| CTRI Number |
CTRI/2011/04/001681 [Registered on: 18/04/2011] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A post licensure clinical trial to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five) administered to healthy Indian infants in comparison with a licensed Pentavac SD™ vaccine available in Indian market |
|
Scientific Title of Study
|
A multicentric, single blind, parallel, randomized, phase-IV non-inferiority study to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy Indian infants at 6-10-14 weeks schedule in comparison with a marketed SIIL’s Pentavac SD™ vaccine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT011/DTwP-rHepB-HIB-PIV/CTP-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTSA Kishore |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Biological E Limited |
| Address |
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
|
| Name |
DrTSA Kishore |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Biological E Limited |
| Address |
Biological E.Limited,
18/1&3, Azamabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Public Query
|
| Name |
MrShekhar 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 |
| Phone |
09741111101 |
| Fax |
08041534831 |
| Email |
shekhar.gupta@d2lpharma.com |
|
|
Source of Monetary or Material Support
|
| Biological E.Limited (self) |
|
|
Primary Sponsor
|
| Name |
Biological ELimited |
| Address |
Biological E.Limited
18/1&3, Azamabad, Hyderabad-500020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBKrishna Murthy |
Cheluvamba Hospital |
Dept of Paediatrics, Cheluvamba Hospital, Irwin Road, Mysore - 570001, Karnataka, India
Mysore
KARNATAKA |
0944805007
bkm6@rediffmail.com |
| DrJampana Venkateswara Rao |
Gandhi Hospital |
Dept of Paediatrics, Gandhi Hospital, Musheerabad, Secunderabad - 500003, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
09848027709
dr_jvrao@yahoo.co.in |
| DrDNarayanappa |
JSS Medical college |
Department of Paediatrics, Jagadguru Sri Shivarathreeshwara Medical College & Hospital, Mahatma Gandhi Road, Mysore - 570004, Karnataka, India
Mysore
KARNATAKA |
09845112560
sinchabhi@yahoo.com |
| Dr Mallikarjunaiah |
K.C General Hospital |
Dept of Paediatrics, K.C General Hospital, 5th Cross,Malleshwaram, Nr Malleswaram Police Station, Bangalore - 560003, Karnataka, India
Bangalore
KARNATAKA |
09008999330
lakshmipathysr@gmail.com |
| Dr Pandit Anand Nilkanth |
KEM Hospital Research Centre |
Dept of Paediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune - 411011, Maharashtra, India
Pune
MAHARASHTRA |
09822002327
kemhrc@vsnl.com |
| DrPVenugopal |
King George Hospital |
Dept of Paediatrics, King George Hospital (KGH), Near Collectorate Maharanipeta, Visakhapatnam - 530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
09848027203
venugopal_kgh@yahoo.com |
| Dr Jain Manish Ajeet |
Mahatma Gandhi institute of Medical Sciences |
Dept of Paediatrics, Mahatma Gandhi institute of Medical Sciences, PO Sewagram - 442102, Wardha District, Maharashtra, India
Wardha
MAHARASHTRA |
09822695195
dr_manishjain@rediffmail.com |
| Dr Deokule Amita Shrikrishna |
Oyster and Pearl Hospital |
Dept of Paediatrics, Oyster and Pearl Hospital, 1671-75 Ganesh Khind Road, Near Hotel Pride, Pune-411005, Maharashtra, India
Pune
MAHARASHTRA |
09822068480
aap.phadnis@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee MGIMS, Sewagram |
Approved |
| Ethics Committee of Mysore Medical College, Research Institute and Associated Hospital(Cheluvamba Hospital) |
Approved |
| Human Ethics Committee, Gandhi Hospital |
Approved |
| Independent Ethics Committee Consultants (K.C General Hospital) |
Approved |
| Institute Ethics Committee,Padmashree Dr.D.Y.Patil Medical College, Pimpri, Pune. |
Approved |
| Institutional Ethics Committee King George Hopital, Visakhapatnam |
Approved |
| JSS Institutional Ethical Committee |
Approved |
| O & P Institutional Ethics Committee(Oyster and Pearl Hospital) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| 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
|
| Type |
Name |
Details |
| Intervention |
BEs combined Liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five) |
0.5 mL per dose administered intramuscularly 3 dose schedule in the anterolateral aspect of thigh. The duration is 56 days (6-10-14 schedule) with 28 day interval between doses. |
| Comparator Agent |
SIIL’s Pentavac SD™ vaccine (DTwP-rHepB-Hib vaccine) |
0.5 mL per dose administered intramuscularly 3 dose schedule in the anterolateral aspect of thigh. The duration of treatment is 56 days (6-10-14 schedule) with 28 day interval between doses. |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
Healthy infants between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) of either gender at the time of 1st vaccination.
Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian.
Healthy infants with weight equal to or more than 3300 gms at the time of screening.
Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature).
Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.
Infants or their mothers not participating in any other clinical trials.
Infants without contraindications or precautionary circumstances for participating in the trial
Ability of the infants parent or legally acceptable representative/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 &/or Inactivated polio vaccine.
Current illness (especially fever) or any acute or congenital illness or disability.
Subjects receiving immunosuppressive therapy.
Known or suspected allergy to any of the vaccine components.
Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS).
Known family history of SIDS (Sudden Infant Death Syndrome).
Planned or elective surgery during the course of the study.
Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
Subjects and their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
Inability or unwillingness to abide by the requirements of the protocol.
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
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Seroprotection rates (SPR) as defined by percentage of subjects with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres above their seroprotective cut off values. |
1.At Day 84. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Proportion of subjects achieving 4-fold rise in antibody titres.
2.Geometric mean titres(GMTs)estimation.
3.Solicited local and systemic AEs.
4.Solicited and unsolicited AEs.
5.Rate of SAEs and medically attended AEs.
6.Vital signs.
|
1.At day 84
2.At screening & day 84
3.60 minutes post vaccination till day 7.
4.During the subsequent Followup period up to 28th day
5.Until 84th day after 1st vaccination
6.At each visit |
|
|
Target Sample Size
|
Total Sample Size="408"
Sample Size from India="408"
Final Enrollment numbers achieved (Total)= "408"
Final Enrollment numbers achieved (India)="408" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/04/2011 |
| Date of Study Completion (India) |
13/09/2011 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A multicentric, single blind, parallel, randomized, phase-IV non-inferiority study to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy Indian infants at 6-10-14 weeks schedule in comparison with a marketed SIIL’s Pentavac SD™ vaccine. This study to be conducted at 08 study sites.All the study sites will be located in India. There will be a total of 408 healthy subjects of either sex randomised into two groups in 2:1 ratio.
The primary outcome measure is to evaluate non-inferiority of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine with SIIL’s Pentavac SD™ in terms of difference in proportion of subjects achieving seroprotection with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres at day 84.
The secondary outcome measures are to a) compare proportion of subjects achieving fold rise in anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres, above the seroprotection cut off value, between BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine and Pentavac SD™ at Day 84; b) To compare immunogenicity in terms of GMTs for anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres of BE’s combined pentavalent DTwP-rHepB-HIB vaccine with that of Pentavac SD™ at 84; c) To assess the safety and tolerability of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine in comparison with Pentavac SD™ for the entire study period of 84 days after the first vaccination.
|