Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Completed · Phase 3

Conditions studied: Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus, Acellular Pertussis, Hepatitis B

In brief

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Key facts

Study ID

NCT02096263

Run by

GlaxoSmithKline

People needed

585

Starts

2014-04-16

Expected to finish

2015-11-13

Last updated by the study team

2019-11-27

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) (LARs) 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.
• Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks [259 to 293 days]).
• Written informed consent obtained from parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• 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 enrolment.

You may not qualify if…

• Child in care
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study:
• Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
• Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
• 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 (pharmaceutical product or device).
• History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases.
• Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast).
• Hypersensitivity to latex.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders including seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
• History of Severe Combined Immunodeficiency Disease (SCID).
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred route for recording temperature in this study will be rectal for Epoch 001 and axillary for Epoch 002.
• Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Where it is running

• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Fayetteville, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Daly City, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Hayward, California, United States
• GSK Investigational Site — Oakland, 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 — 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 — Colorado Springs, Colorado, United States
• GSK Investigational Site — Altamonte Springs, Florida, United States
• GSK Investigational Site — Orange City, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Augusta, Kansas, United States
• GSK Investigational Site — Newton, Kansas, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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