A clinical study to check safety and immuno response of combination vaccine in children.

Phase 2/3

Completed

• Conditions: Encounter for immunization,

• Registration Number: CTRI/2020/09/027553
• Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary

This is an open label, randomized, active-controlled, multi-centric study to be conducted in two parts in healthy Indian toddlers and infants to assess the immunogenicity and safety of SIIPL DTaPIPVHib vaccine in comparison with Pentaxim.

In Part I of the study, 112 toddlers, aged 15-18 months will be randomized to receive a booster dose of SIIPL DTaPIPVHib vaccine or Pentaxim. Toddlers will be followed up for 28 days post-vaccination for safety and immunogenicity. In Part II of the study, 786 infants aged 6-8 weeks will be randomized  to receive a 3-dose primary vaccination series of  DTaPIPVHib vaccine or the comparator viz., Pentaxim.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-09
• Study Completion: 2022-09-03
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 898

Inclusion Criteria

• For both Part I and Part II: 1.
• Subject of either sex with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
• Informed consent form signed by at least one parent or legally acceptable representative.
• Subject and parent/legally acceptable representative able to attend all scheduled visits and willing to comply with all study procedures during the entire duration of the trial.
• Additional inclusion criteria for Part I only: 4a.
• Subject is between 15-18 months of age at the time of vaccination.
• Subject who has completed primary immunization series against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and poliomyelitis (OPV and/or IPV) and has not received the booster dose scheduled at 15-18 months of age.
• The weight-for-length z-score for the subject is greater than or equal to -2 SD.
• Additional inclusion criteria for Part II only: 4b.
• Subject aged 6-8 weeks (42-56 days, both inclusive) at the time of first vaccination.
• Subject born at full term pregnancy (greater than or equal to 37 weeks) with a birth weight greater than or equal to 2.5 kg.
• Subject who have received the birth dose of OPV and BCG vaccine at least four weeks before the first trial vaccination.

Exclusion Criteria

• For both Part I and Part II: 1.
• History of Diphtheria/Tetanus/Pertussis/Haemophilus influenzae type b/Poliomyelitis, Infection(s).
• Presence of evolving or changing neurological disorder or subject with a history of seizures and/or encephalopathy.
• Fever greater than or equal to 38°C/100.4°F in the past 7 days and/or any evidence of acute illness or infection within the past 7 days.
• Planned surgery during the course of the study.
• History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or constituent of study vaccine.
• History of any clinically significant chronic disease such that in the opinion of the investigator, it might interfere with the evaluation of the study objectives.
• History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
• Known thrombocytopenia or a bleeding disorder.
• Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
• Subject whose families are planning to leave the area of the study site before the end of the study period.
• Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
• Additional exclusion criteria for Part I only: 12a.
• Subject with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or received immunosuppressive therapy within 6 months prior to study entry 14a.
• Administration of any vaccine (except OPV during immunization campaign) in the 4 weeks preceding the trial vaccination or planned receipt of any non study vaccine during the study period.
• Additional exclusion criteria for Part II only: 12b.
• Receipt of any vaccine (except OPV during immunization campaign) in the 4 weeks preceding the first dose of trial vaccine.
• Previous or planned vaccination against diphtheria, tetanus, pertussis, poliomyelitis (except OPV) or Haemophilus influenzae type b infection apart from trial vaccines during the study period.
• Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response.
• Subject with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or received immunosuppressive therapy prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For Part I:	For Part I: | 1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period | For Part II : | 1. 28 days post completion of a 3 dose primary vaccination series.
1. Occurrence of local and systemic solicited and unsolicited adverse events.	For Part I: | 1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period | For Part II : | 1. 28 days post completion of a 3 dose primary vaccination series.
For Part II :	For Part I: | 1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period | For Part II : | 1. 28 days post completion of a 3 dose primary vaccination series.
1. Percentage of infants achieving seroprotection/seroconversion after 3 dose primary vaccination	For Part I: | 1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period | For Part II : | 1. 28 days post completion of a 3 dose primary vaccination series.
series.	For Part I: | 1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period | For Part II : | 1. 28 days post completion of a 3 dose primary vaccination series.

Secondary Outcome Measures

Name	Time	Method
For Part I : Immunogenicity (Seroprotection/seroresponse rates and GMCs/GMTs)	For Part II : 1. Safety after each study vaccination 2. Immunogenicity w.r.t. Geometric Mean Titre/Concentration (GMT/GMC)

Trial Locations

Locations (11)

Baramati Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Bharti Vidyapeeth Deemed University Medical college and Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Government Medical College and Hospital; 🇮🇳 Chandrapur, MAHARASHTRA, India

Institute of Child Health; 🇮🇳 Kolkata, WEST BENGAL, India

JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

KEM Hospital Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

KLEs Dr Prabhakar Kore Hospital and Medical research Centre; 🇮🇳 Belgaum, KARNATAKA, India

LifePoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Niloufer Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Postgraduate Institute, Yashwantrao Chavan Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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Baramati Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Bhaskar Jedhe deshmukh

Principal investigator

9822402772

bhaskar.jedhe@gmail.com