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

September 7, 2018 updated by: Serum Institute of India Pvt. Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtr
      • Pune, Maharashtr, India, 411011
        • Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
    • Maharasthra
      • Pune, Maharasthra, India, 411043
        • Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600116
        • Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Pentavac
Device: Disposable Syringe Jet Injector (DSJI)
Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
Other Names:
  • 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 Names:
  • Pentavac
Other: Needle & Syringe
The conventional needle syringe that is routinely used for vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one month after administration of third dose of the vaccine

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of solicited reactions
Time Frame: within 4 days following the administration of each of the three vaccine dose
within 4 days following the administration of each of the three vaccine dose
Occurrence of adverse event
Time Frame: 84 days after first vccine dose
84 days after first vccine dose
Occurrence of serious adverse event
Time Frame: 84 days after first vccine dose
84 days after first vccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serum Institute of India Pvt. Ltd.

Collaborators

PATH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 6, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Penta-01/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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