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CTRI Number  CTRI/2014/04/004543 [Registered on: 16/04/2014] Trial Registered Prospectively
Last Modified On: 17/11/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A multicenter, open label, comparative study to evaluate and compare Safety, Tolerability And Immunogenicity Of 10-Valent Pneumococcal Polysaccharide Conjugate Vaccine in healthy infant 
Scientific Title of Study   A Randomized, Comparative, Open Labeled, Multicentric, Phase I Study To Evaluate And Compare The Safety, Tolerability And Immunogenicity Of Two Formulations (With And Without Preservative) Of 10-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Nucovac® Of Panacea Biotec Ltd. With Synflorix® Of Glaxosmithkline Ltd. In Healthy Infants 
Trial Acronym  Nucovac Infant 
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/CR/2013/03/CT/NUCOI version 01 Dated 14-10-13  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalitendu Mohanty 
Designation  GM-Clinical Research 
Affiliation  Panacea Biotec Limited 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,

South West
DELHI
110044
India 
Phone  011-41679000  
Fax  011-41578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalitendu Mohanty 
Designation  GM-Clinical Research 
Affiliation  Panacea Biotec Limited 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,

South West
DELHI
110044
India 
Phone  011-41679000  
Fax  011-41578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Public Query  
Name  Dr Lalitendu Mohanty 
Designation  GM-Clinical Research 
Affiliation  Panacea Biotec Limited 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,

South West
DELHI
110044
India 
Phone  011-41679000  
Fax  011-41578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Source of Monetary or Material Support  
Panacea Biotec Limited 
 
Primary Sponsor  
Name  Panacea Biotec Limited 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venugopal  King George Hospital  KGH Down Rd, Maharani Peta
Visakhapatnam
ANDHRA PRADESH 		 09848027203

venugopal_kgh@yahoo.com 
Dr Ashish Ramchandra Dhongade  Sant Dnyaneshwar Medical Education Research Centre  695/A, Sadashiv Peth Opp Vijay Talkies Laxmi Road
Pune
MAHARASHTRA 		 9011095436

ashishdhongade@shaishavclinic.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional Ethics Committee, Sant Dnyaneshwar Medical Education Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pneumonia  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pneumococcal Polysaccharide Conjugate Vaccine with and without preservative.  0.5 ml, Intramuscular, single dose Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 10-valent (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F) with or without Preservative  
Comparator Agent  Synflorix(GSK)  0.5 ml, Intramuscular, single dose Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 10-valent (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F) 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  1.Infants 6-10 weeks of age, whose parents/LAR willing to give written informed consent prior to the study entry.
2.Infants with good health as determined by:
• Medical history
• Physical examination
• Clinical judgment of the investigator
3.Subjects judged to be able to attend all scheduled study visits and to comply with trial procedures.
 
 
ExclusionCriteria 
Details  1.History of previous vaccination against S. pneumonia
2.History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically)
3.Infants expected to receive any vaccine other than the EPI schedule.
4.Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
5.Known HBsAg positivity in mother.
6.Infants less than 6 weeks or more than 10 weeks of age.
7.Infants weighing less than 3.3 Kg at the time of enrollment.
8.Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition.
9.Known history of administration of blood or blood-derived products
10.Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulin, immunosuppressant or other immune-modifying drugs in past or at any time during the study.
11.Febrile illness (temperature ≥38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
12.Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
13.Infants who have participated in another trial or received an investigational agent within 30 days of enrolment.
14. Infants with any clinically significant disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or autoimmune disease under treatment) or major congenital defects, such that it would endanger the infant’s well-being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
15.History or presence of significant asthma, urticaria or other allergic reactions.
16.Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
17.Planned participation in another clinical trial during the trial period.
18.Subject’s Parents/LAR planning to leave the area of study before completion of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence, intensity, causality and relationship to vaccination of solicited reactions (local and
systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each
vaccination.
Incidence, intensity, causality and relationship to vaccination of unsolicited adverse events
(including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination.
Serious Adverse Events (SAEs) during the entire study period
 		 Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination.
Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination.
Serious Adverse Events (SAEs) during the entire study period
 
 
Secondary Outcome  
Outcome  TimePoints 
Primary analysis Proportion of subjects achieving seroprotection
against Pneumococcal Serotypes
Seroresponsiveness is defined as
Seroprotection against Pneumococcal serotypes Anti-
Pneumococcal IgG concentration ≥ 0.35 μg/ml
Secondary Analysis Serotype-specific opsonophagocytic antibody
(OPA) titres post vaccination titer 1:8 or Change from nondetectable
( 8 reciprocal titre) to detectable (≥ 8 reciprocal titre)
Geometric mean concentration (GMT/GMC) 		 Sample for the secondary outcome will be withdrawn on day 0 before vaccination and on week 12 in follow up visit.
Results of the secondary outcome shall be come after 4 months of completion of the trial. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   19/04/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="20" 
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  

This study will be conducted as a randomized, open label, comparative, phase I study. The enrolled subjects will be randomly allocated in a ratio of 1:1:1 to one of the three study arm A, Arm B and Arm C (24 subjects per arm including anticipated 20% dropout rate). Enrolled and randomized subjects will receive treatment (vaccination). Infants 6-10 weeks of age will be Screened, Enrolled and Randomized to one of the three study arms (A, B and C), upon receipt of written informed consent from Parents/LAR. Subjects will receive 3-dose of one the study vaccines (NUCOVAC® with or without preservative or SYNFLORIX®) based on randomization at 0, 4, 8 weeks of enrollment. The vaccines will be administered by a deep intramuscular route in the antero-lateral aspect of right thigh. Subjects will be observed after vaccination at site for Solicited local and systemic reactions for 6 hours after vaccination and for the next 7 days through diary card. Adverse events will also be monitored for 28 days after each vaccination. Blood samples will be obtained from subjects at visit 1(before first vaccination) and at visit 4 (Follow up visit, 4 weeks after the third vaccine dose) for estimation of lab safety parameters and neutralizing antibodies against pneumococcal polysaccharide. Safety analysis will be done at study site laboratory while immunogenicity analysis will be done at central lab, Mohali.

 
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