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

You may qualify if…

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive).
• Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.

You may not qualify if…

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. Inhaled and topical steroids are allowed.
• Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB.
• History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
• Major congenital defects or serious chronic illnesses.
• History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed.
• Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions.
• Acute disease and/or fever at the time of enrollment.
• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Fayetteville, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Pleasanton, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Fall River, Massachusetts, United States
• GSK Investigational Site — Woburn, Massachusetts, United States
• GSK Investigational Site — Niles, Michigan, United States
• GSK Investigational Site — Stevensville, Michigan, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Hermitage, Pennsylvania, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Layton, Utah, United States
• GSK Investigational Site — Murray, Utah, United States
• GSK Investigational Site — Orem, Utah, United States
• GSK Investigational Site — Roy, Utah, United States

Full record on ClinicalTrials.gov

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