Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age

This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Hemophilus Influenzae B Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Virus Diseases Whooping Cough

Age range

42 day–64 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rajarajeshwari Medical College and Hospital, Bangalore, Karnataka, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female subjects ≥ 42 days to ≤ 64 days of age.
Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements

Exclusion criteria

Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
Administration of parenteral immunoglobulin preparation and/or blood products since birth.

Treatment and study plan

DTwP-HepB-Hib Vaccine

Biological

Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.

Primary outcomes

Seroprotection rate one month after the last dose of vaccine administration

Time frame: One month after last vaccination

Secondary outcomes

Seroprotection rate and GMCs one month after the last vaccine administration

Time frame: One month after last vaccination

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 11, 2011
Registry last updated: May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed