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Annexure - II(b)
Details of clinical trial Permissions (Form CT-06)
Year 2021
S.No. File No. Firm Name Name of Product Phase Title of the study Permission No. Date of Issue Summary
1 BIO/CT/20/000178 M/s Bharat Serums AndEquine COVID 19 Phase I/II A Prospective, Randomized, CT- 01/2021 20-01-2021 Based on review of
Vaccines Limited, 17thAntiserum (Liquid Multi-center, Open label, documentssubmitted
Floor, Hoechst House,Injection) Phase 1/2 study to Evaluate and the
Nariman Point Mumbai the Safety and Efficacy of recommendations of
(India) – 400 021 EquineCOVID-19Antiserum Subject Expert
[F(ab')2] (BSVEQAb) plus Committee (SEC)
Standard of Care in meeting dated
Comparison to Standard of 17.12.2020 CT
CarealoneinCOVID-19RT- permission was
PCR positive Patients” vide granted.
Protocol no.
BSV_EQ(cid:2)AB_20_08,
Version 02 dated 30.12.2020
2 BIO/CT/20/000182 M/s GennovamRNA Vaccine for Phase I/II The phase I/II clinical trial CT- 02/2021 25-01-2021 Based on review of
BiopharmaceuticalsLimited,Injection(COVID-19) should be conducted as per documentssubmitted
Emcure House, T-184, protocol no. and the
MIDC, Bhosari, Pune, GBL/HGCO19/2020/01 recommendations of
Maharashtra, – 411 026 Version1.0dated11.11.2020 Subject Expert
subject to the conditions as Committee (SEC)
mentioned under this meeting dated
permission 09.12.2020 CT
permission was
granted.
3 BIO/CT/20/000186 M/sSerumInstituteofIndiaSARS-CoV-2 rS Protein Phase II/III "Aphase2/3,observer(cid:2)blind, CT- 03/2021 11-02-2021 Based on review of
Pvt.Ltd.,S.No.105-110,(COVID-19) recombinant randomized, controlled study documentssubmitted
ManjariBk. Pune (lndia) -spikeproteinNanoparticle to determine the safety and and the
412307 Vaccine immunogenicity of recommendations of
COVOVAX [SARS-CoV-2 Subject Expert
recombinant spike protein Committee (SEC)
nanoparticle vaccine (SARS- meeting dated
CoV-2rS)withMatrix-M1™ 03.02.2021 CT
adjuvant] in Indian adults permission was
granted.
4 BIO/CT/21/000001 M/s Bharat BiotechChimpanzee Adenovirus Phase I “A Phase 1, Randomized, CT- 04/2021 12-02-2021 Based on review of
International Limited,Vectored COVID-19 Double-blinded, Multicenter documentssubmitted
GenomeValley,ShameerpetVaccine (BBV154) Study to Evaluate the and the
(India) -500078 Reactogenicity, Safety, and recommendations of
Immunogenicity of an Subject Expert
Intranasal Adenoviral vector Committee (SEC)
COVID-19vaccine(BBV154) meeting dated
in Healthy Volunteers” vide 03.02.2021 CT
Protocol No: permission was
BBIL/BBV154/2020 Version granted.
No: 2.0; Date: 20-01-20215 BIO/CT/20/000071 M/s Biological E Limited,Pneumococcal Phase III A single blind randomised CT- 05/2021 05-03-2021 Based on review of
Plot No 1, S.P.Polysaccharide Conjugate active-controlled Phase-III documentssubmitted
Biotechnology Park, PhaseVaccine (Adsorbed) (14 study to evaluate safety and and the
II, Kolthur Village,Valent) immunogenicityofacandidate recommendations of
ShameerpetMandal(India)- 14- valent pneumococcal Subject Expert
500078 polysaccharide conjugate Committee (SEC)
vaccine administered to 6-8 meeting dated
weeks old healthy Indian 06.07.2020 CT
Infants in 6-10 -14 weeks permission was
dosing schedule” vide Protocol granted.
No.: BECT061/PCV(cid:2)Phase-
III/CTP-01, Version No.:1.0
Final dated 14.05.2020”
6 BIO/CT/21/000009 M/sCadilaHealthcareLtd.,NovelCoronavirus-2019- Phase I/II “A prospective, randomized, CT- 06/2021 15-03-2021 Based on review of
Plot Survey No. 23, 25/P,nCoV Vaccine phase I/II clinical study to documentssubmitted
37, 40/P, 42 to 47, Opp. evaluate the safety and and the
Ramdev Masala, Sarkhej- immunogenicityof3mgdose recommendations of
Bavla,N.H.No.8A,Village- ofNovelCoronaVirus-2019- Subject Expert
Changodar, Taluka - nCovvaccinecandidateofM/s Committee (SEC)
Sanand,Dist.Ahmedabad- CadilaHealthcareLimitedby meeting dated
382 213 intradermal route in healthy 03.02.2021 CT
subjects”protocolno.:project permission was
no. 21-01 version No. 01 granted.
dated 17- 02-2021
7 BIO/CT/20/000187 M/sTergeneBiotechPrivatePneumococcal Phase III A Phase 3, Observer blind, CT- 07/2021 26-03-2021 Based on review of
Limited ,Suite 121 &122,Polysaccharide Conjugate Randomized, Active- documentssubmitted
Building 450, GenomeVaccine (adsorbed), I.P. ControlledTrialEvaluatingthe and the
Valley, Turkapally (V),(15 valent ) Immunologic Non-inferiority, recommendations of
Shamirpet (M), RR Dist, SafetyandTolerabilityofa15- Subject Expert
HYDERABAD (India) - valent Pneumococcal Committee (SEC)
500078 ConjugateVaccineCompared meeting dated
to a 13-valent Pneumococcal 04.02.2021 CT
ConjugateVaccineinHealthy permission was
Infants Given with Routine granted.
Pediatric Vaccinations” &
Protocol Number
–CBCC/2020/029, Version
number:1.0, 09/Nov/2020. II.
The firm is required to
constituteaDSMBtoreview
the safety data.8 BIO/CT/21/000051 M/s Biological E Limited,Covid-19 vaccine Phase III "A Prospective, Open-label, CT- 08/2021 23-04-2021 Based on review of
Plot No 1, S.P.containing Receptor Single-arm,PhaseIIIClinical documentssubmitted
Biotechnology Park, PhaseBinding Domain of Study to Evaluate the and the
II, Kolthur Village,SARS(cid:2)CoV-2 (RBD ImmunogenicityandSafetyof recommendations of
ShameerpetMandal(India)-antigen of SARS CoV-2 Biological E’s SARS-CoV-2 Subject Expert
500078 (Cov COVID-19 Vaccine for Committee (SEC)
ProtectionAgainstCOVID-19 meeting dated
Diseasewhenadministeredto 20.04.2021, CT
COVID-19-negative adult permission was
subjects” vide protocol no. granted.
BECT/COVID-19-
PHASE(cid:2)III/069 version 1.0
dated 14-APR-2021
9 BIO/CT/21/000055 M/s.HeteroLimited,H.No.Gam-COVID-Vac Phase III “A Prospective,Randomized, CT- 09/2021 27-04-2021 Based on review of
8-3-166/1&2,105To108,combined vector vaccine Interventional,Parallel,Multi- documentssubmitted
1st Floor, G Block, East(Component I & Center, Comparative Clinical and the
Wing, Challa Estates,Component II) Trial to Evaluate the Safety recommendations of
Erragadda, Hyderabad and Immunogenicity of Subject Expert
(India) - 500018 COVID-Vac Combined Committee (SEC)
Vector Vaccine (Manufactured meeting dated
by Hetero) in HealthyAdult 23.04.2021 CT
HumanSubjects”&Protocol permission was
Number– granted.
HCR/III/SARSCOV2VAC/04/
2021, Version:2.0, dated
24.04.2021.
10 BIO/CT/21/000004 M/s JSS Medical ResearchEquine Anti Covid Phase I/II “A prospective, randomized, CT- 10/2021 05-05-2021 Based on review of
India Private Limited, PlotAntibody Fragments multicentric, comparative documentssubmitted
No.12/2,6thFloor,VatikaF(ab’) 2 PhaseI/PhaseIIclinicaltrial and the
Mindscapes, Tower-B, toevaluatetheclinicalsafety, recommendations of
Sector-27 D, Faridabad efficacy and tolerability of Subject Expert
(India) -121003 Equine Anti Covid Antibody Committee (SEC)
FragmentsF(ab’)2asanadd meeting dated
ontherapytoStandardofCare 23.04.2021 CT
(SOC)incomparisontoSOC permission was
alone in hospitalized adult granted.
subjects with COVID-19
infection, with moderate
severity”, protocol no. VBP-
EAF-001version4.0dated27
Apr 2021.
11 BIO/CT/20/000138 M/s Bharat BiotechPurified, Inactivated Phase III A Phase III, Open Label to CT- 11/2021 13-05-2021 Based on review of
International Limited,Japanese Encephalitis evaluate safety and documentssubmitted
GenomeValley,ShameerpetVaccine IP immunogenicity in healthy and the
(India) -500078 volunteers followed by non- recommendations of
interferenceimmuneresponse Subject Expert
studyofinactivatedJapanese Committee (SEC)
encephalitis vaccine meeting dated
(JENVAC) when co- 04.02.2021. CT
administered with Measles, permission was
Mumps and Rubella (MMR) granted.
Vaccine. Vide Protocol No:
BBIL/JENVAC/2021,Version
No: 2.0 dated: 04-02-202112 BIO/CT/21/000021 M/s Bharat BiotechWhole Virion Inactivated Phase II/III A Phase II/III, Open Label, CT- 12/2021 12-05-2021 Based on review of
International Limited,Corona Virus Vaccine, MulticenterStudytoEvaluate documentssubmitted
GenomeValley,Shameerpet[BBV152] theSafety,Reactogenicityand and the
(India) -500078 ImmunogenicityoftheWhole- recommendations of
VirionInactivatedSARS-CoV- Subject Expert
2 Vaccine (COVAXIN®) in Committee (SEC)
HealthyVolunteers ages ≤18 meeting dated
to ≥ 2 Years. 24.02.2021 CT
Protocol No: permission was
BBIL/BBV152/2021 Version granted.
No:2.0; Date: 17-04-2021.
13 BIO/CT/20/000135 M/s TechinventionLifecareOral Cholera Vaccine Phase III A Phase III, open label, CT- 13/2021 20-05-2021 Based on review of
Pvt Ltd, 702, Samarpan(Inactivated) multicenter, parallel group, documentssubmitted
Complex, New Link Road randomizedClinicalStudyto and the
Chakala, Andheri East, compare the Immunogenicity recommendations of
Mumbai Mumbai (India) - and Safety of Euvichol-Plus Subject Expert
400099 vaccine with Oral Cholera Committee (SEC)
Vaccine ShancholTM in meeting dated
healthy adults and children 10.02.2021 CT
above age of one year” permission was
[Protocol: EPV/TLC/P- granted.
III/2020, Version No.:2.0,
Date: 7th March 2021]”.
14 BIO/CT/21/000038 M/s Urihk PharamceuticalRecombinant Hepatitis E Phase III A Prospective, Randomized, CT- 14/2021 19-05-2021 Based on review of
Pvt. Ltd. 602-603, SaiVaccine (E.Coli) Double Blind, Placebo documentssubmitted
SamarthPark, NearWasan controlled Phase III, and the
Motors, Deonar Village Multicenter studytoevaluate recommendations of
Road, Deonar, Govandi theImmunogenciityandSafety Subject Expert
(East) Mumbai (India)- of Recombinant Hepatitis E Committee (SEC)
400088 VaccineinHealthyAdults& meeting dated
Adolescents, Protocol: 12.11.2018 CT
(Note: Earlier, granted to URI/HEV/CT-01/21, Version: permission was
M/sWockhardtandlateron 01 dated: 24-02-2021 granted
transfer of sponsor to M/s
Urihk.
15 BIO/CT/20/000065 M/sCadilaPharmaceuticalsQuadrivalent Influenza Phase III Double Blind” as per SEC CT- 15/2021 03-06-2021 Based on review of
Limited,1389-TrasadRoadSeasonal Vaccine (QIV) (Vaccine) recommendations documentssubmitted
Dholka Dholka (India) -(Virus Like Particle) dated 04-Feb-2021 and the and the
387810 remainingprotocolshouldbe recommendations of
as per the protocol no. Subject Expert
CRSC20002,versionno.:2.0, Committee (SEC)
dated 20th April, 2021 meeting dated
04.02.2021 CT
permission was
granted.
16 BIO/CT/20/000149 M/sIndianImmunologicalDiphtheria and Tetanus Phase II/III A Phase II/III Multicentric CT- 16/2021 02-06-2021 Based on review of
Limited, Rakshapuram,Vaccine (Adsorbed) for Randomized Single Blind documentssubmitted
GachibowlipostHyderabadAdults and Adolescents IP Study to Compare the and the
Rangareddi Hyderabad- ImmunogenicityandSafetyof recommendations of
500032, India Diphtheria and Tetanus Subject Expert
vaccine(Adsorbed)forAdults Committee (SEC)
andAdolescents(Tdvaccine) meeting dated
ofHBIwithBETd®Vaccine 31.03.2021 CT
intwoagegroupsofHealthy permission was
Subjects”. Protocol no.: granted.
