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

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.

• DTP-HB-Hib vaccine (Biological), also known as Pentavac: 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) (Device), also known as Stratis: Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
• Needle & Syringe (Other): The conventional needle syringe that is routinely used for vaccination.

Primary outcomes

• 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 outcomes

• Occurrence of solicited reactions [within 4 days following the administration of each of the three vaccine dose]
• Occurrence of adverse event [84 days after first vccine dose]
• Occurrence of serious adverse event [84 days after first vccine dose]

Sex: All, ages: 6 Weeks to 8 Weeks, accepts healthy volunteers

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

• Results publication: 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. PMID 30899835