| CTRI Number |
CTRI/2009/091/000456 [Registered on: 09/07/2009] |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A phase III clinical trial to study the safety and immunogenicity of BEs combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy Infants of either gender in comparison with a marketed vaccine. |
Scientific Title of Study
Modification(s)
|
A multicentric, single blind, parallel, randomized, phase-III study to evaluate the immunogenicity & safety of BEs combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy Indian subjects at 6-10-14 weeks EPI schedule in comparison with marketed Shan5 vaccine. |
| Trial Acronym |
None |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BECT012/DTwP-rHepB-HIB-PIII/CTP-01 Version:01date 09.03.09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrTSAKishore |
| Designation |
Deputy General Manager |
| Affiliation |
Biological E. Limited |
| Address |
Trial Coordinator, Biological E. Limited, 18/1&3,
Azamabad
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrTSAKishore |
| Designation |
Deputy General Manager |
| Affiliation |
Biological E. Limited |
| Address |
Trial Coordinator, Biological E. Limited, 18/1&3,
Azamabad
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Shekhar Gupta |
| Designation |
Chief Operating Officer |
| Affiliation |
D2L Pharma Research Solutions |
| Address |
D2L Pharma Research Solutions 1615, 5th Main, E Block, AECS Layout, Kundalahalli, Bangalore
Bangalore
KARNATAKA
560037
India
Bangalore
KARNATAKA
560037
India |
| Phone |
08041534831 |
| Fax |
08041534831 |
| Email |
shekhar.gupta@d2lpharma.com |
|
Source of Monetary or Material Support
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|
| Biological E. Limited (Self)
18/1&3, Azamabad, Hyderabad,India-500020 |
|
Primary Sponsor
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|
| Name |
Biological E Limited Azamabad Hyderabad AP India |
| Address |
Biological E.Limited, 18/1&3,Azamabad, Hyderabad,India-500020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
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|
Countries of Recruitment
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India |
Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAAmaresh |
Niloufer Hospital for Women and Children |
Bazarghat, Red hills,Lakdikapool-500004
Hyderabad
ANDHRA PRADESH |
9440055990
adyaramaresh@yahoo.com |
| Dr.Agarkhedkar Sharad |
Padmashree Dr.D.Y.Patil Pratishthan Hospital & Research Centre |
Sant Tukaram nagar,Pimpri-411018
Pune
MAHARASHTRA |
9341231285
ashalaka@gmail.com |
| Dr.E.Adarsh |
Rajarajeshwari Medical College & Hospital |
College Campus: Kambipura, ,Mysore Road, Kengeri Hobli-560074
Bangalore
KARNATAKA |
9341231285
dradarsh.d2l@gmail.com |
|
Details of Ethics Committee
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|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr.D.Y.Patil Medical College |
Approved |
| Ethics Committee, Osmania Medical College |
Approved |
| Ethics Committee, Rajarajeshwari Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
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|
|
Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive protection against Diphtheria, Tetanus, Petussis, Hepatitis-B and Haemophilus Influenzae type B diseases. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Combined pentavalent DTwP-rHepB-HIB liquid vaccine of BE Ltd |
0.5mL/dose administered intramuscularly at 6-10-14 weeks in three dose EPI schedule. |
| Comparator Agent |
Shan5 (Combined DTwP-rHepB-HIB Liquid Vaccine) |
0.5mL/dose administered intramuscularly at 6-10-14 weeks in three dose EPI schedule. |
|
Inclusion Criteria
Modification(s)
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| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
1.Intended subjects will be healthy infants between 6 to8 weeks of age that is 42 to 56 days of age,both days inclusive of either gender at the time of 1st vaccination.
2.Written informed consent obtained from the subject’s parents or legal representative or guardian.
3.Healthy infants with weight greater than or equal to 3300 gms at the time of screening.
4.Good clinical condition established by medical history and physical examination with no acute disease, infection or high temperature that is greater then 38.5 degrees C axillary temperature.
5.Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.
6.Subjects or their mothers not participating in any other trials.
7.Infants without contraindications or precautionary circumstances for participating in the trial
8.Ability of the subject’s parent or legal representative or guardian to understand and comply with the requirements of the protocol.
|
|
| ExclusionCriteria |
| Details |
Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral polio vaccine; Current illness (especially fever) or any acute or congenital illness or disability; Known or suspected allergy to any of the vaccine components;Â Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS); Known family history of SIDS (Sudden Infant Death Syndrome);Â Inability or unwillingness to abide by the requirements of the protocol;Â Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol. |
|
Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant Blinded |
Primary Outcome
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| Outcome |
TimePoints |
Primary Endpoint - Proportion of subjects achieving seroprotection rates in antibody titres against all the five components in each treatment group at Day 84.
|
By the end of 84th day from 1st vaccination. |
|
Secondary Outcome
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| Outcome |
TimePoints |
| Antibody titres rise against each of the five antigen component |
GMTs estimated both at baseline 0 day and again on 84th day. |
| Proportion of subjects achieving 4-fold rise of antibody titres above the cutoff levels. |
Estimated at 84th day after 1st vaccination |
| Occurance of both solicited and unsolicited local and systemic adverse events |
1. First 60 minutes post vaccination.
2. until 7 days post vaccination through diary.
3. upto 28th day post vaccination.
4. SAEs over the entire course of the study. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
10/07/2009 |
| Date of Study Completion (India) |
30/10/2009 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
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|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
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|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A multicentric, single blind, parallel, randomized (2:1), phase-III study to evaluate the immunogenicity & safety of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy infants at three centres in India. The primary outcome measure is To evaluate BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine in comparison with Shan5 based on proportion of subjects achieving seroprotection levels of antibody titres against diphtheria, tetanus, pertussis, hepatitis-B and HI type B at Day 84. The secondary outcomes will be to evaluate a) immunogenicity of both the vaccines at Day 84 in terms of Geometric Mean Titres (GMTs) b) fold rise in antibody titres above the seroprotection cut off value against each of the five components c) safety and reactogenicity of BE’s liquid pentavalent DTwPrHepB-HIB vaccine in comparison with Shan5. |