| CTRI Number |
CTRI/2015/04/005688 [Registered on: 10/04/2015] Trial Registered Prospectively |
| Last Modified On: |
29/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to evaluate the safety and immunogenicity of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) combination vaccine in two age groups of healthy subjects. |
|
Scientific Title of Study
|
A Phase I/II (Pilot) Trial to Evaluate the Safety and Immunogenicity of HBI Pentavalent (DTwP-Hb-Hib [Liquid]) Combination Vaccine in two groups of Healthy Subjects from 16 Months to 24 Months of Age and Two Years to Five Years of Age. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SC-HBDTPHbHib-012, Version:03 Amendment 1: Date 18 NOV 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sai Krishna |
| Designation |
Manager- Medical Services |
| Affiliation |
Human Biologicals Institute |
| Address |
Human Biologicals Institute
(A division of Indian Immunologicals Limited)
Rakshapuram, Gachibowli Post,
Hyderabad.
Rangareddi
ANDHRA PRADESH
500032
India |
| Phone |
04023000211 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sai Krishna |
| Designation |
Manager- Medical Services |
| Affiliation |
Human Biologicals Institute |
| Address |
Human Biologicals Institute
(A division of Indian Immunologicals Limited)
Rakshapuram, Gachibowli Post,
Hyderabad.
Bid
ANDHRA PRADESH
500032
India |
| Phone |
04023000211 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sai Krishna |
| Designation |
Manager- Medical Services |
| Affiliation |
Human Biologicals Institute |
| Address |
Human Biologicals Institute
(A division of Indian Immunologicals Limited)
Rakshapuram, Gachibowli Post,
Hyderabad.
Bid
ANDHRA PRADESH
500032
India |
| Phone |
04023000211 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
|
Source of Monetary or Material Support
|
| Human Biologicals Institute |
|
|
Primary Sponsor
|
| Name |
Human Biologicals Institute |
| Address |
Human Biologicals Institute
(A division of Indian Immunologicals Limited)
Rakshapuram, Gachibowli Post,
Hyderabad. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay K Lalwani |
Bharati Vidyapeeth Deemed University Medical College, Pune |
Professor and Head,
Department of Pediatrics,
Bharati Vidyapeeth Deemed University Medical College,
Pune
Pune
MAHARASHTRA |
020-24364308
sanjaylalwani2007@rediffmail.com |
| Dr Potula Venugopal |
King George Hospital, Vishakapatnam |
Professor of Pediatrics Department of Pediatrics, King George Hospital,
Visakhapatnam- 530016
Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
09848027203
fbnc.amc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College,Pune, IEC |
Approved |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention against Diphtheria,Tetanus, Pertussis, Hepatitis B and Haemophillus Influenza Type B diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Pentavalent (DTwP-Hb-Hib vaccine)liquid combination vaccine, Human Biologicals Institute. |
Single booster dose of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufactured by Human Biologicals Institute will be administered by intramuscular route in the anterolateral aspect of thigh region. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy children between 16 months and five years of age who have not received booster dose or have received booster dose >1 year earlier
2.Subjects who have received primary immunization as per EPI schedule
3.Born after a normal gestational period (36 – 42 weeks) with a birth weight ≥2.5 kg
4.Judged to be in good health on the basis of reported medical history and history-directed physical examination
5.Plans to remain in the study area for the length of the trial
6.Parent or legally acceptable representative has provided Informed consent as per Schedule Y and Indian GCP guidelines.
|
|
| ExclusionCriteria |
| Details |
1.Participation in another clinical trial in the 4 weeks preceding the trial vaccination
2.Planned participation in another clinical trial during the present trial period
3.Infant born to known HIV I&II seropositive mother (documented laboratory result of HIV assay from the maternal blood sample is available)
4.Previous evidence of infection with Diphtheria, Tetanus, Pertussis Hepatitis B and H. influenzae
5.History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics
6.Children having any intercurrent illness
7.Evidence of evolving neurological signs and symptoms
8.Known or suspected primary or acquired disease of the immune system
9.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)
10.Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction
11.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures
12.Receipt of blood products or immunoglobulin by mother in any trimester or by the child since birth
13.Daily use of non-steroidal anti-inflammatory drugs
14.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
15.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 (e.g. wheezing, shortness of breath)
16.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
17.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
18.Thrombocytopenia or bleeding disorder that would pose as a contraindication to an IM vaccination.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of the subjects experiencing local and/or systemic reactions.
2.Number of serious adverse events occurring. |
Till 4 to 6 weeks after vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Seroconversion rate and Seroprotection rate of HBI Pentavalent DTwP-Hb-Hib vaccine |
4 to 6 weeks after vaccination |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/04/2015 |
| Date of Study Completion (India) |
22/07/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Phase I/II (Pilot) study to evaluate the safety and immunogenicity of HBI Pentavalent (DTwP-Hb-Hib[Liquid])Combination vaccine in two groups of Healthy Subjects from 16 months to 24 months of age and two years to Five years of age. The primary objective is to measure the Proportion of the subjects experiencing local and/or systemic reactions and the secondary objective is to measure the immunogenicity ( Seroconversion rate and Seroprotection rate) of the vaccine in both the age groups after a single booster dose. Blood samples will be collected from the subjects on visit 1 (before the vaccination) and at visit 2 (follow up visit after 4 -6 weeks) for estimation of antibodies. The samples will be sent to central lab at SRL for analysis. The study will be conducted in two centres in India. |