CTRI

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CTRI Number

CTRI/2025/02/081007 [Registered on: 20/02/2025] Trial Registered Prospectively

Last Modified On:

18/03/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Vaccine

Study Design

Other

Public Title of Study

A Randomized, Open label, Multicenter, Phase II / III study to assess and compare the immunogenicity and safety of NUCOVAC®-11

Scientific Title of Study

A Randomized, Open label, Multicenter, Phase II / III study to assess and compare the immunogenicity and safety of NUCOVAC®-11 {Pneumococcal Polysaccharide conjugate vaccine (Adsorbed), 11 valent} of Panacea Biotec Ltd. with PREVENAR 13® of Pfizer Inc. in healthy infants (3+1 immunization schedule)

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
PBL/20/01/PNCV, Version 03 dated 31-07-2021	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr LALITENDU MOHANTY
Designation	Vice President
Affiliation	Panacea Biotec Limited
Address	B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,New Delhi South DELHI 110044 India
Phone	9811923256
Fax
Email	lalitendumohanty@panaceabiotec.com

Details of Contact Person
Scientific Query

Name	Dr LALITENDU MOHANTY
Designation	Vice President
Affiliation	Panacea Biotec Limited
Address	B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,New Delhi South DELHI 110044 India
Phone	9811923256
Fax
Email	lalitendumohanty@panaceabiotec.com

Details of Contact Person
Public Query

Name	Dr Nidhi Singh
Designation	Head Clinical Operations
Affiliation	Clinical Research Network India
Address	B-806-807, Advant Navis Business park, Plot#7, Noida-Greater Noida Expressway, sector 142 Gautam Budh Nagar,UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH 201305 India
Phone	9695237796
Fax
Email	nidhisingh@crnindia.org

Source of Monetary or Material Support

PANACEA BIOTEC LIMITED B-1 Extn/G-3, Mohan Cooperative Industrial Estate (MCIE), Mathura Road, New Delhi-110044, India

Primary Sponsor

Name	PANACEA BIOTEC LIMITED
Address	B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Clinical Research Network India	-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway Sector 142, Noida, Delhi-NCR Gautam Buddha Nagar, UTTAR PRADESH- 201305

Countries of Recruitment

India

Sites of Study

No of Sites = 7
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Rama Shankar Rath	AIIMS Gorakhpur	AIIMS, Room No-241, Department of Community and Family Medicine, 2nd Floor, Academic Block, Gorakhpur-273008 Gorakhpur UTTAR PRADESH	9968856471 rsr14585@gmail.com
Dr Chinmayi Joshi	Belagavi Institute of Medical Sciences	Department of Paediatrics, Belagavi Institute of Medical Sciences, Dr B R Ambedkar Road, Belagavi-590001, Karnataka, India Belgaum KARNATAKA	9535962258 bimsclinicalresearch@gmail.com
Dr Shailaja Mane	Dr. D. Y. Patil Medical College, Hospital & Research Centre	Sant Tukaram Nagar, Pimpri, Pune, Maharashtra-411018 Pune MAHARASHTRA	9822595553 shailaja.mane@dpu.edu.in
Dr BS Chakravarthy	King George Hospital	Department of Pediatrics, 1st Floor, Collectorate Junction, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH	9848253535 chakravarthy.kghamc@gmail.com
Dr Niranjana S Mahantshetti	KLES Dr Prabhakar Kore Hospital & MRC	KLES Dr Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgavi-590010, Karnataka, India Belgaum KARNATAKA	9448157237 niranjanakle@gmail.com
Dr Virendra Nath Tripathi	New Leelamani Hospital	14/116, C-1, Parade Chauraha, Civil Lines, Kanpur, Uttar Pradesh -208001, India Kanpur Dehat UTTAR PRADESH	9415050777 dr.vntripathicr@gmail.com
Dr N Ravi Kumar	Niloufer Hospital	Department of Pediatrics, Niloufer Hospital (Affiliated to Osmania Medical College), Red Hills, Lakdikapool, Hyderabad-500004, Telangana, India Hyderabad TELANGANA	9490919293 ravik1961@yahoo.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 7
Name of Committee	Approval Status
Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pune	Submittted/Under Review
Institutional Ethic Committee, King George hospital, Andhra Pradesh	Approved
Institutional Ethics Committee BIMS, Belagavi	Approved
Institutional Ethics Committee, KLE University, KLE Dr. PK Hospital and MRC, Belagavi (Belgaum) Karnataka	Submittted/Under Review
Institutional Ethics Committee, Osmania Medical College, Hyderabad	Submittted/Under Review
Institutional Ethics Committee-Leelamani Hospital, New Leelamani Hospital, Kanpur, Uttar Pradesh	Approved
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy Indian male and female infants between 6-8 weeks of age

Intervention / Comparator Agent

Type	Name	Details
Intervention	NUCOVAC®-11 [Pneumococcal Polysaccharide conjugate vaccine (Adsorbed), 11 valent.]	Vaccination will be done on Day 0 , Day 28, Day 56 i.e. at 6–8 weeks, 10–12 weeks, and 14–16 weeks of age respectively, and booster dose at 15-18 month of age.
Comparator Agent	PREVENAR 13® [Pneumococcal Polysaccharide Conjugate Vaccine (13-valent, adsorbed)]	Vaccination will be done on Day 0 , Day 28, Day 56 i.e. at 6–8 weeks, 10–12 weeks, and 14–16 weeks of age respectively, and booster dose at 15-18 month of age.

