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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02853929




Registration number
NCT02853929
Ethics application status
Date submitted
14/07/2016
Date registered
3/08/2016

Titles & IDs
Public title
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Scientific title
Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Infanrix Hexa™ (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Secondary ID [1] 0 0
2014-001120-30
Secondary ID [2] 0 0
201334
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diphtheria 0 0
Hepatitis B 0 0
Acellular Pertussis 0 0
Haemophilus Influenzae Type b 0 0
Tetanus 0 0
Poliomyelitis 0 0
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Infanrix hexa

Experimental: dTpa Group - This group will consist of healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure

Active comparator: Control Group - This group will consist of healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure


Treatment: Other: Infanrix hexa
All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Timepoint [1] 0 0
At one month after the booster dose (Day 30)
Primary outcome [2] 0 0
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))
Timepoint [2] 0 0
At one month after the booster dose (Day 30)
Secondary outcome [1] 0 0
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP.
Timepoint [1] 0 0
Before the booster dose (Day 0)
Secondary outcome [2] 0 0
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Timepoint [2] 0 0
Before the booster dose (Day 0)
Secondary outcome [3] 0 0
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
Timepoint [3] 0 0
Before the booster dose (Day 0)
Secondary outcome [4] 0 0
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Timepoint [4] 0 0
Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Secondary outcome [5] 0 0
Anti-poliovirus Type 1, 2, 3 Antibody Titres
Timepoint [5] 0 0
Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Secondary outcome [6] 0 0
Anti-HBs Antibody Concentrations
Timepoint [6] 0 0
Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Secondary outcome [7] 0 0
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations
Timepoint [7] 0 0
Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Secondary outcome [8] 0 0
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Timepoint [8] 0 0
At one month after the booster dose (Day 30)
Secondary outcome [9] 0 0
Number of Subjects With Solicited Local Symptoms
Timepoint [9] 0 0
During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)
Secondary outcome [10] 0 0
Number of Subjects With Solicited General Symptoms
Timepoint [10] 0 0
During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
Secondary outcome [11] 0 0
Number of Subjects With Unsolicited Adverse Events (AEs)
Timepoint [11] 0 0
During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
Secondary outcome [12] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [12] 0 0
From booster dose up to study end (approximately 6 or 7 months, per subject)
Secondary outcome [13] 0 0
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone
Timepoint [13] 0 0
At 9 months of age, 18 months of age, and 9 or 18 months of age
Secondary outcome [14] 0 0
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III)
Timepoint [14] 0 0
At 9 months of age, 18 months of age, and 9 or 18 months of age
Secondary outcome [15] 0 0
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III)
Timepoint [15] 0 0
At 9 months of age, 18 months of age, and 9 or 18 months of age

Eligibility
Key inclusion criteria
* Subjects' parent(s)/Legally acceptable representatives (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 child 9 months of age at the time of enrolment.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study and having completed their primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048 PRI].
Minimum age
9 Months
Maximum age
19 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Child in care
* Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster 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).
* A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunization 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 immunization 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 Product Information (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Major congenital defects.
* Serious chronic illness.
* Administration of immunoglobulins and/or any blood products during the period within three months before the booster dose of study vaccines or planned administration during the study period.
* Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination with Infanrix hexa and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
* History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
* Previous booster vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (e.g: antigen, excipients).
* Hypersensitivity to latex.
* History of any neurological disorders or seizures.
* Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Acute disease and/or fever at the time of vaccination.

* Fever is defined as temperature = 37.5°C /99.5°F for oral, axillary or tympanic route, or = 38.0°C /100.4°F on 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2019
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Czechia
State/province [4] 0 0
Brno
Country [5] 0 0
Czechia
State/province [5] 0 0
Hradec Kralove
Country [6] 0 0
Czechia
State/province [6] 0 0
Ostrava - Vitkovice
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 4
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
Finland
State/province [9] 0 0
Kokkola
Country [10] 0 0
Finland
State/province [10] 0 0
Oulu
Country [11] 0 0
Finland
State/province [11] 0 0
Seinajoki
Country [12] 0 0
Finland
State/province [12] 0 0
Tampere
Country [13] 0 0
Finland
State/province [13] 0 0
Turku
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardia
Country [15] 0 0
Italy
State/province [15] 0 0
Piemonte
Country [16] 0 0
Spain
State/province [16] 0 0
Andalucia
Country [17] 0 0
Spain
State/province [17] 0 0
Antequera/Málaga
Country [18] 0 0
Spain
State/province [18] 0 0
Aravaca
Country [19] 0 0
Spain
State/province [19] 0 0
Burgos
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Majadahonda (Madrid)
Country [22] 0 0
Spain
State/province [22] 0 0
Móstoles
Country [23] 0 0
Spain
State/province [23] 0 0
Santiago de Compostela
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02853929