Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
2 other identifiers
interventional
585
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
April 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2015
CompletedResults Posted
Study results publicly available
August 1, 2018
CompletedNovember 27, 2019
November 1, 2019
10 months
March 21, 2014
July 5, 2018
November 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
At Month 5, one month after the third dose of the primary vaccination.
Secondary Outcomes (42)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Tetanus (T).
At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Diphtheria (D).
At Month 5, one month after the third dose of the primary vaccination.
Antibody Concentrations for Anti-T.
At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-D.
At Month 5, one month after the third dose of the primary vaccination
- +37 more secondary outcomes
Study Arms (3)
Infanrix hexa Group
EXPERIMENTALSubjects 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.
Pediarix Group
ACTIVE COMPARATORSubjects 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.
Pentacel Group
ACTIVE COMPARATORSubjects 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.
Interventions
Eligibility Criteria
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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (43)
GSK Investigational Site
Tucson, Arizona, 85741, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Anaheim, California, 92804, United States
GSK Investigational Site
Daly City, California, 94015, United States
GSK Investigational Site
Fresno, California, 93726, United States
GSK Investigational Site
Hayward, California, 94545, United States
GSK Investigational Site
Oakland, California, 94611, United States
GSK Investigational Site
Pleasanton, California, 94588, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
San Jose, California, 95119, United States
GSK Investigational Site
Santa Clara, California, 95051, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Colorado Springs, Colorado, 80922, United States
GSK Investigational Site
Altamonte Springs, Florida, 32701, United States
GSK Investigational Site
Orange City, Florida, 32763, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Nampa, Idaho, 83686, United States
GSK Investigational Site
Augusta, Kansas, 67010, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Topeka, Kansas, 66604, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Louisville, Kentucky, 40291, United States
GSK Investigational Site
Nicholasville, Kentucky, 40356, United States
GSK Investigational Site
Columbia, Maryland, 21045, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Dayton, Ohio, 45414, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Payson, Utah, 84651, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
St. George, Utah, 84790, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Charlottesville, Virginia, 22902, United States
GSK Investigational Site
Ellensburg, Washington, 98926, United States
Related Publications (1)
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.
PMID: 30444673BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2014
First Posted
March 26, 2014
Study Start
April 16, 2014
Primary Completion
February 6, 2015
Study Completion
November 13, 2015
Last Updated
November 27, 2019
Results First Posted
August 1, 2018
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD is available via the Clinical Study Data Request site (click on the link provided below)