A clinical trial to observe the safety and reactogenicity of pentavalent vaccine, after reconstitution of freeze dried HIB Vaccine with DTwP-rHepB liquid vaccine, before administration.

A multicentric open label non-comparative phase-IV observational study to evaluate safety and reactogenicity of BEs reconstituted Pentavalent DTwPrHepB/HIB vaccine in 6-8 week old healthy infants as per routine EPI Immunization Schedule - None

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/000649

Enrollment

640

Registered

2010-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Reconstituted Pentavalent DTwPrHepB/HIB vaccine of BE Limited: 0.5ml/dose administered i.m. at 6-10-14 weeks EPI Schedule Control Intervention1: None: None

Eligibility

Inclusion criteria

Inclusion criteria: 1) Healthy subjects of either sex in the age group of 6-8 weeks at the time of 1st vaccination. 2) Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature). 3) Written informed consent obtained prior to screening from subject?s parent or legally acceptable representative/guardian. 4) Healthy infants with weight >= 3300 gms at the time of screening. 5) Ability of the subject?s parent or legally acceptable representative/guardian to understand and comply with the requirements of the subject diary.

Exclusion criteria

Exclusion criteria: 1) Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral polio vaccine. 2) Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period Or preceding the first dose of the study vaccine. 3) Known or suspected allergy to any of the vaccine components. 4) Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.

Design outcomes

Primary

Measure	Time frame
A) Proportion of solicited and unsolicited adverse events (AEs) B) Proportion of solicited and unsolicited local and systemic adverse events (AEs) C) Proportion of solicited and unsolicited adverse events (AEs) D) Proportion of subjects with serious and/or unexpected adverse events E) Rate of SAEs and medically attended AEs.Timepoint: A)during first 30 minutes of vaccine administration B) during 7-day (Day 0-6) post vaccination period, captured through subject diary.C) during the subsequent follow up period up to 28th day after each vaccination D) during the entire course of the study period E) until day 84 after the first vaccination.	—

Measure

Time frame

A) Proportion of solicited and unsolicited adverse events (AEs) B) Proportion of solicited and unsolicited local and systemic adverse events (AEs) C) Proportion of solicited and unsolicited adverse events (AEs) D) Proportion of subjects with serious and/or unexpected adverse events E) Rate of SAEs and medically attended AEs.Timepoint: A)during first 30 minutes of vaccine administration B) during 7-day (Day 0-6) post vaccination period, captured through subject diary.C) during the subsequent follow up period up to 28th day after each vaccination D) during the entire course of the study period E) until day 84 after the first vaccination.

—

Secondary

Measure	Time frame
Clinically significant changes in vital signs (Pulse, axillary body temperature and Respiratory rate)Timepoint: From baseline (0 day) to Day 28, Day 56 and Day 84.	—

Countries

India

Contacts

Public ContactMr Pawan Bhusari

Biological E. Limited

kishore.tsa@biologicale.co.in914030214046

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026