Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants

This is an interventional prevention trial for Pertussis focused on measuring Immunogenicity, Safety, DTaP Vaccine Read More

Inclusion criteria:

• Healthy infants aged 3-5months old as established by medical history and clinical examination
• The subjects' guardians are able to understand and sign the informed consent
• Subjects who can and will comply with the requirements of the protocol
• Subjects with temperature ≤37.0°C on axillary setting

Exclusion criteria:

• Subjects who was premature birth
• Subjects who has a medical history of diphtheria, pertussis or tetanus.
• Had been vaccined for DTwP or DTaP
• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
• Severe malnutrition or dysgenopathy
• Family history of seizures or progressive neurological disease
• Family history of congenital or hereditary immunodeficiency
• Thyroid disease
• Coagulation disorder diagnosed by a doctor(such as the lack of clotting factors, clotting hemorrhagic disease, platelet abnormalities) or significant bruising
• No spleen, functional asplenia, and any situation caused by no spleen or splenectomy
• Any acute infections in last 7 days
• Any prior administration of immunodepressant or corticosteroids
• Any prior administration of blood products in last 3 month
• Any prior administration of other research medicines in last 1 month
• Any prior administration of attenuated live vaccine in last 15 days
• Any prior administration of subunit or inactivated vaccines in last 7 days
• Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Exclusion criteria for the second and third dose:

If subjects who have one condition of 1 to 4 as followed, prohibiting to continue the vaccination, and they will be continue observed in the opinion of the investigator. If Subjects who had one condition of 5 to 6 as followed, must be determined whether to continue by the investigator. If Subjects who had one condition of 7 to 8 as followed, they can had a delayed vaccination during time frame of the program. All participants with adverse events as followed, must be settled in follow-up to the end of events.

• Any serious adverse events caused by vaccination.
• Hypersensitivity after vaccination.
• Anaphylaxis after vaccination
• Any confirmed or suspected autoimmune diseases or immune deficiency disorders, including human immunodeficiency virus (HIV) infection
• Have acute or new chronic disease during vaccination
• Other reactions that in the opinion of the investigator ( include: severely serious symptom of pain, swelling, Limitation of motion, continuous high fever, headache and other Systemic or local reactions )
• Have acute disease during vaccination (Acute disease refers to with or without fever of moderate or severe disease)
• Subjects with temperature >37.0°C on axillary settin.