A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00551629
First received: October 29, 2007
Last updated: April 30, 2013
Last verified: October 2007
  Purpose

A study to evaluate the safety and efficacy of an investigational combination vaccine in infants.

This is an early phase trial and some specific protocol information is in process and not publicly available at this time. (Full information is available to trial participants).


Condition Intervention Phase
Hepatitis B
Biological: V419
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Study Start Date: May 2001
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants 2 months of age who have not received prior vaccinations for hepatitis, Diptheria, Polio, Pertussis (DPT)

Exclusion Criteria :

  • History of HIV, seizures, sensitive to vaccines, elevated temperature (greater than or equal to 100 degrees F)
  • Have previously received any immune globulin, blood, or blood product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551629

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00551629     History of Changes
Other Study ID Numbers: 2007_580
Study First Received: October 29, 2007
Last Updated: April 30, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 28, 2014