HBI/Td/II/III/2020/002.01.01
Dated: 05 April 202117 BIO/CT/20/000137 M/s Bharat BiotechChikungunya vaccine Phase II/III A Seamless Phase II/III, CT- 17/2021 04-06-2021 Based on review of
International Limited,(Inactivated) Double-blind, Multi-centre, documentssubmitted
GenomeValley,Shameerpet Randomized Clinical Trialto and the
(India) -500078 EvaluateImmunogenicityand recommendations of
Safety of BBV87, an Subject Expert
InactivatedChikungunyaVirus Committee (SEC)
Vaccine in Healthy Subjects meeting dated
12-65 Years of Age” vide 30.09.2020 CT
ProtocolNo:BBIL/CHIKV/II- permission was
III/2019VersionNo:1.0Date: granted.
30-07-2020
18 BIO/CT/21/000059 M/s Premium Serums AndAnti-COVID19 Serum Phase I A Phase I, Randomized, CT- 18/2021 09-06-2021 Based on review of
VaccinesPvt. Ltd., 406,B[Equine Anti Covid Controlled,OpenLabelStudy documentssubmitted
Wing,HighwayRoseCo-op.Antibody Fragments to Assess the Safety and and the
Housing Society 92, DixitF(ab’)2] Efficacy of COVID-19 recommendations of
Road Extn., Vile Parle Antiserum in Adult Patients Subject Expert
(East), Mumbai (India) - withSARS-CoV-2/COVID-19 Committee (SEC)
400057 Disease”videprotocolno.SII- meeting dated
COVID19- EqS/IN-01, 27.05.2021 CT
version no. 3 dated permission was
17.05.2021 granted.
19 BIO/CT/21/000069 M/s Virchow BiotechGam-COVID-Vac Phase III ARandomized,Multi-Center, CT- 19/2021 09-06-2021 Based on review of
PrivateLimited,PlotNo.4combined vector vaccine PhaseIIIComparativeClinical documentssubmitted
S.V.Co-op.IndustrialEstate(Component I & Trial to Evaluate the Safety and the
Jeedimetla (India) - 500055 Component II) and Immunogenicity of recommendations of
Virchow Biotech Subject Expert
Manufactured VB- Committee (SEC)
COVIDVAC Combined meeting dated
Vector Vaccine in Healthy 01.06.2021 CT
Adult Human Subjects” permission was
Protocol No: VB- granted.
COVIDVAC/2021-CT1;
Version: 1; Version Date:
01.05.2021
20 BIO/CT/21/000073 M/s.AxisClinicalsLimited,1. Multitope Protein/ Phase II/III A Phase 2/3 Randomized, CT- 20/2021 28-06-2021 Based on review of
1-121/1MiyapurHyderabadPeptide-BasedSARS-CoV- Multicenter, Double-Blind, documentssubmitted
(India) - 500049 2 Vaccine (Manufactured Placebo-Controlled Study to and the
byM/sAurobindoPharma Evaluate the Safety, recommendations of
Limited, Hyderabad) 2. Immunogenicity,andEfficacy Subject Expert
UB-612(Imported from of COVID-19 Vaccine UB- Committee (SEC)
M/s UBI Pharma 612inAdults”videprotocol meeting dated
(UBIP),Taiwan) no.UB-612-302,Version:1.1; 01.06.2021,02.06.20
Version Date: 15.06.2021. 21 and 03.06.2021
CT permission was
granted.
21 BIO/CT/21/000079 M/s Bharat BiotechCoronavirus vaccine Phase I APhaseI,Openlabel,Dose CT- 21/2021 09-07-2021 Based on review of
International Limited,(rDNA) – BBV151 escalation, Randomized, documentssubmitted
GenomeValley,Shameerpet MulticenterStudytoEvaluate and the
(India) -500078 theReactogenicity,Safety,and recommendations of
Immunogenicity of an Subject Expert
Intramuscular inactivated Committee (SEC)
rabiesvectorplatformCorona meeting dated
Virus Vaccine (rDNA- 14.06.2021 CT
BBV151) in Healthy permission was
Volunteers”videprotocolno. granted.
BBIL/BBV151/2021, version
no. 1.0 dated 05-06-202122 BIO/CT/21/000044 M/sG.C.ChemiePharmie23-valent Pneumococcal Phase III A Randomized, CT- 22/2021 16-07-2021 Based on review of
limited, 5/C, Shree LaxmiPolysaccharide Vaccine Double(cid:2)blinded, Multicenter documentssubmitted
Indl. Estate, New LinkI.P. Phase III Clinical Trial to and the
Road, Andhderi (West), Evaluate the Immunogenicity recommendations of
Mumbai – 400 053 and Safety of 23- Valent Subject Expert
Pneumococcal Polysaccharide Committee (SEC)
Vaccine in Healthy Adults” meeting dated
vide protocol number: 10.02.2021 CT
CRN_India/ 2711/2020, permission was
versionno.1.0dated20-Oct- granted.
