Clinical trial NCT02409095: Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Immune Response to DTP-HB-Hib Vaccine
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2015-04-06
Enrollment: 211
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis
timeFrame: one month after administration of third dose of the vaccine
Secondary outcomes:
measure: Occurrence of solicited reactions
timeFrame: within 4 days following the administration of each of the three vaccine dose
measure: Occurrence of adverse event
timeFrame: 84 days after first vccine dose
measure: Occurrence of serious adverse event
timeFrame: 84 days after first vccine dose
Other outcomes:
Locations:
city: Pune
country: India
facility: Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
state: Maharashtr
city: Pune
country: India
facility: Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
state: Maharasthra
city: Chennai
country: India
facility: Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
state: Tamil Nadu
Study officials:
References:
citation: 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.