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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02422264
Registration number
NCT02422264
Ethics application status
Date submitted
19/03/2015
Date registered
21/04/2015
Titles & IDs
Public title
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
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Scientific title
Immunogenicity and Safety Study of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated Polio-virus and Haemophilus Influenzae Type b Vaccine (Infanrix Hexa™) (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
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Secondary ID [1]
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2014-001117-41
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Secondary ID [2]
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201330
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acellular Pertussis
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Tetanus
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Poliomyelitis
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0
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Diphtheria
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0
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Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Respiratory
0
0
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0
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Other respiratory disorders / diseases
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Neurological
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Other neurological disorders
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Metabolic and Endocrine
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Infanrix hexa
Treatment: Drugs - Prevnar13
Experimental: dTpa Group - This group will consist of infants born to mothers belonging to the dTpa Group in study 116945 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of BoostrixTM during pregnancy and a dose of placebo immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®.
Active comparator: Control Group - This group will consist of infants born to mothers belonging to the Control group in study 116945 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of BoostrixTM immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®.
Treatment: Other: Infanrix hexa
• All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.
Treatment: Drugs: Prevnar13
• All subjects will receive Infanrix hexa co-administered with Prevenar13\* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. \*In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
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Assessment method [1]
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Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (\<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (=) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
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Timepoint [1]
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1 month after the last dose of the primary vaccination
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Primary outcome [2]
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Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
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Assessment method [2]
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A seroprotected subject is a subject whose antibody concentration/titre was = the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).
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Timepoint [2]
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1 month after the last dose of the primary vaccination
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Primary outcome [3]
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Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off
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Assessment method [3]
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A seroprotected subject is a subject whose antibody concentration/titre was = to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).
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Timepoint [3]
0
0
1 month after the last dose of the primary vaccination
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Primary outcome [4]
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Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
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Assessment method [4]
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A seroprotected subject is a subject whose antibody titre was = the level defining clinical protection, of 8 ED50.
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Timepoint [4]
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1 month after the last dose of the primary vaccination
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Primary outcome [5]
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Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off
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Assessment method [5]
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A seroprotected subject is a subject whose antibody concentration/titre was = the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).
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Timepoint [5]
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1 month after the last dose of the primary vaccination
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Secondary outcome [1]
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Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
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Assessment method [1]
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A seroprotected subject is a subject whose antibody concentration was = the level defining clinical protection, of 0.1 IU/mL.
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Timepoint [1]
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Before the first dose of Infanrix hexa
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Secondary outcome [2]
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Anti-D and Anti-T Antibody Concentrations
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Assessment method [2]
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Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
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Timepoint [2]
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Before the first dose of Infanrix hexa
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Secondary outcome [3]
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Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
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Assessment method [3]
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A seropositive subject is a subject whose antibody concentration is = the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
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Timepoint [3]
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Before the first dose of Infanrix hexa
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Secondary outcome [4]
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Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
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Assessment method [4]
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Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
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Timepoint [4]
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Before the first dose of Infanrix hexa
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Secondary outcome [5]
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Anti-D and Anti-T Antibody Concentrations
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Assessment method [5]
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Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
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Timepoint [5]
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1 month after the last dose of the primary vaccination
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Secondary outcome [6]
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Anti-Polio Type 1, 2 and 3 Antibody Titers
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Assessment method [6]
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Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT).
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Timepoint [6]
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1 month after the last dose of the primary vaccination
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Secondary outcome [7]
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Anti-HBs Antibody Concentrations
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Assessment method [7]
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Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
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Timepoint [7]
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1 month after the last dose of the primary vaccination
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Secondary outcome [8]
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Anti-PRP Antibody Concentrations
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Assessment method [8]
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Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL.
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Timepoint [8]
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1 month after the last dose of the primary vaccination
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Secondary outcome [9]
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Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
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Assessment method [9]
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Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
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Timepoint [9]
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1 month after the last dose of the primary vaccination
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Secondary outcome [10]
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Anti-pneumococcal Antibody Concentrations
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Assessment method [10]
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Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL.
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Timepoint [10]
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1 month after the last dose of the primary vaccination
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Secondary outcome [11]
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Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
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Assessment method [11]
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A seropositive subject is a subject whose antibody concentration is = the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
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Timepoint [11]
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1 month after the last dose of the primary vaccination
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Secondary outcome [12]
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Number of Subjects With Solicited Local Symptoms
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Assessment method [12]
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Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose.
