PoliomyelitisPhase 3NCT02096263

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

A Phase 3 study testing Infanrix hexa, Pediarix and ActHIB in people with Poliomyelitis and Diphtheria, run by GlaxoSmithKline at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b
What is being tested?: Infanrix hexa, Pediarix and ActHIB
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 585 participants
Where: 43 sitesUnited States
Study dates: 16 Apr 2014to 13 Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Show all 21Show fewer

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.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

GSK Investigational Site
Altamonte Springs, Florida, 32701
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Augusta, Kansas, 67010
GSK Investigational Site
Charlottesville, Virginia, 22902
GSK Investigational Site
Colorado Springs, Colorado, 80922
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Dayton, Ohio, 45414
GSK Investigational Site
Ellensburg, Washington, 98926
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Nicholasville, Kentucky, 40356
GSK Investigational Site
Oakland, California, 94611
GSK Investigational Site
Orange City, Florida, 32763
GSK Investigational Site
Payson, Utah, 84651
GSK Investigational Site
Pleasanton, California, 94588
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Sellersville, Pennsylvania, 18960
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Topeka, Kansas, 66604
GSK Investigational Site
Tucson, Arizona, 85741
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Wichita, Kansas, 67205
GSK Investigational Site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Conditions: Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus, Acellular Pertussis, Hepatitis B
Being tested: Infanrix hexa, Pediarix, ActHIB, Pentacel, Engerix-B
Keywords: Infants, Safety, Healthy, Infanrix Hexa, Immunogenicity
Medical subject headings: Poliomyelitis, Diphtheria, Haemophilus Infections, Tetanus, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Infanrix hexaBiological
3 doses administered intramuscularly in the right thigh.
PediarixBiological
3 doses administered intramuscularly in the right thigh
ActHIBBiological
4 doses administered intramuscularly in the upper left thigh
PentacelBiological
4 doses administered intramuscularly in the right thigh
Engerix-BBiological
2 or 3 doses administered intramuscularly in the upper left thigh
InfanrixBiological
1 dose administered intramuscularly in the right thigh
HiberixBiological
1 dose administered intramuscularly in the left thigh
Prevnar13Biological
3 doses administered intramuscularly in the lower left thigh
RotarixBiological
2 doses administered orally

Study groups in NCT02096263
Study group	Role	What they receive
Infanrix hexa Group	Experimental	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. Receives: Biological: Infanrix hexa; Biological: Infanrix; Biological: Hiberix; Biological: Prevnar13; Biological: Rotarix
Pediarix Group	Active comparator	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. Receives: Biological: Pediarix; Biological: ActHIB; Biological: Infanrix; Biological: Prevnar13; Biological: Rotarix
Pentacel Group	Active comparator	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. Receives: Biological: Pentacel; Biological: Engerix-B; Biological: Prevnar13; Biological: Rotarix

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Measured: At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Tetanus (T).
A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Diphtheria (D).
A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination.
Antibody Concentrations for Anti-T.
Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-D.
Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Measured: At Month 5, one month after the third dose of the primary vaccination
Antibody Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Measured: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).
A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-PRP.
Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).
Measured: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-HBs.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Measured: At Month 5, one month after the third dose of the primary vaccination
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Measured: During the 4-day (Days 0-3) post-vaccination period following Dose 1
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Measured: During the 4-day (Days 0-3) post-vaccination period following Dose 2
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA
Measured: During the 4-day (Days 0-3) post-vaccination period following Dose 3
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Measured: During the 4-day (Days 0-3) post-vaccination period following any dose.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following Dose 1.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following Dose 2.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following Dose 3.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following any dose.
Number of Subjects With Specific Adverse Events (AEs).
Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Measured: From Month 0 up to 6 months post primary-vaccination (Month 10)
Number of Subjects With Unsolicited AEs.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day (Days 0-30) post-primary vaccination period.
Number of Subjects With Serious Adverse Events (SAEs).
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: From Month 0 up to 6 months post-primary vaccination (Month 10)
Number of Seroprotected Subjects Against Anti-T.
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-D.
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-T.
Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-D.
Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Measured: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-PT, Anti-FHA and 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.
Measured: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.
Booster response to PT, FHA and PRN antigens was defined as:
- For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off.
- For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration.
- For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration.
The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Measured: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-PRP.
A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Antibody Concentrations for Anti-PRP.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Antibody Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-HBs.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Antibody Concentrations for Anti-HBs.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Measured: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Measured: During the 4-day (Days 0-3) post-booster vaccination.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Measured: During the 4-day (Days 0-3) post-booster vaccination.
Number of Subjects With Specific AEs.
Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Measured: During the 31-day (Days 0-30) post-booster vaccination.
Number of Subjects With Unsolicited AEs.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day (Days 0-30) post-booster vaccination.
Number of Subjects With SAEs.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: During the 31-day (Days 0-30) post-booster vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 201413 Nov 2015

First posted26 Mar 2014 (estimated)
Study start16 Apr 2014
Primary completion6 Feb 2015
Study completion13 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PoliomyelitisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 585 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02096263
Sponsor's protocol ID: 117119
Other IDs: 2013-004304-19
Status last verified: Nov 2019
First submitted: 21 Mar 2014
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

