Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
NCT ID: NCT03621670
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1196 participants
INTERVENTIONAL
2018-07-27
2024-12-27
Brief Summary
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Detailed Description
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* Epoch 1- Primary- From Day 1 to Day 301
* Epoch 2-Secondary-From Day 301 to Day 331
* Epoch 3-Safety follow up -From Day 331 to study end (Day 481 or Day 661). For subjects who have not yet reached the 6-month safety follow-up after the last dose at the time protocol amendment 7 takes effect, Visit 7 will take place on Day 481.
In addition to receiving the study vaccines, infants will 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 ease the disruption to the standard infant vaccine schedule caused by participating in this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
The serological data, which would lead to the unblinding of the study groups, will not be available during the course of the study to any investigator or any person involved in the clinical conduct of the study. The laboratory in charge of the laboratory testing will be blinded to the treatment, subject and visit number, and codes will be used to link the subject, visit and study to each sample.
Study Groups
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MenB+PCV Group
Approximately 800 subjects enrolled in this group will receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prev-nar13) and other RIV (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6 and 12 months of age. Subjects who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose will either receive PCV13 or PCV20 at 12 months of age (Visit 5).
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.
Prevnar13
Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Pediarix
Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Hiberix
Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Rotarix
Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.
M-M-R II
M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Varivax
Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Prevnar 20
Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.
Placebo+PCV Group
Approximately 400 subjects enrolled in this group will receive PCV13 concomitantly with placebo and other RIV at 2, 4, 6 and 12 months of age. Subjects who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose will either receive PCV13 or PCV20 at 12 months of age (Visit 5).
Prevnar13
Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Pediarix
Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Hiberix
Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Rotarix
Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.
M-M-R II
M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Varivax
Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Placebo (saline water)
Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group.
Prevnar 20
Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.
Interventions
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Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.
Prevnar13
Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Pediarix
Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Hiberix
Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Rotarix
Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.
M-M-R II
M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Varivax
Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Placebo (saline water)
Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group.
Prevnar 20
Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.
Eligibility Criteria
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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 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
• 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).
6 Weeks
12 Weeks
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Daly City, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Lake Mary, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Fall River, Massachusetts, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Liverpool, New York, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Boone, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Fairfield, Ohio, United States
GSK Investigational Site
South Euclid, Ohio, United States
GSK Investigational Site
Hermitage, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Sioux Falls, South Dakota, United States
GSK Investigational Site
Clarksville, Tennessee, United States
GSK Investigational Site
Kingsport, Tennessee, United States
GSK Investigational Site
Beaumont, Texas, United States
GSK Investigational Site
Bryan, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Orem, Utah, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Syracuse, Utah, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Tacoma, Washington, United States
GSK Investigational Site
Marshfield, Wisconsin, United States
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Edinburgh, United Kingdom, United Kingdom
Countries
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Other Identifiers
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2016-003268-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V72_57
Identifier Type: OTHER
Identifier Source: secondary_id
205239
Identifier Type: -
Identifier Source: org_study_id
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