Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ); Biological: Prevnar13; Biological: Pediarix; Biological: Hiberix; Biological: Rotarix; Biological: M-M-R II; Biological: Varivax; Biological: Prevnar 20; Biological: Placebo (saline water)

Detailed Description

This study is divided into three timepoints:

Epoch 1 - Primary: Day 1 to Day 301 Epoch 2 - Secondary: Day 301 to Day 331 Epoch 3 - Safety follow-up: Day 331 to the end of the study (Day 481 or Day 661). For participants who have not yet reached the 6-month safety follow-up after their last dose at the time Protocol Amendment 7 takes effect, visit 7 takes place on Day 481.

In addition to receiving the study vaccines, infants also receive non-study vaccines such as Diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix) to minimize disruption to the standard infant vaccination schedule caused by participation in this study.

Participants receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prevnar13) and other routine infant vaccines (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6, and 12 months of age. Participants who have received three PCV13 doses before 12 months of age but have not yet received their fourth booster dose receive either PCV13 or PCV20 at 12 months of age (Visit 5).

• Study Type: Interventional
• Enrollment (Actual): 1196
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00907
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • GSK Investigational Site
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • GSK Investigational Site
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
  • California
    • Anaheim, California, United States, 92804
      • GSK Investigational Site
    • Oakland, California, United States, 94611
      • GSK Investigational Site
    • Roseville, California, United States, 95661
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94596
      • GSK Investigational Site
    • West Covina, California, United States, 91790
      • GSK Investigational Site
  • Florida
    • Lake Mary, Florida, United States, 32746
      • GSK Investigational Site
    • Miami, Florida, United States, 33142
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
  • Idaho
    • Nampa, Idaho, United States, 83686
      • GSK Investigational Site
    • Nampa, Idaho, United States, 83702
      • GSK Investigational Site
  • Kansas
    • Newton, Kansas, United States, 67114
      • GSK Investigational Site
    • Topeka, Kansas, United States, 66604
      • GSK Investigational Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40202
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40207
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40291
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21021
      • GSK Investigational Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • GSK Investigational Site
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68128
      • GSK Investigational Site
  • New York
    • Liverpool, New York, United States, 13090
      • GSK Investigational Site
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45414
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45406
      • GSK Investigational Site
    • Fairfield, Ohio, United States, 45014
      • GSK Investigational Site
    • South Euclid, Ohio, United States, 44121
      • GSK Investigational Site
  • Pennsylvania
    • Hermitage, Pennsylvania, United States, 16148
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • GSK Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • GSK Investigational Site
  • Tennessee
    • Clarksville, Tennessee, United States, 37040
      • GSK Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • GSK Investigational Site
  • Texas
    • Beaumont, Texas, United States, 77706
      • GSK Investigational Site
    • Bryan, Texas, United States, 77802
      • GSK Investigational Site
    • Edinburg, Texas, United States, 78504
      • GSK Investigational Site
    • Houston, Texas, United States, 77090
      • GSK Investigational Site
    • Houston, Texas, United States, 77065
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78244
      • GSK Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • GSK Investigational Site
    • Orem, Utah, United States, 84057
      • GSK Investigational Site
    • Provo, Utah, United States, 84604
      • GSK Investigational Site
    • Roy, Utah, United States, 84067
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84121
      • GSK Investigational Site
    • Syracuse, Utah, United States, 84075
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23298
      • GSK Investigational Site
  • Washington
    • Spokane, Washington, United States, 99202
      • GSK Investigational Site
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

• 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 eDiary, 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, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term (i.e. after a gestation period of ≥ 38 weeks).

Exclusion Criteria:

If any exclusion criterion applies, the subject must not be included in the study:

• Child in care

Each subject must not have:

• Progressive, unstable or uncontrolled clinical conditions.
• Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study.
• Hypersensitivity to latex.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

• Abnormal function of the immune system resulting from:

  • Clinical conditions.
  • Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth.
  • Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth.
  • Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
• Received immunoglobulins or any blood products from birth.
• Received an investigational or non-registered medicinal product from birth.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
• Neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
• Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
• Study personnel as an immediate family or household member.
• Current or previous, confirmed or suspected disease caused by N. meningitidis
• Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization.
• Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent.
• Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is allowed.
• Serious chronic illness.
• Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenB+PCV Group; Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.	Biological: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ); Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.; Biological: Prevnar13; Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.; Biological: Pediarix; Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121.; Biological: Hiberix; Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121.; Biological: Rotarix; Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.; Biological: M-M-R II; M-M-R II (MMR) was administered intramuscularly on Day 301.; Biological: Varivax; Varivax (VV) was administered intramuscularly on Day 301.; Biological: Prevnar 20; Prevnar 20 (PCV13) was administered intramuscularly as a booster dose on Day 301 group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.
Placebo Comparator: Placebo+PCV Group; Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.	Biological: Prevnar13; Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.; Biological: Pediarix; Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121.; Biological: Hiberix; Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121.; Biological: Rotarix; Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.; Biological: M-M-R II; M-M-R II (MMR) was administered intramuscularly on Day 301.; Biological: Varivax; Varivax (VV) was administered intramuscularly on Day 301.; Biological: Prevnar 20; Prevnar 20 (PCV13) was administered intramuscularly as a booster dose on Day 301 group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.; Biological: Placebo (saline water); Placebo was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1	Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.	Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1	Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.	Day 1 to Day 7
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61	Rotarix was administered orally; therefore, no administration site events were analyzed.	Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61		Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121		Day 121 to Day 127
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121		Day 121 to Day 127
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301		Day 301 to Day 307
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301		Day 301 to Day 307
Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301	Systemic events assessed included rash, parotid/salivary gland swelling, and fever. These systemic adverse events were recorded for 30 days following MMR and VV vaccine administration. Any solicited systemic events = occurrence of the event regardless of intensity grade.	Day 301 to Day 330
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered at Day 1	An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Any = occurrence of the event regardless of the intensity grade.	Day 1 to Day 30
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered at Day 61		Day 61 to Day 90
Number of Participants Reporting Any Unsolicted AEs After the Third Vaccination Administered at Day 121		Day 121 to Day 150
Number of Participants Reporting Any Unsolicited AEs After the Fourth Vaccination Administered at Day 301		Day 301 to Day 330
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs	An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the participant from the study. AESIs are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. MAAEs includes any AEs that required hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.	Day 1 up to study end (Day 481 for participants who have not reached 6-month follow-up at the time of Protocol Amendment 7; Day 661 for all others)
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)	Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 60% for each of the M14459, 96217, NZ98/254, M13520 test strain. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.	At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Titers >= LLOQ Against All Serogroup B Test Strains Combined (Composite Response)	The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 50% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.	At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217	Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for each of the M14459, 96217, NZ98/254, M13520 test strains. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.	At Day 331 (1 month after the fourth vaccination)
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp), NZ98/254 (PorA P1.4), and M13520 (NHBA) and >= 16 for Strain 96217 (NadA) (Composite Response Across All Strains)	The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.	At Day 331 (1 month after the fourth vaccination)
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination	The immune response to PCV13 is evaluated by measuring IgG levels using electrochemiluminescence (ECL) assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the third vaccination.	At Day 151 (1 month after the third vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301	The immune response to PCV13 is evaluated by measuring IgG levels using ECL assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the 4th vaccination.	At Day 331 (1 month after the fourth vaccination)
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL	The immune response to PCV13 is evaluated by measuring the percentage of participants with serum IgG concentrations ≥ 0.35 μg/mL for each of the 13 PCV13 antigens at 1 month after the third and fourth vaccinations.	At Day 151 (1 month after the third vaccination) and Day 331 (1 month after the fourth vaccination)
Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])	The immune response to DTaP-HBV-IPV (Pediarix) vaccine is evaluated. IgG concentrations for pertussis antigens (PT, FHA, PRN) are measured at 1 month after the third vaccination and are expressed as international units per millilitre (IU/mL).	At Day 151 (1 month after the third vaccination)
Percentage of Participants With Antibodies Concentrations Against Hepatitis B Surface Antigen (AntiHBsAg) >= 10 mIU/mL	The immune response to DTaP-HBV-IPV vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for Hepatitis B (HepB) antigens are measured at 1 month after the third vaccination.	At Day 151 (1 month after the third vaccination)
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 0.1 IU/mL	The immune response to DTaP-HBV-IPV vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for diphtheria (D) and tetanus (T) were measured at 1 month after the third vaccination.	At Day 151 (1 month after the third vaccination)
Percentage of Participants With Anti-polyribosyl-ribitol Phosphate (PRP) Concentration >= 0.15 µg/mL and >= 1 µg/mL	The immune response to Hib vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for Haemophilus influenzae type b (Hib) are measured at 1 month after the third vaccination.	At Day 151 (1 month after the third vaccination)
Adjusted GMCs for Anti-measles Antibodies	The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for measles antigens are measured using adjusted GMCs at 1 month after fourth vaccination and are expressed as milli-International Units per milliliter (mIU/mL).	At Day 331 (1 month after the fourth vaccination)
Adjusted GMCs for Anti-mumps Antibodies	The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for mumps antigens are measured using adjusted GMCs at 1 month after fourth vaccination.	At Day 331 (1 month after the fourth vaccination)
Adjusted GMCs for Anti-rubella Antibodies	The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for rubella antigens are measured using adjusted GMCs at 1 month after fourth vaccination.	At Day 331 (1 month after the fourth vaccination)
Adjusted GMCs for Anti-Varicella (VV) Antibodies	The immune response to varicella (VV) vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for varicella antigens are measured using GMCs at 1 month after fourth vaccination.	At Day 331 (1 month after the fourth vaccination)
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.	At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.	At Day 301 (6 months after third vaccination)
Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.	At Day 331 (1 month after the fourth vaccination)
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.	At Day 151 (1 month after the third vaccination), Day 301 (6 months after the third vaccination), and Day 331 (1 month after the fourth vaccination)
hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.	At Day 331 (1 month after the fourth vaccination) compared to Day 301 (pre-fourth vaccination)
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.	At Day 301 (6 months after the third vaccination) and Day 331 (1 month after the fourth vaccination)
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)	A 4-fold rise in hSBA titers is defined as - if pre-vaccination titer <Limit of Detection (LOD), then a post-vaccination titer >= 4 times the LOD or >= LLOQ, whichever is greater; - if pre-vaccination titer is >= LOD but <LLOQ, then a post-vaccination titer >= 4 times the LLOQ; - if pre-vaccination titer is >= LLOQ, then a post-vaccination titer >= 4 times the pre-vaccination titer, where pre-vaccination titer=pre-4th dose titers (Day 301). This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.	At Day 331 (1 month after the fourth vaccination) relative to Day 301 (pre-fourth vaccination)
Percentage of Participants With Anti-HBs Antibody Concentrations >= 100 mIU/mL		At Day 151 (1 month after the third vaccination)
GMCs for Anti-HBsAg Antibodies		At Day 151 (1 month after the third vaccination)
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 1 IU/mL		At Day 151 (1 month after the third vaccination)
GMCs for Anti-diphtheria and Anti-tetanus Antibodies		At Day 151 (1 month after the third vaccination)
Percentage of Participants With Anti-polio Type 1, 2 and 3 Neutralization Antibody Titers >= 8		At Day 151 (1 month after the third vaccination)
Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies	Seroresponse is defined as post-vaccination anti-VZV virus, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentration >= a protective threshold among participants who were seronegative (antibody concentration < assay cut-off) before vaccination.	At Day 331 (1 month after the fourth vaccination)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): December 27, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Meningitis; Immune response; Bexsero; Sufficiency; Neisseria meningitides
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Central Nervous System Infections; Neisseriaceae Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningitis; Meningococcal Infections; Meningitis, Meningococcal; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Biological Products; Complex Mixtures; Vaccines; Vaccines, Combined; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Herpesvirus Vaccines; Measles-Mumps-Rubella Vaccine; 4CMenB vaccine; PEDIARIX; Chickenpox Vaccine; RIX4414 vaccine; Hiberix; Saline Waters
• Other Study ID Numbers: 205239; 2016-003268-37 (EudraCT Number); V72_57 (Other Identifier: Novartis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No