Meningococcal DiseasePhase 3NCT02173704

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.

A Phase 3 study testing Bexsero® and Routine vaccines in people with Meningococcal Disease and Infections, Meningococcal, run by GlaxoSmithKline at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 55 to 89 daysHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Infections, Meningococcal
What is being tested?: Bexsero® and Routine vaccines
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 2 sitesTaiwan
Study dates: 11 Sep 2014to 17 Jun 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 89 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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;
for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
available for all the visits scheduled in the study;
in good health as determined by medical history, physical examination and clinical judgment of the investigator.

Who cannot join

History of any meningococcal vaccine administration;
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;
Previous ascertained or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Significant acute or chronic infection within the previous 7 days or body temperature higher or equal to 38C degrees within the previous day;

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Antibiotics within 6 days prior to enrollment;
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);
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;
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
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.
Participation in another clinical trial since birth or planned for during study;
Family members and household members of research staff;
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

GSK Investigational Site
Taipei, 10041
GSK Investigational Site
Taipei, 10449

Other trials in Taiwan

About this study

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.

Conditions: Meningococcal Disease, Infections, Meningococcal
Being tested: Bexsero®, Routine vaccines
Keywords: Meningitis, Infants, Meningococcal B Recombinant Vaccine
Medical subject headings: Meningococcal Infections, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bexsero®Biological
Four doses administered in the anterolateral area of the right or left thigh.
Routine vaccinesBiological
Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.

Study groups in NCT02173704
Study group	Role	What they receive
Bexsero + Routine Group	Experimental	Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. Receives: Biological: Bexsero®
Routine Group	Active comparator	Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. Receives: Biological: Routine vaccines

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains
Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
Measured: At Day 1 and at one month after the third vaccination (Day 152)
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains
Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
Measured: At Day 1 and at one month after third vaccination (Day 152)

Secondary outcomes (9)

Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)
Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered.
Measured: 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
hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered.
Measured: At Day 1, Day 152, Day 305 and Day 335
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.
GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305).
Measured: 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
Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines [Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines [Priorix® and Varilrix® vaccine],as compared to when only routine vaccines were administered.
Measured: 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.
Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months. Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness.
Measured: 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.
Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months. Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C)
Measured: 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.
Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age. Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration.
Measured: From Day 1 to Day 28 after vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines
Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.
Measured: 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.
Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination. Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Measured: Throughout the study period (Day 1 to Day 335)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201417 Jun 2016

First posted25 Jun 2014 (estimated)
Study start11 Sep 2014
Primary completion25 Dec 2015
Study completion17 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02173704
Sponsor's protocol ID: 205249
Other IDs: V72_60, 2014-005568-14, 2014
Status last verified: Aug 2020
First submitted: 5 Jun 2014
Last updated: 25 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Chiu NC, Huang LM, Willemsen A, Bhusal C, Arora AK, Reynoso Mojares Z, Toneatto D. 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. 2018 May 4;14(5):1075-1083. doi: 10.1080/21645515.2018.1425659. Epub 2018 Feb 15.
PubMed 29337653

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02173704
Acronym / sponsor ID: 205249
Conditions: Meningococcal Disease, Infections, Meningococcal
Keywords: Meningitis, Infants, Meningococcal B Recombinant Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: 11 Sep 2014 (actual)
Primary completion: 25 Dec 2015 (actual)
Study completion: 17 Jun 2016 (actual)
First posted: 25 Jun 2014 (estimated)
Results: Posted 15 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bexsero + Routine Group	Experimental	Biological: Bexsero®Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.
Routine Group	Active comparator	Biological: Routine vaccinesSubjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.

Who may qualify

Ages: 55 to 89 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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;
for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
available for all the visits scheduled in the study;
in good health as determined by medical history, physical examination and clinical judgment of the investigator.

Key exclusion criteria (14 listed)

History of any meningococcal vaccine administration;
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;
Previous ascertained or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bexsero®Four doses administered in the anterolateral area of the right or left thigh.	Biological	Bexsero + Routine Group
Routine vaccinesInfanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.	Biological	Routine Group

Primary outcome

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains
Time frame: At Day 1 and at one month after the third vaccination (Day 152)
Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains
Time frame: At Day 1 and at one month after third vaccination (Day 152)
Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).

9 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)
Time frame: 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
Time frame: At Day 1, Day 152, Day 305 and Day 335
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to Day 28 after vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines
Time frame: 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.
Time frame: Throughout the study period (Day 1 to Day 335)

Results and safety

Results posted to the registry on 15 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bexsero + Routine Group	150	137
Routine Group	75	71

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains

Time frame: At Day 1 and at one month after the third vaccination (Day 152). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	Bexsero + Routine Group n = 135	Routine Group n = 71
H44/76 strain [Day 1]	0 (0.0 to 3.1)	0 (0.0 to 6.1)
H44/76 strain [Day 152]	100 (97.2 to 100)	0 (0.0 to 5.4)
5/99 strain [Day 1]	1 (0.02 to 4.4)	1 (0.04 to 7.8)
5/99 strain [Day 152]	100 (97.2 to 100)	0 (0.0 to 5.1)
M10713 strain [Day 1]	10 (4.9 to 17.6)	19 (10 to 31.9)
M10713 strain [Day 152]	59 (50.1 to 68.1)	8 (2.5 to 17)
NZ98/254 strain [Day 1]	0 (0.0 to 2.7)	0 (0.0 to 5.1)
NZ98/254 strain [Day 152]	79 (71.4 to 85.8)	0 (0.0 to 5.1)

Bexsero + Routine Group vs Routine Group: Single binomial proportion: 100 (95% CI 97.2 to 100), Exact test of binomial proportion
Bexsero + Routine Group vs Routine Group: single binomial proportion: 79 (95% CI 71.4 to 85.8), Exact test of binomial proportion

Population analysed: Analysis was done on Full Analysis Population (FAS) population day 152, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains

Time frame: At Day 1 and at one month after third vaccination (Day 152). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Bexsero + Routine Group n = 136	Routine Group n = 71
H44/76 strain [Day 1]	0 (0.0 to 3.1)	0 (0.0 to 6.1)
H44/76 strain [Day 152]	100 (97.2 to 100)	0 (0.0 to 5.4)
5/99 strain [Day 1]	1 (0.02 to 4.4)	1 (0.04 to 7.8)
5/99 strain [Day 152]	100 (97.2 to 100)	0 (0.0 to 5.1)
M10713 strain [Day 1]	11 (5.6 to 18.8)	25 (14.1 to 37.8)
M10713 strain [Day 152]	71 (61.9 to 78.6)	8 (2.5 to 17.0)
NZ98/254 strain [Day 1]	0 (0.0 to 2.7)	0 (0.0 to 5.1)
NZ98/254 strain [Day 152]	87 (80.6 to 92.5)	0 (0.0 to 5.1)

Population analysed: Analysis was done on Full Analysis Set (FAS) population day 152. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local AEs and systemic symptoms: from Day 1 to Day 7 after each vaccination; Unsolicited AEs and SAEs: throughout the study period (from Day 1 to Day 335).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bexsero + Routine Group	13 of 145 (9%)	148 of 148 (100%)	0 of 148
Routine Group	8 of 72 (11.1%)	72 of 73 (98.6%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29337653Chiu NC, Huang LM, Willemsen A, Bhusal C, Arora AK, Reynoso Mojares Z, Toneatto D. 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. 2018 May 4;14(5):1075-1083. doi: 10.1080/21645515.2018.1425659. Epub 2018 Feb 15.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bexsero® and Routine vaccines in people with Meningococcal Disease and Infections, Meningococcal, run by GlaxoSmithKline at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains (time frame: At Day 1 and at one month after the third vaccination (Day 152)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02173704, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.