Phase 4 Hepatitis B Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The parent or legal guardian must be willing and able to follow the study requirements, such as filling in diary cards and attending follow-up visits.
• The parent or legal guardian must give written consent before any study procedures take place.
• The child must be between 6 and 14 weeks and 6 days old at the time of the first vaccination.
• The child must be in good general health, confirmed by a medical history review and physical check-up.
• The child must have been born to a mother who took part in a specific related study (study 116945).
• Babies born prematurely after 27 to 36 weeks of pregnancy may be able to join, as long as they are medically stable and no longer need significant medical support (this is decided by the doctor).

Who may not be able to join:

• Children who are in the care of local authorities or social services ("child in care") cannot join.
• Children who have received immunosuppressant or immune-modifying medicines for more than 14 days total since birth cannot join — this includes steroid tablets at certain doses, though inhaled or skin-applied steroids are allowed.
• Children who have received long-acting immune-modifying medicines (such as infliximab) at any point during the study cannot join.
• Children who are taking any ongoing regular medication that would continue throughout the study cannot join.
• Children who received a vaccine not included in the study plan within 30 days before or after any study vaccine dose cannot join — routine national/regional vaccines and inactivated flu vaccines are generally still allowed.
• Children who are already taking part in another clinical trial involving any medicine, vaccine, or medical device cannot join.
• Children who have already received any vaccination against Hib, diphtheria, tetanus, whooping cough, pneumococcus, or polio since birth cannot join.
• Children who have previously had Hib disease, diphtheria, tetanus, whooping cough, pneumococcal disease, polio, or hepatitis B cannot join.
• Children with a known or suspected condition that weakens the immune system (including severe combined immunodeficiency) cannot join.
• Children with a family history of inherited or genetic immune system problems cannot join.
• Children with a history of allergic or adverse reactions to any ingredient in the study vaccine cannot join.
• Children with major birth defects cannot join.
• Children with a serious ongoing illness cannot join.
• Children with a history of any neurological (brain or nerve) disorders or seizures cannot join.
• Children who are currently unwell or have a fever at the time of enrolment cannot join (fever is defined as 37.5°C or above depending on how it is measured — confirm with trial site if unsure).
• Children who have received immunoglobulins or any blood products since birth, or who are planned to receive them during the study, cannot join.
• Children with a known allergy to latex cannot join.

Important: Always verify eligibility with the trial site directly before applying.