Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
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|ClinicalTrials.gov Identifier: NCT00617812|
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : June 25, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B||Biological: Shan5||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
- Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. [ Time Frame: 4 months ]
- Solicited and unsolicited local and systemic adverse events following vaccination [ Time Frame: 4 months ]
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|Ages Eligible for Study:||6 Weeks to 8 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Healthy children in the age group six to eight weeks
- Born after a normal gestational period (36 - 42 weeks)
- Mother's HBsAg assured negative.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents willing to fill the Diary Card
- Administration of immunoglobulin or any blood products since birth.
- Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV & BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
- Previous vaccination or evidence of infection with DTP.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
- Major congenital or hereditary immunodeficiency.
- Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
- Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
- Parent/s or guardian of subject unable to maintain diary card
- Simultaneous participation in any other clinical study
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): NCT00617812
|Deccan College of Medical Sciences|
|Hyderabaad, Andhra Pradesh, India, 500058|
|Ankur Institute of Child Health|
|Ahmedabad, Gujrat, India, 380009|
|JSS Medical College|
|Mysore, Karnataka, India, 570015|
|Institute of Child Health|
|Kolkata, West Bengal, India, 700017|
|Study Director:||Raman Rao, MD||Shantha Biotechnics Limited, Hyderabad, India|
|Responsible Party:||Head Clinical Research and Medical Affairs, Shantha Biotechnics Limited|
|Other Study ID Numbers:||
|First Posted:||February 18, 2008 Key Record Dates|
|Last Update Posted:||June 25, 2009|
|Last Verified:||June 2009|
Haemophilus influenzae type b
Digestive System Diseases
Hepatitis, Viral, Human
Respiratory Tract Infections
Respiratory Tract Diseases
DNA Virus Infections
Gram-Negative Bacterial Infections
Bacterial Infections and Mycoses
Gram-Positive Bacterial Infections