Safety Study of ProQuad® rHA in Infants (V221-037)

NCT00560755 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V221-037MRV01C2007-002438-12
• Study Type: interventional
• Target: 3,388
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life. Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.

Conditions

Measles; Mumps; Rubella; Varicella

Keywords

Prevention of: measles, mumps, rubella and varicella

Outcome Measures

Primary Outcomes (11)

• Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2

  The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2

  The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2

  The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.

  Up to Day 46 (for 4 days following ProQuad® Dose 2)

• Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2

  The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2

  Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2

  Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2

  Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2

  Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2

  The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.

  Up to Day 70 (up to 28 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2

  Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.

  Up to Day 84 (up to 42 days after ProQuad® Dose 2)

• Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2

  Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.

  Up to Day 84 (up to 42 days after ProQuad® Dose 2)

Secondary Outcomes (4)

• Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1

  From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)

• Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1

  Up to Day 28 (28 days after ProQuad® Dose 1)

• Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1

  Up to Day 28 (28 days after ProQuad® Dose 1)

• Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1

  Up to Day 28 (28 days after ProQuad® Dose 1)

Study Arms (1)

ProQuad®

EXPERIMENTAL

Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.

Biological: ProQuad®

Interventions

ProQuad® BIOLOGICAL

ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.

ProQuad®

Eligibility Criteria

• Age: 12 Months - 22 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy subject of either gender,
• Age from 12 to 22 months,
• Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
• Informed consent form signed by the parent(s) or by legal representative
• Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures

You may not qualify if:

• Recent (≤ 3 days) history of febrile illness
• Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
• Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
• Prior known sensitivity/allergy to any component of the vaccine
• Severe chronic disease,
• Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• Humoral or cellular immunodeficiency,
• Current immunosuppressive therapy
• Family history of congenital or hereditary immunodeficiency
• Hereditary problems of fructose intolerance
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
• Known active tuberculosis
• Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
• Receipt of immunoglobulins or blood-derived products in the past 150 days

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ruger G, Gabutti G, Rumke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Hogh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M. Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b.

  PMID: 22772170 DERIVED

MeSH Terms

Conditions

Measles; Mumps; Rubella; Chickenpox

Interventions

measles, mumps, rubella, varicella 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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Anne FIQUET, MD

  MCM Vaccines B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 19, 2007
• First Posted: November 20, 2007
• Study Start: October 24, 2007
• Primary Completion: November 24, 2008
• Study Completion: November 24, 2008
• Last Updated: October 17, 2017
• Results First Posted: October 17, 2017

Record last verified: 2017-09