Immune Response to DTP-HB-Hib Vaccine Clinical Trial
Official title:
A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India
| Verified date | September 2018 |
| Source | Serum Institute of India Pvt. Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a study planned to determine and compare immunogenicity and reactogenicity of
DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or
disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of
enrollment.
It will provide information to aid managers, device regulatory control officials,
immunization programs, and clinicians who make decisions on safe clinical practice standards.
| Status | Terminated |
| Enrollment | 211 |
| Est. completion date | March 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Weeks to 8 Weeks |
| Eligibility |
Inclusion Criteria: 1. Normal healthy infants of age 6-8 weeks at the time of the first vaccination. 2. Born after a normal gestation period (36-42 weeks). 3. Parents of subjects willing to give written informed consent. 4. Parents willing to comply with study protocol. 5. Free of obvious health problems as established by medical history and screening evaluation including clinical examination. 6. The participant should be the resident of study area Exclusion Criteria: 1. Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period. 2. Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of = 1 week. 3. Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. 4. Infant with any chronic illness including hepatic, renal, respiratory, CVS, endocrine and neurological illness. 5. Infants who have received blood or blood-derived products in the past. 6. History of diphtheria, tetanus, pertussis, and hepatitis B or Haemophilus influenzae type b (confirmed either clinically, serologically or microbiologically). 7. Previous history of vaccination against the diphtheria, tetanus, pertussis or Hib. 8. Known history of a bleeding disorder contraindicating intramuscular vaccination. 9. History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode. 10. History of febrile illness at the time of inclusion is a temporary exclusion criterion. 11. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives 12. Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol |
| Country | Name | City | State |
|---|---|---|---|
| India | Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur, | Chennai | Tamil Nadu |
| India | Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi | Pune | Maharasthra |
| India | Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, | Pune | Maharashtr |
| Lead Sponsor | Collaborator |
|---|---|
| Serum Institute of India Pvt. Ltd. | PATH |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis | one month after administration of third dose of the vaccine | ||
| Secondary | Occurrence of solicited reactions | within 4 days following the administration of each of the three vaccine dose | ||
| Secondary | Occurrence of adverse event | 84 days after first vccine dose | ||
| Secondary | Occurrence of serious adverse event | 84 days after first vccine dose |