A clinical trial to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine DTwP-Hib-HepB in Indian infants

A Ph III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem (DTwP-Hib-HepB Vaccine) when Administered to Indian Infants at 6, 10, and 14 Weeks of Age

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002118

Enrollment

175

Registered

2011-11-11

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

None listed

Interventions

Intervention1: Quinvaxem vaccine: 3 doses of 0.5ml at 6, 10,14 weeks of age. Route of administration Intramuscular Control Intervention1: Not applicable: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: Healthy infants without any contradictions to receive investigational vaccine

Exclusion criteria

Exclusion criteria: 1.Parents unwilling or unable to provide written informed consent 2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine. 3.Known hypersensitivity or allergic reactions after previous vaccinations 4.Presence of any significant medical condition

Design outcomes

Primary

Measure	Time frame
Immunogenicity Endpoints: Seroprotection rates one month after the last dose of vaccine administrationTimepoint: one month after the third study injection	—

Secondary

Measure	Time frame
GMCs one month after last dose of vaccine administrationTimepoint: one month after the third study injection;Safety Endpoints: Safety and TolerabilityTimepoint: after vaccination	—

Countries

India

Contacts

Public ContactDr Rekha J

Novartis Healthcare Pvt Ltd

hoshang.vakil@novartis.com912266930860

Outcome results