Last updated: 08/13/2020 12:10:23
Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered concomitantly with Routine Vaccines to Healthy Infants of 2 months of age and older, in Taiwan.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Meningococcal B Recombinant Vaccine When Administered concomitantly with Routine Vaccines to Healthy Infants in Taiwan.
Trial description: Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of subjects with Human Serum Bactericidal Activity (hSBA) titer ≥ 1:5 against Neisseria meningitidis serogroup B.
Timeframe: At Day 1 and at one month after the third vaccination (Day 152)
Secondary outcomes:
Percentage of subjects with hSBA titer ≥ 1:5 against Neisseria meningitidis serogroup B, when Bexsero® booster was given with routine vaccines (Priorix® + Varilrix® vaccines)
Timeframe: At Day 305 and Day 335
hSBA Geometric Mean Titers (GMTs) against Neisseria meningitidis serogroup B indicator strains, when Bexsero® vaccine was given with routine vaccines
Timeframe: At Day 1, Day 152, Day 305 and Day 335
hSBA Geometric Mean Ratios (GMRs) against Neisseria meningitidis serogroup B strains.
Timeframe: At Day 1, Day 152, Day 305 and Day 335
Percentages of subjects with hSBA titers ≥1:8 against Neisseria meningitidis serogroup B, when Bexsero® vaccine was given with routine vaccines
Timeframe: At Day 1,Day 152,Day 305, Day 335
Number of subjects reporting solicited local adverse events (AEs) after receiving Bexsero® vaccine with routine vaccine or routine vaccines alone, at 2, 4, 6 and 12 months of age.
Timeframe: From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination)
Number of subjects reporting solicited systemic adverse events (AEs) after receiving Bexsero® vaccine with routine vaccine or routine vaccines alone, at 2, 4, 6 and 12 months of age.
Timeframe: From day 1 (6 hours) to day 7 after each vaccination
Number of subjects reporting solicited systemic AEs after receiving Priorix® and Varilrix® routine vaccines (with and without Bexsero® vaccine) at 12 months of age.
Timeframe: From Day 1 to Day 28 after vaccination
Number of subjects reporting unsolicited adverse events after receiving Bexsero® vaccination with routine vaccines
Timeframe: From day 1 to day 7 after each vaccination
Number of subjects reporting serious adverse events (SAEs), medically attended AEs (MAEs) and AEs leading to premature withdrawal and Death and AEs Leading to Hospitalization.
Timeframe: Throughout the study period (Day 1 to Day 335)
Interventions:
Biological/vaccine: Bexsero®
Biological/vaccine: Routine vaccines
Enrollment:
225
Observational study model:
Not applicable
Primary completion date:
2015-25-12
Time perspective:
Not applicable
Clinical publications:
Chiu NC et al. (2018) Safety and immunogenicity of a meningococcal B recombinant vaccine when administered with routine vaccines to healthy infants in Taiwan: a phase 3, open-label, randomized study. Hum Vaccin Immunother. 14(5):1075-1083.
Medical condition
Meningococcal disease
Product
GSK3536829A, SB208133, SB209762, SB213503, SKF103860
Collaborators
Novartis Vaccines
Study date(s)
September 2014 to June 2016
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
55 - 89 days
Accepts healthy volunteers
Yes
- 1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
- 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
- 1. History of any meningococcal vaccine administration;
- 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib),
Inclusion and exclusion criteria
Inclusion criteria:
- 1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg; 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by medical history, physical examination and clinical judgment of the investigator.
Exclusion criteria:
- 1. History of any meningococcal vaccine administration; 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), Pneumococcal, MMR or varicella antigens; 3. Previous ascertained or suspected disease caused by N. meningitidis; 4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. Significant acute or chronic infection within the previous 7 days or body temperature higher or equal to 38C degrees within the previous day; 7. Antibiotics within 6 days prior to enrollment; 8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth; 10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of rotavirus vaccine, influenza vaccine and second HepB vaccine), within 28 days prior and throughout the study period. Furthermore, subjects must have received HepB vaccine preferably at 0, 1 month of age, with the second dose at least 14 days prior to study vaccination. Influenza vaccine should be administered at least 14 days before or 14 days after study vaccination; Rotavirus vaccine may be administered during the study as per local practice. 12. Participation in another clinical trial since birth or planned for during study; 13. Family members and household members of research staff; 14. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-25-12
Actual study completion date
2016-17-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
IPD for this study will be made available via the Clinical Study Data Request site.
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