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.
PubMed 30444673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

All Poliomyelitis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
ClinicalTrials.gov ID: NCT02096263
Acronym / sponsor ID: 117119
Conditions: Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus, Acellular Pertussis, Hepatitis B
Keywords: Infants, Safety, Healthy, Infanrix Hexa, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 585 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Apr 2014 (actual)
Primary completion: 6 Feb 2015 (actual)
Study completion: 13 Nov 2015 (actual)
First posted: 26 Mar 2014 (estimated)
Results: Posted 1 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Infanrix hexa Group	Experimental	Biological: Infanrix hexa, Biological: Infanrix, Biological: Hiberix, Biological: Prevnar13, Biological: RotarixSubjects 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 comparator	Biological: Pediarix, Biological: ActHIB, Biological: Infanrix, Biological: Prevnar13, Biological: RotarixSubjects 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 comparator	Biological: Pentacel, Biological: Engerix-B, Biological: Prevnar13, Biological: RotarixSubjects 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.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (21 listed)

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:
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Infanrix hexa3 doses administered intramuscularly in the right thigh.	Biological	Infanrix hexa Group
Pediarix3 doses administered intramuscularly in the right thigh	Biological	Pediarix Group
ActHIB4 doses administered intramuscularly in the upper left thigh	Biological	Pediarix Group
Pentacel4 doses administered intramuscularly in the right thigh	Biological	Pentacel Group
Engerix-B2 or 3 doses administered intramuscularly in the upper left thigh	Biological	Pentacel Group
Infanrix1 dose administered intramuscularly in the right thigh	Biological	Infanrix hexa Group, Pediarix Group
Hiberix1 dose administered intramuscularly in the left thigh	Biological	Infanrix hexa Group
Prevnar133 doses administered intramuscularly in the lower left thigh	Biological	Infanrix hexa Group, Pediarix Group, Pentacel Group
Rotarix2 doses administered orally	Biological	Infanrix hexa Group, Pediarix Group, Pentacel Group

Primary outcome

Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Time frame: At Month 5, one month after the third dose of the primary vaccination.
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.

42 secondary outcomes

Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Tetanus (T).
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Diphtheria (D).
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Antibody Concentrations for Anti-T.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-D.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Titres for Anti-polio Types 1, 2 and 3.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-PRP.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-HBs.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.
Number of Subjects With Specific Adverse Events (AEs).
Time frame: From Month 0 up to 6 months post primary-vaccination (Month 10)
Number of Subjects With Unsolicited AEs.
Time frame: During the 31-day (Days 0-30) post-primary vaccination period.
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Month 0 up to 6 months post-primary vaccination (Month 10)
Number of Seroprotected Subjects Against Anti-T.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-D.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-T.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-D.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-PRP.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Antibody Concentrations for Anti-PRP.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Antibody Titres for Anti-polio Types 1, 2 and 3.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-HBs.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Antibody Concentrations for Anti-HBs.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Number of Subjects With Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-booster vaccination.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-booster vaccination.
Number of Subjects With Specific AEs.
Time frame: During the 31-day (Days 0-30) post-booster vaccination.

Results and safety

Results posted to the registry on 1 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infanrix Hexa Group	195	161
Pediarix Group	194	158
Pentacel Group	196	157

Primary outcome: Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).

Time frame: At Month 5, one month after the third dose of the primary vaccination.. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Infanrix Hexa Group n = 146	Pediarix Group n = 149	Pentacel Group n = 149
Anti-PT	43.2 (38.1 to 48.9)	48.3 (42.7 to 54.5)	24.2 (21.1 to 27.7)
Anti-FHA	106.3 (95.0 to 119.0)	122.7 (109.9 to 137.0)	59.9 (51.7 to 69.3)
Anti-PRN	57.4 (49.5 to 66.6)	46.9 (39.9 to 55.3)	33.0 (27.8 to 39.1)

Infanrix Hexa Group vs Pediarix Group: Adjusted GMC ratio: 1.1 (95% CI 0.92 to 1.31)
Infanrix Hexa Group vs Pediarix Group: Adjusted GMC ratio: 1.14 (95% CI 0.97 to 1.35)
Infanrix Hexa Group vs Pediarix Group: Adjusted GMC ratio: 0.79 (95% CI 0.63 to 0.99)

Population analysed: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

42 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix Hexa Group	8 of 195 (4.1%)	188 of 195 (96.4%)	0 of 195
Pediarix Group	1 of 194 (0.5%)	190 of 194 (97.9%)	0 of 194
Pentacel Group	8 of 196 (4.1%)	187 of 196 (95.4%)	0 of 196

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30444673Klein 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.
Full CSR redacted with additional report posting on GSK.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

Related trials for Poliomyelitis

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infanrix hexa, Pediarix and ActHIB in people with Poliomyelitis and Diphtheria, run by GlaxoSmithKline at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). (time frame: At Month 5, one month after the third dose of the primary vaccination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02096263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.