Phase 4 Hepatitis B Trial, Completed

Written by an AI model from the 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 child's parent(s) or legal guardian(s) are willing and able to follow the study requirements, such as filling in diary cards and attending follow-up appointments.
• The parent(s) or legal guardian(s) have given written permission for their child to take part before any study procedures begin.
• The child is 9 months old at the time of joining the study.
• The child is in good general health, confirmed by a medical history review and physical check-up before entering the study.
• The child was born to a mother who received a vaccine in a specific earlier study (study 116945), and the child themselves completed a primary vaccination series in another linked study (study 201330).

Who may not be able to join:

• The child is in the care of an authority or institution (for example, in foster or local authority care).
• The child is currently taking part in, or has taken part in, another clinical study involving any investigational or non-investigational product within the three months before the booster dose or at any point during this study.
• The child has taken medications that suppress or modify the immune system for more than 14 days in total within the six months before the booster vaccine dose (steroid inhalers and skin-applied steroids are generally allowed — confirm with trial site).
• The child has received any long-acting drugs that affect the immune system at any point during the study period (for example, infliximab).
• The child has received a vaccine not included in this study's plan within 30 days before or 30 days after the booster dose, with some exceptions such as flu vaccines or routine national/regional childhood vaccines (confirm with trial site).
• The child has a confirmed or suspected condition that weakens or suppresses the immune system, based on their medical history and a physical examination.
• The child has a major birth defect.
• The child has a serious long-term illness.
• The child has received immunoglobulins or any blood products within three months before the booster vaccine dose, or is planned to receive them during the study.
• The child has had a serious brain or nervous system reaction (such as loss of consciousness, severe seizures, or failure to recover within 24 hours) within 7 days of receiving a specific earlier vaccine called Infanrix hexa.
• The child has had any of the following diseases since completing the earlier linked study (study 201330): Hib, diphtheria, tetanus, whooping cough, pneumococcal disease, polio, or hepatitis B.
• The child has already received a booster vaccination against any of the following since completing the earlier linked study (study 201330): Hib, diphtheria, tetanus, whooping cough, pneumococcus, hepatitis B, or polio.
• The child has a history of allergic or hypersensitivity reactions that could be triggered by any ingredient in the study vaccines.
• The child has a latex allergy.
• The child has a history of any neurological (brain or nervous system) disorders or seizures.
• The child has any condition that, in the doctor's opinion, would make receiving an injection into the muscle unsafe.
• The child has an acute illness or a fever at the time of vaccination (fever is defined as a temperature of 37.5°C/99.5°F or above for most measurement methods, or 38.0°C/100.4°F or above when measured rectally).

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