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

NCT01470287 | Completed Phase 3

• 1 other identifier: V66_05
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Hemophilus Influenzae B

Keywords

Infants,; Immunogenicity,; Safety

Outcome Measures

Primary Outcomes (1)

• Seroprotection rate one month after the last dose of vaccine administration

  One month after last vaccination

Secondary Outcomes (1)

• Seroprotection rate and GMCs one month after the last vaccine administration

  One month after last vaccination

Study Arms (1)

Arm 1

EXPERIMENTAL

Biological: DTwP-HepB-Hib Vaccine

Interventions

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.

Arm 1

Eligibility Criteria

• Age: 42 Days - 64 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

Rajarajeshwari Medical College and Hospital

Bangalore, Karnataka, India

Location

Bharathi Vidyapeeth University

Pune, Maharashtra, India

Location

Medical College Kolkata

Kolkata, West Bengal, India

Location

Related Publications (1)

• Eregowda A, Lalwani S, Chatterjee S, Vakil H, Ahmed K, Costantini M, Lattanzi M. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants. Hum Vaccin Immunother. 2013 Sep;9(9):1903-9. doi: 10.4161/hv.25166. Epub 2013 Jun 19.

  PMID: 23783081 DERIVED

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B

Interventions

DtwP-HepB-Hib vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

IN (3)