2020.
23 BIO/CT/20/000079 M/sSerumInstituteofIndiaVPM1002 (rBCG) Phase III A Multicenter, Phase III, CT-23/2021 16-07-2021 Based on review of
Pvt.Ltd.(SIIPL),212/2,OffVaccine Double-blind, Randomized, documentssubmitted
Soli Poonawalla Road, Placebo-Controlled Study to and the
Hadapsar, Pune -411028, Evaluate the Efficacy and recommendations of
India Safetyof VPM1002 Vaccine Subject Expert
in the Prevention of Committee (SEC)
Tuberculosis Infection in meeting dated
Health Care Workers” vide 31.03.2021 CT
ProtocolNumber:VPM1002- permission was
HCW Version: 2.0 dated granted.
27Apr 2021
24 BIO/CT/21/000092 M/s Christian MedicalWhole Virion Inactivated Phase IV “Comparisonofreactogenicity CT- 24/2021 07-08-2021 Based on review of
College,IdaScudderRoad,Corona Virus Vaccine, and immunogenicity of documentssubmitted
Vellore- 632004, Tamil[BBV152] (COVAXIN), heterologousprime-boostand and the
Nadu ChAdOx1 nCoV-19 heterologous boost of recommendations of
Corona Virus ChAdOx1 nCoV-19 Subject Expert
Vaccine (Recombinant) (Covishield), BBV152 Committee (SEC)
(COVISHIELD) (COVAXIN) and other meeting dated
COVID vaccines with 29.07.2021 CT
homologousadministrationof permission was
COVISHIELD and granted.
COVAXIN”videProtocolNo:
Mixing of COVID vaccines
study,Version:1.0Date:10th
July 2021.
25 BIO/CT/21/000077 M/s Bharat BiotechChimpanzee Adenovirus Phase II A Phase 2, Randomized, CT- 25/2021 08-08-2021 Based on review of
International Limited,Vectored COVID-19 Double Blind, Multicenter documentssubmitted
GenomeValley,ShameerpetVaccine (BBV154) Study to Evaluate the and the
(India) -500078 Immunogenicity, recommendations of
Reactogenicity and Safety of Subject Expert
an Intranasal Adenoviral Committee (SEC)
vector COVID-19 vaccine meeting dated
Healthy Volunteers.” vide 22.06.2021 CT
Protocol No: BIL/BBV154- permission was
II/2021VersionNo:3.0;Date: granted.
07-08-
2021.
26 BIO/CT/21/000096 M/s Bharat BiotechWhole Virion Inactivated Phase II APhase2randomized,multi- CT- 26/2021 11-08-2021 Based on review of
International Limited,Corona Virus Vaccine, centric, Clinical Trial of documentssubmitted
GenomeValley,Shameerpet[BBV152] (COVAXIN), Heterologus Prime-Boost and the
(India) -500078 Chimpanzee Adenovirus CombinationofSARS-CoV-2 recommendations of
Vectored Vaccines to evaluate the Subject Expert
COVID-19 Vaccine immunogenicityandsafetyof Committee (SEC)
(BBV154) BBV152 (COVAXIN®) with meeting dated
BBV154 (Adenoviral 29.07.2021 CT
IntranasalCOVID-19vaccine) permission was
in Healthy Volunteers.” granted.27 BIO/CT/21/000102 M/s Dr Reddy’sA vector vaccine for the Phase III “Phase III, open label, un- CT- 27/2021 16-08-2021 Based on review of
LaboratoriesLimited,IPDO,prevention of the controlled, multicentre, documentssubmitted
Survey no 54 Bachupallycoronavirus infection bridging study to evaluate and the
VilageQutubullapurMandalinducedbytheSARSCoV- immunogenicityandsafetyof recommendations of
(India) - 500090 2 virus - (Sputnik Light) singledoseofSputnikLightin Subject Expert
Indian adults and elderlyfor Committee (SEC)
prevention of SARS-CoV-2 meeting dated
Infection” Protocol No: 06.08.2021 CT
DRL(cid:2)SPL-005 Date of permission was
ProtocolVersion2.0dated09 granted.
Aug 2021.
