Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants
NCT ID: NCT02409095
Last Updated: 2018-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
211 participants
INTERVENTIONAL
2015-01-31
2016-03-31
Brief Summary
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It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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DISPOSABLE-SYRINGE JET INJECTOR (DSJI)
Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc
DTP-HB-Hib vaccine
Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases.
Disposable Syringe Jet Injector (DSJI)
Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
NEEDLE & SYRINGE (N-S)
Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via conventional needle and Syringe
DTP-HB-Hib vaccine
Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases.
Needle & Syringe
The conventional needle syringe that is routinely used for vaccination.
Interventions
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DTP-HB-Hib vaccine
Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases.
Disposable Syringe Jet Injector (DSJI)
Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
Needle & Syringe
The conventional needle syringe that is routinely used for vaccination.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
6 Weeks
8 Weeks
ALL
Yes
Sponsors
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PATH
OTHER
Serum Institute of India Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
Pune, Maharashtr, India
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
Pune, Maharasthra, India
Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
Chennai, Tamil Nadu, India
Countries
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References
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Bavdekar A, Malshe N, Ravichandran L, Sapru A, Kawade A, Lalwani S, Palkar S, Hanumante N, Gunale B, Kapse D, Chaudhari A, Miller T, Saganic L, Jarrahian C, McGray S, Zehrung D, Kulkarni PS. Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India. Contemp Clin Trials Commun. 2019 Jan 9;14:100321. doi: 10.1016/j.conctc.2019.100321. eCollection 2019 Jun.
Other Identifiers
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Penta-01/12
Identifier Type: -
Identifier Source: org_study_id
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