The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
Who can participate
Age range7 Weeks ā 10 Weeks
SexALL
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Inclusion Criteria:
* Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
* Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
* Male and female infants who are identified to be healthy based on physical examination and medical history.
Exclusion Criteria:
* Subjects who have acute febrile illness with tympanic temperature of ā„38.0 ā on the day of vaccination.
* Subjects who have moderate or severe acute disease (regardless of fever).
* Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
* Subjects who have major congenital defects.
* Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
* Subjects who have abnormalities in the immune system, or congenital/acquired immune deļ¬ciency.
* Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
* Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
* Subjects who are allergic to the ingredients of the investigational products.
* Subjects who have received immunoglobulins or blood products or plan to get thosā¦
What they're measuring
1
Vaccine response rate
Timeframe: 4 weeks after the three-dose primary vaccination