A clinical study to evaluate safety and compare immune responses of two formulations of a combined 5-in-1 DTwP-HepB-Hib vaccine in children

Phase 3

Completed

• Conditions: Vaccination for the prevention of tetanus, diphtheria, pertussis (whooping cough), hepatitis B (Hep B) and invasive Haemophilus influenzae type b (Hib) diseases.

• Registration Number: CTRI/2018/12/016692
• Lead Sponsor: Shantha Biotechnics Pvt Ltd

Brief Summary

This will be a multi-center, randomized, active controlled, two arm, observer blind study in 460 infants followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed vaccine formulation of SHAN 5® at 6-8, 10-12 and 14-16 weeks of age. Followed by single arm, open label study in the subjects upon attaining 12-24 months of age followed up for safety and immunogenicity for 28 days after administration of single booster dose of the investigational vaccine formulation of SHAN 5®.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-28
• Study Completion: 2021-02-13
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• For Infants (Stage 1): 1.Infants between 6-8 weeks of age on the day of enrollment.
• 2.Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2.5 kg 3.Informed consent form signed by the parent or by the legally acceptable representative (LAR).
• 4.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
• For Toddlers (Stage 2): 1.Toddlers aged between 12-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5® vaccine formulation at 6-8, 10-12 and 14-16 weeks of age during stage 1 of the trial.
• 2.Informed consent form signed by the parent or by the LAR.

Exclusion Criteria

• Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period 2.Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
• 3.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV.
• 4.For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
• 5.For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
• 6.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
• 7.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long-term systemic corticosteroid therapy.
• 8.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections.
• 9.Known personal or maternal history of HIV or hepatitis B seropositivity.
• 10.Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
• 11.Known thrombocytopenia.
• 12.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
• 13.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
• 14.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness on the day of inclusion.
• 15.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
• 16.Subject with definite seizure disorder and getting anticonvulsant therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity in terms of Hep B seroprotection rate and pertussis immune responses	Baseline; 28 days after Dose-3 in infants

Secondary Outcome Measures

Name	Time	Method
Immunogenicity in terms of Seroprotection/seroresponse rates/GMCs for D,T,wP,HepB and Hib antigens	Baseline; 28 days post Dose-3 in infants and 28 days after single dose in toddlers
Safety after each and after any study vaccine dose, as applicable.	Immediate adverse events within 30 min, Solicited reactions within 7 days and Unsolicited Events within 28 days of vaccination.

Trial Locations

Locations (10)

Dhiraj General Hospital; 🇮🇳 Vadodara, GUJARAT, India

Acharya Vinoba Bhave Rural Hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Cheluvamba Hospital; 🇮🇳 Mysore, KARNATAKA, India

Christian Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Government Victoria Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Kalinga Institute of Medical Sciences (KIMS); 🇮🇳 Khordha, ORISSA, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

KLES Dr. Prabhakar Kore Hospital & Medical Research Center; 🇮🇳 Belgaum, KARNATAKA, India

Prakhar Hospital Pvt Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

SRM Medical College Hospital & Research Center (SRMCH); 🇮🇳 Chennai, TAMIL NADU, India

Dhiraj General Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Prasad Muley

Principal investigator

9825282700

djg_48@yahoo.co.in