To evaluate the Safety and Immunogenicity of the Tetrabhay DTwP-H (Diphtheria, Tetanus, whole cell Bordetella Pertussis and Hepatitis B) vaccine in comparison with commercially available ShantetraTM vaccine in healthy childre

Phase 1

Completed

• Registration Number: CTRI/2010/091/001125
• Lead Sponsor: Human Biologicals Institute Indian Immunologicals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

?Healthy children between 1 to 5 year of age

?Mothers of the enrolled child to be serologically negative for HBsAg

?Born after a normal gestational period (36 ? 42 weeks) with a birth weight ≥ 2.5 kg

?Judged to be in good health on the basis of reported medical history and history-directed physical examination.

?Plans to remain in the study area for the length of the trial.

?Legally acceptable representative has provided Informed consent as per ICH ?GCP guidelines.

Exclusion Criteria

?Participation in another clinical trial in the 4 weeks preceding the trial vaccination
?Planned participation in another clinical trial during the present trial period
?Infant born to known HIV I&II seropositive mother (documented laboratory result of HIV assay from the maternal blood sample is available).
?Previous evidence of infection with Diphtheria, Tetanus ,Pertussis and hepatitis B
?History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics
?Children having any intercurrent illness
?Evidence of evolving neurological signs and symptoms.
?Known or suspected primary or acquired disease of the immune system.
?Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (participants who are taking topical and inhaled steroids could be included in the study as would participants on a ?short course? of oral steroids, <7 days, as long as there are not two courses within the previous two weeks prior to vaccination).
?Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
?Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures.
?Receipt of blood products or immunoglobulin by mother in any trimester or infant since birth.
?Daily use of non-steroidal anti-inflammatory drugs.
?Receipt of any vaccine other than OPV, BCG and or investigational product within the 30 days prior to enrollment, or planning to receive any other vaccine within 28 days after receiving study vaccine.
?Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (eg. wheezing, shortness of breath).
?Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
?History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis and Hepatitis B vaccine in a sibling.
?Thrombocytopenia or bleeding disorder that would pose a contraindication to an IM vaccination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the safety of Tetrabhay vaccine manufactured by Human Biologicals Institute in healthy childrenTimepoint:

Secondary Outcome Measures

Name	Time	Method
?To determine that the Immunogenicity (seroconversion rate) of Tetrabhay vaccine (Human Biologicals Institute group) is not inferior to ShantetraTM vaccine groupTimepoint: