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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02422264




Registration number
NCT02422264
Ethics application status
Date submitted
19/03/2015
Date registered
21/04/2015
Date last updated
9/07/2019

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
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
Secondary ID [1] 0 0
2014-001117-41
Secondary ID [2] 0 0
201330
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acellular Pertussis 0 0
Tetanus 0 0
Poliomyelitis 0 0
Diphtheria 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
Other interventions - 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®.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Timepoint [1] 0 0
1 month after the last dose of the primary vaccination
Primary outcome [2] 0 0
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
Timepoint [2] 0 0
1 month after the last dose of the primary vaccination
Primary outcome [3] 0 0
Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off
Timepoint [3] 0 0
1 month after the last dose of the primary vaccination
Primary outcome [4] 0 0
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
Timepoint [4] 0 0
1 month after the last dose of the primary vaccination
Primary outcome [5] 0 0
Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off
Timepoint [5] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [1] 0 0
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
Timepoint [1] 0 0
Before the first dose of Infanrix hexa
Secondary outcome [2] 0 0
Anti-D and Anti-T Antibody Concentrations
Timepoint [2] 0 0
Before the first dose of Infanrix hexa
Secondary outcome [3] 0 0
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
Timepoint [3] 0 0
Before the first dose of Infanrix hexa
Secondary outcome [4] 0 0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Timepoint [4] 0 0
Before the first dose of Infanrix hexa
Secondary outcome [5] 0 0
Anti-D and Anti-T Antibody Concentrations
Timepoint [5] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [6] 0 0
Anti-Polio Type 1, 2 and 3 Antibody Titers
Timepoint [6] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [7] 0 0
Anti-HBs Antibody Concentrations
Timepoint [7] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [8] 0 0
Anti-PRP Antibody Concentrations
Timepoint [8] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [9] 0 0
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Timepoint [9] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [10] 0 0
Anti-pneumococcal Antibody Concentrations
Timepoint [10] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [11] 0 0
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
Timepoint [11] 0 0
1 month after the last dose of the primary vaccination
Secondary outcome [12] 0 0
Number of Subjects With Solicited Local Symptoms
Timepoint [12] 0 0
During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Secondary outcome [13] 0 0
Number of Subjects With Solicited General Symptoms
Timepoint [13] 0 0
During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Secondary outcome [14] 0 0
Number of Subjects With Unsolicited Adverse Events
Timepoint [14] 0 0
During the 31-day (days 0-30) follow-up period after each vaccination
Secondary outcome [15] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [15] 0 0
From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)

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.
Minimum age
6 Weeks
Maximum age
14 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
22/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/03/2018
Sample size
Target
Accrual to date
Final
601
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02422264
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