28 BIO/CT/21/000103 M/s Biological E Limited,Covid-19 vaccine Phase III A Prospective, Single-blind, CT- 28/2021 20-08-2021 Based on review of
Plot No 1, S.P.containing Receptor Randomized, Active- documentssubmitted
Biotechnology Park, PhaseBindingDomainofSARS- controlled Phase III Clinical and the
II, Kolthur Village,CoV-2 (RBD antigen of Study to Evaluate the recommendations of
ShameerpetMandal(India)-SARS CoV-2 (Covid-19) ImmunogenicityandSafetyof Subject Expert
500078 Biological E’s CORBEVAX Committee (SEC)
VaccineforProtectionAgainst meeting dated
COVID-19 Disease When 19.08.2021 CT
Administered to RT-PCR permission was
NegativeAdultSubjects.”vide granted.
protocol no. BECT/COVID-19-
PHASE-III/074.
29 BIO/CT/21/000105 M/s GennovaHGCO19 Lyophilized Phase II/III A Prospective, Multicentre, CT- 29/2021 22-08-2021 Based on review of
Biopharmaceuticals LimitedmRNA Vaccine for Randomized, Active- documentssubmitted
,T-184 emcure houseInjection (COVID(cid:2)19) controlled, Observerblind, and the
bhosari MIDC pune pune Phase II study seamlessly recommendations of
(India) - 411026 followedbyaPhaseIIIstudy Subject Expert
to evaluate the Safety, Committee (SEC)
Tolerability and meeting dated
Immunogenicity of the 19.02.2021 &
candidateHGCO19(COVID- 22.08.2021 CT
19 vaccine) in healthy permission was
subjects.” vide protocol no. granted.
GBL/HGCO19/2021/01
Version 1.1 Dated 21 Aug
2021.
30 BIO/CT/21/000089 M/s Biological E Limited,SARS-CoV-2 (Covid-19) Phase II/III A Prospective, Randomised, CT- 30/2021 01-09-2021 Based on review of
Plot No 1, S.P.Vaccine(RBDantigenof Double-blind, Placebo documentssubmitted
Biotechnology Park, PhaseSARS CoV-2 (Covid-19) controlled, Phase-II by III and the
II, Kolthur Village, Study to Evaluate Safety, recommendations of
ShameerpetMandal(India)- Reactogenicity, Tolerability Subject Expert
500078 and Immunogenicity of Committee (SEC)
CORBEVAX Vaccine in meeting dated
Children and Adolescents” 26.08.2021 CT
vide protocol no. permission was
BECT072/Covid-19-phase- granted.
II&III/CTP-01, Version no.
1.1 dated 11.08.2021.
31 BIO/CT/21/000108 M/sRelianceLifeSciences,Protein subunit vaccine Phase I A prospective, open label, CT- 31/2021 03-09-2021 Based on review of
Center,R-282,TTCAreaofagainst SARS-CoV-2 doseescalationphaseIclinical documentssubmitted
MIDC, Thane -BelapurVirus study to evaluate the safety, and the
Road,Rabale,NaviMumbai tolerability and recommendations of
(India) – 400 701 immunogenicity of Reliance Subject Expert
Life Sciences SARS-CoV-2 Committee (SEC)
Recombinant protein subunit meeting dated
vaccineinhealthyvolunteers” 26.08.2021 CT
as per protocol no. permission was
RLS/VAC/2021/07. granted.32 BIO/CT/21/000062 M/s Cadila HealthcareTyphoid Vi Conjugate Phase III A prospective, randomized, CT- 32/2021 08-09-2021 Based on review of
Limited,plotsurveyno.23,Vaccine I.P. two-arm, parallel, active- documentssubmitted
25/P, 37, 40/P, 42 To 47 controlled, multicentre, non- and the
Sarkhej-BavlaN.H.No-8A, inferiority, phase III clinical recommendations of
Opposite Ramdev Masala, trial to evaluate the Subject Expert
Village Changodar, Tal. immunogenicityandsafetyof Committee (SEC)
SanandAhmedabad(India)- ZyVac TCV of M/s Cadila meeting dated
382213 HealthcareLimitedcompared 06.08.2021 CT
toTypbarTCVofM/sBharat permission was
Biotech International Limited granted.
inhealthyadultsaged45to65
years"videprotocolno.21-03,
version 01 dated 17.08.2021
33 BIO/CT/21/000084 M/s GlaxosmithklineHerpes Zoster Vaccine Phase III A phase 3, randomised, CT- 33/2021 16-09-2021 Based on review of
Pharmaceuticals Limited,(Recombinant, observer(cid:2)blind, placebo- documentssubmitted
252,Dr.AnnieBesantRoad,Adjuvanted) controlled, multi-centre study and the
Worli, Mumbai-400030, to evaluate the immune recommendations of
Maharashtra,India.Mumbai response and safety of the Subject Expert
(India) - 400030 HerpesZostersubunitvaccine Committee (SEC)
when administered meeting dated
intramuscularly on a 2-dose 06.08.2021 CT
schedule in adults aged 50 permission was
years and older in India” as per granted.
