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

Novartis

Status and phase: Completed; Phase 3

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

Treatments: Biological: DTwP-HepB-Hib Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470287

V66_05

Details and patient eligibility

About

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

Enrollment: 175 patients

Sex: All

Ages: 42 to 64 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and female subjects ≥ 42 days to ≤ 64 days of age.
2. 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

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Biological: DTwP-HepB-Hib Vaccine