Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
NCT ID: NCT02096263
Last Updated: 2019-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
585 participants
INTERVENTIONAL
2014-04-16
2015-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Infanrix hexa Group
Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Infanrix hexa
3 doses administered intramuscularly in the right thigh.
Infanrix
1 dose administered intramuscularly in the right thigh
Hiberix
1 dose administered intramuscularly in the left thigh
Prevnar13
3 doses administered intramuscularly in the lower left thigh
Rotarix
2 doses administered orally
Pediarix Group
Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Pediarix
3 doses administered intramuscularly in the right thigh
ActHIB
4 doses administered intramuscularly in the upper left thigh
Infanrix
1 dose administered intramuscularly in the right thigh
Prevnar13
3 doses administered intramuscularly in the lower left thigh
Rotarix
2 doses administered orally
Pentacel Group
Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Pentacel
4 doses administered intramuscularly in the right thigh
Engerix-B
2 or 3 doses administered intramuscularly in the upper left thigh
Prevnar13
3 doses administered intramuscularly in the lower left thigh
Rotarix
2 doses administered orally
Interventions
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Infanrix hexa
3 doses administered intramuscularly in the right thigh.
Pediarix
3 doses administered intramuscularly in the right thigh
ActHIB
4 doses administered intramuscularly in the upper left thigh
Pentacel
4 doses administered intramuscularly in the right thigh
Engerix-B
2 or 3 doses administered intramuscularly in the upper left thigh
Infanrix
1 dose administered intramuscularly in the right thigh
Hiberix
1 dose administered intramuscularly in the left thigh
Prevnar13
3 doses administered intramuscularly in the lower left thigh
Rotarix
2 doses administered orally
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
6 Weeks
12 Weeks
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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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
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Nicholasville, Kentucky, United States
GSK Investigational Site
Columbia, Maryland, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Sellersville, Pennsylvania, United States
GSK Investigational Site
Kingsport, Tennessee, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Payson, Utah, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
St. George, Utah, United States
GSK Investigational Site
West Jordan, Utah, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Ellensburg, Washington, United States
Countries
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References
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Klein NP, Abu-Elyazeed R, Cheuvart B, Janssens W, Mesaros N. Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States. Hum Vaccin Immunother. 2019;15(4):809-821. doi: 10.1080/21645515.2018.1549449. Epub 2019 Jan 4.
Related Links
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Full CSR redacted with additional report posting on GSK.
Other Identifiers
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2013-004304-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
117119
Identifier Type: -
Identifier Source: org_study_id
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