Protocol No.: 214461
(ZOSTER-081), Version No.
01, Dated 08-June-2021
34 BIO/CT/21/000134 M/sCadilaHealthcareLtd.,NovelCoronavirus-2019- Phase III A prospective, open-label, CT- 34/2021 30-09-2021 Based on review of
Plot Survey No. 23, 25/P,nCoV Vaccine singlearm,multicenter,phase documentssubmitted
37, 40/P, 42 to 47, Opp.(recombinant) III clinical study to evaluate and the
Ramdev Masala, Sarkhej- theimmunogenicityandsafety recommendations of
Bavla,N.H.No.8A,Village- of3mg (2 dose) regimenof Subject Expert
Changodar, Taluka - Novel Corona Virus -2019- Committee (SEC)
Sanand,Dist.Ahmedabad- nCovvaccinecandidateofM/s meeting dated
382 213 CadilaHealthcareLimitedby 23.09.2021 CT
intradermal route in healthy permission was
subjects Project No.:21- granted.
103.AmendmentNo.:01dated
17.09.2021.
35 BIO/CT/21/000065 M/sSanofiHealthcareIndiaQuadrivalent Influenza Phase III "Immunogenicityand Safety CT- 35/2021 12-10-2021 Based on review of
Private Limited Sanofivaccine (Split Virion, oftheQuadrivalentInactivated documentssubmitted
House,C.T.S-117B,L&TInactivated) Split-VirionInfluenzaVaccine and the
Business Park, Saki Vihar in Participants 6 Months of recommendations of
Road, Powai Mumbai – Age and Older in India." Subject Expert
400072, Maharashtra. [Study Code: GQM00023, Committee (SEC)
ProtocolVersionNumber:2.0, meeting dated
Dated 22-February-2021 06/08/2021 CT
permission was
granted.36 BIO/CT/21/000074 M/s Biological E Limited,Diphtheria, Tetanus, Phase IV "A prospective open label CT- 36/2021 12-10-2021 Based on review of
Plot No 1, S.P.Pertussis (Whole cell), comparative phase-IV bridging documentssubmitted
Biotechnology Park, PhaseHepatitis B (r-DNA) and studytoassesstheequivalence and the
II, Kolthur Village,Haemophilus influenza oftherevisedDTwP(cid:2)rHepB- recommendations of
ShameerpetMandal(India)-typebConjugateVaccine HIBvaccineformulationwith Subject Expert
500078 (Adsorbed) that ofthe currentlylicensed Committee (SEC)
DTwP-rHepB-HIB meeting dated
formulationin6-8weeksold 06.08.2021 CT
infants” vide protocol no. permission was
BECT068/LPV-PIV- granted.
Bridging/CTP-01,Versionno.
1.0 dated 26.03.2021.
37 BIO/CT/21/000130 M/s Cadila HealthcareTyphoid Vi Conjugate Phase IV An active post-marketing CT- 37/2021 13-10-2021 Based on review of
Limited,plotsurveyno.23,Vaccine I.P. surveillancestudytoevaluate documentssubmitted
25/P, 37, 40/P, 42 To 47 thesafetyandimmunogenicity and the
Sarkhej-BavlaN.H.No-8A, ofZyVacTCVofM/sCadila recommendations of
Opposite Ramdev Masala, HealthcareLimitedinhealthy Subject Expert
Village Changodar, Tal. subjects"videprotocolno.21- Committee (SEC)
SanandAhmedabad(India)- 09, version 00 dated meeting dated
382213 20.08.2021 21.09.2021 CT
permission was
granted.
38 BIO/CT/21/000032 M/s Biological E Limited,Inactivated Hepatitis A Phase I A prospective open label CT- 38/2021 21-10-2021 Based on review of
Plot No 1, S.P.Vaccine (Adsorbed) single arm phase-I study to documentssubmitted
Biotechnology Park, Phase assess the safety, tolerability, and the
II, Kolthur Village, reactogenicity and recommendations of
ShameerpetMandal(India)- immunogenicity of a single Subject Expert
500078 intramuscular dose of BE’s Committee (SEC)
indigenously developed meeting dated
inactivatedHepatitisAvaccine 31.03.2021 CT
(adsorbed)administeredto18- permission was
45 years old healthy human granted.
adults.[Protocol no:
BECT067/HepA-Phase-I/CTP-
01, Protocol Version 1.0,
dated 27.01.2021
39 BIO/CT/21/000033 M/s Ra (biologicals)Pneumococcal Phase I A Randomized, Open label, CT- 39/2021 22-10-2021 Based on review of
PanaceaBiotecLtd.,A-27,Polysaccharide Conjugate Multicenter,PhaseII/IIIstudy documentssubmitted
B-1 Extension MohanVaccine (Adsorbed) (11- to assess and compare the and the
Cooperative Industrialvalent) immunogenicityandsafetyof recommendations of
Estate,MathuraRoadNew NUCOVAC®-11 Subject Expert
Delhi (India) - 110044 {Pneumococcal Committee (SEC)
Polysaccharide conjugate meeting dated
vaccine (Adsorbed), 11 31.03.2021 CT
valent}ofPanaceaBiotecLtd. permission was
with PREVENAR13®of granted.
Pfizer Inc.in healthy infants
(3+1immunization schedule)
[Protocol no:
PBL/20/01/PNCV, Version
Number: 03, Dated 31-July-
2021].40 BIO/CT/21/000060 M/s Biological E Limited,Typhoid Conjugate Phase IV A prospective multicentre CT- 40/2021 01-12-2021 Based on review of
Plot No 1, S.P.Vaccine (Monovalent) phase-IV clinical study to documentssubmitted
Biotechnology Park, Phase[Typhoid Vi Conjugate evaluate the safety of single and the
II, Kolthur Village,Vaccine] intramuscular dose of recommendations of
ShameerpetMandal(India)- Biological E’s typhoid Subject Expert
500078 conjugatevaccinein6months Committee (SEC)
to 45 years old participants meeting dated
and its impact on measles 06.08.2021 CT
immunogenicity when co- permission was
administered with licensed granted.
Measles-Rubella(MR)vaccine
inasubsetof9-12monthsold
infants” vide protocol no.
BECT064TCVPhase(cid:2)IV
version 1.1 dated 20.09.21.
41 BIO/CT/21/000097 M/s Biological E Limited,Measles (Edmonston Phase I APhaseIOpenLabelStudyto CT- 41/2021 28-12-2021 Based on review of
Plot No 1, S.P.Zagreb) and Rubella Evaluate the Safety, documentssubmitted
Biotechnology Park, Phase(RA27/3) Vaccine Live, Tolerability and and the
II, Kolthur Village,Attenuated(FreezeDried), ImmunogenicityofBiological recommendations of
ShameerpetMandal(India)-IP E’sLive,AttenuatedMeasles Subject Expert
500078 RubellaVaccine(MR)in4-5 Committee (SEC)
year Old Healthy Children” meeting dated
vide protocol no. 21.09.2021 CT
BECT073/MRV-PI/CTP-01, permission was
version no: 01, dated granted.
10/07/2021
42 BIO/CT/21/000142 M/s Biological E Limited,SARS-CoV-2 (Covid-19) Phase III A Prospective double-blind CT- 42/2021 28-12-2021 Based on review of
Plot No 1, S.P.Vaccine(RBDantigenof randomisedPhaseIIIClinical documentssubmitted
Biotechnology Park, PhaseSARS CoV-2 (Covid-19)) Study to Evaluate the and the
II, Kolthur Village, ImmunogenicityandSafetyof recommendations of
ShameerpetMandal(India)- Single Booster dose of Subject Expert
500078 Biological E’s CORBEVAX Committee (SEC)
vaccinewhenAdministeredto meeting dated
COVID-19-Negative Adult 27.12.2021 CT
Volunteers Previously permission was
vaccinated with 2-doses of granted.
either COVISHIELD or
COVAXIN”videprotocolno.
BECT/COVID-19-PHASE-
III/070.
43 BIO/CT/21/000133 M/s Bharat BiotechCholera Vaccine Phase III A Phase III randomized, CT- 43/2021 31-12-2021 Based on review of
International Limited,(Inactivated, Oral), I.P modified double-blind, multi- documentssubmitted
GenomeValley,Shameerpet centric,comparativestudy,to and the
(India) -500078 evaluatethenon-inferiorityof recommendations of
immunogenicityandsafetyof Subject Expert
single strain oral cholera Committee (SEC)
vaccine Hillchol® to the meeting dated
comparator vaccine 21.09.2021 CT
Shanchol™alongwithlot-to- permission was
lotconsistencyofHillchol®.” granted.
videProtocolNo:BBIL/BBV-
Hillchol®(BBV131)/2021
Version No: 2.0; Date: 21-
Sept-2021
Format No. QMS-GNL-019/F02(b)-00