A clinical trial to assess and compare the safety of Pentavac Vaccine (DTP-HB+Hib) of SIIL with Tritanrix-HB-HIB of GSK in Indian infants.

Phase 4

Completed

Conditions: The safety of Diphtheria, Tetanus, Pertussis, Hepatitis-B and H. influenzae type-B vaccine in infants.

Registration Number: CTRI/2009/091/000615

Lead Sponsor: Serum Institute of India Research Foundation

Brief Summary: 1500 subjects will be screened for eligibility criteria after written informed consent from their parents/guardian. Eligible subjects will be randomized (2:1) to receive either 0.5 ml of Pentavac vaccine of SIIL or Tritanrix-HB-Hib of GSK. Study vaccine will be administered deep intramuscularly in the right anterolateral thigh. At first 3 visits (6, 10, and 14 weeks of age), the study vaccines will be administered. The parents/Legal Guardian will be informed to visit the study centre on 28th day (2nd visit), 56th day (3rd visit) and 84th day (4th visit). At each visit, the subjects will be physically examined and parents will be asked for adverse events and concomitant medication. Diaries will be collected and transcribed into Case Record Form. The study is planned in Indian Infants only.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1500

Inclusion Criteria

1)Normal healthy infants of age 6-8 weeks at the time of the first vaccination2)Parents/Legal Guardian of subject willing to give written informed consent 3)Parents/Legal Guardian willing to comply with study protocol.4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.5)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 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component 4)Infant with chronic illness.
5)Infant who receive blood or blood?derived products in the past.
6)Known history of a bleeding disorder.
7)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of solicited adverse reaction within 3 days of each vaccine dose.	within 3 days of each vaccine dose.

Secondary Outcome Measures

Name	Time	Method
1)Occurrence of unsolicited adverse events	within 28 days following the administration of each vaccine dose.

Trial Locations

Locations (3): Department of Pediatrics
🇮🇳
Pune, MAHARASHTRA, India
Department Of PSM
🇮🇳
Nanded, MAHARASHTRA, India
Department PSM
🇮🇳
Wardha, MAHARASHTRA, India
Department of Pediatrics
🇮🇳Pune, MAHARASHTRA, India
DR. DEEPALI AMBIKE
Principal investigator
02114228532
deepali.ambike@rediffmail.com
Dr. Ashok D. Rathod
Principal investigator
adrathod@yahoo.com
Dr. C. S. Rajput
Principal investigator
drudayrajput@gmail.com
Dr. C.T. Deshmukh
Principal investigator
022-24136051
infopediatrics@kem.edu
Dr. Deepti Jain
Principal investigator
dipty47@rediffmail.com
Dr. Mamta Manglani
Principal investigator
mmanglani@hotmail.com
Dr. S. S. More
Principal investigator
deanvngmcstudentsection@rediffmail.com
Dr. Sanjay K. Lalwani
Principal investigator
020-24364308
sanjaylalwani2007@rediffmail.com