Inclusion Criteria

Age From	42.00 Day(s)
Age To	56.00 Day(s)
Gender	Both
Details	1. Healthy Infants between 6 to 8 weeks of age Both Inclusive on the day of enrollment whose parents or LAR willing to participate and 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. Infants judged to be able to attend all scheduled study visits and to comply with trial procedures 4. Weight of the Infant at enrolment visit greater than or equal to 3.2 kg 5. Infants with an up to date minimal vaccination status at the time of enrollment as per UIP schedule as per local or regional protocols Inclusion Criteria for Booster Immunization Phase 1. Infants with good health as determined by Medical history Physical examination Clinical judgment of the investigator 2. Infants who have completed primary immunization series of the study vaccine in the present study

ExclusionCriteria

Details

Exclusion Criteria for Primary Immunization Phase:

1. The parents or LAR are unwilling or unable to give written informed consent to participate in the study
2. Infants who have participated in another trial of an investigational agent within 30 days prior to enrolment
3. Planned participation in another clinical trial during the present trial period
4. Infants whose families are planning to leave the area of the study site before the end of the study period
5. History of culture-proven invasive disease caused by S pneumoniae
6. Infants who have received any Pneumococcal vaccine prior to enrollment
7. Bleeding disorder, contraindicating IM vaccination or receipt of anticoagulants in the 3 weeks preceding inclusion
8. History of Human Immunodeficiency Virus HIV, hepatitis B or hepatitis C in infant or mother
9. Presence of evolving or changing neurological disorder
10. Infants with history of seizures
11. Axillary temperature greater than or equal to 38 degree C in past 3 days
12. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days
13. Planned or elective surgery during the course of the study
14. Infants with a known or suspected impairment of the immune function or those receiving immunosuppressive therapy or having received immunosuppressive therapy within 1 month prior to study entry including systemic corticosteroids or those who have received a parenteral immunoglobulin preparation
15. Infants who have received any blood products, cytotoxic agents or radiotherapy
16. Infants with history of anaphylaxis or any serious vaccine reaction or allergy to any vaccine component
17. Infants with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject

Exclusion criteria for the second or third dose

1. Generalized allergic reaction within 48 hours of administration of previous vaccine dose
2. Seizures
3. Encephalopathy
4. Axillary temperature of greater than 40 degree Celsius within 48 hours of previous vaccine dose
5. Inconsolable persisting crying defined as greater than 3 hours within 48 hours of previous vaccination
6. Generalized cyanosis within 48 hours of previous vaccine dose
7. Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial

Exclusion Criteria for Booster immunization Phase

1. Infants who have participated in another trial after primary immunization
2. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days
3. History of culture-proven invasive disease caused by S pneumonia after primary immunization
4. Infants who have already received pneumococcal vaccine booster dose other than Investigational vaccine from other resources from different doctor or hospital
5. Bleeding disorder contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding booster dose
6. History of Human Immunodeficiency Virus HIV hepatitis B or hepatitis C in infant after primary immunization
7. Presence of evolving or changing neurological disorder after primary immunization
8. Axillary temperature greater than or equal to 38 degree Celsius in past 3 days
9. Any history of elective surgery after primary immunization
10. Infants with a known or suspected impairment of the immune function or those receiving immunosuppressive therapy or having received immunosuppressive therapy within 1 month prior to booster vaccination including systemic corticosteroids or those who have received a parenteral immunoglobulin preparation
11. Infants who have received any blood products cytotoxic agents or radiotherapy
12. Infants with history of anaphylaxis seizures or any serious vaccine reaction or allergy to any vaccine component
13. Infant with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To evaluate the immune response in terms of serotype-specific IgG concentrations induced by 11 common serotypes of NUCOVAC®-11 vaccine alone and in comparison, to 13-valent PREVENAR 13®, 1 month after three dose series.	Day 0 and Day 84

Secondary Outcome

Outcome

TimePoints

1. To evaluate the immune response in terms of serotype-specific IgG concentrations
induced by 11 common serotypes of NUCOVAC®-11 vaccine alone and in comparison, to
13-valent PREVENAR 13®, 4 weeks after booster dose.
2. To evaluate serum functional antibody response in terms of serotype specific OPA titers
in random subset of 25% vaccinated subjects of NUCOVAC®-11 compared to an equal number of subjects vaccinated with PREVENAR 13® vaccine at 4 weeks after a three-dose primary series & four weeks after the booster dose.
3. To assess and compare the safety and reactogenicity of NUCOVAC®-11 vaccine with PREVENAR 13® throughout the study.

Day 0, Day 84 for primary series; and Pre-booster and 4 weeks after the booster dose.

Target Sample Size

Total Sample Size="446"
Sample Size from India="446"
Final Enrollment numbers achieved (Total)= "446"
Final Enrollment numbers achieved (India)="446"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

07/03/2025

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The clinical trial is a randomized, open-label, multicenter Phase II/III study designed to assess and compare the immunogenicity and safety of NUCOVAC®-11 (11-valent Pneumococcal Polysaccharide Conjugate Vaccine) with PREVENAR 13® in healthy infants. The primary objective is to evaluate the immune response, measured through serotype-specific IgG concentrations, four weeks after a three-dose primary immunization series. Secondary objectives include assessing immune responses after a booster dose, serum OPA titers, and comparing safety and reactogenicity between the two vaccines. The study involves 446 participants (223 per arm), with a subset undergoing additional antibody testing. Conducted over 18 months, the study includes a primary immunization phase (doses at 6–8 weeks, 10–12 weeks, and 14–16 weeks) and a booster phase (at 15–18 months). Participants will be monitored for adverse events, with blood samples collected for immunogenicity analysis.