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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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ClinicalTrials.gov Identifier: NCT02422264
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Acellular Pertussis Tetanus Poliomyelitis Diphtheria Biological: Infanrix hexa Drug: Prevnar13 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : January 22, 2016
Actual Primary Completion Date : March 7, 2018
Actual Study Completion Date : March 7, 2018


Arm Intervention/treatment
Experimental: Boostrix 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®.
Biological: 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.

Drug: 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.

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®.
Biological: 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.

Drug: 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.




Primary Outcome Measures :
  1. Vaccine response to PT, FHA and PRN antigens [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  2. Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T). [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  3. Number of seroprotected subjects for anti-HBs. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  4. Number of seroprotected subjects for anti poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  5. Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (anti-PRP). [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]

Secondary Outcome Measures :
  1. Number of seroprotected subjects for anti-D and anti-T. [ Time Frame: Month 0 ]
  2. Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  3. Solicited local and general symptoms [ Time Frame: During 4 day (Day 0-Day 3) after each dose of study vaccines ]
  4. Unsolicited adverse events (AEs) [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after each dose of study vaccines ]
  5. Occurrence of serious adverse events (SAEs) [ Time Frame: From Month 0 up to Month 3 or Month 5 (depending on vacci-nation schedule of the country) ]
  6. Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.. [ Time Frame: Month 0 ]
  7. Antibody concentrations for anti-PT, anti-FHA and anti-PRN. [ Time Frame: Month 0 ]
  8. Antibody concentrations for anti-D and anti-T. [ Time Frame: Month 0 ]
  9. Antibody concentrations for anti-D and anti-T. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  10. Antibody concentrations for anti-poliovirus type 1, anti-poliovirus type 2 and anti-poliovirus type 3. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  11. Antibody concentrations for anti-PRP. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  12. Antibody concentrations for anti-PT, anti-FHA and anti-PRN. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  13. Antibody concentrations for anti-HBs. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]
  14. Antibody concentrations for anti-pneumococcal serotypes. [ Time Frame: Month 3 or Month 5 (depending on vaccination schedule of the country) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 14 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422264


Locations
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T3B 6A8
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1C5
Czechia
GSK Investigational Site
Brno, Czechia, 613 00
GSK Investigational Site
Hradec Kralove, Czechia, 500 02
GSK Investigational Site
Ostrava - Vitkovice, Czechia, 703 84
GSK Investigational Site
Praha 4, Czechia, 140 59
GSK Investigational Site
Praha, Czechia, 14700
Finland
GSK Investigational Site
Kokkola, Finland, 67100
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20122
GSK Investigational Site
Milano, Lombardia, Italy, 20142
GSK Investigational Site
Milano, Lombardia, Italy, 20154
GSK Investigational Site
Novara, Piemonte, Italy, 28100
GSK Investigational Site
Torino, Piemonte, Italy, 10126
Spain
GSK Investigational Site
Málaga, Andalucia, Spain, 29004
GSK Investigational Site
Antequera/Málaga, Spain, 29200
GSK Investigational Site
Aravaca, Spain, 28023
GSK Investigational Site
Burgos, Spain, 09006
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Madrid, Spain, 28050
GSK Investigational Site
Majadahonda (Madrid), Spain, 28222
GSK Investigational Site
Móstoles, Spain, 28938
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41014
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02422264     History of Changes
Other Study ID Numbers: 201330
2014-001117-41 ( EudraCT Number )
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs