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Major vaccine study shows meningitis b and pneumonia shots are safe for babies

NCT ID NCT03621670

Vaccine Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study looked at whether giving the meningitis B vaccine (Bexsero) and the pneumonia vaccine (PCV13) along with routine baby shots is safe and works well. About 1,200 healthy infants aged 6 to 12 weeks took part. Researchers checked for side effects like pain, redness, fever, and fussiness, and measured immune responses to see if the vaccines triggered protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,196 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

meningitis meningococcal meningitis meningococcal infection prevention target pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infections, meningococcal

Contacts and locations

Locations

  • GSK Investigational Site

    Birmingham, Alabama, 35205, United States

  • GSK Investigational Site

    Fayetteville, Arkansas, 72703, United States

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401, United States

  • GSK Investigational Site

    Anaheim, California, 92804, United States

  • GSK Investigational Site

    Oakland, California, 94611, United States

  • GSK Investigational Site

    Roseville, California, 95661, United States

  • GSK Investigational Site

    Walnut Creek, California, 94596, United States

  • GSK Investigational Site

    West Covina, California, 91790, United States

  • GSK Investigational Site

    Lake Mary, Florida, 32746, United States

  • GSK Investigational Site

    Miami, Florida, 33142, United States

  • GSK Investigational Site

    Tampa, Florida, 33613, United States

  • GSK Investigational Site

    Nampa, Idaho, 83686, United States

  • GSK Investigational Site

    Nampa, Idaho, 83702, United States

  • GSK Investigational Site

    Newton, Kansas, 67114, United States

  • GSK Investigational Site

    Topeka, Kansas, 66604, United States

  • GSK Investigational Site

    Bardstown, Kentucky, 40004, United States

  • GSK Investigational Site

    Louisville, Kentucky, 40202, United States

  • GSK Investigational Site

    Louisville, Kentucky, 40207, United States

  • GSK Investigational Site

    Louisville, Kentucky, 40291, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21021, United States

  • GSK Investigational Site

    Fall River, Massachusetts, 02721, United States

  • GSK Investigational Site

    Bingham Farms, Michigan, 48025, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64108, United States

  • GSK Investigational Site

    Lincoln, Nebraska, 68516, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68128, United States

  • GSK Investigational Site

    Liverpool, New York, 13090, United States

  • GSK Investigational Site

    Syracuse, New York, 13210, United States

  • GSK Investigational Site

    Boone, North Carolina, 28607, United States

  • GSK Investigational Site

    Raleigh, North Carolina, 27609, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45245, United States

  • GSK Investigational Site

    Dayton, Ohio, 45406, United States

  • GSK Investigational Site

    Dayton, Ohio, 45414, United States

  • GSK Investigational Site

    Fairfield, Ohio, 45014, United States

  • GSK Investigational Site

    South Euclid, Ohio, 44121, United States

  • GSK Investigational Site

    Hermitage, Pennsylvania, 16148, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29406, United States

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105, United States

  • GSK Investigational Site

    Clarksville, Tennessee, 37040, United States

  • GSK Investigational Site

    Kingsport, Tennessee, 37660, United States

  • GSK Investigational Site

    Beaumont, Texas, 77706, United States

  • GSK Investigational Site

    Bryan, Texas, 77802, United States

  • GSK Investigational Site

    Edinburg, Texas, 78504, United States

  • GSK Investigational Site

    Houston, Texas, 77065, United States

  • GSK Investigational Site

    Houston, Texas, 77090, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    San Antonio, Texas, 78244, United States

  • GSK Investigational Site

    Layton, Utah, 84041, United States

  • GSK Investigational Site

    Orem, Utah, 84057, United States

  • GSK Investigational Site

    Provo, Utah, 84604, United States

  • GSK Investigational Site

    Roy, Utah, 84067, United States

  • GSK Investigational Site

    Salt Lake City, Utah, 84121, United States

  • GSK Investigational Site

    Syracuse, Utah, 84075, United States

  • GSK Investigational Site

    Richmond, Virginia, 23298, United States

  • GSK Investigational Site

    Spokane, Washington, 99202, United States

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449, United States

  • GSK Investigational Site

    San Juan, 00907, Puerto Rico

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Other studies related to the condition(s) this trial covers.