Immune Responses to Two Dose Varivax +/- MMR-II

NCT00258726 | Terminated Phase 1

• 1 other identifier: 04-073
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety and how well the body's immune system responds to a live, but weakened varicella (chickenpox) vaccine, known as Varivax, given with and without ProQuad, another measles, mumps, rubella, and varicella virus vaccine (MMR-II). One hundred five healthy children will be enrolled in the study when they are 12 months old. All subjects will be vaccinated at 12 months of age and some subjects will receive a second vaccination at 18 months of age. All subjects will participate for 1 year. This study is a single-site, two-year trial with post-licensure vaccines.

Conditions

Measles; Mumps; Rubella; Varicella

Keywords

Measels, Mumps, Varicella, Rubella, vaccine, children

Interventions

MMR-II BIOLOGICAL

Pro-Quad BIOLOGICAL

Varivax BIOLOGICAL

Eligibility Criteria

• Age: 12 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 12 months (+ 4 weeks) of age.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study. This includes all chronic health problems and immunodeficiencies.
• Parent/legal guardian has provided signed, written informed consent.
• Parent/legal guardian expected to be available for entire study.
• Parent/legal guardian can be reached by telephone.

You may not qualify if:

• Former premature infants (\<36 weeks).
• Birth weight \< 2500 grams.
• Significant underlying chronic illness.
• Immunodeficiency disease or use of immunosuppressive therapy by the participant.
• Any other condition that in the clinical judgment of the investigator might interfere with vaccine evaluation.
• Allergy to any components of the vaccine, including anaphylaxis or anaphylaxoid reaction to neomycin or eggs for MMR-II, and/or hypersensitivity to gelatin and anaphylaxis or anaphylaxoid reaction to neomycin for Varivax.
• Plans for participation in another clinical trial with an investigational drug or vaccine for the duration of this study.
• Blood products within 3 months prior to initial enrollment.
• Previous receipt of MMR and Varivax or ProQuad.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Measles; Mumps; Rubella; Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 28, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 27, 2010

Record last verified: 2010-04

Locations

US (1)