A post licensure clinical trial to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five) administered to healthy Indian infants in comparison with a licensed Pentavac SD™ vaccine available in Indian market

Phase 4

Completed

• Conditions: Preventive protection against Diphtheria, Tetanus, Petussis, Hepatitis-B and Haemophilus Influenzae type B diseases; Encounter for immunization,

• Registration Number: CTRI/2011/04/001681
• Lead Sponsor: Biological ELimited

Brief Summary

A multicentric, single blind, parallel, randomized, phase-IV non-inferiority study to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy Indian infants at 6-10-14 weeks  schedule in comparison with a marketed SIIL’s Pentavac SD™ vaccine. This study to be conducted at 08 study sites.All the study sites will be located in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. There will be a total of 408 healthy subjects of either sex randomised into two groups in 2:1 ratio.

The primary outcome measure is to evaluate non-inferiority of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine with SIIL’s Pentavac SD™  in terms of difference in proportion of subjects achieving seroprotection with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres at day 84.

xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /The secondary outcome measures are to a) compare proportion of subjects achieving fold rise in anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres, above the seroprotection cut off value, between BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine and Pentavac SD™  at  Day 84; b) To compare immunogenicity in terms of GMTs for anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres of BE’s combined pentavalent DTwP-rHepB-HIB vaccine  with that of Pentavac SD™ at 84; c) To assess the safety and tolerability of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine in comparison with Pentavac SD™ for the entire study period of 84 days after the first vaccination.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-19
• Study Completion: 2011-09-13
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

• Healthy infants between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) of either gender at the time of 1st vaccination.
• Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian.
• Healthy infants with weight equal to or more than 3300 gms at the time of screening.
• Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.
• Infants or their mothers not participating in any other clinical trials.
• Infants without contraindications or precautionary circumstances for participating in the trial Ability of the infants parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.

Exclusion Criteria

• Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral &/or Inactivated polio vaccine.
• Current illness (especially fever) or any acute or congenital illness or disability.
• Subjects receiving immunosuppressive therapy.
• Known or suspected allergy to any of the vaccine components.
• Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS).
• Known family history of SIDS (Sudden Infant Death Syndrome).
• Planned or elective surgery during the course of the study.
• Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
• Subjects and their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
• Inability or unwillingness to abide by the requirements of the protocol.
• Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Seroprotection rates (SPR) as defined by percentage of subjects with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres above their seroprotective cut off values.	1.At Day 84.

Secondary Outcome Measures

Name	Time	Method
1.Proportion of subjects achieving 4-fold rise in antibody titres.	2.Geometric mean titres(GMTs)estimation.

Trial Locations

Locations (8)

Cheluvamba Hospital; 🇮🇳 Mysore, KARNATAKA, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

JSS Medical college; 🇮🇳 Mysore, KARNATAKA, India

K.C General Hospital; 🇮🇳 Bangalore, KARNATAKA, India

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

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Mahatma Gandhi institute of Medical Sciences; 🇮🇳 Wardha, MAHARASHTRA, India

Oyster and Pearl Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Cheluvamba Hospital

🇮🇳Mysore, KARNATAKA, India

DrBKrishna Murthy

Principal investigator

0944805007

bkm6@rediffmail.com