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Timepoint [12]
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During the 4-day (Day 0-Day 3) follow-up period after each vaccination
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Secondary outcome [13]
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Number of Subjects With Solicited General Symptoms
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Assessment method [13]
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Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as axillary route temperature = 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose.
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Timepoint [13]
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During the 4-day (Day 0-Day 3) follow-up period after each vaccination
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Secondary outcome [14]
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Number of Subjects With Unsolicited Adverse Events
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Assessment method [14]
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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Timepoint [14]
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During the 31-day (days 0-30) follow-up period after each vaccination
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Secondary outcome [15]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [15]
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SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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Timepoint [15]
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From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)
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Eligibility
Key inclusion criteria
* 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 (e.g. completion of the diary cards, return for follow-up visits).
* Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
* A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the first vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
* Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of the investigator.
* Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.
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Minimum age
6
Weeks
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Maximum age
14
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Child in care
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean prednisone =0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* Administration of any chronic drug therapy to be continued during the study period.
* A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation schedule, that are allowed at any time during the study period.
* In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or package insert (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
* 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 vaccine/product (pharmaceutical product or device).
* Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
* History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID), 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 vaccine.
* Major congenital defects
* Serious chronic illness.
* History of any neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature =37.5°C/99.5°F for oral, axillary or tympanic route, or =38.0°C/100.4°F for rectal route.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or planned administration during the study period.
* Hypersensitivity to latex.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/01/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/03/2018
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Sample size
Target
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Accrual to date
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Final
601
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - Carlton
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Recruitment postcode(s) [1]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
0
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Canada
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State/province [2]
0
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Nova Scotia
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Country [3]
0
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Canada
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State/province [3]
0
0
Quebec
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Country [4]
0
0
Czechia
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State/province [4]
0
0
Brno
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Country [5]
0
0
Czechia
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State/province [5]
0
0
Hradec Kralove
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Country [6]
0
0
Czechia
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State/province [6]
0
0
Ostrava - Vitkovice
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Country [7]
0
0
Czechia
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State/province [7]
0
0
Praha 4
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Country [8]
0
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Czechia
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State/province [8]
0
0
Praha
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Country [9]
0
0
Finland
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State/province [9]
0
0
Kokkola
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Country [10]
0
0
Finland
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State/province [10]
0
0
Oulu
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Country [11]
0
0
Finland
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State/province [11]
0
0
Seinajoki
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Country [12]
0
0
Finland
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State/province [12]
0
0
Tampere
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Country [13]
0
0
Finland
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State/province [13]
0
0
Turku
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Country [14]
0
0
Italy
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State/province [14]
0
0
Lombardia
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Country [15]
0
0
Italy
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State/province [15]
0
0
Piemonte
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Country [16]
0
0
Spain
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State/province [16]
0
0
Andalucia
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Country [17]
0
0
Spain
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State/province [17]
0
0
Antequera/Málaga
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Country [18]
0
0
Spain
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State/province [18]
0
0
Aravaca
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Country [19]
0
0
Spain
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State/province [19]
0
0
Burgos
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Country [20]
0
0
Spain
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State/province [20]
0
0
Madrid
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Country [21]
0
0
Spain
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State/province [21]
0
0
Majadahonda (Madrid)
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Country [22]
0
0
Spain
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State/province [22]
0
0
Móstoles
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Country [23]
0
0
Spain
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State/province [23]
0
0
Santiago de Compostela
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Country [24]
0
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Spain
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State/province [24]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 \[DTPA (BOOSTRIX)-047\]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
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Trial website
https://clinicaltrials.gov/study/NCT02422264
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Trial related presentations / publications
Perrett KP, Halperin SA, Nolan T, Carmona Martinez A, Martinon-Torres F, Garcia-Sicilia J, Virta M, Vanderkooi OG, Zuccotti GV, Manzoni P, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Stranak Z, Merino Arribas JM, Cilleruelo Ortega MJ, Miranda-Valdivieso M, Arias Novas B, Ramos Amador JT, Omenaca F, Baca M, Marchisio PG, Mesaros N. Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial. Vaccine. 2020 Feb 18;38(8):2105-2114. doi: 10.1016/j.vaccine.2019.10.104. Epub 2019 Nov 24.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
0
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Fax
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0
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Email
0
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Contact person for public queries
Name
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/64/NCT02422264/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/64/NCT02422264/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02422264