Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem® when Administered to Indian Infants at 6, 10, and 14 Weeks of Age

• Conditions: Prophilaxis against diphtheria, tetanus, pertussis, hepatitis B and invasive Haemophilus influenzae type b disease.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005309-18-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-10
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 175

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
3.Subjects in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator
4.Available for all scheduled study visits

Are the trial subjects under 18? yes
Number of subjects for this age range: 175
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
4.Known or suspected impairment of immune function, known HIV positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed)
5.Administration of parenteral immunoglobulin preparation and/or blood products since birth
6.Planned administration of a vaccine not foreseen by the study protocol
7.Significant acute infection
8.Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
9.Subject meeting with a nutritional status grades of I - IV according to the Indian Academy of Pediatrics (IAP) grading of nutritional status.
10.Participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified