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Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409095
Recruitment Status : Terminated (Due to increased rate of local injection site reactions in the DSJI group.)
First Posted : April 6, 2015
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
PATH
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Immune Response to DTP-HB-Hib Vaccine Biological: DTP-HB-Hib vaccine Device: Disposable Syringe Jet Injector (DSJI) Other: Needle & Syringe Phase 4

Detailed Description:
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of Serum Institute of India Ltd. delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B (HBsAg) and Hemophilus Influenza B at 28 days after administration of a third dose of the vaccine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Biological: 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.
Other Name: Pentavac

Device: Disposable Syringe Jet Injector (DSJI)
Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
Other Name: Stratis

Active Comparator: 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
Biological: 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.
Other Name: Pentavac

Other: Needle & Syringe
The conventional needle syringe that is routinely used for vaccination.




Primary Outcome Measures :
  1. Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis [ Time Frame: one month after administration of third dose of the vaccine ]

Secondary Outcome Measures :
  1. Occurrence of solicited reactions [ Time Frame: within 4 days following the administration of each of the three vaccine dose ]
  2. Occurrence of adverse event [ Time Frame: 84 days after first vccine dose ]
  3. Occurrence of serious adverse event [ Time Frame: 84 days after first vccine dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409095


Locations
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India
Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
Pune, Maharashtr, India, 411011
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
Pune, Maharasthra, India, 411043
Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
Chennai, Tamil Nadu, India, 600116
Sponsors and Collaborators
Serum Institute of India Pvt. Ltd.
PATH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Serum Institute of India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02409095    
Other Study ID Numbers: Penta-01/12
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018