V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

Measles Clinical Trial

Official title:

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109343
• Other study ID #: V221-019
• Secondary ID: 2005_027
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2005
• Last updated: February 11, 2015
• Start date: March 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1027
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 15 Months

Eligibility

Inclusion Criteria:

• In good health

• 12 to 15 months of age

• Negative clinical history to measles, mumps, rubella, varicella and/or zoster

• Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines

• Signed consent

Exclusion Criteria:

• Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination

• Any condition resulting in depressed immunity

• Any allergy to any vaccine component as stated in the package circulars

• Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination

• History of seizure disorder

• Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days

• Recent febrile illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• Comparator: ProQuad™ (V221)
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
• Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schödel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 4		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 6B		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 9V		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 14		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 18C		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 19F		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Other	Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 23F		6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Primary	Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer =255 mIU/mL	Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	Yes
Primary	Number of Participants With Postvaccination Mumps ELISA Antibody Titer =10 Ab Units/mL	Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	No
Primary	Number of Participants With Postvaccination Rubella ELISA Antibody Titer =10 IU/mL	Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	No
Primary	Number of Participants With Postvaccination Varicella Antibody Titer =1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and =5 gpELISA Units/mL	Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone	No
Primary	Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Primary	Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.	No
Primary	Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Primary	Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Primary	Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Primary	Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No
Primary	Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F	6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site